Randomized Trial of KEEP-P, a Preventive Intervention for Foster Preschoolers
Phase: NA
Conditions: Child Behavior
Sponsor: University of Oregon

 
Randomized Trial of KEEP-P, a Preventive Intervention for 
Foster Preschoolers (KEEP-P) 
 
 
NCT03106636 
 
June 2, 2020 

Table of Contents 
1. STATISTICAL ANALYSIS PLAN APPROVAL SIGNATURES .................................................................1 
Revision History .................................................................................................................................................... 1 
2. ABBREVIATIONS .........................................................................................................................1 
3. INTRODUCTION ..........................................................................................................................2 
4. STUDY OBJECTIVES .....................................................................................................................3 
Primary Objective ..........................................................................................................................3 
Secondary Objective ............................................................................................................................................. 3 
5. STUDY DESIGN ...........................................................................................................................3 
6. TREATMENTS .............................................................................................................................7 
7. SAMPLE SIZE JUSTIFICATION .......................................................................................................9 
8. DEFINITION OF ANALYSIS POPULATIONS .....................................................................................9 
Analysis Sets/Populations/Subgroups .................................................................................................................. 9 
9. STATISTICAL METHODOLOGY......................................................................................................9 
General..........................................................................................................................................9 
10. INTERIM ANALYSES ................................................................................................................ 11 
11. DATA PRESENTATION ............................................................................................................. 11 
Tables .................................................................................................................................................................. 11 
12. Data & Results ........................................................................................................................ 13 
13. Institutional Review Board (IRB) Protocol Documents ............................................................. 15 
14. Informed Consent Forms ........................................................................................................ 15 
 
1. STATISTICAL ANALYSIS PLAN APPROVAL SIGNATURES 
 
Revision History 
 
Version 1: 4/30/2020 
Version 2: 6/2/2020 
 
2. ABBREVIATIONS 
 
DD 
 
Developmental Disabilities 
PMT 
 
Parenting Management Training 
FIND  
Filming Interaction to Nurture Development 
KEEP-P  
Keeping Parents Supported and Trained – Preschool 
KEEP-P+ 
Keeping Parents Supported and Trained – Preschool + FIND  
EF 
 
Executive Function 

ANOVA 
Analysis of variance 
T1 
 
Time 1 
T2 
 
Time 2 
PSI 
 
Parenting Stress Index 
PSOC  
Parenting Sense of Competency Scale 
FRQ 
 
Family Routines Questionnaire 
ADRY  
Parent Attachment Diary 
IEMP  
Interpersonal Mindfulness in Parenting 
CBCL  
Child Behavior Checklist 
PKBS  
Preschool and Kindergarten Behavior Scales 
PDR 
 
Parent Daily Report 
ASQ 
 
Ages and Stages Questionnaire 
DCCS  
Dimensional Change Card Sort 
KRISP  
Kansas Reflection-Impulsivity Scale for Preschoolers 
 
3. INTRODUCTION 
 
During the transition into school, children encounter a range of developmental challenges 
which impose significant social and cognitive demands. Emotional and behavioral self-
regulation is critical to successful school adjustment. This transition may be particularly 
challenging for children with emerging developmental delays or disabilities (e.g., autism, 
intellectual disability) who experience more self-regulation difficulties and problem behaviors 
than typically-developing children. Early intervention is critical to minimize negative outcomes, 
and there is evidence to suggest that consistent, supportive parenting practices is effective for 
children with developmental disabilities (DD), particularly for promoting self-regulatory abilities 
and managing problem behaviors (Roberts, Mazzucchelli, Studman, Sanders, 2006). Given the 
importance of regulatory skills during the transition to school, parenting may be an early, 
malleable target to support school readiness and improve behavioral, emotional, and cognitive 
outcomes, especially for children with DD.  
 
Parenting management training (PMT) programs have been implemented extensively with 
parents of typically developing children to improve behavior problems and promote positive 
adjustment (Kazdin, 2005). Keeping Parents Supported and Trained (KEEP) is a PMT Oregon 
model originally developed for supporting parents of foster children. It has been consistently 
effective in improving child and parent outcomes, including reduced behavior problems and 
associated parenting stress (Chamberlain & Reid, 1987; Chamberlain, 2002; Chamberlain, 2008; 
Price & Walsh, 2015; Price, Roesch, & Walsh, 2012). Filming Interactions to Nurture 
Development (FIND) is a video-coaching method which aims to increase the frequency of 
developmentally supportive interactions by showing parents instances of themselves engaging 
in such behaviors. It has been shown useful in enhancing child-supportive parenting which 
consequently reduces children’s problem behaviors and improves parenting stress and 
competence (Fisher et al., 2016). Although PMT programs are well-validated, there is increasing 
interest in integrating traditional PMT models, which can focus on skill deficits, with models 
that emphasize and potentiate parenting strengths and capabilities.  

 
The Keeping Parents Supported and Trained – Preschool (KEEP-P) study introduced a variation 
of the KEEP intervention model which included the strengths-based video-coaching methods of 
FIND. With participating families randomly assigned to either the KEEP-P program or the KEEP-P 
+ FIND (KEEP-P+) program, the study was a randomized control trial that compared the efficacy 
of the two varied models of KEEP in children with DD. The study used a two-group 
(experimental and active control) mixed design that examined repeated measures, but was not 
factorial. Institutional review board (IRB) approval was obtained from the University of Oregon, 
and the trial is registered with Clinical Trials.gov (NCT03106636). 
 
 
4. STUDY OBJECTIVES 
 
Primary Objective 
 
The primary objective of the study is to examine and compare the efficacy of a traditional KEEP 
parenting management training intervention (KEEP-P) with a variation of the KEEP model (KEEP-
P+) on a range of both child and parent outcomes, specifically in families with children with DD. 
We hypothesize that the addition of the video coaching in the KEEP-P+ condition will result in 
significantly enhanced socioemotional functioning, executive function (EF), and longer-term 
educational outcomes (i.e., KEEP-P+ > KEEP-P). 
 
As the title describes, the project began as a study on foster preschoolers. However, due to a 
number of practical and logistical problems that led to low recruitment numbers, the 
investigative team added recruitment through early intervention/early childhood special 
education service providers with approval from NICHD. The EI/ECSE population has 
considerable overlap with the foster care population in terms of high risk for poor outcomes 
and negative life course trajectories. While analyzing the study’s results, the investigative team 
found that 1) The EI/ECSE sample made up the vast majority of the total sample and 2) The 
effects and baseline scores differed greatly between EI/ECSE and DHS. Because of this, it was 
decided that the published results from this study would be of the EI/ECSE participants only. 
 
Secondary Objective 
 
The secondary objective of the study is to examine associations between sociodemographic 
covariates and change-over-time outcome variables, including the 12- and 18-month post-
baseline outcomes. At the time of this report, only the pre- and post-intervention data has been 
analyzed. 
 
 
 
5. STUDY DESIGN  
 

Conceptual Model. The conceptual model for the proposed research is shown in Figure 1 
(below). This model has guided our program of research involving foster preschoolers for over a 
decade. The foundation of the model (replicated in many of our prior experimental studies) is 
that parenting is a central mediating mechanism of interventions to improve child adjustment. 
Specifically, the parenting variables that have proven most malleable and most strongly 
associated with child outcomes include the use of positive reinforcement techniques and non-
harsh discipline and reducing parent stress associated with child behavior problems. As 
illustrated in Figure 1, we hypothesize that KEEP-P and KEEP-P+ will produce significant main 
effects in terms of immediate and longer-term child outcomes in placement stability and 
behavioral adjustment. We hypothesize that these intervention effects will be mediated 
through targeted parenting variables. We further hypothesize that additional direct 
intervention effects will be observed for the KEEP-P+ children regarding socioemotional 
adjustment, early literacy, and EF, which will in turn mediate longer-term educational 
outcomes. The conceptual model also includes a number of observed child characteristics as 
control variables, including child demographics, and intervention dosage and fidelity as well as 
foster placement history from Child Welfare records, which might influence intervention 
effects.  
 
 
Data Collection Procedures. Interviews were conducted at the University of Oregon in the 
Stress Neurobiology and Prevention (SNAP) assessment space. Caregivers and their children 
completed a 90 minutes assessment prior to the start of any intervention activities [Time 1 (T1)] 
and following the intervention [Time 2 (T2)]. Children completed standardized tests and various 
tabletop tasks, and parents completed semi-structured interviews and questionnaires. 
Caregivers were compensated $50 for completing each wave of data collection. Families also 
received assistance with transportation and childcare costs to facilitate participation.  
 
 
Caregiver and child measures. The assessment strategy used a multiagent, multimethod 
approach aimed at minimizing measurement bias and error. To measure immediate and longer-
term child outcomes, we assessed attachment behavior, internalizing and externalizing 
symptoms, behavioral and socioemotional adjustment, and cognitive function. For parenting 

outcomes, we measured parenting self-efficacy, parenting stress, and mindfulness in parenting. 
Control variables (e.g., demographics and intervention fidelity/dosage) was assessed. The 
measures were selected based on their psychometric properties, utility in defining the 
constructs of interest, and relevance to the proposed study. All measures have acceptable 
reliability and validity information on psychometric characteristics.  
 
Table of Measures Included in Current Analyses. 
 
Domain 
Measures 
Measure Description 
Variable 
Time 
Administered 
Child and 
Parent 
Characteristics 
Family demographics 
and characteristics 
Parent-report 
Basic 
Demographic 
Info 
Baseline (T1) 
Parenting 
Constructs 
Parenting Stress Index 
(PSI) Short Form 
Parent-report, 36-item, 5-
point Likert scale from 
strongly agree to strongly 
disagree 
Parenting stress 
Baseline (T1) 
& Post-
intervention 
(T2) 
Parenting Sense 
of Competency 
Scale (PSOC) 
Modified version, parent-
report, 17-item, 4-point Likert 
scale from strongly agree to 
strongly disagree 
Parenting self-
efficacy 
Parenting 
Interactions with 
Children: 
Checklist of 
Observations 
Linked to 
Outcomes 
(PICCOLO) 
Observational video coding 
measure 
 
Developmentally-
supportive 
parenting across 
four domains: 
affection, 
responsiveness, 
encouragement, 
and teaching 
Family Routines 
Questionnaire 
(FRQ) 
Modified version, parent-
report, 28-item, measure both 
the frequency and rated 
importance of family routines, 
only scores of Frequency of 
Routines are calculated and 
included in the analysis 
Frequency of 
family routines 
Interpersonal 
Mindfulness in 
Parenting (IEMP) 
Modified version, parent-
report, 10-item, yield scores 
on three subscales: Awareness 
and Present-Centered 
Mindful 
parenting 

Attention, Non-Judgment, and 
Non-reactivity 
 
Parent 
Attachment 
Diary (ADRY) 
Parent-report, on child’s 
reactions to three distressing 
incidents that are commonly 
experienced on a daily basis 
Child attachment 
Child Mental 
Health and 
Behavior 
Child Behavior 
Checklist (CBCL) 
Parent-report, 100-item, 3-
point Likert scale (0 = not 
true, 1 = 
somewhat/sometimes true, 3 
= very/often true), generates 
scores on 9 psychopathology 
subscales 
Child 
internalizing and 
externalizing 
symptoms 
Preschool and 
Kindergarten Behavior 
Scales (PKBS) 
Parent-report, 76-item, 4-
point Likert scale (0 = never; 
1 = rarely; 2 = sometimes; 3 = 
often) 
Child behavior 
problems and 
social skills 
Parent Daily Report 
(PDR) 
Parent-report, 31-item, 
administered via telephone, 
parents were asked to indicate 
whether the listed behaviors 
occurred and rated the degree 
of stress related to the 
behavior using a 3-point 
Likert scale (0 = not at all; 1 = 
somewhat/a little; 2 = quite a 
lot) 
Child behavior 
problems and 
associated 
parental stress 
occurring in the 
past 24 hours 
Three times 
Baseline (T1) 
& Three 
times Post-
intervention 
(T2) 
Child 
Cognitive 
Function and 
Development 
Ages and Stages 
Questionnaire (ASQ) 
Parent-report, has 5 different 
versions for children age from 
24-26 months/27-32 
months/33-41 months/42-53 
months/54-65 months 
Child skills 
across five 
developmental 
areas: 
communication, 
fine motor, gross 
motor, problem-
solving, and 
personal-social 
Baseline (T1) 
& Post-
intervention 
(T2) 
Dimensional Change 
Card Sort (DCCS) 
Tabletop tasks measuring 
child executive function 
Child executive 
function 
Bear/Dragon Task 

Kansas Reflection-
Impulsivity Scale for 
Preschoolers (KRISP) 
Delay Choice 
Paradigm 
Spin the Pots 
Silly Animal 
Categories 
 
 
6. TREATMENTS 
 
KEEP-P: caregiver support groups. The KEEP-P caregiver support groups employ a manualized 
12-session, weekly curriculum for foster, kinship, and biological caregivers. Curriculum topics 
comprise areas that have been found in previous studies to be malleable targets for change. 
The primary focus is on increasing the use of positive reinforcement and the consistent use of 
non-harsh discipline methods, such as redirection and brief timeouts. In addition, strategies for 
avoiding power struggles, reducing caregiver stress, and improving success at school are 
included. Each weekly 2 hour session is structured so that the curriculum content is integrated 
into group discussions, and primary concepts are illustrated via role-play. The 2-hour length is 
optimal to allow for the combination of curriculum content delivery and mutual support to 
occur. Home practice assignments are given weekly and relate to the topics covered during 
sessions to assist parents in implementing the behavioral procedures taught. If  parents miss a 
group session, the material is delivered via a home visit. Home visits have been found to be an 
effective means of increasing the dosage of the intervention for families in such cases. Finally, 
the participants are telephoned weekly by the facilitator. They troubleshoot any problems the 
caregiver is having in implementing the assignment and collect information about behavior 
problems and caregiver stress in the past 24 hours via a behavior checklist: Parent Daily Report. 
The facilitator can then discuss  these data at the next group meeting as a means for illustrating 
concepts and providing support. In prior research on the KEEP program for older children, as 
well as in our pilot testing of KEEP-P, these activities were not overly burdensome for 
caregivers, as indicated by the high rates of participation previously noted.  
The curriculum is designed to be delivered by well-trained and supervised paraprofessionals, 
who videotape each group meeting and receive weekly supervision to ensure that the program 
is delivered as intended (see section on fidelity below). Our prior research demonstrating the 
efficacy of the original KEEP program also employed paraprofessionals. Although others have 
questioned the use of paraprofessional intervention staff, we have found it to be an efficient 
and effective way to deliver services in this population that increases the scalability of an 
intervention.  
 

KEEP-P + FIND: caregiver support groups plus video coaching component. The KEEP-P + FIND 
condition was called KEEP-Video for our project participants. This group completed the KEEP-P 
curriculum as above, with the addition of information about recent findings in early brain 
development and the elements of the FIND video coaching program. The FIND video coaching 
program was designed for parents and other caregivers of high-risk children. The program 
employs video of caregivers’ natural interactions with their child to show ways that they are 
supporting children’s healthy development.  It is a simple and practical approach that 
emphasizes caregivers’ strengths and capabilities. The video coaching program has been 
implemented in both individual and group settings. It begins with video recordings of a 
caregiver and child in their home or other natural setting. The film is carefully edited to show 
brief clips in which the caregiver is engaged in developmentally supportive interactions with the 
child. At a group coaching session, a Coach reviews the edited clips in detail with the caregivers.  
To cover the core concepts and elements, the Coach will review 5 sets of films with the 
caregivers, as well as videos developed at the Harvard Center on the Developing Child on the 
concept of “Serve and Return” and toxic stress. The KEEP-P + FIND component utilizes serve 
and return as the framework within which developmentally supportive interactions are 
identified. A serve occurs when a child initiates an interaction using words or gestures, or by 
focusing their attention on something or someone. The serve is returned when the caregiver 
notices and responds. Within this context, 5 specific elements of serve and return are 
emphasized, with an element introduced within the KEEP-P session, followed by a coaching 
session showing video clips from each member of the group. The five FIND elements are: 
• Sharing the Child’s Focus: This occurs when the adult identifies or notices what the child 
is interested in and then puts his/her attention there as well. 
• Supporting and Encouraging: Having noticed the child’s focus of attention, the adult 
responds in a supportive and/or positive way, adding his or her own reaction by giving 
the child further information about or acknowledging what he/she is seeing, doing, or 
feeling.  
• Naming: An extension of the Supporting and Encouraging element, Naming occurs when 
the caregiver uses words to label what the child is seeing, doing, or feeling.  
• Back & Forth Interaction: After the child has “served” and the caregiver noticed and 
returned the serve by Supporting and Encouraging or Naming, the interaction continues. 
The interaction goes back and forth between child and adult, with the adult waiting for 
the child’s further initiations. 
• Endings and Beginnings: This occurs when a Back and Forth interaction between child 
and caregiver ends and a new serve and return interaction begins. The end of the back 
and forth interaction is signaled by the child or the episode naturally comes to its 
conclusion (e.g., the book is finished).  
Both the KEEP-P and KEEP-P + FIND curriculums are designed to be delivered by well-trained 
and supervised paraprofessionals, who videotape each group meeting and receive weekly 
supervision to ensure that the program is delivered as intended. Our prior research 
demonstrating the efficacy of the original KEEP program also employed paraprofessionals. 
Although others have questioned the use of paraprofessional intervention staff, we have found 
it to be an efficient and effective way to deliver services in this population that increases the 
scalability of an intervention.  

 
Fidelity Monitoring and Dosage. All caregiver groups are videotaped and coded for fidelity. 
Caregiver group fidelity were measured using the Facilitator Adherence Ratings. This 14-item 
rating scale measures adherence to fidelity on three domains: content (e.g., “caregivers were 
encouraged to/or used a behavioral management system”), process (e.g., “The facilitator did 
not make critical or corrective comments”), and structure (e.g., “Facilitator managed meeting 
time well”). Research assistants, who were trained in the intervention model and did not 
participate in the delivery of the intervention, completed the ratings evaluating adherence on a 
5-point scale (1 [not at all] to 5 [very much]), resulting in a summary score for each domain. We 
also assessed dosage via measures of participation in intervention activities. We tracked session 
attendance and recorded when missed sessions are delivered via home visit. Fidelity and 
dosage measures were included in analyses of intervention effectiveness.  
 
 
7. SAMPLE SIZE JUSTIFICATION 
 
To investigate the extent to which outcome measures of interest changed over time (one of the 
primary objectives of the study) we will use repeated measures ANOVAS with time and 
time*condition (KEEP-P vs. KEEP-P+).  
To justify the sample size of the present study, we ran an F-test: Repeated Measures, within-
between interaction for ANOVA using G*Power to compute power and sample size. Time is the 
within-subjects variable, and the intervention condition (KEEP-P vs. KEEP-P+) is the between-
subjects variable. Partial eta squared is the effect size measure for the interaction between the 
within- and between-subjects variables. We assume a medium effect size here which means 
partial eta squared = .06, alpha error probability = 0.05, power = 95%, number of groups = 2, 
number of measurements = 2, total sample size = 54. 
There is a 95% chance of correctly rejecting the null hypothesis of no significant effect of the 
interaction with 27 families in the KEEP-P condition and 27 families in the KEEP-P+ condition for 
a total of 54 families. Therefore, our sample size of n=175 provides more than enough power to 
conduct the analyses.  
 
8. DEFINITION OF ANALYSIS POPULATIONS 
 
Analysis Sets/Populations/Subgroups 
 
175 caregivers with children were recruited through Early Childhood CARES, an EI/ECSE 
provider in Lane County, Oregon, and randomly assigned to KEEP-P (n = 87) or KEEP-V (n = 88). 
To be eligible for study participation, the child had to be identified as being at risk or with a 
documented developmental disability.  
 
9. STATISTICAL METHODOLOGY  
General  
 

All data will be summarized by intervention group. For continuous variables, sample maximum, 
minimum, median, mean, and standard deviation will be reported. For categorical variables, 
counts and percentages will be reported. A significance level of 0.05 is applied for all hypothesis 
tests. 
 
 
 
 
Handling of Missing Values and Other Data Conventions 
 
Missing data strategies.  
Our research team used several strategies to minimize missing data. During collection, the 
research team took great care to format the surveys and tasks in a clean and straight-forward 
way. If missing data was found shortly after the visit and the information could be clarified or 
collected, (e.g. missing item on a survey) research team members called the caregiver to ask for 
the information. In order to maximize our power to detect effects in scale measures, we 
interpolated cases with at least 80% of data available in a given subscale or total score to create 
a useable score.   
 
Statistical Tests 
 
All families who attended at least one group were included in analyses. We first investigated 
the extent to which outcome measures of interest changed over time using repeated measures 
ANOVAS with time and time*condition (KEEP-P vs. KEEP-P+) conditions. For outcomes with 
either time or time*condition effects, we conducted follow-up analyses investigating the 
influence of condition and intervention dosage (i.e., % of groups attended). 
 
Covariates investigated included caregiver level (i.e. caregiver education, family income) and 
child level (i.e. child age, child gender) variables. Chi-square tests (child gender) and 
independent sample t-tests (caregiver education, family income, child age) were run to 
determine the presence of group differences at baseline. The presence of either significant 
group differences or associations between a covariate and change-over-time resulted in the 
covariate being included in all subsequent analyses. 
 
One-way ANOVAs were then conducted between condition and covariate measures on change 
scores of outcome measures for outcome constructs that were of primary interest to the theory 
of change and that evidenced change over time, we also conducted exploratory subscale 
analyses (i.e., Parent Stress, Child Mental Health and Behavior, Child Development). This 
analytic approach was taken to demonstrate transparency of results across all measures 
collected. 
 
Linear regressions were conducted to examine predictors of change-over-time in all 12 
variables established to change in the main analysis. Variables included as predictors included 
child age, child sex, group assignment (KEEP-P or KEEP-P+), and intervention dosage (% groups 
attended). 

 
 
  
10. INTERIM ANALYSES  
There is no planned interim analysis for this study. 
 
11. DATA PRESENTATION 
Tables 
Table 1. Means of study variables 
 
Variable 
KEEP-P 
Pre 
KEEP-P 
Post 
KEEP-P 
Change 
KEEP-
P+ 
Pre 
KEEP-
P+ 
Post 
KEEP-
P+ 
Change 
All 
Pre 
All 
Post 
All 
Change 
Parenting 
Constructs 
 
 
 
 
 
 
 
 
 
    Parent Stress 
Index 
80.87 
(20.28) 
74.62 
(20.29) 
-5.29 
(9.45) 
86.18 
(23.83) 
80.80 
(22.76) 
-5.72 
(13.97) 
83.55 
(22.23) 
77.98 
(21.80) 
-5.53 
(12.07) 
    Parenting Sense 
of Competence 
49.42 
(5.18) 
51.60 
(5.46) 
2.14 
(3.39) 
49.82 
(6.33) 
50.15 
(5.22) 
.30 
(4.84) 
49.62 
(5.78) 
50.82 
(5.36) 
1.15 
(4.32) 
    PICCOLO 
42.58 
(7.22) 
42.85 
(8.45) 
.14 
(8.67) 
43.36 
(6.65) 
43.08 
(7.65) 
-.76 
(8.57) 
42.98 
(6.92) 
42.97 
(8.02) 
-.34 
(8.59) 
    Family Routines 
51.66 
(11.66) 
52.63 
(9.79) 
1.37 
(10.34) 
50.43 
(9.00) 
52.09 
(9.32) 
1.30 
(6.62) 
51.05 
(10.41) 
52.34 
(9.51) 
1.33 
(8.53) 
    IEMP     
37.87 
(3.33) 
38.80 
(3.36) 
.81 
(2.67) 
37.17 
(4.55) 
37.56 
(4.00) 
.69 
(4.03) 
37.52 
(4.00) 
38.12 
(3.76) 
.74 
(3.47) 
    ADRY 
Proximity Behavior 
7.53 
(3.89) 
7.75 
(3.83) 
.22 
(3.41) 
8.42 
(3.73) 
7.87 
(3.78) 
-.49 
(4.17) 
7.98 
(3.82) 
7.81 
(3.79) 
-.16 
(3.84) 
    ADRY Avoidant 
Behavior 
1.84 
(2.22) 
1.78 
(2.33) 
-.03 
(2.15) 
1.95 
(2.19) 
2.06 
(2.53) 
-.04 
(2.22) 
1.90 
(2.20) 
1.93 
(2.43) 
-.04 
(2.18) 
    ADRY Resistant 
Behavior 
.72 
(1.03) 
.57 
(1.08) 
-.08 
(.95) 
.88 
(1.15) 
.70  
(.99) 
-.21 
(1.10) 
.80 
(1.09) 
.64 
(1.03) 
-.15 
(1.03) 
Child Behavior and 
Development 
 
 
 
 
 
 
 
 
 
    CBCL total  
59.60 
(12.13) 
57.18 
(12.44) 
-3.24 
(6.95) 
61.65 
(11.72) 
57.47 
(12.14) 
-3.76 
(6.63) 
60.61 
(11.94) 
57.33 
(12.24) 
-3.52 
(6.76) 
    CBCL 
internalizing 
56.62 
(11.64) 
55.29 
(12.07) 
-1.90 
(7.04) 
58.67 
(10.22) 
54.84 
(11.05) 
-3.17 
(7.03) 
57.64 
(10.98) 
55.05 
(11.50) 
-2.58 
(7.04) 
    CBCL 
externalizing 
58.84 
(11.75) 
55.87 
(11.93) 
-3.11 
(7.42) 
60.64 
(12.98) 
57.27 
(12.48) 
-3.41 
(7.89) 
59.73 
(12.37) 
56.61 
(12.20) 
-3.27 
(7.64) 
    PDR stressful  
6.56 
(5.65) 
4.48 
(4.81) 
-1.90 
(4.59) 
7.26 
(5.36) 
4.58 
(4.11) 
-2.80 
(3.98) 
6.91 
(5.50) 
4.53 
(4.44) 
-2.38 
(4.29) 
    PKBS total 
problems 
55.86 
(19.56) 
50.60 
(21.93) 
-3.44 
(10.80) 
54.63 
(19.70) 
52.39 
(18.30) 
-3.09 
(11.02) 
55.24 
(19.58) 
51.56 
(20.00) 
-3.25 
(10.88) 
    ASQ total 
121.35 
(77.58) 
105.00 
(74.47) 
-14.33 
(33.95) 
125.81 
(66.21) 
119.13 
(71.29) 
-2.39 
(42.64) 
123.60 
(71.91) 
112.56 
(72.84) 
-7.95 
(39.15) 
Child Cognitive 
Function 
 
 
 
 
 
 
 
 
 
    Delay Choice 
Paradigm 
4.86 
(3.11) 
5.24 
(3.26) 
.19 
(3.13) 
5.55 
(2.91) 
4.54 
(3.50) 
-.89 
(3.41) 
5.21 
(3.02) 
4.88 
(3.39) 
-.37 
(3.31) 
    Attention 
Shifting DCCS 
1.76 
(1.43) 
2.12 
(1.54) 
.48 
(1.29) 
1.61 
(1.32) 
2.05 
(1.54) 
.43 
(1.37) 
1.68 
(1.37) 
2.08 
(1.53) 
.45 
(1.33) 
    Bear Dragon 
21.52 
(7.58) 
23.60 
(6.81) 
1.56 
(6.41) 
20.42 
(8.25) 
22.42 
(7.37) 
3.24 
(8.50) 
20.96 
(7.91) 
22.97 
(7.11) 
2.47 
(7.63) 
    Spin the Pots 
.58 (.16) 
.62 (.20) 
.05 (.22) 
.55 (.16) 
.59 (.18) 
.06 (.23) 
.57 (.16) 
.61 (.19) 
.06 (.22) 
    Silly Animal 
Categories 
.64 (.38) 
.67 (.35) 
.05 (.33) 
.61 (.34) 
.71 (.31) 
.10 (.31) 
.63 (.36) 
.69 (.33) 
.07 (.32) 
    KRISP 
35.76 
(7.90) 
37.81 
(6.23) 
2.16 
(8.97) 
33.52 
(7.78) 
35.80 
(7.60) 
3.96 
(7.55) 
34.65 
(7.89) 
36.79 
(7.00) 
3.11 
(8.26) 

 
 
 
Table 2. Primary Outcomes Change Over Time 
 
Primary Outcomes 
df 
Time 
(F) 
Time X  
Group (F) 
Group  
(F) 
Key Parenting Measures 
 
 
 
 
    Parent Stress Index 
(1,125) 
26.81*** 
.093 
3.00 
    Parenting Sense of Competence 
(1,122) 
10.20** 
5.82* 
.43 
    Family Routines 
(1,124) 
2.32 
.18 
.98 
    ADRY Proximity Behavior 
(1,125) 
.15 
1.07 
.23 
    ADRY Avoidant Behavior 
(1,125) 
.04 
.00 
.00 
    ADRY Resistant Behavior 
(1,125) 
2.50 
.43 
.43 
    PICCOLO 
(1,117) 
.09 
.53 
.45 
    IEMP      
(1,126) 
5.29* 
.07 
3.49 
Child Mental Health & Behavior  
 
 
 
 
    CBCL internalizing 
(1,130) 
17.10*** 
1.07 
.01 
    CBCL externalizing 
(1,124) 
23.79*** 
.05 
.56 
    PDR total 
(1,130) 
40.67*** 
1.32 
.34 
    PKBS total problems 
(1,121) 
10.91** 
.03 
.95 
Child Cognitive Function and Development 
 
 
 
 
   ASQ total  
(1,127) 
5.95* 
3.03 
.51 
   DCCS Attention Shift 
(1,117) 
13.86*** 
.05 
.04 
   Bear-Dragon Total 
(1,92) 
9.23** 
1.13 
1.74 
   Delay Choice Paradigm 
(1,106) 
1.23 
2.95 
.72 
   Spin the pots 
(1,114) 
3.02 
.55 
2.89 
   KRISP  
(1,87) 
13.02*** 
.121 
2.75 
   Silly Animal Cat. 
(1,106) 
5.80* 
.56 
.41 
 * p <.05; ** p <.01; *** p <.001 
 
 
Table 3. 
 
 
df  
Child Age 
Child  
Gender 
Group 
Dosage 
Parenting Constructs 
 
 
 
 
 
    Parent Stress Index 
(1,119) 
.00 
.15 
.04 
.04 
    Parenting Sense of Competence 
(1,116) 
.01 
.39 
6.25* 
1.54 
    IEMP      
(1,120) 
.98 
1.31 
.00 
.25 
Child Mental Health & Behavior  
 
 
 
 
 
    CBCL internalizing 
(1,124) 
.05 
1.51 
1.27 
3.07 
    CBCL externalizing 
(1,124) 
.95 
1.15 
.12 
.16 
    PDR total 
(1,125) 
.24 
7.84** 
.25 
5.62* 

    PKBS total problems 
(1,116) 
2.84 
1.49 
.01 
1.88 
Child Cognitive Function & Development 
 
 
 
 
 
  ASQ total 
(1,121) 
2.45 
1.33 
2.57 
.30 
  DCCS Attention Shift 
(1,111) 
3.90 
.09 
.01 
.43 
   Bear-Dragon Total 
(1,86) 
3.70 
.01 
.72 
6.07* 
   KRISP  
(1,87) 
.93 
.28 
1.02 
.70 
   Silly Animal Cat. 
(1,106) 
.11 
.02 
.58 
.58 
  
12. Data & Results  
 
Sociodemographic descriptives 
Caregivers were predominantly female (n = 151, 91.0%), versus male (n = 15, 9.0%) at an 
average age of 33.58 years (SD = 7.07; range 20 - 63) years. Nearly all caregivers reported being 
a child’s biological parent (161, 97.0%) with other caregivers being foster or adoptive parents 
(5, 3.0%). 
  
The sample primarily included children and caregivers of Euro-American/Caucasian/White 
race/ethnicity (n = 135, 77.1% children and n = 121, 69.1% caregivers). The next most 
commonly reported race/ethnic category Mixed Race/Ethnicity, (n = 17, 9.2% children, n = 34, 
16.9% caregivers) and all other race/ethnic categories represented < 10% of the sample. 
  
Primary caregiver education was coded on a continuous 14-point scale with responses ranging 
from 4: partial high school to 14: graduate degree. The median education level was a partial 4-
year college degree (at least 1 year). 
  
Gross annual household income was asked on a continuous 12-point scale, with response 
ranging from less than $4,999 to more than 100,000. The median annual household income was 
$30,000 -39,000. All families reported receiving social assistance. 
 
Participating children were predominantly male (n = 124, 74.7%) with an average age of 47.70 
months (SD = 10.48, range 28 – 70 months). The majority of caregivers reported being the 
child’s biological parent (n = 161, 97.0%) with other caregivers being foster or adoptive parents 
(n = 5, 3.0%).  
 
 
Attendance 
Out of the 175 families, 153 attended at least one session. This included of 86.2% KEEP-P (n = 
75) and 88.6% KEEP-V (n = 78), with no significant differences between groups [c2 (1,175) = .24, 
p = .63]. Average group attendance was 77.8%. 20.3% of families completed 8-49% of sessions; 
17.0% of families completed 50-89% of sessions and 62.7% of families completed 90-100% of 
sessions. 
 

Change over time   
Repeated measures ANOVAS of collected data generally indicated a main effect of 
intervention, such that improvements in parent, child, and family function were observed over 
time for those assigned to the KEEP intervention. However minimal differences between KEEP-
P and KEEP-V groups were observed. (See Table 1 for all means and Table 2 for inferential 
statistics). 
In the Parenting domain, scores on the parent stress index decreased over time [F(1,125) 
= 26.81, p < .001] and scores on the parenting sense of competence [F(1,122) = 10.21, p < .01] 
and IEMP [F(1,126) = 5.29, p < .05] both increased over time. On the parenting sense of 
competence, there was also a significant Time*Group effect (F(1,122)-5.82, p <.05) such that 
parents in the KEEP-P group reported greater gains over time than parents in the KEEP-V group. 
There were no observed changes in either the ADRY or the PICCOLO observation scales. 
In the Child Mental Health and Behavior domain, parent-reported scores on all domains 
of child function significantly improved including the CBCL internalizing scale, CBCL 
internalizing scale, PDR, and PKBS (stats?). No Time*Group effects were observed. 
In the Child Cognitive Function and Development domain, children exhibited fewer 
development problems, as measured on the Ages and Stages Questionnaire and improved 
executive function on 4 of 6 measures. In particular, children exhibited better performance on the 
DCCS, Bear-Dragon Task, KRISP, and Silly Animal Categories Tasks, with no change on the 
Delay Choice Paradigm or Spin the Pots measures. 
 
Multivariate analyses 
Covariate analyses indicated minimal sociodemographic covariates between groups, with 
the exception of child age [t(113) = 2.19, p = .03]. Children were older in the Keep-P group 
[M(SD) = 48.87 (10.96) months] compared to the Keep-V group [M(SD) = 44.63 (9.77) 
months]. For all other variables of interest including child gender, caregiver education, and 
household income, there were no significant differences between groups (p>.05). 
 Analyses examining associations between sociodemographic covariates and change-
over-time outcome variables indicated that child sex was associated with PDR Mean Stressful 
Behaviors change-over-time (t(103) = 2.89, p = .005) with female children more likely to exhibit 
reduced stressful behaviors over time [M(SD): females – 4.92 (5.07) ; males -2.03 (3.91)]. Child 
age was associated with PICCOLO change scores in that older children were more likely to have 
parents with declining PICCOLO scores over time (r  = - .20, p = .045). There were no other 
associations between sociodemographic covariates of interest and any outcome variables (for full 
list, see Table 1).  Based on these analyses, child age and sex were included as covariates in 
subsequent analyses. 
 Linear regressions were conducted to examine predictors of change-over-time in all 12 
variables established to change in the repeated measures ANOVAS. Variables included as 
predictors included child age, child sex, group assignment (KEEP-P or KEEP-V), and 
intervention dosage (% groups attended). Results are presented in Table 3. Across the 12 
regression analyses, higher intervention dosage predictor a greater reduction in PDR of child 
stressful behaviors and greater improvements in child performance on the Bear Dragon Task. 
Consistent with reported covariate analyses, female children were also more likely to exhibit a 
greater reduction in PDR of child stressful behaviors. Consistent with the reported repeated 
measures ANOVAS, group was a significant predictor of change in Parenting Sense of 
Competency over time, with parents in the KEEP-P group reporting greater gains relative to 

those in the control condition. Group was not a predictor in change over time for any other 
variable. 
 
13. Institutional Review Board (IRB) Protocol Documents  
 
IRB protocol amendment forms are included in the pages that follow. 
 
 
14. Informed Consent Forms 
 
Informed Consent Forms are included in the pages that follow.  
 

 
 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://humansubjects.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
 
DATE:  
January 28, 2015 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
 
Notice of IRB Review and Approval – Amendment 
Full Board Review as per Title 45 CFR Part 46 
 
The amendment submitted on December 18, 2014 to the above identified project has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services. The amendment was reviewed by the fully convened IRB in 
accordance with HHS regulations requiring the IRB to employ additional criteria when 
reviewing research that does not qualify for an expedited review. This approval is based on 
the assumption that the materials, including changes/clarifications that you submitted to the 
IRB contain a complete and accurate description of all the ways in which human subjects 
are involved in your research. 
 
Amendment:   
 
Research Plan: Minor changes are proposed for clarification or to complete 
information that was in draft form at the time of initial IRB submission.  
o KEEP-P: Caregiver support groups. The description of the support groups 
being 90 minutes was inaccurate and should have read 2 hours. 
o Intervention Manuals. Draft versions of the KEEP-P and KEEP-P+ intervention 
manuals were included with the initial IRB submission. These manuals have 
since been finalized, as is now noted in the research plan. 
 
Informed Consent Documents: Requested some small changes, corrections and 
additions to the consents for clarity and to provide additional information to 
participants.  
o Changes to Interview Visit Chart in Consent forms for Caseworker and 
Caregiver (Foster) 
o The Foster Child was removed from the interview chart at the 3rd and 4th 
visits.  
o Corrections to Caregiver Statement of Informed Consent. What will we ask 
you to do if you choose to be in the project? Correct text to read that the 
parent and child will complete two assessments together and the parent will 
complete two without the child. 

 
 
 
 
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o Address info added for the parent group held at Oregon Community Program 
(OCP) located at 1170 Pearl St, Eugene, OR 97401. 
o Corrections to Caseworker Statement of Informed Consent: What is the 
purpose of the project? Corrected the total post-test visits the child 
participates in from three post-test visits to one post-test visit. 
o Address info added: As above. Requesting the addition of the address for the 
parent group held at Oregon Community Programs (OCP) located at 1170 
Pearl St, Eugene, OR 97401. 
o What will we ask the child to do if she/he joins the project: Corrected the 
information to read that they will ask the child to complete two interviews 
over the next 18 months. 
o How long is the project? Updated the information to be consistent throughout 
the caseworker consent.  The child will be in the project for 6 months and 
data will be collected about the child for 18 months. 
o Addition of Parent Informed Consent (Bio/Adoptive): As we anticipate that 
participating children will be reunified with their biological families or 
placed with adoptive families, we have added Parent consent documents. 
 
Requesting the addition of the interview instrument All My Children Family 
Summary (AMC, attached)  
 
Service Utilization Interview (SERV, attached) was updated with newer. 
 
Caregiver Demographics Questionnaire (DEMO,attached) has been shortened and 
where necessary language has been updated. 
 
Shortened the Early Learning Interview (ELINT, attached) and are only administering 
section D - Emerging Literacy and Numeracy. 
 
Removed the Caregiver Interview (CARINT), Peabody Picture Vocabulary Test IV and 
Vineland Adaptive Behavior Scales II questionnaires. 
 
Submitted a copy of the Interaction Task script (attached). 
 
Changes to KEEP-P CG Group Info Letter: Corrected this caregiver information sheet 
for the KEEP-P and KEEP-P+ conditions by removing mention of the Parent Daily 
Report (PDR) calls. The PDR calls are completed by the research team. 
 
Addition of Teleform and Qualtrics options for completing the interview and 
questionnaires via Teleform versions or via computer using Qualtrics. 
 
Addition of Assessor/Interviewer Impressions for Child and Caregiver/Parent 
Assessments. 
 
Addition of Parent Group Fidelity (PARFID, attached): 
 
Changes to Caregiver/Parent Phone Script  
 
Changes to Caseworker Email Text and Attachment 
 
Addition of Caregiver KEEP-P Introduction Letter and Flyer:  

 
 
 
 
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 
Corrections/Updates to the KEEP-P Measures Table 
 
The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) was inadvertently 
included as a post-intervention measure in the KEEP-P measures table. This was an 
error; the WPPSI will only be administered at baseline. The corrected document is 
attached. 
 
The approved protocol includes the Delay Choice Paradigm and the Delay of 
Gratification, which were inadvertently left off of the measures table. This has been 
corrected. 
 
Additions to research team staff: 
o Alexander Wagnon, Bryna Cooper, Alexander Heinz, Lisa Shimomaeda, 
Madeline Cresswell 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a). 
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however the assent process described in 
the protocol should still be utilized. 
 
This approval is given with the following standard conditions: 
 
You are approved to conduct this research only during the period of approval cited 
below; 
 
You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
 
You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
 
You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
 
You will only use the approved informed consent document(s) (enclosed); 
 
You will give each research subject a copy of the informed consent document; 
 
If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on January 13, 2016. 
 
Important Note: Any research personnel that have not completed CITI education certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI education certificate. 
 

 
 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://humansubjects.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
Approval Period: January 28, 2015 - January 13, 2016 
 
The Committee has determined all future continuing reviews are to be conducted via Full 
Board review procedures. 
 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
 
Sincerely, 
 
Kalindi Allen 
Research Compliance Administrator 
 
 
 
CC: 
Sarah Haffner 
 
Kristen Greenley 
 

 
 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://humansubjects.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
DATE:  
July 16, 2015 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
 
Notice of IRB Review and Approval – Amendment 
Full Board Review as per Title 45 CFR Part 46 
 
The amendment submitted on April 27, 2015 to the above identified project has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services. The amendment was reviewed by the fully convened IRB in 
accordance with HHS regulations requiring the IRB to employ additional criteria when 
reviewing research that does not qualify for an expedited review. This approval is based on 
the assumption that the materials, including changes/clarifications that you submitted to the 
IRB contain a complete and accurate description of all the ways in which human subjects 
are involved in your research. 
 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a).  
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however the assent process described in 
the protocol should still be utilized. 
 
Amendment – the amendment request included the following: 
 
Research Plan changes include 
o Updated to include a community-based sample of other high-risk children. The 
community sample will include parents involved in early intervention/early 
childhood special education services and referred to KEEP-P as part of a 
partnership with Early Childhood CARES (EC CARES). 
o Updated recruitment plan to offer intervention services to all caregivers. Mention 
of a services as usual (SAU) research group has been removed. 
o Revised the parent group curriculum from 16 weeks long to 12 weeks. This change 
is less burdensome for families attending the Parent Groups. 
o Sample numbers have been adjusted for the groups but our total sample size will 
remain about the same, up to 240. 
o Added the option of completing the follow-up assessments by phone. 
o Removed Co-Investigator Cynthia Healey who is no longer involved in the project. 

 
 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
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th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://humansubjects.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
o Added EC CARES locations to the section Data Collection Procedures. 
o Updated Staff: Melanie Berry and Madeline Creswell 
 
Previously Approved Informed Consent Documents - small changes, corrections and 
additions to the current consents for clarity, continuity and to provide additional 
information to participants as well as update the procedures for the changes noted 
above in the Research Plan. 
 
Community Informed Consent - created a new consent document for the community 
sample.  
 
Measures were updated as follows 
o All Caregivers/Parents - two measures (Behavior Management Questionnaire 
(BMQ) and our Caregiver Demographic Questionnaire (DEMO)) updated the word 
“foster” from in front of parent to facilitate administration to the community 
sample. 
o Community Sample Only – added two measures to be completed by the 
community sample in order to allow for comparison with the child welfare sample 
including the Adverse Childhood Experiences Survey (Adult Version) and 
Childhood Experiences Survey (Child Version). 
 
KEEP-P Measures Table – was updated to reflect the above noted changes/additions to 
measures. 
 
This approval is given with the following standard conditions: 
 
You are approved to conduct this research only during the period of approval cited 
below; 
 
You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
 
You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
 
You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
 
You will only use the approved informed consent document(s) (enclosed); 
 
You will give each research subject a copy of the informed consent document; 
 
If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on January 13, 2016. 
 
Important Note: Any research personnel that have not completed CITI education certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI education certificate. 
 
Approval Period: July 16, 2015 - January 13, 2016 
 
The Committee has determined all future continuing reviews are to be conducted via full 
board review procedures. 

 
 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://humansubjects.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
 
Sincerely, 
 
Caitlin Alcorn, CIP 
Research Compliance Administrator 
 
 
CC: 
Sarah Haffner and Kristen Greenley, Project Coordinators 
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
 
DATE:  
January 20, 2016 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 
Expedited Categories # 5, 6, 7 
 
The amendment submitted on December 14, 2015 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval is based on the assumption that the materials, including changes/ 
clarifications that you submitted to the IRB contain a complete and accurate description of 
all the ways in which human subjects are involved in your research.  
 
Amendment:  This amendment updates research personnel to clarify roles, add personnel, 
and remove those no longer engaged in related human subject research activities.  
Additionally, the Personnel Form for this protocol is formally established with this 
amendment. 
 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a).  
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however, the altered assent process 
described in the protocol is to be utilized. 
 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on December 15, 2016. 
 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
 
Approval period: January 20, 2016 - December 15, 2016 
 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
 
 
Sincerely, 
 
Caitlin Alcorn, CIP 
Research Compliance Administrator 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
April 28, 2016 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 #5, 6, 7 
 
 
The amendment submitted on April 19, 2016 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval is based on the assumption that the materials, including changes/ 
clarifications that you submitted to the IRB contain a complete and accurate description of 
all the ways in which human subjects are involved in your research.  
 
Amendments: 
 
Added Kaitlyn Franklin, Sevag Makasdjian, Adrian Lopez, and Cassandra Acosta to 
the protocol as research assistants 
 
Added a participant re-contact form 
 
Updated question #15 of the Demographic interview 
 
Updated the KEEP-screener 
 
Added the option of texting to contact participants 
 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a). 
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however, the altered assent process 
described in the protocol is to be utilized. 
 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on December 15, 2016. 
 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
 
Approval period: April 28, 2016 - December 15, 2016 
 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
 
 
Sincerely, 
 
Daniel Berman 
Research Compliance Administrator 
 
 
CC: 
Sarah Beecroft-Haffner, Project Coordinator 
 
Kristen Greenley, Project Coordinator 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
 
DATE:  
July 18, 2016 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 
Expedited Categories # 5, 6, 7 
 
The amendment submitted on May 31, 2016 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval is based on the assumption that the materials, including changes/ 
clarifications that you submitted to the IRB contain a complete and accurate description of 
all the ways in which human subjects are involved in your research.  
 
Amendment:  Update screening form as well as update personnel.  
 
*Note- Two versions of the screening form were submitted and reviewed because the 
formatted pdf version was hard to update so a word version was created and submitted for 
these submissions and it is assumed the pdf version is then updated once the content is 
finalized. Two different screening forms are not used.  
 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a).  
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however, the altered assent process 
described in the protocol is to be utilized. 
 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on December 15, 2016. 
 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
 
Approval period: July 18, 2016 - December 15, 2016 
 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
 
 
Sincerely, 
 
Kalindi Allen 
Research Compliance Administrator 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
October 03, 2016 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # 5, 6, 7 
 
 
The amendment submitted on September 26, 2016 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval is based on the assumption that the materials, including changes/ 
clarifications that you submitted to the IRB contain a complete and accurate description of 
all the ways in which human subjects are involved in your research.  
For this research, the following additional determinations have been made: 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in the 
research. 
• 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a).  
The IRB determined that the capability of some or all of the children is so limited that 
they cannot reasonably be consulted, however, the altered assent process described in 
the protocol is to be utilized. 
 
The purpose of this Amendment is to: 
• 
Update research personnel to include Jenette Arellano, Jessie Moyer, and Danielle 
Schaer and remove Catherine Hamby, Sevag Makasdjian, and Aundrea Braniff. 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on December 15, 2016. 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
Approval period: October 03, 2016 - December 15, 2016 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
Sincerely, 
 
Lizzy Utterback 
Research Compliance Administrator 
 
 
 
CC: 
Kristen Greenley, Project Coordinator 
Alexander Wagnon, Research Coordinator 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
February 15, 2017 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Psychology, Department of 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # 5, 6, 7 
 
 
The amendment submitted on February 01, 2017 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval is based on the assumption that the materials, including changes/ 
clarifications that you submitted to the IRB contain a complete and accurate description of 
all the ways in which human subjects are involved in your research.  
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a). 
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however, the altered assent process 
described in the protocol is to be utilized. 
The purpose of this Amendment is to: 
 
Add text message prompt; 
 
Add research staff, Da Yeon Kwon, Justyne Ortquist, and Kelsie Arsenault. 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research according to the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
IRB approval expiration date. Without continuing approval the Protocol will 
automatically expire on November 22, 2017. 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
Approval period: February 15, 2017 - November 22, 2017 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
Sincerely, 
 
 
Christina (Davis) Spicer, J.D., C.I.P. 
Research Compliance Administrator 
Research Compliance Services 
University of Oregon 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
April 13, 2017 
IRB Protocol Number:  06112013.016 
 
TO:     
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # 5, 6, 7 
 
 
The amendment submitted on March 28, 2017 for the project identified above has been 
reviewed and approved by the University of Oregon Institutional Review Board (IRB) and 
Research Compliance Services using an expedited review procedure. This is a minimal risk 
study. This approval assumes that the materials, including changes/ clarifications that you 
submitted to the IRB contain a complete and accurate description of all the ways in which 
human subjects are involved in your research.  
 
For this research, the following additional determinations have been made: 
 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a). 
The IRB determined that the capability of some or all of the children is so limited 
that they cannot reasonably be consulted, however, the altered assent process 
described in the protocol is to be utilized. 
The purpose of this Amendment is to: 
 
Add two new versions of the consent form for families that enter the study without 
enough time to complete all data collection points. 
 
Revise the Research Plan and recruitment materials accordingly. 
This approval is given with the following standard conditions: 
1. You are approved to conduct this research only during the period of approval cited 
below; 
2. You will conduct the research in accordance with the plans and protocol submitted 
(approved copy enclosed); 
3. You will immediately inform Research Compliance Services of any injuries or 
adverse research events involving subjects; 
4. You will immediately request approval from the IRB of any proposed changes in 
your research, and you will not initiate any changes until they have been reviewed 
and approved by the IRB;  
5. You will only use the approved informed consent document(s) (enclosed); 
6. You will give each research subject a copy of the informed consent document; 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
7. If your research is anticipated to continue beyond the IRB approval dates, you must 
submit a Continuing Review Request to the IRB approximately 60 days prior to the 
IRB approval expiration date. Without continuing approval, the Protocol will 
automatically expire on November 22, 2017. 
Additional Conditions: Any research personnel that have not completed CITI certificates 
should be removed from the project until they have completed the training. When they have 
completed the training, you must submit a Protocol Amendment Application Form to add 
their names to the protocol, along with a copy of their CITI certificates. 
Approval period: April 13, 2017 - November 22, 2017 
The University of Oregon and Research Compliance Services appreciate your efforts to 
conduct research in compliance with University of Oregon Policy and federal regulations 
that have been established to ensure the protection of human subjects in research. Thank 
you for your cooperation with the IRB process.  
Sincerely, 
 
Daniel Berman 
Research Compliance Administrator 
 
 
CC: 
Kristen Greenley, Alex Wagnon 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
September 14, 2017 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # [5, 6, 7] 
 
 
The amendment submitted on September 13, 2017 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility to 
submit any proposed changes for IRB review and approval prior to implementation. 
 
Amendment Description: 
• 
Add research personnel Tim Matthews, Huna Yim Dockery, Sarah Horn, Rod Salgado, 
Christina Gamache Martin, and Maureen Zalewski. Remove Hoda Tirafkan, Jillian 
Tuso, and Julia Bartlett. 
 
This research has been determined to be no greater than minimal risk and qualifies for 
expedited review procedures. For this research, the following additional determinations have 
been made: 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in the 
research. 
• 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a) as 
the IRB determined that the capability of some or all of the children is so limited that 
they cannot reasonably be consulted, however, the altered assent process described in 
the protocol is to be utilized. 
Approval period: September 14, 2017 - November 22, 2017 
 
If you anticipate the research will continue beyond the IRB approval period, you must submit 
a request for continuing review approximately 60 days prior to the expiration date. Without 
continued approval, the protocol will expire on November 22, 2017 and human subject 
research activities must cease. A closure report must be submitted once human subject 
research activities are complete. Failure to maintain current approval or properly close the 
protocol constitutes non-compliance.  
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
this letter below. You are responsible for conduct of the research and must maintain oversight 
of all research personnel to ensure compliance with the IRB approved protocol. 
The University of Oregon and Research Compliance Services appreciate your commitment to 
the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Chris Duy 
Research Compliance Specialist 
Research Compliance Services 
 
CC: 
Kristen Greenley 
Alex Wagnon  
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
November 20, 2017 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # [5, 6, 7] 
 
 
The amendment submitted on November 16, 2017 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes 
to the research as described in the attached materials. As a reminder, it is your 
responsibility to submit any proposed changes for IRB review and approval prior to 
implementation. 
Amendment Description: 
• 
Added: Traci Crum, Jack Kapustka, Rachel Klein, Ashlee Erickson; Removed: 
Maeghan Scriven, Nasina Ellis, Sarah Nachbar 
 
This research has been determined to be no greater than minimal risk and qualifies for 
expedited review procedures. For this research, the following additional determinations 
have been made: 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
• The permission of one parent or guardian is sufficient for a child’s involvement 
in the research.  
• 
• The IRB has waived the requirement to obtain child assent under 45 CFR 
46.408(a) as the IRB determined that the capability of some or all of the children is 
so limited that they cannot reasonably be consulted, however, the altered assent 
process described in the protocol is to be utilized. 
Approval period: November 20, 2017 - October 31, 2018 
If you anticipate the research will continue beyond the IRB approval period, you must 
submit a request for continuing review approximately 60 days prior to the expiration date. 
Without continued approval, the protocol will expire on October 31, 2018 and human 
subject research activities must cease. A closure report must be submitted once human 
subject research activities are complete. Failure to maintain current approval or properly 
close the protocol constitutes non-compliance.  
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end 
of this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Chris Duy 
Research Compliance Specialist 
Research Compliance Services 
 
CC: 
Kristen Greenley, Alex Wagnon  
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
May 14, 2018 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # 5, 6, 7 
 
 
The amendment submitted on April 23, 2018 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility to 
submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Updating the protocol for assessment follow-up with a select group of families who 
have finished the study. 
• 
Remove Matthews, Tim ; Yim Dockery, Huna ; Horn, Sarah ; Salgado, Rod; Ellis, 
Nasina; Nachbar, Sarah; Scriven, Maeghan; Skolnick, Kayleigh; Gamache Martin, 
Christina; Zalewski, Maureen from the research team. 
 
This research has been determined to be no greater than minimal risk and qualifies for 
expedited review procedures. For this research, the following additional determinations have 
been made: 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in the 
research. 
• 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a) as 
the IRB determined that the capability of some or all of the children is so limited that 
they cannot reasonably be consulted, however, the altered assent process described in 
the protocol is to be utilized. 
Approval period: May 14, 2018 - October 31, 2018 
If you anticipate the research will continue beyond the IRB approval period, you must submit 
a request for continuing review approximately 60 days prior to the expiration date. Without 
continued approval, the protocol will expire on October 31, 2018 and human subject 
research activities must cease. A closure report must be submitted once human subject 
research activities are complete. Failure to maintain current approval or properly close the 
protocol constitutes non-compliance.  
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 
this letter below. You are responsible for conduct of the research and must maintain oversight 
of all research personnel to ensure compliance with the IRB approved protocol. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
The University of Oregon and Research Compliance Services appreciate your commitment to 
the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Chris Duy 
Research Compliance Administrator 
Research Compliance Services 
 
CC: 
Kristen Greenley, Alex Wagnon 
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
 
DATE:  
July 24, 2018 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
 
Notice of IRB Review and Approval-Amendment 
Expedited Review as per Title 45 CFR Part 46 # 5, 6, 7 
 
 
The amendment submitted on July 20, 2018 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility 
to submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Add Sylvia Shaykis to the research team;  
• 
Remove Kristen Greenley, Celeste Mena, Jessie Moyer, Kelsie Arsenault, Traci Crum, 
Jack Kapustka, Rachel Klein, and Ashlee Erickson 
 
This research has been determined to be no greater than minimal risk and qualifies for 
expedited review procedures. For this research, the following additional determinations 
have been made: 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
• 
The IRB has waived the requirement to obtain child assent under 45 CFR 46.408(a) as 
the IRB determined that the capability of some or all of the children is so limited that 
they cannot reasonably be consulted, however, the altered assent process described 
in the protocol is to be utilized. 
Approval period: July 24, 2018 - October 31, 2018 
If you anticipate the research will continue beyond the IRB approval period, you must 
submit a request for continuing review approximately 60 days prior to the expiration date. 
Without continued approval, the protocol will expire on October 31, 2018 and human 
subject research activities must cease. A closure report must be submitted once human 
subject research activities are complete. Failure to maintain current approval or properly 
close the protocol constitutes non-compliance.  
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 
this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Chris Duy 
Research Compliance Administrator 
Research Compliance Services 
 
CC: 
Alex Wagnon  

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
February 05, 2019 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of CAS Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of Expedited IRB Review and Expedited Approval 
Amendment Review 
 
 
The amendment submitted on January 28, 2019 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility to 
submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Add Andrea Imhof, Adriana Conn, Andi Casteel, Jinzhu Hong, Eric Nguy, Lauren 
Kinnucan, Madisen Wolleck, Michiko Srinutthakul, Millie Halverson, Rachel 
Rozenfeld, Rebecca Namyet, Rylee Siebers, Yubin Cho, and Gracie Arnone to the 
research team. 
• 
Remove Mary Wood, Katherine Denney, and Melanie Berry 
For this research, the following determinations have been made: 
• 
This study has been reviewed under the pre-2018 Common Rule.  The study has been 
determined to be no greater than minimal risk and to qualify for expedited review as 
per Title 45 CFR 46.110 under Categories 5, 6, & 7. 
o Continuing Review is required for this study. 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in the 
research. 
• 
The IRB has approved an altered informed consent procedure under 45 CFR 46.116(d) 
to allow for the follow-up verbal consent process as an extension of the consent 
procedure for the follow-up activities. 
 
Approval period: February 05, 2019 - October 07, 2019 
 
If you anticipate the research will continue beyond the IRB approval period, you must submit 
a Continuing Review Application at least 45-days prior to the expiration date. Without 
continued approval, the protocol will expire on October 07, 2019 and human subject 
research activities must cease.  A closure report must be submitted once human subject 
research activities are complete.  Failure to maintain current approval or properly close the 
protocol constitutes non-compliance.    
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
this letter below. You are responsible for conduct of the research and must maintain oversight 
of all research personnel to ensure compliance with the IRB approved protocol. 
The University of Oregon and Research Compliance Services appreciate your commitment to 
the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Chris Duy 
Research Compliance Administrator 
Research Compliance Services 
 
CC: 
Alex Wagnon  
 
 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
May 23, 2019 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
CAS Psychology - Psychology, Dept. of 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of Expedited IRB Review and Expedited Approval 
Amendment Review 
 
 
The amendment submitted on May 22, 2019 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility 
to submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Add research staff: Bianca Benitez, Leticia Hayes, Sarah Horn, Leslie Roos, Elizabeth 
(Lizzie) Wilson 
For this research, the following determinations have been made: 
• 
This study has been reviewed under the pre-2018 Common Rule.  The study has 
been determined to be no greater than minimal risk and to qualify for expedited 
review as per Title 45 CFR 46.110 under Category (5, 6, 7). 
o Continuing Review is required for this study. 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research. 
• 
The IRB has approved an altered informed consent procedure under 45 CFR 
46.116(d) to allow for the follow-up verbal consent process as an extension of the 
consent procedure for the follow-up activities. 
 
Approval period: May 23, 2019 - October 07, 2019 
 
If you anticipate the research will continue beyond the IRB approval period, you must 
submit a Continuing Review Application at least 45-days prior to the expiration date. 
Without continued approval, the protocol will expire on October 07, 2019 and human 
subject research activities must cease.  A closure report must be submitted once human 
subject research activities are complete.  Failure to maintain current approval or properly 
close the protocol constitutes non-compliance.    
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 
this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
Christina Spicer, J.D., C.I.P. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
August 8, 2019 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
CAS Psychology - Psychology, Dept. of 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of Expedited IRB Review and Expedited Approval 
Amendment Review 
 
 
The amendment submitted on August 05, 2019 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility 
to submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Addition of the following research personnel: Oscar Becerra, Melissa Casas Carreno, 
Fabiola Cruz Aguilar, Amina Curto Serrano, Mirna Espinoza, Ana Hernandez, Olivia 
Kim, Jacqueline Luna, Alejandro Valdez-Alvarez, Lucy Zepeda 
For this research, the following determinations have been made: 
• 
This study has been reviewed under the pre-2018 Common Rule.  The study has 
been determined to be no greater than minimal risk and to qualify for expedited 
review as per Title 45 CFR 46.110 under Category (5, 6, 7). 
o Continuing Review is required for this study. 
• 
The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research.  
• 
The IRB has approved an altered informed consent procedure under 45 CFR 
46.116(d) to allow for the follow-up verbal consent process as an extension of the 
consent procedure for the follow-up activities. 
 
Approval period: August 8, 2019 - October 07, 2019 
 
If you anticipate the research will continue beyond the IRB approval period, you must 
submit a Continuing Review Application at least 45-days prior to the expiration date. 
Without continued approval, the protocol will expire on October 07, 2019 and human 
subject research activities must cease.  A closure report must be submitted once human 
subject research activities are complete.  Failure to maintain current approval or properly 
close the protocol constitutes non-compliance.    
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 
this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Carolyn J. Craig, PhD, CIP 
Senior Research Compliance Administrator 
 
CC: 
Alex Wagnon 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
November 18, 2019 
IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
CAS Psychology - Psychology, Dept. of 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive Intervention 
for Foster Preschoolers” 
 
Notice of Expedited IRB Review and Expedited Approval 
Amendment Review 
 
 
The amendment submitted on November 14, 2019 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes to 
the research as described in the attached materials. As a reminder, it is your responsibility 
to submit any proposed changes for IRB review and approval prior to implementation. 
Amendment Description: 
• 
Add Research Staff: Bianca Benitez, Camille Poritzky; Removed: Gracie Arnone, 
Patricia Chamberlain, Hyoun Kim, Katherine Pears, Sylvia Shaykis, Sally Guyer, 
Oscar Becerra, Andi Casteel, Mirna Espinoza, Mille Halverson, Leticia Hayes, Jinzhu 
(Chloe) Hong, Olivia Kim, Lauren Kinnucan, Rebecca Namyet, Eric Nguy, Rachel 
Rozenfeld, Alejandro Valdez-Alvarez, Elizabeth (Lizzie) Wilson, Madison Wolleck, 
Luzy Zepeda 
For this research, the following determinations have been made: 
• 
This study has been reviewed under the pre-2018 Common Rule.  The study has 
been determined to be no greater than minimal risk and to qualify for expedited 
review as per Title 45 CFR 46.110 under Category (5, 6, 7). 
o Continuing Review is required for this study.  
• 
 The activities approved with this continuation are limited to data analysis only.  
No new enrollment, consenting, or data collection may occur under this approval 
status; any previously approved consents may not be used.  If you would like to 
reopen enrollment or collect new data for this protocol please submit an amendment 
application. 
• 
 The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in the 
research.  
• 
The IRB has approved an altered informed consent procedure under 45 CFR 
46.116(d) to allow for the follow-up verbal consent process as an extension of the 
consent procedure for the follow-up activities. 
 
Approval period: November 18, 2019 - October 14, 2020 
 
If you anticipate the research will continue beyond the IRB approval period, you must submit 
a Continuing Review Application at least 45-days prior to the expiration date. Without 
continued approval, the protocol will expire on October 14, 2020 and human subject 
research activities must cease.  A closure report must be submitted once human subject 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
research activities are complete.  Failure to maintain current approval or properly close the 
protocol constitutes non-compliance.    
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end of 
this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
Christina Spicer, J.D., C.I.P. 

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
DATE:  
March 11, 2020 
   IRB Protocol Number:  06112013.016 
 
 
TO:   
Philip Fisher, Principal Investigator 
 
Department of Psychology 
 
RE: 
Protocol entitled, “(KEEP-P) Randomized Trial of KEEP-P, a Preventive 
Intervention for Foster Preschoolers” 
 
Notice of Expedited IRB Review and Expedited Approval 
Amendment Review 
 
 
The amendment submitted on March 10, 2020 for the project identified above has been 
reviewed and approved by the Committee for Protection of Human Subjects (CPHS), the 
University of Oregon Institutional Review Board (IRB). The IRB has approved the changes 
to the research as described in the attached materials. As a reminder, it is your 
responsibility to submit any proposed changes for IRB review and approval prior to 
implementation. 
Amendment Description: 
• 
Addition of Camy Sibley to research personnel. 
For this research, the following determinations have been made: 
• 
This study has been reviewed under the pre-2018 Common Rule.  The study 
has been determined to be no greater than minimal risk and to qualify for 
expedited review as per Title 45 CFR 46.110 under Categories 5, 6, & 7. 
o 
Continuing Review is required for this study. 
• 
The activities approved with this continuation are limited to data analysis 
only.  No new enrollment, consenting, or data collection may occur under this 
approval status; any previously approved consents may not be used.  If you would 
like to reopen enrollment or collect new data for this protocol please submit an 
amendment application. 
• 
 The study as described satisfies the requirements for additional protections for 
children involved as subjects in research under 45 CFR Part 46.404. 
• 
The permission of one parent or guardian is sufficient for a child’s involvement in 
the research.  
• 
The IRB has approved an altered informed consent procedure under 45 CFR 
46.116(d) to allow for the follow-up verbal consent process as an extension of the 
consent procedure for the follow-up activities. 
 
Approval period: March 11, 2020 - October 14, 2020 
 
If you anticipate the research will continue beyond the IRB approval period, you must 
submit a Continuing Review Application at least 45-days prior to the expiration date. 
Without continued approval, the protocol will expire on October 14, 2020 and 
human subject research activities must cease.  A closure report must be submitted 
once human subject research activities are complete.  Failure to maintain current 
approval or properly close the protocol constitutes non-compliance.    

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
You are responsible for adhering to the Investigator Agreement submitted with the initial 
application for IRB review. The responsibilities of the agreement are reiterated at the end 
of this letter below. You are responsible for conduct of the research and must maintain 
oversight of all research personnel to ensure compliance with the IRB approved protocol. 
The University of Oregon and Research Compliance Services appreciate your commitment 
to the ethical and responsible conduct of research with human subjects.  
Sincerely, 
 
 
Brandi Fleck 
Research Compliance Administrator 
 
INVESTIGATOR AGREEMENT 
Principal Investigator and Faculty Advisor Responsibilities 
A. Conduct of the Research 
1. I accept responsibility for the ethical conduct of this research and protection 
of participants as set forth in the Belmont Report, Declaration of Helsinki, the 
Nuremberg Code, the Common Rule, and the ethical principles of my 
discipline. 
2. I accept responsibility for the conduct of this research ensuring this research 
is conducted according to 
a. 
sound research design and methods;  
b. 
the IRB approved protocol including the informed consent process;  
c. 
the applicable terms of the grant, contract and/or signed funding 
agreements; and 
d. 
applicable laws and regulations, including those for protecting the 
rights, safety, and welfare of human subjects.  
3. I certify that I am or my faculty advisor is sufficiently qualified by education, 
training, and/or experience to assume responsibility for the proper conduct of 
this research. I accept responsibility for ensuring that members of this 
research team, including study staff and trainees, are appropriately qualified, 
trained and supervised.  
4. I accept responsibility to personally conduct and/or directly supervise this 
research. I certify that I have sufficient time and resources to properly 
conduct and/or supervise this research for which I am responsible. 
B. Ensuring and Maintaining Compliance 
1. I will comply with relevant regulatory and institutional requirements, including 
those relating to conflicts of interest, responsible conduct of research and 
research misconduct.  

 
 
 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS ● RESEARCH COMPLIANCE SERVICES 
 
677 E. 12
th Ave., Suite 500, 5237 University of Oregon, Eugene OR 97401-5237 
 
T 541-346-2510  F 541-346-5138  http://rcs.uoregon.edu 
 
 
An equal-opportunity, affirmative-action institution committed to cultural diversity and compliance with the Americans with Disabilities Act 
INVESTIGATOR AGREEMENT 
Principal Investigator and Faculty Advisor Responsibilities 
2. I understand it is my responsibility to ensure that any research personnel, 
including myself, responsible for the design, conduct, and reporting of 
research declare any potential conflicts of interests related to the research 
and to maintain current records. I will ensure changes in conflicts of interest 
are promptly disclosed to the IRB.  
3. I will ensure that informed consent is obtained as approved by the IRB and a 
copy is provided to participants, unless the IRB waives these requirements.  
4. I will obtain initial IRB approval prior to implementing human subject research 
activities as well as prior approval for any amendments to this research.  
5. I will conduct this research within the approval period issued by the IRB. I 
agree to submit a request for continuing review of this research at least 45 
days in advance of the expiration date.  
6. I will submit a closure report form prior to protocol expiration or within 45 
days of completion of all activities involving human subjects or identifiable 
participant data. 
7. I will maintain approval, as applicable, with collaborative entities including 
approvals from other countries or jurisdictions. 
8. I will promptly report to the IRB (no later than seven days of discovery) any 
instances of noncompliance with the approved protocol or requirements of the 
IRB and any unanticipated problems.  
9. I will assist in the facilitation of any monitoring and/or auditing of study 
activities and/or records as required by the IRB, funding entities, sponsors, 
and any federal and state regulatory agencies.  
C. Investigator Records, Reports and Documentation 
1. I will maintain research records, all protocol materials, and any other 
documents associated with this research (e.g., research plan, signed consent 
forms, and IRB correspondence). 
2. I will maintain records for at least three years after this research ends, or for 
the length of time specified in applicable regulations or institutional or sponsor 
requirements, whichever is longer. I will take measures to prevent accidental 
or premature destruction of these documents. 
3. I will ensure the safe and secure storage of this research data (whether in 
paper or electronic formats) and for protecting the confidentiality of the data 
in accordance with the approved protocol. 
4. I will submit written reports to the IRB and permit inspection of the research 
records as required by the IRB.  
 

Page 1 of 5 
KEEP-P Caseworker Consent 
IRB: 07/16/2015 
	  
	  
 
Statement of Informed Consent: Caseworker 
KEEP-P project 
	  
The foster family of a child on your caseload has been invited to be in a research project at the University of 
Oregon Prevention Science Institute called Keeping Foster and Kinship Parents Supported and Trained – 
Preschoolers (KEEP-P); the child will participate in parent-child interactions and developmental assessments. 
The KEEP-P project’s main goal is to find out what type of services can be helpful for foster families, 
particularly in reducing stress for foster parents and young foster children and in improving placement stability. 
This study is being conducted by Phil Fisher, PhD from the University of Oregon. Dr. Fisher is also affiliated 
with Oregon Social Learning Center (OSLC) and OSLC Community Programs. The National Institute of Child 
Health and Human Development is funding this project (grant #1R01HD0757516-01). 
	  
Do you want this child to participate? 
As this child’s caseworker, you are part of the decision process for this child to be in the project. The child’s 
foster parent(s) will also provide consent. Before you decide, you need to know the risks and benefits for this 
child. You should also know what we would ask him/her to do. Please take your time to read this form. The 
form explains the project. A staff member will also explain the project and answer your questions. 
	  
If you allow this child to be in this project, you will sign this consent form. When you sign the consent form, 
you “give consent.” This means that you agree to allow this child to be in the project. It also means that you 
understand what we will ask him/her to do. Please review this form and the consent form carefully. Staff will 
answer any questions you have before you sign this form. 
	  
What is the purpose of the project? 
KEEP-P is a new program being evaluated by researchers at the University of Oregon (UO). This project is a 
research and intervention study. We collect information about foster parents and children’s lives. We will use 
this information to learn more about caregiver stress and child behavior. During this study, the child will 
complete one pre-test visit and one post-test visits. This project will compare two types of parenting support. 
What makes this a research study is that we don’t know which is better. By the end of the project, we hope to 
know more about the types of support that best help parents. 
	  
Every child in the project will be put into one of two groups. Both groups will attend parent meetings for 12 
weeks. All families will do the research assessments described below. One group will do the regular KEEP-P 
curriculum and one group will do a revised version (KEEP-V) that includes a video coaching component.  The 
family/child will be put in one of these groups randomly, such as by a lottery system. You will not be able to 
choose the group.  This is part of the research design. 
	  
KEEP-P parent groups have two main purposes: (1) to help parents build skills to support their child’s development 
and (2) to provide parents with support.  Topics include tools caregivers can use everyday like setting up routines, 
praising good behavior and setting limits.  KEEP-P foster parent groups meet weekly for twelve-weeks. Groups are 
two hours long. Childcare and food is provided. 
  
KEEP-V includes video coaching. The KEEP-V facilitator will film the caregiver and child together and show the 
caregiver clips of the things that they are already doing to help the child learn and grow. The filming sessions are 
quick and easy. Every other week, a facilitator will meet with the caregiver and child at their home or at the group 
location to film them both together for 10 minutes doing everyday activities like playing or having a snack. The next 
week at the group meeting the facilitator will show parts of the video in which families are doing things that support 

2	  
KEEP-P Caseworker Consent 
 
	  
the child’s development. The coach will encourage caregivers to notice these skills at home in-between sessions. 
Whether you, or the family and/or child, choose to take part in this research or not, none of the usual services 
the family or child receive through the child welfare system will be affected. 
 
What will we ask the child to do if she/he joins the project? 
We will ask the child to do two interviews over the next 18 months.  The details of each visit are listed in the 
chart below:  
	    
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“BASELINE”             
1st   
Foster Parent 
In person interview & questionnaires 
Videotaped interaction between foster 
parent and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Foster Child 
Game-like activities 
 About 90 mins. 
Prize 
 
Parent Group Meetings	  
2 hours a week for  
12 weeks	    
“6 MONTH”             
2nd   
Foster Parent 
In person interview & questionnaires 
Videotaped interaction between foster 
parent and child   
 About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Foster Child 
Game-like activities 
 About 90 mins. 
Prize 
“12 MONTH”           
3rd 
Foster Parent 
Interview & questionnaires 
 About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
“18 MONTH”           
4th 
Foster Parent 
Interview & questionnaires 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
	  
The interviews and questionnaires cover many topics.  We will be asking the foster parent about the child’s 
behaviors, social skills, and about parenting practices and attitudes. We will ask the foster parent and the child to 
complete parent-child interaction games/tasks and will be completing developmental assessments with the child. 
We will also be calling the foster parent 3 times after each assessment period to ask about the child’s behaviors. 
The parent groups occur between the 1st interview and the 2nd interview.  
	  
What other types of information will the project collect? 
This project collects information in different ways. We will ask the child to interact with project staff during 
game-like activities.  This child will also be asked to interact with his/her caregiver in an activity.  We will also 
collect information from foster parents from questionnaires. We record activities with video cameras. 
 
We also collect: 

Page 3 of 5 
KEEP-P Caseworker Consent 
IRB: 07/16/2015 
	  
	  
•   information from agencies such as child welfare 
•   physical information (height, weight, head circumference) 
 
How long is the project? 
The project is planned to last for five years until June 2018. The child will be asked to be in 6 months of this 
project but we will collect data about the child for 18 months. 
	  
Who else will take part? 
About 240 children and their foster parents will be in this project. All of the families have foster children who 
are ages 2.5 to 6 years old. 
	  
	  
Would the UO ever ask this family to stop participating? 
Yes, sometimes situations change.  For example, this child might return home to his/her biological parents or 
move to another foster home. If the child leaves his/her current foster placement, the foster family would no 
longer be able to participate. We will continue to ask for the child’s participation, seeking consent from the 
child’s current caregiver (foster, biological, adoptive). 
	  
	  
What happens if the child needs more or different services/treatment? 
Sometimes you or project staff might feel that the child needs other help. We can give you or their current 
caregiver information or contacts for other services. 
	  
What are this child’s rights as a participant in this project? 
This child has certain rights while he/she is in this project. These rights help protect him/her. 
•   You and this child can decide to be in the project or not. It is voluntary and always your and the child’s 
choice. 
•   You or this child can change your mind about being in this project at any time. If this child decides to 
quit the project, or if you decide that the child should quit the project, there will be no negative results of 
any kind. 
•   The child can choose not to participate in any or all of the interview activities. They are important to the 
project and we would like him/her to answer them completely. But if there are some questions he/she 
does not want to answer or activities he/she does not want to complete, he/she may skip them and move 
on to other questions. 
•   The child also has the right not to do other parts of the project. 
•   You will get a copy of this Consent Form. 
•   You and this child are free to ask questions about the project at any time. You may contact the Principal 
Investigator, Phillip Fisher, PhD at 541-346-4968 or philf@uoregon.edu or the Program Manager, 
Kristen Greenley at 541-346-8073 or kdg@uoregon.edu. You can call collect. The address is: 427 LISB 
6217 University of Oregon, Eugene, OR 97403. 
•   If you would like to contact someone outside the study with questions or concerns about the study or 
your rights or the child’s rights as a research participant, please feel free to contact the Research 
Compliance Services, 5237 University of Oregon, Eugene, OR 97403, (541) 346-2510. The UO 
Research Compliance Services oversees the review of the research to protect your rights and is not 
involved with this study. 
 

4	  
KEEP-P Caseworker Consent 
 
	  
 
How will this child’s privacy (or confidentiality) be protected? 
We will do all we can to keep everything about this child completely private. Here are the ways that we protect 
his/her privacy. 
•   We use a number instead of his/her name on all the information about him/her that we study and 
analyze. 
•   We store all information in safe, locked areas. 
•   We study information from everyone in the project as a group, not as individuals. When we share 
project results, we will not identify any one person. We will not use names or other personal 
information. 
•   We train all staff members to protect the child’s privacy. Only a small number of them will see his/her 
information. In some cases, the agency, the National Institutes of Child Health and Human 
Development, that is responsible for and funding this project might see information about him/her as part 
of their review of our project. They are also required to protect this child’s privacy. 
•   We will not share this child’s answers with anyone without your permission. We will not share 
anyone else’s answers with you or this child, including answers from his/her family 
members/caregivers. 
Are there times when we will share information about this child? 
Yes, these are called “exceptions to confidentiality.” Project staff will keep all of this child’s information 
private, except in the following cases:  
•   We might hear or see something that we think is current or past abuse of a child. We might see or hear 
something that tells us that a child is in danger. Or we might learn that a child has witnessed violence 
(such as adults fighting in the home). In cases like these, we will take action to protect the child. We 
will talk to the child’s caregiver and/or the child welfare agency. 
•   We will also report if we hear that this child plans to hurt themselves or someone else. 
	  
What are the possible risks to this child as a participant in the project? 
As a participant in this project, there are a few risks: 
•   We collect personal information about this child. There is the chance that someone who should not see 
his/her information might see it. 
•   This child might feel uncomfortable with some parts of the project. For example, the game-like activities 
may be frustrating to some children.  He/she is free to say “no” or stop at any part. 

Page 5 of 5 
KEEP-P Caseworker Consent 
IRB: 07/16/2015 
	  
	  
	  
	  
What are the benefits to this family and child as participants? 
 
Potential benefits for the children include prevention of behavioral and emotional problems and improved 
adjustment at home, in daycare, preschool and school, and in the community. Benefits to foster, kin, and 
biological parents may be an increase in their knowledge and ability to work with their child, resulting in greater 
satisfaction in their role as parents or foster parents. In addition, with increased skills, foster parents may be less 
likely to request that a foster child be removed because of difficult behaviors. All participants are expected to 
benefit in that they will derive satisfaction from contributing to the knowledge gained from this research.  
	  
What will be done with the information we collect for this project? 
We will use information from this project for research and education only. We will share the results of the 
project in papers, books and presentations. We might share results and data with other education or research 
centers. We will not use names or other personal information when we share project results or data. 
	  
	  
I have read and I understand the information on this consent form. I have had all my questions answered. I agree 
to participate in the KEEP-P research and intervention study at the University of Oregon, Prevention Science 
Institute. 
	  
	  
	  
	  
	  
	  
Signature 
Date 
	  
	  
Print name 
	  
	  
Participating Child’s Name 
	  
	  
KEEP-P Staff Signature 
 
 
Authorization for Audiovisual Recording 
I authorize the KEEP-P team to use audiovisual recording made of the child for the purpose of providing services 
and training. 
 
Upon written notice I may have all of the audiovisual recordings erased and/or restrict their use to one or more of the 
above stated purposes. I understand that all audiovisual recordings are available for viewing by me.  
 
Print name_______________________________________Date _______  Initial   ________ 
 

Page 1 of 5 
KEEP-P Caregiver Consent  
IRB: 7/16/2015 
	  
	  
Statement of Informed Consent: Caregiver 
KEEP-P project 
	  
You are invited to be in a research project at the University of Oregon Prevention Science Institute called Keeping 
Parents Supported – Preschoolers (KEEP-P) with your foster child. The KEEP-P project’s main goal is to find out 
what type of services can be helpful for foster families, particularly in reducing stress for foster parents and young 
foster children and in improving placement stability. This study is being conducted by Phil Fisher, PhD from the 
University of Oregon. Dr. Fisher is also affiliated with Oregon Social Learning Center (OSLC) and OSLC 
Community Programs. The National Institute of Child Health and Human Development is funding this project 
(grant #1R01HD0757516-01). 
 
Do you want to participate? 
It is your decision to be in the project and to give permission for your foster child to be in the project. Before you 
decide, you need to know the risks and benefits. You should also know what we will ask you and your child to do. 
Please take your time to read this form. The form explains the project. A staff member will also explain the project 
and answer your questions. 
 
If you agree to be in this project you will sign this consent form. When you sign the consent form, you “give 
consent.” This means that you agree to be in the project. It also means that you understand what we will ask you to 
do. Please review this form and the consent form carefully. Staff will answer any questions you have before you 
sign these forms. 
 
What is the purpose of the project? 
KEEP-P is a new program being evaluated by researchers at the University of Oregon (UO). This project is a 
research and intervention study. We will collect information about foster parents and children’s lives. We will use 
this information to learn more about caregiver stress, child placement stability, and child behavior.  This project 
will compare two types of parenting support. What makes this a research study is that we don’t know which is 
better.  By the end of the project, we hope to know more about the types of support that best help parents. 
 
Every family in the project will be put into one of two groups. Both groups will attend parent meetings for 12 
weeks. One group will do the regular KEEP-P curriculum and one group will do a revised version (KEEP-V) that 
includes a video coaching component.  You will be put in one of the groups randomly, such as by a lottery system. 
You will not be able to choose the group.  This is part of the research design.  
 
KEEP-P parent groups have two main purposes: (1) to help foster parents build skills to support their child’s 
development and (2) to provide foster parents with support.  Topics include tools foster parents can use everyday 
like setting up routines, praising good behavior and setting limits.  KEEP-P parent groups meet weekly for twelve-
weeks. Groups are two hours long. Childcare and food is provided. 
  
KEEP-V includes video coaching. Your KEEP-V facilitator will film you and your child together and show you 
clips of things that you are already doing that help your child learn and grow. The filming sessions are quick and 
easy. Every other week, your facilitator will meet with you at home or at the group location to film you and your 
child together for 10 minutes doing everyday activities like playing or having a snack. The next week at the group 
meeting your facilitator will show parts of the video in which you are doing things that support your child’s 
development. Your coach will encourage you to notice these skills at home in-between sessions. 
 
Whether you choose to take part in this research or not, none of the usual services you receive through the child 
welfare system will be affected. However, because this is a research and intervention study participants who take 
part in the research will have priority in attending the parent group meetings. 
 

2	  
KEEP-P Caregiver Consent 
	  
 
 
What will we ask you to do if you choose to be in the project? 
We will ask you and your foster child to do two interviews and then two more with just you, over the course of 
the next 18 months.  The details of each visit are listed in the chart below:  
 
	    
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“BASELINE”             
1st   
Foster Parent 
In person interview & questionnaires 
Videotaped interaction between foster 
parent and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Foster Child 
Game-like activities 
About 90 mins. 
Prize 
 
Parent Group meetings	  
2 hours a week for 
12 weeks	    
“6 MONTH”             
2nd   
Foster Parent 
In person interview & questionnaires 
Videotaped interaction between foster 
parent and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Foster Child 
Game-like activities 
About 90 mins. 
Prize 
“12 MONTH”            
3rd 
Foster Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
“18 MONTH”            
4th 
Foster Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
 
The interviews and questionnaires cover many topics. We will be asking you about your child’s behaviors, social 
skills, and about parenting practices and attitudes. We will ask you and your child to complete parent- child 
interaction games/tasks and will be completing developmental assessments with your child. We will also be calling 
you 3 times after each assessment period to ask about your child’s behaviors. The parent groups occur between the 
1st interview and the 2nd interview.  
	  
What other types of information will the project collect? 
This project collects information in different ways. We will ask your child to interact with project staff during 
game-like activities and we will ask your child to interact with you in an activity. We will ask you questions using 
questionnaires. You will answer questions on paper or on a computer. We record activities with video cameras. 
	  
We also collect: 
•  
information from agencies such as child welfare 
•  
physical information (height, weight, head circumference) 
 

Page 3 of 5 
KEEP-P Caregiver Consent  
IRB: 7/16/2015 
	  
	  
 
How long is the project? 
The project is planned to last for five years until June 2018. You and your family will be asked to be in 18 months 
of this project. 
	  
Who else will take part? 
About 240 children and their foster parents will be in this project. All of the families have foster children who are 
ages 2.5 to 6 years old. 
	  
Would the U of O ever ask you to stop participating? 
Yes, sometimes situations change.  For example, your foster child might return home to his/her biological parents 
or move to another foster home. If your foster child leaves your home, you would no longer be able to participate. 
We will continue to ask for the child’s participation, seeking consent from the child’s current caregiver (foster, 
biological, adoptive). 
	  
What happens if you need more or different services/treatment? 
Sometimes you or project staff might feel that you or your foster child needs other help. We can give you 
information or contacts for other services. 
	  
What are your rights as a participant in this project? 
You have certain rights while you are in this project. These rights help protect you. 
 
•  
You and your child can decide to be in the project or not. It is voluntary and always your and your 
child’s choice. 
•  
You can change your mind about being in this project at any time. If you decide to quit the project, there 
will be no negative results of any kind. 
•  
You can skip or not answer any question. Some questions might be personal or sensitive. They are 
important to the project and we would like you to answer them honestly. But if there are some questions 
you do not want to answer, you may skip them and move on to other questions. 
•  
You also have the right not to do other parts of the project. 
•  
You will get a copy of this Consent Form. 
•  
You are free to ask questions about the project at any time. You may contact the Principal Investigator, 
Phillip Fisher, PhD at 541-346-4968 or philf@uoregon.edu or the Project Coordinator, Kristen Greenley at 
541-346-8073 or kdg@uoregon.edu. You can call collect.                                                                          
The address is: 427 LISB, 6217 University of Oregon, Eugene, OR 97403. 
•  
If you would like to contact someone outside the study with questions or concerns about the study or your 
rights as a research participant, please feel free to contact the Research Compliance Services, 5237 
University of Oregon, Eugene, OR 97403, (541) 346-2510. The UO Research Compliance Services 
oversees the review of the research to protect your rights and is not involved with this study. 
 
 
 
 
 

4	  
KEEP-P Caregiver Consent 
	  
 
How will your privacy (or confidentiality) be protected? 
We will do all we can to keep everything about you and your family completely private. Here are the ways that we 
protect your privacy. 
•  
We use a number instead of your name on all the information about you that we study and analyze. 
•  
We store all information in safe, locked areas. 
•  
We study information from everyone in the project as a group, not as individuals. When we share 
project results, we will not identify any one person. We will not use names or other personal 
information. 
•  
We train all staff members to protect your privacy. Only a small number of them will see your 
information. In some cases, the agency, the National Institute of Child Health and Human Development, 
that is responsible for and funding this project might see information about you as part of their review of 
our project. They are also required to protect your privacy. 
•  
We will not share your answers with anyone without your permission. We will not share anyone else’s 
answers with you, including answers from your family members. 
 
Are there times when we will share information about you? 
Yes, these are called “exceptions to confidentiality.” Project staff will keep all of your information private, except 
in the following cases:  
•  
We might hear or see something that we think is abuse of a child. We might see or hear something that 
tells us that a child is in danger. Or we might learn that a child has witnessed violence (such as adults 
fighting in the home). In cases like these, we will take action to protect the child. We will talk to you 
and/or the child welfare agency. 
•   We will also report when we hear that someone plans to hurt themselves or someone else. 
What are the possible risks to you as a participant in the project? 
As a participant in this project, there are a few risks to you: 
•   We collect personal information about you and your foster child. There is the chance that someone who 
should not see your information might see it. 
•  
You might feel uncomfortable with some parts of the project. For example, some questions we ask are 
personal. Or you might feel uncomfortable being videotaped. You are free to say “no” to any part. 
 
What are the benefits to you as a participant? 
Potential benefits for the children include prevention of behavioral and emotional problems and improved 
adjustment at home, in daycare, preschool and school, and in the community. Benefits to foster, kin, and biological 
parents may be an increase in their knowledge and ability to work with their child, resulting in greater satisfaction in 
their role as parents or foster parents. In addition, with increased skills, foster parents may be less likely to request 
that a foster child be removed because of difficult behaviors. All participants are expected to benefit in that they will 
derive satisfaction from contributing to the knowledge gained from this research.  
	  
Payments 
If you receive over $600 per year from the University of Oregon for participating in research studies, you will be 
asked to fill out information for an IRS W9 form for tax purposes. We will report the amount you receive as a 
participant for tracking purposes. 
	  
	  

Page 5 of 5 
KEEP-P Caregiver Consent  
IRB: 7/16/2015 
	  
	  
 
What will be done with the information we collect for this project? 
We will use information from this project for research and education only. We will share the results of the project 
in papers, books and presentations. We might share results and data with other education or research centers. We 
will not use names or other personal information when we share project results or data. 
 
I have read and I understand the information on this consent form. I have had all my questions answered.  
I agree to take part in the KEEP-P research and intervention study at the University of Oregon, Prevention Science 
Institute. 
	  
	  
	  
	  
	  
	  
Signature 
Date 
	  
	  
Print name 
 
	  
Signature 
Date 
	  
	  
Print name 
 
 
Print Participating Child’s Name 
 
	  
	  
Staff Signature 
Date 
 
Authorization for Audiovisual Recording 
I authorize the KEEP-P team to use audiovisual recording made of me (us) and of my (our) family for the purpose 
of providing services and training. 
 
Upon written notice I (we) may have all of the audiovisual recordings erased and/or restrict their use to one or more 
of the above stated purposes. I (we) understand that all audiovisual recordings are available for viewing by me (us). 
This release must be initialed by all family members 14 years or over participating in services. 
 
Print name_______________________________________Date _______  Initial   ________ 
 
Print name _______________________________________Date _______  Initial   ________ 
 
	  

Page 1 of 5 
KEEP-P Parent Consent  
IRB: 7/16/15     
 	  
	  
	  
Statement of Informed Consent: Parent  
KEEP-P project 
	  
You are invited to be in a continuing research project at the University of Oregon Prevention Science 
Institute called, Keeping Parents Supported – Preschoolers (KEEP-P) with your child. The KEEP-P project’s 
main goal is to find out what type of services can be helpful for foster parents, particularly in reducing stress 
and improving placement stability. This study is being conducted by Phil Fisher, PhD from the University of 
Oregon. Dr. Fisher is also affiliated with Oregon Social Learning Center (OSLC) and OSLC Community 
Programs. The National Institute of Child Health and Human Development is funding this project (grant 
#1R01HD0757516-01). 
	  
Do you want to participate? 
It is your decision to be in the project and to give permission for your child to be in the project. Before you 
decide, you need to know the risks and benefits. You should also know what we will ask you and your child 
to do. Please take your time to read this form. The form explains the project. A staff member will also explain 
the project and answer your questions. 
	  
If you agree to be in this project you will sign this consent form. When you sign the consent form, you “give 
consent.” This means that you agree to be in the project. It also means that you understand what we will ask 
you to do. Please review this consent form carefully. Staff will answer any questions you have before you 
sign the form. 
	  
What is the purpose of the project? 
KEEP-P is a new program being evaluated by researchers at the University of Oregon (UO). This project is a 
research and intervention study. We collect information about parents and children’s lives. We will use this 
information to learn more about caregiver stress, child placement stability, and child behavior. By the end of 
the project, we hope to know more about the types of support that best help children.  
 
Whether you choose to take part in this research or not, none of the usual services you may receive through 
the child welfare system will be affected. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

2	  
KEEP-P Parent Consent  
	  
	  
 
What will we ask you to do if you choose to be in the project? 
This chart lists the details of the visit(s):  
NOTE: the caregiver/parent will receive the version of the chart that coincides with the Interview time 
point. 
[VERSION FOR PARENTS JOINING STUDY AT 6 MONTH VISIT] 
	    
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“6 MONTH”             
1st   
Caregiver/Parent 
In person interview & questionnaires 
Videotaped interaction between parent 
and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Child 
Game-like activities 
About 90 mins. 
Prize 
“12 MONTH”           
    2nd 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
“18 MONTH”         
    3rd 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
 About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
 
[VERSION FOR PARENTS JOINING STUDY AT 12 MONTH VISIT] 
   
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“12 MONTH”           
1st 
Parent 
 Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
“18 MONTH”         
    2nd 
 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
 About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
 
[VERSION FOR PARENTS JOINING STUDY AT 18 MONTH VISIT] 
   
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“18 MONTH”           
 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
 About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
 

Page 3 of 5 
KEEP-P Parent Consent  
IRB: 7/16/15     
 	  
	  
The interviews and questionnaires cover many topics. We will be asking you about your child’s behaviors, 
social skills, and about parenting practices and attitudes. [For 6 MONTH interview only] We will ask you 
and your child to complete parent-child interaction games/tasks and will be completing developmental 
assessments with your child. We will also be calling you 3 times after each assessment period to ask about 
your child’s behaviors. 
	  
What other types of information will the project collect? 
This project collects information in different ways. [For 6 MONTH interview only] We will ask your child to 
interact with project staff during game-like activities and we will ask your child to interact with you in an 
activity. We will ask you questions using questionnaires. You will answer questions on paper or on a 
computer. [For 6 MONTH interview only] We record activities with video cameras. 
	  
We also collect: 
•   information from agencies such as child welfare 
•   physical information (height, weight, head circumference) [For 6 MONTH interview only] 
	  
How long is the project? 
The project is planned to last for five years until June 2018. You and your family will be asked to be in [12, 6 
or 1 month(s)] of this project. 
	  
Who else will take part? 
About 240 children and their caregivers will be in this project.  
	  
Would the U of O ever ask you to stop participating? 
Yes, sometimes situations change. If your child leaves your home, you would no longer be able to participate. 
If this happens, we may continue to ask for the child’s participation, seeking consent from the child’s current 
caregiver. 
	  
What happens if you need more or different services/treatment? 
Sometimes you or project staff might feel that you or your child needs help. We can give you information or 
contacts for other services. 
	  
What are your rights as a participant in this project? 
You have certain rights while you are in this project. These rights help protect you. 
 
•   You and your child can decide to be in the project or not. It is voluntary and always your and 
your child’s choice. 
•   You can change your mind about being in this project at any time. If you decide to quit the project, 
there will be no negative results of any kind. 
•   You can skip or not answer any question. Some questions might be personal or sensitive. They are 
important to the project and we would like you to answer them honestly. But if there are some 
questions you do not want to answer, you may skip them and move on to other questions. 
•   You also have the right not to do other parts of the project. 
•   You will get a copy of this Consent Form. 
•   You are free to ask questions about the project at any time. You may contact the Principal 
Investigator, Phillip Fisher, PhD at 541-346-4968 or philf@uoregon.edu or the Project Coordinator, 

4	  
KEEP-P Parent Consent  
	  
	  
Kristen Greenley at 541-346-8073 or kdg@uoregon.edu. You can call collect.                                                 
The address is: 427 LISB, 6217 University of Oregon, Eugene, OR 97403. 
•   If you would like to contact someone outside the study with questions or concerns about the study or 
your rights as a research participant, please feel free to contact the Research Compliance Services, 
5237 University of Oregon, Eugene, OR 97403, (541) 346-2510. The UO Research Compliance 
Services oversees the review of the research to protect your rights and is not involved with this study. 
How will your privacy (or confidentiality) be protected? 
We will do all we can to keep everything about you and your family completely private. Here are the ways 
that we protect your privacy. 
	  
•   We use a number instead of your name on all the information about you that we study and analyze. 
•   We store all information in safe, locked areas. 
•   We study information from everyone in the project as a group, not as individuals. When we 
share project results, we will not identify any one person. We will not use names or other 
personal information. 
•   We train all staff members to protect your privacy. Only a small number of them will see your 
information. In some cases, the agency, the National Institute of Child Health and Human 
Development, that is responsible for and funding this project might see information about you as part 
of their review of our project. They are also required to protect your privacy. 
•   We will not share your answers with anyone without your permission. We will not share anyone 
else’s answers with you, including answers from your family members. 
Are there times when we will share information about you? 
Yes, these are called “exceptions to confidentiality.” Project staff will keep all of your information private, 
except in the following cases:  
 
•   We might hear or see something that we think is abuse of a child. We might see or hear something 
that tells us that a child is in danger. Or we might learn that a child has witnessed violence (such as 
adults fighting in the home). In cases like these, we will take action to protect the child. We will talk 
to you and/or the child welfare agency. 
•   We will also report when we hear that someone plans to hurt themselves or someone else. 
What are the possible risks to you as a participant in the project? 
As a participant in this project, there are a few risks to you: 
•   We collect personal information about you and your child. There is the chance that someone who 
should not see your information might see it. 
•   You might feel uncomfortable with some parts of the project. For example, some questions we ask 
are personal. Or you might feel uncomfortable being videotaped. You are free to say “no” to any 
part. 
	  
	  
What are the benefits to you as a participant? 
Potential benefits for the children include prevention of behavioral and emotional problems and improved 
adjustment at home, in daycare, preschool and school, and in the community. Benefits to foster, kin, and 
biological parents may be an increase in their knowledge and ability to work with their child, resulting in 
greater satisfaction in their role as parents or foster parents. All participants are expected to benefit in that they 
will derive satisfaction from contributing to the knowledge gained from this research.  
	  

Page 5 of 5 
KEEP-P Parent Consent  
IRB: 7/16/15     
 	  
	  
	  
Payments 
If you receive over $600 per year from the University of Oregon for participating in research studies, you will be 
asked to fill out information for an IRS W9 form for tax purposes. We will report the amount you receive as a 
participant for tracking purposes. 
	  
What will be done with the information we collect for this project? 
We will use information from this project for research and education only. We will share the results of the 
project in papers, books and presentations. We might share results and data with other education or research 
centers. We will not use names or other personal information when we share project results or data. 
 
	  
I have read and I understand the information on this consent	  form. I have had all my questions answered. 
I give permission for my own participation and [For	  6	  MONTH	  interview	  only]	  my child (listed below) to take 
part in the KEEP-P research	  study	  at	  the	  University	  of	  Oregon,	  Prevention	  Science	  Institute. 
 
[For	  6	  MONTH	  interview	  only]	  By signing this consent, I am stating that I am legally authorized to consent for 
this child to take part. 
	  
	  
	  
Signature 
Date 
	  
	  
Print name 
	  
 
Signature 
Date 
	  
	  
Print name 
 
 
Print Participating Child’s Name 
 
	  
	  
Staff Signature 
Date 
 
[For 6 MONTH interview only] Authorization for Audiovisual Recording 
I authorize the KEEP-P team to use audiovisual recording made of me (us) and of my (our) family for the purpose 
of providing services and training. 
 
Upon written notice I (we) may have all of the audiovisual recordings erased and/or restrict their use to one or more 
of the above stated purposes. I (we) understand that all audiovisual recordings are available for viewing by me (us). 
This release must be initialed by all family members 14 years or over participating in services. 
 
Print name_______________________________________Date _______  Initial   ________ 
 
Print name _______________________________________Date _______  Initial   ________	  

Page 1 of 5 
KEEP-­‐‑P	  Community	  Consent	  	  
IRB:	  July	  16,	  2015	  
	  
	  
Statement of Informed Consent: Parent  
KEEP-P project 
	  
You are invited to be in a continuing research project at the University of Oregon Prevention Science Institute 
called, Keeping Parents Supported – Preschoolers (KEEP-P) with your child. The KEEP-P project’s main goal is 
to find out what type of services can be helpful for parents, particularly in reducing stress and improving 
placement stability. This study is being conducted by Phil Fisher, PhD from the University of Oregon. Dr. Fisher 
is also affiliated with Oregon Social Learning Center (OSLC) and OSLC Community Programs. The National 
Institute of Child Health and Human Development is funding this project (grant #1R01HD0757516-01). 
	  
Do you want to participate? 
It is your decision to be in the project and to give permission for your child to be in the project. Before you decide, 
you need to know the risks and benefits. You should also know what we will ask you and your child to do. Please 
take your time to read this form. The form explains the project. A staff member will also explain the project and 
answer your questions. 
	  
If you agree to be in this project you will sign this consent form. When you sign the consent form, you “give 
consent.” This means that you agree to be in the project. It also means that you understand what we will ask you to 
do. Please review this consent form carefully. Staff will answer any questions you have before you sign the form. 
	  
What is the purpose of the project? 
KEEP-P is a new program being evaluated by researchers at the University of Oregon (UO). This project is a 
research and intervention study. We will collect information about parents and children’s lives. We will use this 
information to learn more about caregiver stress, and child behavior. By the end of the project, we hope to know 
more about the types of support that best help children.  
 
Every family in the project will be put into one of two groups. Both groups will attend parent meetings for 12 
weeks. One group will do the regular KEEP-P curriculum and one group will do a revised version (KEEP-V) that 
includes a video coaching component. You will be put in one of the groups randomly, such as by a lottery system. 
You will not be able to choose the group.  This is part of the research design.  
 
KEEP-P parent groups have two main purposes: (1) to help parents build skills to support their child’s development 
and (2) to provide parents with support.  Topics include tools parents can use everyday like setting up routines, 
praising good behavior and setting limits.  KEEP-P parent groups meet weekly for twelve-weeks. Groups are two 
hours long. Childcare and food is provided. 
  
KEEP-V includes video coaching. Your KEEP-V facilitator will film you and your child together and show you 
clips of things that you are already doing that help your child learn and grow. The filming sessions are quick and 
easy. Every other week, your facilitator will meet with you at home or at the group location to film you and your 
child together for 10 minutes doing everyday activities like playing or having a snack. The next week at the group 
meeting your facilitator will show parts of the video in which you are doing things that support your child’s 
development. Your coach will encourage you to notice these skills at home in-between sessions. 
 
Whether you choose to take part in this research or not, none of the other services your family receives (such as 
through EC CARES) will be affected. However, because this is a research and intervention study participants who 
take part in the research will have priority in attending the parent group meetings. 
 
	  
 
 
 

2	  
KEEP-­‐‑P	  Community	  Consent	  
	  
	  
 
What will we ask you to do if you choose to be in the project? 
We will ask you and your child to do two interviews and then two more with just you, over the course of	  the	  next	  18	  
months.	   
This chart lists the details of the visit(s):  
   
Interviews   
What will happen   
How long 
How much 
you will 
receive 
“BASELINE”             
1st   
Parent 
In person interview & questionnaires 
Videotaped interaction between parent 
and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Child 
Game-like activities 
About 90 mins. 
Prize 
 
Parent Group meetings	  
2 hours a week for  
12 weeks   
“6 MONTH”             
2nd   
Parent 
In person interview & questionnaires 
Videotaped interaction between parent 
and child   
About 90 mins.   
$50 
3 telephone interviews 
5 minutes each   
Child 
Game-like activities 
About 90 mins. 
Prize 
“12 MONTH”             
3rd 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
“18 MONTH”             
4th 
Parent 
Interview & questionnaires 
(Completed in person or by phone and mail) 
About 90 mins. 
$50 
3 telephone interviews 
5 minutes each   
 
The interviews and questionnaires cover many topics. We will be asking you about your child’s behaviors, social 
skills, and about parenting practices and attitudes. We will ask you and your child to complete parent-child 
interaction games/tasks and will be completing developmental assessments with your child. We will also be calling 
you 3 times after each assessment period to ask about your child’s behaviors.  
The parent groups occur between the 1st interview and the 2nd interview.  
	  
What other types of information will the project collect? 
This project collects information in different ways. We will ask your child to interact with project staff during 
game-like activities and we will ask your child to interact with you in an activity. We will ask you questions using 
questionnaires. You will answer questions on paper or on a computer. We record activities with video cameras. 
	  
We also collect physical information (height, weight, head circumference)  
	  
	  
	  
	  

Page 3 of 5 
KEEP-­‐‑P	  Community	  Consent	  	  
IRB:	  July	  16,	  2015	  
	  
	  
 
 
How long is the project? 
The project is planned to last for five years until June 2018. You and your family will be asked to be in 18 months 
of this project. 
	  
Who else will take part? 
About 240 children and their caregivers will be in this project.  
 
What happens if you need more or different services/treatment? 
Sometimes you or project staff might feel that you or your child needs help. We can give you information or 
contacts for other services. 
	  
What are your rights as a participant in this project? 
You have certain rights while you are in this project. These rights help protect you. 
 
•  
You and your child can decide to be in the project or not. It is voluntary and always your and your 
child’s choice. 
•  
You can change your mind about being in this project at any time. If you decide to quit the project, there 
will be no negative results of any kind. 
•  
You can skip or not answer any question. Some questions might be personal or sensitive. They are 
important to the project and we would like you to answer them honestly. But if there are some questions 
you do not want to answer, you may skip them and move on to other questions. 
•  
You also have the right not to do other parts of the project. 
•  
You will get a copy of this Consent Form. 
•  
You are free to ask questions about the project at any time. You may contact the Principal Investigator, 
Phillip Fisher, PhD at 541-346-4968 or philf@uoregon.edu or the Project Coordinator, Kristen Greenley at 
541-346-8073 or kdg@uoregon.edu. You can call collect.                                                                              
The address is: 427 LISB, 6217 University of Oregon, Eugene, OR 97403. 
•  
If you would like to contact someone outside the study with questions or concerns about the study or your 
rights as a research participant, please feel free to contact the Research Compliance Services, 5237 
University of Oregon, Eugene, OR 97403, (541) 346-2510. The UO Research Compliance Services 
oversees the review of the research to protect your rights and is not involved with this study. 
 
 
 
 
 
 
 
 
 

4	  
KEEP-­‐‑P	  Community	  Consent	  
	  
	  
 
How will your privacy (or confidentiality) be protected? 
We will do all we can to keep everything about you and your family completely private. Here are the ways that we 
protect your privacy. 
	  
•  
We use a number instead of your name on all the information about you that we study and analyze. 
•  
We store all information in safe, locked areas. 
•  
We study information from everyone in the project as a group, not as individuals. When we share 
project results, we will not identify any one person. We will not use names or other personal 
information. 
•  
We train all staff members to protect your privacy. Only a small number of them will see your 
information. In some cases, the agency, the National Institute of Child Health and Human Development, 
that is responsible for and funding this project might see information about you as part of their review of 
our project. They are also required to protect your privacy. 
•  
We will not share your answers with anyone without your permission. We will not share anyone else’s 
answers with you, including answers from your family members. 
Are there times when we will share information about you? 
Yes, these are called “exceptions to confidentiality.” Project staff will keep all of your information private, except 
in the following cases:  
•  
We might hear or see something that we think is abuse of a child. We might see or hear something that 
tells us that a child is in danger. Or we might learn that a child has witnessed violence (such as adults 
fighting in the home). In cases like these, we will take action to protect the child. We will talk to you 
and/or the child welfare agency. 
•  
We will also report when we hear that someone plans to hurt themselves or someone else. 
What are the possible risks to you as a participant in the project? 
As a participant in this project, there are a few risks to you: 
•  
We collect personal information about you and your child. There is the chance that someone who should 
not see your information might see it. 
•  
You might feel uncomfortable with some parts of the project. For example, some questions we ask are 
personal. Or you might feel uncomfortable being videotaped. You are free to say “no” to any part. 
	  
	  
What are the benefits to you as a participant? 
Potential benefits for the children include prevention of behavioral and emotional problems and improved 
adjustment at home, in daycare, preschool and school, and in the community. Benefits to biological parents may be 
an increase in their knowledge and ability to work with their child, resulting in greater satisfaction in their role as 
parents. All participants are expected to benefit in that they will derive satisfaction from contributing to the 
knowledge gained from this research.  
	  
Payments 
If you receive over $600 per year from the University of Oregon for participating in research studies, you will be 
asked to fill out information for an IRS W9 form for tax purposes. We will report the amount you receive as a 
participant for tracking purposes. 
	  
	  
	  
	    

Page 5 of 5 
KEEP-­‐‑P	  Community	  Consent	  	  
IRB:	  July	  16,	  2015	  
	  
	  
 
What will be done with the information we collect for this project? 
We will use information from this project for research and education only. We will share the results of the project 
in papers, books and presentations. We might share results and data with other education or research centers. We 
will not use names or other personal information when we share project results or data. 
     
I have read and I understand the information on this consent form. I have had all my questions answered.  
 
I give permission for my own participation and my child (listed below) to take part in the KEEP-P research	  and	  
intervention	  study	  at	  the	  University	  of	  Oregon,	  Prevention	  Science	  Institute. 
 
By signing this consent, I am stating that I am legally authorized to consent for this child to take part. 
	  
	  
	  
Signature 
Date 
	  
	  
Print name 
	  
 
Signature 
Date 
	  
	  
Print name 
 
 
Print Participating Child’s Name 
 
	  
	  
Staff Signature 
Date 
 
Authorization for Audiovisual Recording 
I authorize the KEEP-P team to use audiovisual recording made of me (us) and of my (our) family for the purpose 
of providing services and training. 
 
Upon written notice I (we) may have all of the audiovisual recordings erased and/or restrict their use to one or more 
of the above stated purposes. I (we) understand that all audiovisual recordings are available for viewing by me (us). 
This release must be initialed by all family members 14 years or over participating in services. 
 
Print name_______________________________________Date _______  Initial   ________ 
 
Print name _______________________________________Date _______  Initial   ________ 
 

 
 
Prevention  Science  Institute  |  6217  University  of  Oregon  |  Eugene,  OR  97403-­6217  |  (541)  346-­4684  
  
  
Consent for Mutual Exchange of Information 
Date:   
 
 
Child Name: 
Birthdate:   
 
 
 
Parent/Legal Guardian/Surrogate Parent Name:   
 
This agency is hereby authorized to contact the following agencies or individuals listed below to share information which will 
help us to better serve you and your child. This authorization expires one year from the date signed. Choosing not to sign it 
will not affect your ability to participate. 
Name  
Type  of  Information  
Parent  Group  
  
Early Childhood CARES 
University of Oregon, 299 E. 18th Ave. Eugene OR. 97401 (541)346-2578 
Progress  
Other  
(Specify)  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
The parent has the right to revoke consent in writing at anytime. 
 
 
 
 
 
Parent, guardian or surrogate parent signature 
date 
 
 
 
 
 
Parent, guardian or surrogate parent signature 
date 
 
 
 
 
 
Staff signature 
date 
 
 
 
 
 
 
 
 
 
 
 
 
IRB: 07/16/15 
X