SMART Optimization of a Parenting Program for Active-duty Families
Phase: NA
Conditions: Parenting
Sponsor: University of Minnesota

PROTOCOL TITLE: SMART optimization of a parenting program for active-duty families 
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PROTOCOL TITLE: 
SMART optimization of a parenting program for active-duty families  
 
PRINCIPAL INVESTIGATOR or FACULTY ADVISOR: 
Abigail Gewirtz 
Institute of Translational Research in Children’s Mental Health  
612-624-1475 
agewirtz@umn.edu  
 
STUDENT INVESTIGATOR: NA 
 
VERSION NUMBER/DATE: 
V10, June 2019. 
 
 

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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
February 2017 
Initial IRB application  
 
2 
April 2017 
U of MI removed, ISII added, 
IIA for Glen Bloomstrom, waiver 
of consent and waiver of 
documentation of consent added, 
teacher consent updated, clearer 
language about how a copy of 
consent is provided 
Y- main consent, 
video consent and 
teacher consent 
 
June 2017 
Main consent was updated to 
reflect more accurate language 
regarding intervention 
descriptions, subject payments 
and additional language 
regarding mandated reporting 
(requirement to report to FAP). 
Y – main consent 
(v3 of consent) 
 
June 2017 
Final marketing materials 
submitted  
 
3 
August 2017 
Updated measures list, updated 
description of FITS, addition of 
child care for in-home 
assessments, clarification of 
randomization of child 
participant, 
clarification/inclusion of waiver 
of documentation of consent and 
waiver of consent that was 
approved in original application, 
other minor grammatical and 
clarifying edits. 
N 
4 
October 2017  
Additional language added to the 
Consent Process section. 
N 
5 
December 2017 
Certificate of Confidentiality 
obtained by NICHD; updated 
confidentiality section 
Y, main consent 
V4, teacher 
consent V3 
6 
May 2018  
Additional recruitment method 
added (refer a friend postcard) 
N 
7 
October 2018  
Addition of IIA’s for study sites 
with supervisor letters of 
support; added identification of 
facilitators at each site and 
description of their role; updated 
letter of support from study sites; 
Y – teacher 
consent (V4), 
main consent (V5) 
 

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Revision # 
Version Date 
Summary of Changes 
Consent Change? 
removal of JBLM as previous 
study site; addition of $100 
drawing for online only 
participants; TPRISK was added 
to the teacher consent form as an 
already approved measure; 
addition of telehealth delivery for 
the individual booster condition 
in Phase 2. 
8 
November 2018  Addition of childcare stipend to 
participants during intervention 
delivery 
N 
9 
May 2019 
Addition of Forts Belvoir and 
Myer as combined study site 
(FBM), recruitment from all 
active duty military branches 
affiliated with these sites, not just 
Army exclusive, as potential 
study participants. Updated 
power analysis. 
N 
10 
June 2019 
Moving of Focus Group activity 
to occur after Cohort 1 of 
intervention and not before 
program delivery per change in 
our Statement of Work approved 
by DoD. Submission of Fort 
Belvoir letter of support and Fort 
Myer Memo of Agreement. 
Y, addition of 
Focus Group 
consents form 
(V1) 
 
 
 
 

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Table of Contents 
 
1.0 
Objectives ................................................................................................................ 7 
2.0 
Background .............................................................................................................. 7 
3.0 
Study Endpoints/Events/Outcomes .......................................................................... 8 
4.0 
Study Intervention(s)/Interaction(s) ......................................................................... 8 
5.0 
Procedures Involved................................................................................................. 9 
6.0 
Data Banking ......................................................................................................... 21 
7.0 
Sharing of Results with Participants ...................................................................... 21 
8.0 
Study Duration ....................................................................................................... 21 
9.0 
Study Population .................................................................................................... 21 
10.0 Vulnerable Populations .......................................................................................... 22 
11.0 Number of Participants .......................................................................................... 23 
13.0 Withdrawal of Participants .................................................................................... 27 
14.0 Risks to Participants ............................................................................................... 27 
15.0 Incomplete Disclosure or Deception ...................................................................... 29 
16.0 Potential Benefits to Participants ........................................................................... 29 
17.0 Data Management .................................................................................................. 30 
18.0 Confidentiality ....................................................................................................... 31 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 34 
20.0 Provisions to Protect the Privacy Interests of Participants .................................... 34 
21.0 Compensation for Research-Related Injury ........................................................... 34 
22.0 Consent Process ..................................................................................................... 34 
23.0 Setting .................................................................................................................... 36 
24.0 Multi-Site Research ............................................................................................... 36 
25.0 Resources Available............................................................................................... 37 
26.0 References .............................................................................................................. 38 
 

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ABBREVIATIONS/DEFINITIONS: NA 
 
 

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STUDY SUMMARY 
 
Study Title 
SMART optimization of a parenting program for 
active-duty families 
Study Design 
Sequential multiple assignment randomization trial 
Primary Objective 
advance the “development, adaptation, efficiency or 
optimization, and testing of a prevention intervention 
by using a sequential, multiple assignment, 
randomized trial/SMART to test multiple components 
of an empirically-supported parent training prevention 
intervention – After Deployment Adaptive Parenting 
Tools (ADAPT)  
Secondary Objective(s) 
 
Primary Study Intervention 
or Interaction 
ADAPT, which is a Parent Management Training-
Oregon (PMTO) program for military families with 
children ages 5-12 years old. 
Study Population 
Active duty families 
Sample Size (number of 
participants) 
525 
Study Duration for 
Individual Participants 
2 years 
 
 
 

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1.0 
Objectives 
1.1 
Purpose:  
The overarching goal of the "SMART Optimization of a Parenting Program for 
Active-Duty Families" study is to advance the “development, adaptation, 
efficiency or optimization, and testing of a prevention intervention by using a 
sequential, multiple assignment, randomized trial/SMART to test multiple 
components of an empirically-supported parent training prevention intervention – 
After Deployment Adaptive Parenting Tools (ADAPT) for active-duty families 
negotiating multiple deployments and high deployment OPTEMPO (an army 
program that provides critical responses).   
2.0 
Background 
2.1 
Significance of Research Question/Purpose:  
Deployment (and particularly high deployment operational 
tempo/OPTEMPO can generate family and personal stressors that disrupt 
supportive social relationships and functioning at home, thereby 
weakening the strength of our military force in the field. Stressors include 
separation from, and reunification with families, concerns about 
mobilizations and combat stressors. These stressors, in turn, are associated 
with reduced parenting effectiveness, marital/partner difficulties, emotion 
dys-regulation, and increased coercion. Coercion predicts risk for child 
maladjustment, as well as marital disruptions. Without effective 
prevention interventions, such environments may contribute to high 
divorce rates, child maladjustment, and reductions in service member 
wellbeing.  
Most prevention interventions use a one-size-fits-all approach (i.e. all participants 
receive the same dose, format, and type of program) but this approach is often 
inefficient. Some families benefit from this approach but many do not. Adaptive 
interventions maximize efficiency, scalability, and sustainability, by providing 
families with a tailored dose, timing, program format, and/or sequence to improve 
outcomes based on their preferences and needs. 
2.2 
Preliminary Data:  
After Deployment: Adaptive Parenting Tools (ADAPT) is a Parent Management 
Training-Oregon (PMTO) program for military families with children ages 5-12 
years old.  PMTO is a theoretically-based family of interventions with extensive 
research supporting efficacy and effectiveness.  ADAPT was developed and 
tested primary with National Guard/Reserve families.  Program findings, based on 
3 RCTs, indicate positive outcomes. No empirically supported parent training 
programs have been validated in RCTs for active duty military families with 
school-aged children in regular and high deployment OPTEMPO contexts. 
2.3 
Existing Literature:  
We are proposing a Phase III Clinical trial. The SMART optimization of a 
parenting program for active-duty families uses an adaptive intervention strategy 

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to optimize an evidence-based universal prevention intervention, After 
Deployment Adaptive Parenting Tools/(ADAPT). SMART trials are rapidly 
gaining recognition within the medical and mental health fields as an innovative 
approach to developing adaptive treatment regimens (Almirall, Compton, 
Gunlicks-Stoessel, Duan & Murphy, 2012). SMARTs have been successfully 
implemented in diverse areas including interventions for cancer (Thall et al., 
2007), autism spectrum disorders (Kasari et al., 2014), adolescent depression 
(Almirall et al., 2012), and alcoholism (Murphy, Lynch, Oslin, McKay, & Ten 
Have, 2007). SMARTs also show considerable promise in innovating intervention 
approaches within prevention contexts (August, Piehler, & Bloomquist, 2014).   
3.0 
Study Endpoints/Events/Outcomes 
 
3.1 
Primary Endpoint/Event/Outcome: 
 
In this study, we will compress and test a variety of formats, sequences, and doses 
of ADAPT.  We will provide two 'first line' ADAPT programs and two slightly 
more intensive booster ADAPT programs for families who do not 'respond' to the 
first line intervention. Adaptive intervention strategies involve decision rules that 
specify how the type or intensity of an intervention should change depending on 
participants’ response on a predetermined indicator of initial progress within an 
intervention.56, 57, 58 Within a SMART, a measure of initial response is used 
following delivery of an intervention in order to evaluate each families’ need for 
further intervention programming. In this way, programming is tailored to meet 
the needs of individual families by providing additional services only to those 
families who are likely to benefit. This measure of initial response is referred to as 
a primary tailoring variable. In the proposed study, the primary tailoring variable 
is parental locus of control, a key variable shown in our prior studies to predict 
change in observed parenting effectiveness, as well as change in other outcomes 
(PTSD symptoms, suicidality, and child adjustment). 
 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
The tested formats, sequences, and doses of ADAPT include:   
(1) Begin with ADAPT Online.  Parents exhibiting initial response receive 
continued access to online resources.  Parents exhibiting non-response are 
stepped-up to booster individual face-to-face ADAPT. 
(2) Begin with ADAPT Online.  Parents exhibiting initial response receive 
continued access to online resources.  Parents exhibiting non-response are stepped 
-up to booster group-based ADAPT. 
(3) Begin with ADAPT condensed group (with online support). Parents exhibiting 
initial response receive continued access to online resources.  Parents exhibiting 
non-response are stepped to booster group-based ADAPT. 
(4) Begin with ADAPT condensed group (with online support). Parents exhibiting 
initial response continue access to online resources. Parents exhibiting non-
response are stepped-up to booster group-based ADAPT. 

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This approach allows families who do not need intensive services to receive 
appropriately brief services. Those higher-need families receive more intensive 
services. 
5.0 
Procedures Involved 
5.1 
Study Design:  
 
To address Aim 1, we will compress the ADAPT group and individual 
curriculum, through consultation with service members, spouse, and content 
experts. Curriculum adjustments will be initially made based on installation staff 
feedback during two weeks of facilitator training, as well as feedback obtained 
from non-study participants (military parents) during mock-workshops and groups 
led by newly trained facilitators. Focus groups will be convened after the first 
workshop is delivered. Findings will be shared as noted below and further 
modifications of the curriculum will be made, if deemed appropriate.  
 
Focus Groups: We will conduct two focus groups with participating study 
families,  one group with 12 Special Operations (SO) participants and one group 
with 12Regular Army (RA) participants, both at Fort Bragg, NC. To ensure 
gender sensitivity, we will recruit and ask similar questions of mothers and 
fathers.  
 
Study participants (parents) who have already received the study intervention (N 
= 40 families) will be sent an email asking if they would be available for a Focus 
Group to collect feedback on (i) relevance of materials for active duty and high 
OPTEMPO populations, (ii) examples of key parenting challenges related to high 
OPTEMPO, and (iii) preferences for specific program formats (length/time of 
days/days of week). If participants are not able to attend an in person focus group, 
an opportunity to share this feedback by phone with study staff will be offered. 
With permission, anecdotes about deployment will be anonymized and 
incorporated into scripts as teaching vignettes and role plays. Focus groups and 
phone interviews will be scheduled when it is convenient for participants.  
 
After reviewing the report of the focus group results, our Expert Panel will gather 
via videoconference (Month 4). Panel experts will weigh in on the results and be 
provided with two weeks to provide written recommendations. Expert panel and 
focus group feedback will inform (i) how to best compress key ADAPT skills, 
and (ii) address issues specific to high deployment OPTEMPO conditions. The 
focus group data and panel feedback will be used to adjust components for the 
SMART that do not fundamentally change the core components while increasing 
our program deliverers (facilitators) awareness of challenges facing active duty 
populations for future program delivery. 
To address Aims 2,3,4: Among 210 SO and 315 RA families (i.e., total N=525 
families) with 5-12 year-old children, we will examine effects of ADAPT 
modalities and sequences/timing on multiple behaviors and outcomes (i.e., (i) 
coercive family interactions, positive parenting, couple adjustment, and co-

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parenting, (ii) parents PTSD symptoms, depression symptoms, substance use, (iii) 
child behavior and emotional problems, and positive adjustment, by conducting a 
2-stage SMART, and (iv) document participation, satisfaction, and fidelity. To 
assess behaviors and outcomes, we will administer and collect a series of 
assessments (Table 1 appendix) at 4 timepoints. 
For Aims 2, 3, and 4, we will use a 2-stage SMART design to examine the 
optimal sequence, dosage, and delivery formats of ADAPT for active duty 
military families living in a range of operational tempo contexts. We will recruit a 
total of 525 families living on three installations: Fort Bragg (North Carolina),  
Fort Campbell (Kentucky) and Forts Belvoir/Myer, with 210 families recruited 
from Fort Bragg and Fort Campbell and 105 from Forts Belvoir/Myer.  
5.2 Study Procedures: 
Subjects for this study include: (I) 525 active duty clinical trial participants 
recruited from 4 bases who will be randomized to first stage (brief interventions) 
and second stage (more intensive booster ADAPT programs for families who do 
not benefit from the first stage interventions; (II) Twelve current study families (N 
= 24) who will participate in focus groups; (III) 525 children participants between 
the ages of 5-12 of clinical trial participants who will be asked to participate in 
assessments only; (IV) Up to 1890  teachers who will be asked to complete the 
Behavior Assessment System for Children, Second Edition (BASC-3) each yr that 
the child is in the study (usually 3 grades) 
Focus group Participants 
We will hold two focus groups with study parents to inform program 
modifications. Each focus group will consist of 12 participants, one group Special 
Operations (SO) participants and one group Regular Army (RA) participants, both 
on Fort Bragg, NC.     
 
Clinical Trial Participants 
Active duty families will be living in a range of operational tempo (OPTEMPO) 
contexts (i.e., Regular Army/RA and Special Operations/SO) on one of four 
military installations. All participants will be in units with deployments occurring 
during the study period. 525 families will be recruited from target bases as 
follows: (a) Fort Bragg, NC – 210 families recruited, including 105 SO and 105 
RA. (b) Forts Belvoir/Myer, VA   – 105 Active Duty families recruited. (c)  Fort 
Campbell, KY– 210 families recruited, including 105 SO and 105 RA. 
 
Clinical Trial Participants will be asked to do the following:  
(1) Complete assessments at four time points.  Assessments are listed and 
described below and included on the final page of the protocol. 
a. T1 (baseline (BL) and prior to the start of the intervention); both on-line and in-
home data is collected from families; child self-report measures will be gathered 
and are standardized with children over 5. 
b. Responder Checkpoint – Parent Locus of Control 22-item questionnaire 
completed by parents 4 weeks after they start the intervention 

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c. T2 (6 months following baseline); only online parent data will be gathered, (no 
in-home assessment)  
d. T3 (12 months following BL, i.e. following the end of the reintegration 
session(s) and program completion); both on-line and in-home data is collected 
from families, child self-report measures will be gathered from children over age 
5. 
e. T4 (24 months after BL); both on-line and in-home data is collected from 
families, child self-report measures will be gathered from children over age 5. 
2. Participate in videotaped (with audio) in-home parent-child interaction tasks 
lasting a total of 30 minutes at three time points (BL/T1, T3, and T4). These 
interaction tasks are administered and videotaped by trained assessment 
technicians in the participants’ homes. If preferred, participants may complete 
assessments outside the home at project offices. Video and audio of study 
participants will be accessed only by the investigators and trained members of the 
coding team. 
 
3. Fill out online questionnaires at the time of in-home assessments (BL/T1, T3, 
and T4).  
 
Note: childcare provided by study staff is offered during in-home assessments for 
siblings. If study staff are not available to provide childcare, a $30 gift card 
stipend will be offered to the family so that they can arrange their own childcare. 
 
All measures are listed in the table below and include: (1)The Parenting Locus of 
Control (PLOC); (2) The Family Interaction Task (FIT); (3) The Alabama 
Parenting Questionnaire (APQ-22); (4) Deviant Peer Association (PERS); (5) The 
Behavior Assessment System for Children, Third Edition (BASC-3); (6) Coping 
with Children’s Negative Emotions (CCNES); (7) The UCLA PTSD-Reaction 
Index (PTSD-RI); (8) the Children's Depression Inventory (CDI); (9) Describing 
Friends; (10) PTSD Checklist (PCL); (9) Difficulties in Emotion Regulation Scale 
(DERS); (11) The Five Facet Mindfulness Questionnaire (FFMQ); (12) Receipt of 
Help (PSI); (13) Alcohol Use Disorders Identification Test (AUDIT); (14) Center 
for Epidemiologic Studies Depression Scale (CESD); (15) Deployment Risk and 
Resilience Inventory (DRRI); (16) Differential Ability Scales (DAS-7); (17) 
Moral Injury (MIES); (18) Parenting Mindfulness (IEM-P); Parenting Identity; 
(19) NIH Toolbox Flanker (EF – Inhibitory Control); (20) NIH Toolbox 
Peadbody Picture Vocabulary Test; (21) Deviant Peer Association (TPRISK) 
Process measures include: satisfaction questionnaires, attendance, practice, online 
use, and coder ratings to measure fidelity. 
 
(i) The PLOC will be used as the primary tailoring variable measure by all 
participants at 4 weeks following the start of the intervention (when condensed 
group or online programming is completed). The PLOC is a 22-item questionnaire 
that takes about 5 minutes.  A link sent to each parent's email address will provide 
access to the questionnaire. The results of this questionnaire will determine 
responder status for each individual.  If a parent scores below the cut-score 

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threshold on the PLOC or does not complete the PLOC, that family will be re-
randomized to the second stage ADAPT interventions. 
 
(ii) Context measures:  
(a) Demographic information such as gender, age, racial, and ethnic identity for 
parent and child;  
(b) employment;  
(c) income,  
(d) date/s and number of deployments for parents.  Number and length of 
deployments will be assessed from 3 open-ended questions to obtain information 
about the extent of respondents' deployment history.  Combat exposure will be 
measured using subscales from the DRRI, an ecologically valid instrument for 
assessing risk and resilience factors among military personnel participating in 
recent and current deployments. 
(iii) Parenting practice measures: 
(a) Observations of parents and children using the Family Interaction Task (FIT) 
will last approximately 30 minutes. The child will complete a problem-solving 
task and discuss an emotional deployment challenge with each participating 
parent separately. The other tasks include: planning a fun family activity, a 
game/teaching task, and a monitoring task in which parents seek information 
about an activity in which the child was unsupervised. If two parents are 
participating in the study, they will also problem solve a parenting challenge in 
their household. Coder ratings of these tasks yield reliable and valid measures of 
parenting practices that have predictive validity for parent and child;  
(b) Self report measures including the APQ short form, a widely used 9 item 
measure of parenting practices validated in military and community samples. 
 
(iv) Child Adjustment measures:  
(a) The BASC-3 teacher, parent, and child self-report.  The BASC is a multi-
dimensional system assessing broad domains of externalizing problems, 
internalizing problems, and school problems as well as adaptive skills. Items are 
rated on a 4-point scale. Gender-specific normative scores are provided. Parents 
rate child behaviors using the parent version of the BASC2 while teachers use the 
Teacher Report Form. The child self-report version has been validated and 
demonstrated responsive to intervention and will target children ages 5 and older; 
(b) The CDI will be used to measure child distress.  The CDI is a 27-item 
symptom-oriented index, validated with 7-17 year olds, has been shown to 
correlate highly with similar measures of depression, and is sensitive to change 
over time; 
(c) The PTSD-RI is a 20-item child interview assessing post-traumatic stress 
reactions.  The child is asked to endorse how frequently each reaction occurs on a 
four-point scale. Scores are strongly associated with diagnostic measures of 
PTSD; 
(d) Describing Friends is a 5 item index to measure deviant peer association, used 
in previous ADAPT studies and is sensitive to change as a result of the 
intervention; 

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(v) Parent Adjustment measures: 
(a) The PCL is a 17 item, clinically validated, self-report screening tool used to 
assess the presence and severity of PTSD symptoms as defined the DSM-IV; 
(b) The CESD - 20 items - assesses depressive mood, motor, and somatic 
difficulties in the general population and has been widely used and validated in 
national health surveys; 
(c) The AUDIT is a self-report measure developed by the World Health 
Organization as a fast, reliable way to screen for excessive drinking and validated 
in over 2 decades of research with multinational samples and deemed effective for 
early identification in military populations; 
(d) The FFMQ is a 39-item questionnaire used to assess parent mindfulness with 
5 subscales (observing, describing, acting with awareness, non-judging, and non-
reactivity); 
(e) The DERS is a 36-item questionnaire used to assess emotion 
regulation/dysregulation in adults in six domains; 
(f) Receipt of Help (5 items) was developed for the National Survey of Families 
and Households and assesses the degree to which parents receive practical help 
using a scale from low to high.  
 
(vi) Couple Adjustment measures: 
(a) The DAS-7 Short version is a 7 item scale assessing couple adjustment. The 
DAS-7 has well-established criterion validity and discriminant validity. 
 
4.  Participate in one randomly assigned intervention: 
a. ADAPT Online. Participants will have access to the full ADAPT website (12 
modules, online discussion forum). Participants are directed to the first ADAPT 
session, and as each session is completed (all materials in a session opened by at 
least one parent) families receive a personalized congratulations email and 
continue to the next module. Participants may see the entire program on the 
ADAPT dashboard; they are encouraged to proceed in the specified order. Each 
online session consists of a skills video (demonstrating a specific skill), a practice 
video (modeling how parents practice skills with child(ren), downloadable 
summaries of key skills, fillable PDF forms with home practice assignments, a 
knowledge quiz, and downloadable mindfulness exercises that can be played 
directly from the ADAPT site as well as from smartphones, tablets, and 
computers. Participants are compensated at the end of their time period according 
to the portion of the modules completed. In addition, they are encouraged to 
respond to the 7 questions prompted by the online facilitator. To encourage this 
exchange, participants who respond will be entered into a drawing for a $100 gift 
card (up to 7 entries). At the end of the online group, one winner will be drawn at 
random. For example, if there are 10 participants in Cohort 1 and all 10 of them 
answer each of the 7 facilitator questions then there would be 70 entries for the 
drawing (10 participants x 7 entries each). This would give each participant a 7% 
chance that their name would be drawn to receive a $100 gift card;  

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b. Condensed group-based ADAPT. Participants will meet for 2 week/weekend 
days two weeks apart, for 6 hours each day (excluding holidays) at a time 
convenient to participants. Dinner and childcare are provided. If families are 
unable to or elect not to register for CYS childcare on the installation or the 
minimum number of children for CYS childcare is not met, participants will be 
offered a $50 stipend in the form of a gift card to arrange their own childcare in 
order to attend workshop;  
Facilitators who deliver the ADAPT intervention are a combination of U of MN 
paid staff, U of MN volunteers and military affiliated professionals on those 
installations who have the required approval for program delivery. Facilitators 
complete comprehensive face-to-face training prior to starting groups. An 
extensive training and coaching infrastructure already exists (i.e., training 
manuals, videotapes, a HIPAA-compliant database for uploading and storage of 
training and group video material). In our current and past DOD and NIH funded 
ADAPT studies we have successfully trained over 50 individuals as facilitators. 
Training will be delivered either on the installation by Drs. Gewirtz and Willer or 
in Minnesota with prior DOD/MOMRP approval. ADAPT training, which 
consists of two workshops, and, following workshop training, bi-weekly coaching 
focused on facilitation of group sessions. 
 
Facilitators are not involved in the randomization or assessment of participants, 
and it is up to them if they chose to share information about the study with 
military families in order to assist with recruitment. Facilitators will be told when 
there is sufficient number of families to begin a workshop and they are given the 
list of families who will be invited to the workshop. Facilitators plan the 
workshop logistics with the site study coordinator, including the best day and time 
to offer the workshops with facilitator schedules, needs of families and space 
availability in mind. The workshops take place on two full days (6 hours per day, 
excluding breaks and lunch), two weeks apart (e.g. week 1, week 3 of a month). 
Two to three facilitators run each workshop. Attendance and end of day 
evaluations are collected by facilitators and given to the study site coordinator for 
processing. Between workshops, facilitators contact families by phone once a 
week to check in and assist with home practice completion, and troubleshoot 
skills that have been taught.  A brief record of this contact is recorded in a secure 
on-line portal by facilitators for the purposes of coaching.   
 
Following the end of the workshop, participants complete a questionnaire about 
their parenting. This questionnaire is delivered online by the study team, and 
facilitators have no involvement in the survey and no knowledge of participant 
responder status. Based on participants’ responder status, some participants are 
further randomized to an additional program (3 session group, or 3 sessions 
individually). Facilitators will again receive a name or list of names if they are 
delivering a group or individual ADAPT program. (Not all facilitators will 
conduct all groups, instead it is determined by logistics, schedules, etc.). They 
will work directly with the participants during the groups/individual sessions as 
with the workshops. The 3-session groups are delivered weekly, 3 times, on the 

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installation with approximately 6 families per group and two facilitators. The 3 
individual sessions are delivered weekly by one facilitator with an individual 
couple/parent, likely on the installation, at times convenient for the facilitator and 
the family. Once the intervention is over, the facilitator has no further study 
involvement with the family. 
All program components (i.e. workshops, group, and individual sessions) are 
videotaped for quality assurance purposes – i.e. to ensure that facilitators are 
delivering the program with fidelity. Facilitators receive bi-weekly coaching from 
the study team in Minnesota. During coaching, the coach and facilitators meet by 
WebEx (HIPAA-compliant) and view video of the sessions. Videos are later used 
to assess fidelity for the purposes of certifying facilitators in the ADAPT 
program. (Certification is not a research aim, but a practice commitment to the 
sites – i.e. that they would be able to sustain the program after the research ends). 
 
Current ADAPT Trained Facilitators: 
**Note: Per the request of the Human Research Protection Office at the US Army 
Medical Research and Materiel Command, University of Minnesota Individual 
Investigator Agreement (IIA) and Supervisor Letter of Support have been obtained for all 
installation staff involved in the delivery of the ADAPT intervention (noted with asterisks 
by name). 
 
Location 
Name 
Position 
Fort Bragg 
Cheryle Dangle 
U of MN Employee 
Fort Bragg 
Chris Balduf* 
U of MN Employee  
Fort Bragg 
Krista Melton 
U of MN Employee 
Fort Bragg 
Michelle Keller* 
Child Advocate Instructor, Contract employees of Strategic 
Resources Inc. 
Fort Bragg 
Nicollette Love* 
Child Advocate Instructor, Contract employees of Strategic 
Resources Inc. 
Fort Bragg 
Scott Chase* 
ACS Child Advocate - civilian 
Fort Bragg 
Shadia Young* 
Child Advocate Instructor, Contract employees of Strategic 
Resources Inc. 
Fort 
Campbell 
Cortney O’Neal 
U of MN Employee 
Fort 
Campbell 
Dianna Roberts 
U of MN Volunteer 
Fort 
Campbell 
 
Elizabeth Eversole 
U of MN Employee 
Fort 
Campbell 
Elke Sampson 
Military spouse 
Fort 
Campbell 
Jim Mitchem* 
Active Duty Army Chaplain 
Fort 
Campbell 
Jonathan McPherson* 
Active Duty Army Chaplain 
 

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5. Depending on participants’ response to the Condition A and B interventions, 
they may be asked to participate in one of the following: 
• Individual booster ADAPT. Participants will meet for 3 weekly face-to-face 
sessions for individual families with a trained facilitator. Each session lasts 1.5 
hours. Individual sessions include discussion, role-play, and audio-visual material 
about different aspects of parenting such as encouragement, discipline, and 
problem solving. Depending on facilitator availability, individual sessions may 
take place by telehealth (i.e. HIPAA compliant Webex) using U of MN based 
staff in order to keep families on their timeline; 
• Booster Group ADAPT. Participants attend weekly groups for 3 weeks with up 
to 10 other families. Each session lasts 2 hours and includes dinner and childcare. 
If families are unable to or elect not to register for CYS childcare on the 
installation or the minimum number of children for CYS childcare is not met, 
participants will be offered a $30 stipend in the form of a gift card to arrange their 
own childcare in order to attend group. Groups include discussion, role-play, and 
audio-visual material about different aspects of parenting such as encouragement, 
discipline, and problem-solving.  
 
It should be noted that we are not allowed to ask substance use questions to 
Active Duty participants and will encode the online survey with "if-then" logic 
routing that will eliminate those questions from the battery of assessments for 
active duty participants. Lastly, active duty participants are not allowed to receive 
incentives.  
 
Children Participants: 
a. Families must have at least one child between the ages of 5-12; 
b. If participating families have more than one child between the ages of 5 and 12, 
staff will randomly select the child to participate in the study. Children are 
included in the assessment phase only to examine the effectiveness of ADAPT in 
reducing risk for substance use, child maladjustment, and related behavior 
problems.  
 
Teachers will be asked to do the following:  
Up to 1890 teachers will be asked to complete the BASC-3, a 100-139 item 
instrument designed to evaluate various aspects of behavior and personality in 
children, youth, adults ages 2-25. The BASC-3 takes between 10-20 minutes to 
fill out. Teachers will be asked to fill out the questionnaire at T1, T3, and T4. In 
addition, teachers will be asked to complete the TPRISK - a measure on deviant 
peer association. 
ADAPT is a resilience-building program designed to strengthen families through 
the transitions associated with deployment, targeting multiple outcomes in service 
members, spouses, children, and families. This study will yield knowledge about 
the optimal components, sequence, and dosage for improving family adjustment 
in diverse OPTEMPO contexts, yielding an efficient, scalable and sustainable 
universal prevention intervention to strengthen the family at home, and the 
soldier’s functioning at home and in the field. 

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Potential Risks  
Potential discomfort and risks participants may experience as a result of their 
involvement in this study include the following: 
1. Discomfort with assessment procedures (e.g., videotaping) 
2. Discomfort in disclosing sensitive information  
3. Violation of confidentiality as a result of compliance with mandatory reporting 
requirements  
4. A possible violation of confidentiality due to mishaps with identified data 
5. Discomfort resulting from misunderstanding the planned use of data 
Participation in this research involves minimal risk, defined in the Federal 
guidelines, as “the probability and magnitude of harm anticipated in the research 
are not greater in and of themselves than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations or 
tests.” (Federal Register, 1991, 45CFR 46.102(i). Procedures are in place to 
minimize risk of violation of confidentiality, as indicated: If the study child or 
participating caregiver discloses information regarding child abuse or threat to 
self or others, professionals are mandated to report the information to appropriate 
authorities. This information will be clearly stated verbally and on the consent 
forms. It is not likely that participants will experience physical, social or legal 
risks due to enrollment in the study because state mandated procedures exist to 
protect them. There are no financial risks to participants. Procedures are in place 
for providing suitable informed consent, clearly describing the assessment 
activities, emphasizing the voluntary nature of the study, and communicating the 
purpose and use of the data collected. These procedures are intended to minimize 
participant’s misunderstanding of or dissatisfaction with the research. 
 
For informed consent, all letters/online instructions will clearly state that 
participation in this study is voluntary, that the participant’s relationship with their 
employer, the military, and the University of Minnesota will not be adversely 
affected regardless of whether or not they decide to participate. It will be clearly 
stated in written form and verbally expressed in person that participants may 
withdraw from the study at any point without any consequences to themselves or 
these relationships. The consent process will clearly indicate that all information 
gathered from participants will be kept confidential and de-identified for all 
analysis or reports that will be conducted or generated during and after the study 
period. Participants will be given an opportunity to ask questions of the PI and 
research staff during informed consent and throughout the research study and will 
be provided with the University of Minnesota, Office of Human Subjects 
Protection phone number if they have further questions or concerns about the 
study. 
1. Teachers  
At each assessment point, work designated contact information for teachers of 
each targeted child will be obtained from families enrolled in the study. Teachers 
will be contacted via secure, encrypted email, with an explanation of the study 
and a copy of the parent's release of information. They will be directed to the 

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study website to complete online informed consent and study questionnaires. 
Teachers not responding will receive materials by mail with follow-up calls.  
2. Focus Group Participants 
Each focus group will consist of 12 families for a total of 24 focus group 
participants. Focus group participants will be recruited by emailing the 40 
families who have already received the study intervention to gather interest. If 
interested, study participants will be scheduled to attend a focus group that is 
convenient to them. If they are interested but cannot attend, an opportunity to give 
feedback by phone with study staff will be offered.   If they chose not to 
participate, their decision will not affect their relationship with the military, their 
employer, or the University of Minnesota. If they chose to participate, they may 
discontinue at any time without consequences. Their identity will remain 
anonymous. 
 
Per military regulations, all participants will be informed that to be compensated 
for their participation in the research study, they must participate on their own 
time and not while on duty (e.g., in training events). Informed consent will be 
explained verbally and through written consent forms. 
 
3. Clinical Trial Family Participants:  
a. We will create and distribute recruitment flyers to our partners providing a 
study website URL and phone number. We will recruit families in close 
collaboration with the military installations, by (i.) postings on the websites, (ii.) 
flyers and pamphlets at armories and announcements via email, (iii.) attending 
family support groups, family readiness academies, and family reintegration 
training.  
b. To manage study participation and administer online measures, we will create a 
secure web site (separate from the training site) that maintains extremely stringent 
levels of encryption and data storage while also providing flexible design options, 
and sophisticated data management and collection features. The website guides 
parents to a brief explanation of the project, and a description of project 
confidentiality and its limits. This website will be accessible to project staff so 
that they can track participant progress and provide support when needed. Given 
the focus on technology use to enhance outreach and access, as well as minimize 
researcher intervention, participant screening and informed consent (adult only) 
will take place online, unless participants specifically request this process to be 
accomplished by phone.  
c. Eligible adult family participants will next complete a brief contact information 
form, followed by an online informed consent that will provide information about 
study risks, benefits and about the possibility of being randomly assigned to one 
of the conditions. Families will be assured that no services or relationship with the 
military base or the University of Minnesota will change or be adversely affected 
regardless of whether or not they choose to participate in the study.  
d. The voluntary nature of participation and the ability to withdraw from the 
project at any time without penalty will be emphasized. In reintegrating families 

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with two at-home participating parents/caregivers, each will complete a separate 
informed consent. 
e. Consenting adult family participants will be provided a contact number in order 
to speak to the PI or study coordinator with any questions. Families who request a 
telephone screening (e.g., families whose internet is not accessible at the time of 
the call) will be asked for verbal consent for the research team to maintain contact 
through weekly reminder emails and phone calls as needed to complete informed 
consent and baseline (BL) online assessments. Where informed consent is not 
completed prior to the home visit, it may be completed at the beginning of the in-
home assessment. 
4. Child Participants  
a. Parental consent to have child included in the study was completed 
electronically prior to the first in-home assessment.  
b. The informed consent process (assent) for child participation will be conducted 
during the in-home assessment process. The study, procedures, and tasks of the 
study will be explained to the child using developmentally appropriate and child 
friendly language. The research staff will verbally check for the child's 
understanding of the information shared. 
c. Research staff will ask the child if they have any questions or concerns about 
the study. It will be stated very directly to the child that no one will be angry or 
upset with them if they decide not to participate in the study and that they can 
change their mind or ask more questions at any time during the study.  
d. Once the research staff has been able to ascertain that the child understands the 
procedures of the study and what the child will be asked to do, a written signature 
will be requested from the child on the Child Assent form. 
I. Individuals who complete their consent electronically are given the option to 
print the consent form immediately or they can request to have one sent to them. 
If consent is not electronically obtained before first in-home visit, a hard copy is 
reviewed in the home and a signature is obtained.  
The following consent forms will be obtained from participants: 
1. Adult consent to participate in the focus groups (focus group adults only) 
2. Adult consent for participation in the clinical study (all family adults screened 
for participation in the clinical study). A copy of the signed consent is provided at 
baseline and follow-up assessments to all adults.  
3. Child Assent Form for participation in baseline and follow-up assessments (all 
children in study) 
4. Adult Consent to release observational assessment video data (all families) 
5. Teacher consent to participate in study (teachers of targeted child only) 
 
II.  Protections Against Risk  
There are planned procedures in place for protecting against or minimizing 
potential risks, including risks to privacy of individuals or confidentiality of data. 
1. Potential risk #1 (discomfort with assessment procedures), and  
2. Potential risk #2 (discomfort in disclosing sensitive information  
Safeguards: Participants may choose not to answer questions or not to participate 
in particular assessment components. Participants have the right to withdraw from 

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this program at any time. All research staff receives training in building rapport 
with participants and skillful interviewing in order to minimize discomfort and 
embarrassment. Each study participant receives a verbal and written description 
of the study. If a staff member determines that a participant’s reading skills are 
limited, all materials will be presented verbally and questionnaires will be 
administered as an interview. Informed consent is received from the legal 
guardian(s) of all children participating in the study and children will be asked to 
assent through a Child Assent form. Participants are advised of their right to 
withdraw from the project at any time. Experienced research staff members are 
available at all points of the study process to answer questions and to make the 
data collection as easy as possible for families. Assessment results will be shared 
with participants upon completion of the assessments. 
3. Potential risk #3 (violation of confidentiality in accordance with mandatory 
reporting requirements)  
Safeguards: To prevent violation of confidentiality, reporting requirements are 
limited to the mandatory nature of these requirements. Participants are informed 
verbally and in the consent document that professional staff are required by law to 
report to the appropriate authorities any danger of serious physical harm to the 
child, physical injury to any child caused by anything other than accidental 
means, or any case where the professional suspects a child is being neglected. The 
consent document also states that staff will inform parents or guardians if, in the 
judgment of professional staff, their child (under age 18) is in imminent danger of 
attempting to kill him or herself.  Licensed psychologists (e.g., the PI) are 
available at all hours to provide resources for parents whose child appears to be in 
imminent danger of suicide. 
4. Potential risk #4 (violation of confidentiality)  
Safeguards: Extensive procedures are in place to prevent confidentiality violation 
and errors resulting from data processing. Participants are assigned a coded 
identification number that is used on all data collection measures. Identifying 
information necessary for participant contact, such as names, addresses, and 
telephone numbers are kept in locked filing cabinets or in our secure participant 
database. Access to the online database is restricted to those with valid usernames 
and passwords and limited to those staff members whose jobs require use of this 
information for contacting participants. Individuals using this database receive 
unique and identifiable usernames and passwords. Relational database passwords 
must be changed on a regular basis. All staff members are required to close 
password-protected applications or lock their workstations when they are away 
from their desks. During data analysis all identifying information, with the 
exception of the participant identification number is removed from the data. No 
information about identities of the study participants will be published or 
presented at conferences.  
5. Potential risk #5 (misunderstanding regarding the use of the research data) 
Safeguards: Prior to participating in the study, all participants, including children, 
will read or have read to them a detailed consent form described in the 
Recruitment and Informed Consent section above. Participants will only be asked 
to sign the consent form after all of their questions and concerns have been 

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addressed to their satisfaction. In addition to explaining the assessment 
procedures, all potential uses of the collected data, and confidentiality procedures, 
the consent forms emphasize that participation is completely voluntary, and 
participants have the right to withdraw from the study at any time. To avoid 
feelings of coercion, it will be made clear that participation in the study is 
completely voluntary. 
5.3 Follow-Up:  
Complete assessments at four time points.  Assessments are listed and described 
below and included in the Table 1 Appendix. 
a. T1 (baseline (BL) and prior to the start of the intervention); both on-line and in-
home data is collected from families; child self-report measures will be gathered 
and are standardized with children over 8. 
b. Responder Checkpoint – Parent Locus of Control 22-item questionnaire 
completed by parents 4 weeks after they start the intervention 
c. T2 (6 months following baseline); only online parent data will be gathered, (no 
in-home assessment)  
d. T3 (12 months following BL, i.e. following the end of the reintegration 
session(s) and program completion); both on-line and in-home data is collected 
from families, child self-report measures will be gathered from children over age  
8. 
e. T4 (24 months after BL); both on-line and in-home data is collected from 
families, child self-report measures will be gathered from children over age 8. 
6.0 
Data Banking 
NA 
7.0 
Sharing of Results with Participants 
NA 
 
8.0 
Study Duration 
8.1 Describe: 
• 
Study participants can expect to be involved in the study for 2 years. 
• 
21 months (complete recruitment May 2018). 
• 
4 years (complete study September 30, 2020). 
9.0 
Study Population 
 
9.1 
Inclusion Criteria:  
Recruitment is limited to families meeting the following inclusion criteria: (a) one 
parent has returned from deployment (b) at least one child age 5 to 12 in their 
custody and living with parent(s) in the home. (c) We will include both single-and 
two-parent families, as well as families where care is shared between non-
partnered adults (e.g. grandparent and mother), and will control for relationship 
status in the analyses. (d) Participants must agree to randomization, and (e) 
indicate willingness to interact with study materials and complete assessment 

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batteries. Women and minorities are included in the study. Inclusion criteria (a), 
(b), (c), (d), and (e) are necessary to meet the specific aims of the study and to 
meet the requirements of PMTO/ADAPT.  
9.2 
Exclusion Criteria:  
Exclusion criteria include: (a) families with children younger than 5 or older than 
12 – see the above rationale for the age limitation of children; (b) parent has an 
active psychosis, (c) an open child protection case for abuse or neglect in the 
family, (d) a serious child mental health diagnosis, i.e., autism, child psychosis (e) 
youth do not meet age criteria, (f) youth have a documented pervasive 
developmental disability or mental retardation, (g) less than a 5th grade 
comprehension level in English.  Children and families will not benefit from a 
prevention intervention if either the parent or the child has a serious mental 
illness, if the family has an active child protection case, or if the parents are not 
able to comprehend the materials.  
Screening:  
Potential participants will be asked to take an online eligibility survey that will 
screen for inclusion criteria. 
10.0 Vulnerable Populations 
10.1 Vulnerable Populations:  
☒ Children 
☐ Pregnant women/Fetuses/Neonates 
☐ Prisoners 
☐ Adults lacking capacity to consent and/or adults with diminished 
capacity to consent, including, but not limited to, those with acute 
medical conditions, psychiatric disorders, neurologic disorders, 
developmental disorders, and behavioral disorders 
☐ Non-English speakers 
☐ Those unable to read (illiterate) 
☐ Employees of the researcher 
☐ Students of the researcher 
☐ None of the above 
10.2 Adults lacking capacity to consent and/or adults with diminished capacity to 
consent: 
NA 
10.3 Additional Safeguards: 
Potential Risks  
Potential discomfort and risks participants may experience as a result of their 
involvement in this study include the following: 
1. Discomfort with assessment procedures (e.g., videotaping) 
2. Discomfort in disclosing sensitive information  

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3. Violation of confidentiality as a result of compliance with mandatory reporting 
requirements  
4. A possible violation of confidentiality due to mishaps with identified data 
5. Discomfort resulting from misunderstanding the planned use of data 
Participation in this research involves minimal risk, defined in the Federal 
guidelines, as “the probability and magnitude of harm anticipated in the research 
are not greater in and of themselves than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations or 
tests.” (Federal Register, 1991, 45CFR 46.102(i). Procedures are in place to 
minimize risk of violation of confidentiality, as indicated: If the study child or 
participating caregiver discloses information regarding child abuse or threat to 
self or others, professionals are mandated to report the information to appropriate 
authorities. This information will be clearly stated verbally and on the consent 
forms. It is not likely that participants will experience physical, social or legal 
risks due to enrollment in the study because state mandated procedures exist to 
protect them. There are no financial risks to participants. Procedures are in place 
for providing suitable informed consent, clearly describing the assessment 
activities, emphasizing the voluntary nature of the study, and communicating the 
purpose and use of the data collected. These procedures are intended to minimize 
participant’s misunderstanding of or dissatisfaction with the research. 
Practices to minimize the risk with children. 
a. The informed consent process for child participation will be conducted during 
the in-home assessment process. The study, procedures, and tasks of the study 
will be explained to both the parent and the child. Both child assent and parental 
consent forms will be presented to the family and explained.  
b. The research staff conducting the informed consent process will ask each child 
to explain the study process in their own words to assure that they understand 
what is being asked of them and what they will be asked to do (e.g. answer 
questions, play a game with their parents, be willing to be video-taped while 
playing the game).  
c. Research staff will ask both the parent and child, separately and directly, if they 
have any questions or concerns about the study. It will be stated very directly to 
the child that no one will be angry or upset with them if they decide not to 
participate in the study and that they can change their mind or ask more questions 
at any time during the study.  
d. Once the research staff has been able to ascertain that both the child and the 
parent understand the procedures of the study and what the child will be asked to 
do, written signatures will be requested from the parent and child on both the 
Child Assent form and the Parental Consent form. 
11.0 Number of Participants 
11.1 Number of Participants to be Consented:  
525 
12.0 Recruitment Methods 
12.1 Recruitment Process:  

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We will recruit subjects with the assistance of a broad base of collaborators 
including United States Special Operations Command (USSOCOM) Protection of 
the Force and Family (POTFF) staff, component and installation Chaplains, 
Military Family Life Consultants (MFLCs), Family Advocacy Program staff and 
Behavioral Health staff. 
 
We will recruit using three methods found to be effective in prior studies: (i) 
convenience sampling and extensive outreach to military service providers 
(USSOCOM and USASOC directors and deputy directors, Command Chaplains, 
Family Readiness Group (FRG) leaders, Family Readiness Support Assistants 
(FRSAs), Military Family Life Consultants (MFLCs), social workers, 
psychologists, and medical providers); (ii) media and local installation publicity 
including print, television, and social media, and (iii) direct outreach to eligible 
families (via presence at family picnics, reintegration and other installation 
events, and letters, emails, and phone calls to those who indicate initial interest 
and provide contact information to our internet site or at outreach events. 
Recruitment flyers promoting the study will be distributed to our partners 
(chaplains, MFLCs, installation providers) and via installation and unit/group 
websites, picnics, and other outreach events. Flyers will provide the study site 
URL and phone number. 
If recruitment becomes a challenge, a “refer a friend” postcard will be used to 
encourage current study participants to share the opportunity with eligible 
participants. Refer a friend postcards will be distributed to current participants at 
one of their in-home assessments. Current participants will be given five 
postcards to share with up to five friends. Since the referred friend must consent 
to be in the study their enrollment is considered voluntary. The referred friend 
will be asked to name, by typing in, the referring friend (current participant) 
during their initial screening for eligibility and consent process. Current 
participants can earn a $10 gift card per new participant recruited/enrolled as long 
as the new participant completes their initial in-home visit (T1). This requirement 
is stated on the postcard.  The total amount they can be compensated for referring 
a friend is $50 in gift cards (5 postcards given x $10 gift card per referred friend 
that completes a T1).  
12.2 Source of Participants:  
Eligible families will reside on or near the following installations and have at least 
one parent belonging to SO or RA, as follows:  
(i) SO (to include elements of the US Army Special Operations Command 
(USASOC) located at Fort Bragg, NC: 3rd Special Forces Group, JFK Special 
Warfare Center and School, 4th PsyOps Group; 95th Civil Affairs Brigade; 528th 
Sustainment Brigade for a total of roughly 9,000 SO population) or RA (to 
include XVIII Airborne Corps Headquarters, the 1st Theater Sustainment 
Command, 82nd Airborne Division, and associated sustainment units and separate 
Corps support units) assigned to Ft. Bragg.   
   

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(ii) SO elements of USASOC located at Fort Campbell, KY including 5th Special 
Forces group, 160th Special Operations Aviation Regimental headquarters, 1st 
and 2nd Battalions) or 101st Airborne Division and associated separate support 
units 21,500 (not including 5000 SO) service members, (not including SO units) 
of whom approximately 18,000 are married). 
(iii) Active Duty families assigned to, living on or served by Fort Belvoir, VA. 
Fort Belvoir is home to several Army command headquarters, units and agencies 
of nine different Army major commands, 16 different agencies of the Department 
of the Army, eight elements of the U. S. Army Reserve and Army National Guard 
and nine DOD agencies. In addition to U.S. Army forces, the U. S. Navy 
construction battalion, a Marine Corps detachment, one U. S. Air Force unit, and 
an agency of the Department of Treasury are also located at Fort Belvoir.  
(iv) Active Duty families assigned to, living on or served by Fort Myer, VA. Joint 
Base Myer–Henderson Hall (JBMHH) consists of military installations at Fort 
Myer, Virginia, Crystal City, The Pentagon, Fort McNair, the District of 
Columbia, and Henderson Hall – Headquarters Marine Corps, Virginia. It is 
commanded by the United States Army but has resident commands of Army, 
Navy, & Marines. Fort Myer is headquarters to service personnel working 
throughout the National Capital Region.  
 
We will recruit using three methods found to be effective in prior studies: (i) 
convenience sampling and extensive outreach to military service providers 
(USSOCOM and USASOC directors and deputy directors, Command Chaplains, 
Family Readiness Group (FRG) leaders, Family Readiness Support Assistants 
(FRSAs), Military Family Life Consultants (MFLCs), social workers, 
psychologists, and medical providers); (ii) media and local installation publicity 
including print, television, and social media, and (iii) direct outreach to eligible 
families (via presence at family picnics, reintegration and other installation 
events, and letters, emails, and phone calls to those who indicate initial interest 
and provide contact information to our internet site or at outreach events. 
Recruitment flyers promoting the study will be distributed to our partners 
(chaplains, MFLCs, installation providers) and via installation and unit/group 
websites, picnics, and other outreach events. Flyers will provide the study site 
URL and phone number.  
If recruitment becomes a challenge, a “refer a friend” postcard will be used to 
encourage current study participants to share the opportunity with eligible 
participants. Refer a friend postcards will be distributed to current participants at 
one of their in-home assessments. Current participants will be given five 
postcards to share with up to five friends. Since the referred friend must consent 
to be in the study their enrollment is considered voluntary. The referred friend 
will be asked to name, by typing in, the referring friend (current participant) 
during their initial screening for eligibility and consent process. Current 
participants can earn a $10 gift card per new participant recruited/enrolled as long 
as the new participant completes their initial in-home visit (T1). This requirement 
is stated on the postcard.  The total amount they can be compensated for referring 

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a friend is $50 in gift cards (5 postcards given x $10 gift card per referred friend 
that completes a T1).  
12.3 Identification of Potential Participants:  
Participants will self-identify in response to media and local installation publicity, 
attendance at outreach/unit/family events, and through contact with service 
providers such as chaplains, military and family life consultants, and so on. Initial 
contact will be made by site coordinator on each installation only after 
participants express interest and provide their contact information.  
If recruitment becomes a challenge, a “refer a friend” postcard will be used to 
encourage current study participants to share the opportunity with eligible 
participants. Refer a friend postcards will be distributed to current participants at 
one of their in-home assessments. Current participants will be given five 
postcards to share with up to five friends. Since the referred friend must consent 
to be in the study their enrollment is considered voluntary. The referred friend 
will be asked to name, by typing in, the referring friend (current participant) 
during their initial screening for eligibility and consent process. Current 
participants can earn a $10 gift card per new participant recruited/enrolled as long 
as the new participant completes their initial in-home visit (T1). This requirement 
is stated on the postcard.  The total amount they can be compensated for referring 
a friend is $50 in gift cards (5 postcards given x $10 gift card per referred friend 
that completes a T1).   
12.4 Recruitment Materials:  
Primary recruitment materials will be flyers. Flyers will be available through 
service providers and military partners, at installation events and on social media. 
Flyers can also be send as email attachment or embedded as a picture into 
communications.  
If recruitment becomes a challenge, a “refer a friend” postcard will be used to 
encourage current study participants to share the opportunity with eligible 
participants. Refer a friend postcards will be distributed to current participants at 
one of their in-home assessments. Current participants will be given five 
postcards to share with up to five friends. Since the referred friend must consent 
to be in the study their enrollment is considered voluntary. The referred friend 
will be asked to name, by typing in, the referring friend (current participant) 
during their initial screening for eligibility and consent process. Current 
participants can earn a $10 gift card per new participant recruited/enrolled as long 
as the new participant completes their initial in-home visit (T1). This requirement 
is stated on the postcard.  The total amount they can be compensated for referring 
a friend is $50 in gift cards (5 postcards given x $10 gift card per referred friend 
that completes a T1).  
12.5 Payment:  
I. Incentives for Participation in Assessments: 
Off-duty and civilian parents will be paid $25 for each online assessment (up to 2 
parents/caregivers per family); $50.00 for each in-home assessment/family (50); 

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$100.00 for the final in-home / family; $10.00/parent for the PLOC; $25.00/parent 
at 6 month follow-up online only; $25.00/parent at 12 month and 24 month 
follow-ups; $25.00.  
II. Incentives for Participation in the Interventions: 
(a) Self-directed online only: $50.00/family 
(b) Condensed ADAPT: $50.00/family 
(c) Full group ADAPT: $50.00/family 
(d) Individual ADAPT: $50.00/family 
We will also provide small incentives for home practice assignment and group 
attendance via a drawing for snow scrapers, candles, etc. 
Self-directed online only participants will have a chance to enter into a drawing 
based on the number of times (up to 7) that they respond to facilitator questions. 
One winner will be selected per cohort to receive a $100 gift card.  
III. Incentives for Children Participants: 
Children will be given a gift worth approximately $5.00 at Times 1, 3, and 4 for 
participating in the observation (FIT).  Families are eligible to receive up to 
$520.00 in total incentives.  
IV.  Incentives for Teacher Participants: 
Teachers will be paid $10.00 for completing assessments at Times 1, 3, and 4.  
V. Incentives for Focus group Participants   
(a) Focus group participants will be paid $25.00 per feedback session.     
NOTE: Active duty participants are not allowed to receive incentives per DoD 
policy. 
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances:  
Participants will be involuntarily withdrawn from the study in the event of their 
death or the target child or in the case of a parent’s loss of custody of the target 
child.  
13.2 Withdrawal Procedures:  
If a participant voluntarily withdraws from the study there is no further data 
collection and data collected prior to their withdraw date will not be analyzed.  
13.3 Termination Procedures:  
Data that is already collected from participants who are withdrawn without their 
consent (as described in 13.1), will still be used unless they explicitly request that 
we do not.  
14.0 Risks to Participants 
For each risk or set of risks below, include the procedures to be performed to 
lessen the probability, magnitude, duration, or reversibility of those risks. 
14.1 Foreseeable Risks:  
Potential Risks  

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Potential discomfort and risks participants may experience as a result of their 
involvement in this study include the following: 
1. Discomfort with assessment procedures (e.g., videotaping) 
2. Discomfort in disclosing sensitive information  
3. Violation of confidentiality as a result of compliance with mandatory reporting 
requirements  
4. A possible violation of confidentiality due to mishaps with identified data 
5. Discomfort resulting from misunderstanding the planned use of data 
Participation in this research involves minimal risk, defined in the Federal 
guidelines, as “the probability and magnitude of harm anticipated in the research 
are not greater in and of themselves than those ordinarily encountered in daily life 
or during the performance of routine physical or psychological examinations or 
tests.” (Federal Register, 1991, 45CFR 46.102(i). Procedures are in place to 
minimize risk of violation of confidentiality, as indicated: If the study child or 
participating caregiver discloses information regarding child abuse or threat to 
self or others, professionals are mandated to report the information to appropriate 
authorities. This information will be clearly stated verbally and on the consent 
forms. It is not likely that participants will experience physical, social or legal 
risks due to enrollment in the study because state mandated procedures exist to 
protect them. There are no financial risks to participants. Procedures are in place 
for providing suitable informed consent, clearly describing the assessment 
activities, emphasizing the voluntary nature of the study, and communicating the 
purpose and use of the data collected. These procedures are intended to minimize 
participant’s misunderstanding of or dissatisfaction with the research. 
 
II.  Protections Against Risk  
There are planned procedures in place for protecting against or minimizing 
potential risks, including risks to privacy of individuals or confidentiality of data. 
1. Potential risk #1 (discomfort with assessment procedures), and  
2. Potential risk #2 (discomfort in disclosing sensitive information  
Safeguards: Participants may choose not to answer questions or not to participate 
in particular assessment components. Participants have the right to withdraw from 
this program at any time. All research staff receives training in building rapport 
with participants and skillful interviewing in order to minimize discomfort and 
embarrassment. Each study participant receives a verbal and written description 
of the study. If a staff member determines that a participant’s reading skills are 
limited, all materials will be presented verbally and questionnaires will be 
administered as an interview. Informed consent is received from the legal 
guardian(s) of all children participating in the study and children will be asked to 
assent through a Child Assent form. Participants are advised of their right to 
withdraw from the project at any time. Experienced research staff members are 
available at all points of the study process to answer questions and to make the 
data collection as easy as possible for families. Assessment results will be shared 
with participants upon completion of the assessments. 
3. Potential risk #3 (violation of confidentiality in accordance with mandatory 
reporting requirements)  

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Safeguards: To prevent violation of confidentiality, reporting requirements are 
limited to the mandatory nature of these requirements. Participants are informed 
verbally and in the consent document that professional staff are required by law to 
report to the appropriate authorities any danger of serious physical harm to the 
child, physical injury to any child caused by anything other than accidental 
means, or any case where the professional suspects a child is being neglected. The 
consent document also states that staff will inform parents or guardians if, in the 
judgment of professional staff, their child (under age 18) is in imminent danger of 
attempting to kill him or herself.  Licensed psychologists (e.g., the PI) are 
available at all hours to provide resources for parents whose child appears to be in 
imminent danger of suicide. 
4. Potential risk #4 (violation of confidentiality)  
Safeguards: Extensive procedures are in place to prevent confidentiality violation 
and errors resulting from data processing. Participants are assigned a coded 
identification number that is used on all data collection measures. Identifying 
information necessary for participant contact, such as names, addresses, and 
telephone numbers are kept in locked filing cabinets or in our secure participant 
database. Access to the online database is restricted to those with valid usernames 
and passwords and limited to those staff members whose jobs require use of this 
information for contacting participants. Individuals using this database receive 
unique and identifiable usernames and passwords. Relational database passwords 
must be changed on a regular basis. All staff members are required to close 
password-protected applications or lock their workstations when they are away 
from their desks. During data analysis all identifying information, with the 
exception of the participant identification number is removed from the data. No 
information about identities of the study participants will be published or 
presented at conferences.  
5. Potential risk #5 (misunderstanding regarding the use of the research data) 
Safeguards: Prior to participating in the study, all participants, including children, 
will read or have read to them a detailed consent form described in the 
Recruitment and Informed Consent section above. Participants will only be asked 
to sign the consent form after all of their questions and concerns have been 
addressed to their satisfaction. In addition to explaining the assessment 
procedures, all potential uses of the collected data, and confidentiality procedures, 
the consent forms emphasize that participation is completely voluntary, and 
participants have the right to withdraw from the study at any time. To avoid 
feelings of coercion, it will be made clear that participation in the study is 
completely voluntary. 
14.2 Reproduction Risks: NA 
14.3 Risks to Others: NA 
15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception: NA 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits: 

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Families will benefit from receiving prevention services from well-trained and 
well-supported group facilitators. Families will have increased possibility of 
experiencing significant improvements in their child’s adjustment as well as delay 
and prevention of substance use and abuse. The web-enhancement will give 
families access to an online training platform which allows already overburdened 
parents to balance the demands of work and family with their commitment to 
improving their parenting skills and fostering optimal development for their 
children. Additionally, participating in a parenting program designed specifically 
for the families of reintegrating military personnel will reduce the psychological 
barriers to help-seeking for this high-risk population. In light of the considerable 
personal and public costs associated with compromised parenting, the potential 
benefits of participating in this study greatly exceed the potential risks. 
 
17.0 Data Management 
17.1 Data Analysis Plan:  
Analyses will be conducted in several steps, starting with preliminary and 
preparatory analyses including data reduction and evaluation of psychometric 
properties, followed by evaluation of missing data of criterion measures. For the 
primary efficacy evaluation aims of main effect components and the four adaptive 
intervention strategies we will employ standard normal theory Analysis of 
Covariance factorial and fractional factorial analyses to address study aims using 
pre-post assessment scores for parent and child adjustment constructs. To address 
the non-independence of subjects in the embedded adaptive intervention designs 
we will estimate Linear mixed models and weighted least squares regressions for 
estimation of the embedded adaptive intervention contrasts. Descriptive statistics 
(mean, range, SD) will be used in reporting participation, satisfaction (for fathers 
and mothers), and implementation fidelity (for each provider and the group of 
ADAPT providers). 
17.2 Power Analysis: 
First, we chose a power convention of .80 with a two-sided alpha level of .05 to 
reduce the probability of obtaining a false positive improvement or intervention 
effect rejecting the null when it is true (Type-I error at 5% chance). Second, we 
powered the study to detect small to medium effect sizes for the first and second 
stage randomizations. The first stage randomization is allocated with a 1:1 ratio to 
group conditions as depicted in Figure 6. Based on the ROC analyses we estimate 
a potential 50% non-response rate for both the online and weekend condensed 
groups. After the Week 4 assessment of response criteria, non-responders will 
also be randomized to second stage interventions with a 1:1 allocation.   
 
More specifically, power needed to be estimated by addressing the restricted 
randomization scheme and appropriate weighting of the overrepresentation of 
responders and underrepresentation of nonresponders. We employed procedures 
outlined by Oetting and colleagues for estimating power in SMART trial designs. 
As recommended, we specified an alpha level of .10 and power of .80. The first 
main research question (2a) addresses main effects of initial stage randomization, 

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the second question (2b) addresses the main effects of the second stage 
randomization for non-responders. Finally, the third main question (2c) addresses 
the overall optimal adaptive intervention strategy for military. Following methods 
outlined by Oetting et al. (2011), the proposed SMART trial is adequately 
powered to detect small to medium effects for Research Questions 2a, 2b, and 2c. 
Based on our prior studies outlined above, power was estimated using an 
estimated 10% to 20% attrition over the study.  See chart below. 
 
 
 
 
 
 
 
ADAPT SMART Trial Mimimally Detectable Effect (MDE) with .80 Power and 10% and 20% Attrition 
Total Sample 
Research 
Question 
Analysis Contrasts  
Correct 
Strategy p 
10% 
Attrit.   
MDE δ 
20% 
Attrit. 
MDE δ 
525-10% = 473 
Q2a 
[A+B+C] vs. [D+E+F] 
 
.324 
.343 
262-10% = 236 
Q2b 
[B+E] vs [C+F] 
 
.458 
.485 
Nmax = 4731 
Q2c 
[A+B]vs [A+C]vs [D+E]vs [D+F] 
.95 
.285 
.301 
 
17.3 Data Integrity:  
Site coordinators and the project manager will oversee assessment technicians and 
conduct quality control checks regularly throughout the data collection process. If 
needed, additional training will be provided to assessment technicians. Video 
recordings of family interaction tasks will be monitored by the coding coordinator 
to ensure high quality and consistency across assessment technicians. Survey data 
will be cross-checked and cleaned shortly after in-home assessments are 
conducted to ensure data were collected accurately as well as resolve any 
discrepancies in key study variables (e.g., deployment status, marital status, 
gender, etc). 
18.0 Confidentiality 
18.1 Data Security:  
Participants are assigned a coded identification number that is used on all data 
collection measures. This includes a family id (e.g. individual #1 in family #1 is 
0001-1). Identifying information necessary for participant contact, such as names, 
addresses, and telephone numbers are kept in locked filing cabinets or in our 
secure participant database. Access to the online database is restricted to those 
with valid usernames and passwords and limited to those staff members whose 

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jobs require use of this information for contacting participants. Individuals using 
this database receive unique and identifiable usernames and passwords. Relational 
database passwords must be changed on a regular basis. All staff members are 
required to close password-protected applications or lock their workstations when 
they are away from their desks. During data analysis all identifying information, 
with the exception of the participant identification number is removed from the 
data. No information about identities of the study participants will be published or 
presented at conferences.  
To ensure confidentiality, all information will be coded so that it cannot be 
associated with any individual. To minimize the risk of loss of confidentiality, the 
data collected online in this study will be protected by the use of separate 
databases. The first will include the subject consent forms, first names only and 
subject ID. Other databases will include the questionnaire data from the project, 
and participants’ study ID will be the only unique piece of information linking the 
data files to the consent file. Video files of observational assessment tasks will be 
stored in a separate storage area online. Only study IDs will be used to link videos 
to questionnaire data. These files will all be password protected and accessible to 
only a limited number of project personnel. In order to protect participant data 
during internet based research, the project will use Qualtrics, a sophisticated 
online data management system that maintains extremely stringent levels of 
encryption and data storage.  
Qualtrics is specifically designed to meet and exceed industry standards for 
Internet security as well as Institutional Review Board (IRB) and Data Safety and 
Monitoring Board (DSMB) standards for the protection of research participants. 
For participants, secure servers with registered site certificates provided by 
VeriSign Internet Trust Services provide for advanced encryption over the wire. 
To ensure an even greater level of security and confidentiality, Qualtrics also 
requires that participants are authenticated to gain access to the data entry forms. 
Participants will receive an email with the survey name specified as a query string 
parameter in the URL, which is encrypted by Secure Sockets Layer (SSL). As 
users move through the data entry forms, the responses are encrypted while in-
transit between the browser and Qualtrics's server using SSL and 40, 56, or 128-
bit Public Key Encryption. All data collection is performed using SSL with 128-
bit secure key encryption whenever possible. Data will be stored on the Qualtrics 
server and will be downloaded to U of MN and de-identified data to ISII in 
Oregon for analysis. Qualtrics servers are stored in a locked, well-ventilated room 
in locked server cabinet/racks and are protected by alarm security. 
Questionnaires will be designed so that individuals cannot be identified on the 
basis of their data alone, and as noted above, all identifying information will be 
stored in a separate database from the data files. All subject identification data 
will be destroyed at the end of the project. The collected materials will be used 
only for research purposes; participants’ records with identifying information will 
not be released to anyone without participants’ written permission.  
All University of Minnesota and ISII employees who will work on this project, 
including administrative, research, and production staff, have attended at least one 
training session on protecting the rights and welfare of human research subjects. 

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The session(s) included an overview of the history of human subjects’ protection, 
an overview of the Belmont Report, a review of IRB policies and procedures, and 
a discussion of the regulatory requirements regarding informed consent. The 
University of Minnesota has a mandatory IRB curriculum for all Principal 
Investigators, which Dr. Gewirtz and all other project investigators and staff have 
completed.  In addition, all project staff received adequate training in the 
responsible conduct of research involving human subjects through participation 
and completion of the CITI Human Subjects Research Educational Model course 
(delivered by the NIH).  
All data entered into the computerized database will be identifiable by subject 
code number only. All research staff sign confidentiality agreements. No one 
except the research staff will have access to records identifying subjects' names at 
any time. The information gathered will be used only for scientific, educational, 
or instructional purposes. A Certificate of Confidentiality was approved by the 
National Institute of Child Health and Human Development (expires 09/30/2020), 
to further protect privacy of each participant and avoid compelled “involuntary 
disclosure” (e.g., subpoenas) of identifying information about a research subject.  
It should be noted that we are not allowed to ask substance use questions to 
Active Duty participants and will encode the online survey with logic if-then 
routing that will eliminate those questions from the battery of assessment for 
active duty participants. 
The link between identifiers and code will be maintained for 10 years following 
the end of data collection. 
Data will be kept for ten years following the end of data collection in order to 
allow sufficient time for analysis of videotaped observations, which are coded 
using microsocial/second-by-second techniques, and are very time-consuming to 
code. Following this, videotaped data will be destroyed. 
A Certificate of Confidentiality was approved by the National Institute of Child 
Health and Human Development (expires 09/30/2020),  to provide further 
protection of our study participants and our data. 
Most data will be stored electronically, but some situations may require the use of 
paper form. 
Data will be stored on secure, password-protected servers.  
Access to data will be restricted to the Project Offices at the University of 
Minnesota.  All space accessible to the public is separated from research offices 
by locked doors. All staff entrances are secured with locked doors. All paper 
forms will be kept in locked file cabinets. The Department’s computing system is 
protected from outside access. The planned complexity of this system helps 
increase the security of the local network. Servers maintain logs and generate 
reports of access attempts, which are reviewed by the Network Administrator.  
 
During the analysis of the data, all identifying information with the exception of 
the subject identification number is removed from the data. No information about 
the identities of study participants will be published or presented at conferences.   

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19.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants 
NA 
20.0 Provisions to Protect the Privacy Interests of Participants 
20.1 Protecting Privacy:  
Assessments are conducted either online or, if in person, in subjects' homes, to 
ensure convenience for participants. We have conducted in-home assessments in 
prior studies without problems. Military populations may be especially resistant to 
coming to a university or hospital setting for assessment or intervention, which is 
why program activities (for in-person groups) will be held in community locations 
or on base locations convenient to participants (i.e. libraries, community centers). 
As participants are recruited we will determine optimum group locations. 
20.2 Access to Participants: NA 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: NA 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
(1) Interested participants will be directed to an anonymous online 
screening instrument, which determines eligibility based on inclusion 
criteria. 
a. To manage study participation and administer online measures, we have 
a secure website that maintains stringent, HIPAA-compliant levels of 
encryption and data storage, and sophisticated data management and 
collection features.  
b. The website guides parents to an explanation of the project, and a 
description of project confidentiality and its limits. Online procedures 
adhere to guidelines to guarantee the same level of human subjects’ 
protection to online participants as participants in more traditional studies. 
(2). Eligible participants will next complete a brief online contact 
information form, followed by an online informed consent that provides 
information about study risks, benefits and the possibility of being 
randomly assigned to an online or group-based ADAPT program, as well 
as the possibility of being further randomized to additional program 
components. In families with two participating parents, each will complete 
an informed consent. The consent form is attached. 
(3). Consenting participants will be provided a contact number in order to 
speak to the PI or study coordinator with any questions. Families who 
request a telephone screening (e.g., families whose internet is not 
accessible at the time of the call) will be asked for verbal consent for the 
research team to maintain contact through weekly reminder emails and 

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phone calls to complete informed consent and baseline (BL) online 
assessments. Where informed consent is not completed prior, it may be 
completed at the beginning of the in-home assessment. 
(4). Participants who submit their informed consent will automatically be 
directed to log in to the baseline (BL) assessment by providing their email 
and creating a password (the study website will use our existing 
assessment infrastructure to post and administer assessments). Participants 
who lose their password can retrieve it from the system.  
(5). Upon logging in, participants will be given the online portion of the 
BL assessment.  
The assessment package includes self-report measures (Table 1) to be 
completed by each participating parent or caregiver. The assessment 
package takes each adult approximately 35 minutes to complete, and upon 
completion participants are each compensated $25 (per assessment 
package completed; up to two per family). Parents also are asked to 
schedule a 15-minute study orientation call, and in-home assessment 
appointment with project staff. Families who do not complete the online 
assessment will be asked to complete the assessment during the 
assessment in-home visit. 
(6). A copy of the parental consent form will be offered to and left with 
families at the first (BL) in-home visit and all subsequent visits (T3 and 
T4).  
(7). Child assent will be completed at the first (BL) in-home assessment. 
The assent form is attached. 
a. In-home assessments will be conducted by pairs of well-trained research 
assistants located on or near each base who will be employees of the 
University of Minnesota with extensive experience with military families 
(as veterans, spouses or relatives, and/or service providers) and with some 
research experience. They will be provided extensive training in data 
privacy, HIPAA, human subjects’ protection, the consent process, and 
assessments.  
Note: childcare provided by study staff is offered during in-home 
assessments for siblings. If study staff are not available to provide 
childcare, a $30 gift card stipend will be offered to the family so that they 
can arrange their own childcare. 
b. Families who prefer assessment outside the home may go to the local 
project office. Following the BL assessment, participants are electronically 
(via computer program) given random assignment to clinical trial 
conditions, which have been explained during the consent process. 
c. Teachers will be contacted via secure, encrypted email, with an explanation of 
the study, and a copy of the parent’s release of information (see attached) . They 
will be directed to the study website to complete questionnaires. Teachers not 

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responding will receive materials by mail, with follow-up calls (this has been a 
very effective strategy in our prior studies). 
22.2 Waiver or Alteration of Consent Process (when consent will not be 
obtained, required information will not be disclosed, or the research 
involves deception): 
Waiver of consent is being requested because identifying information is collected 
via our online (using Qualtrics) screening process where we administer an 
eligibility survey before potential participants can give consent. After being 
determined eligible, potential participants continue to the on-line consent 
information and are asked to type their name in the box to show "signed" consent. 
A waiver of documentation of consent is also being requested since participant 
signature is collected on-line, by typing, and not in-person with live signature. It 
is essential that we screen for participation before obtaining consent and because 
this process is done on-line, we are asking for a waiver of consent for this process. 
22.3 Non-English Speaking Participants: NA 
22.4 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 
years of age): 
One parent will give consent for their child, under the age of 18, but who is 
between 5 and 12 years old per our eligibility criteria, to take part in the study. 
Assent will be obtained by the child assessment technician from the child 
participant during the first in-home assessment.   
22.5 Cognitively Impaired Adults, or adults with fluctuating or diminished 
capacity to consent: NA 
22.6 Adults Unable to Consent: NA 
23.0 Setting 
23.1 International Research: NA 
23.2 Community Based Participatory Research: NA 
23.3 Research Sites:  
Research will occur on 3 military installations owned by a component of the 
Department of Defense.  
24.0 Multi-Site Research 
24.1 Study-Wide Number of Participants: 525 
24.2 Study-Wide Recruitment Methods: 
Local recruitment methods are described earlier in the protocol. 
24.3 Study-Wide Recruitment Materials:  
Recruitment methods are described earlier in the protocol. 
24.4 Communication Among Sites:  

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• 
A Site Coordinator at the U of MN has been assigned to ensure proper 
dissemination of all relevant study information and has the 
responsibility to ensure that participating sites are conducting the 
study according to provided documents. 
• 
The Site Coordinator at the U of MN has weekly one on one meetings 
with participating sites and periodic meetings with all three sites. 
• 
Participating sites are encouraged to hold their own meetings to 
collaborate and share best practices.  
• 
Participating sites have Site Coordinators that have access to the U of 
MN secure server where all applicable study documents are 
maintained and available.  
• 
All sites have the most current version of the protocol, consent 
document(s), and, when applicable, HIPAA authorization. 
• 
All engaged participating sites will safeguard data, including secure 
transmission of data, as required by local information security policies. 
• 
All local site investigators conduct the study in accordance with 
applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with university or local policy. 
• 
All other reportable events in accordance with university or local policy. 
24.5 Communication to Sites:  
• 
A Site Coordinator at the U of MN has been assigned to ensure proper 
dissemination of all relevant study information and has the 
responsibility to ensure that participating sites are conducting the 
study according to provided documents. 
• 
The Site Coordinator at the U of MN has weekly one on one meetings 
with participating sites. 
• 
Participating sites have Site Coordinators that have access to the U of 
MN secure server where all applicable study documents are 
maintained and available.  
• 
The Site Coordinator at the U of MN sends a monthly power point 
update to each site with relevant and occurring study information. 
25.0 Resources Available 
25.1 Resources Available:  
We are collaborating with Co-Investigators Dave DeGarmo at University of 
Oregon to provide data analysis and Marion Forgatch at Implementation Sciences 
International, Inc. (ISII) to advise on program implementation and fidelity. 
We will recruit subjects with the assistance of a broad base of collaborators 
including United States Special Operations Command (USSOCOM) Protection of 
the Force and Family (POTFF) staff, component and installation Chaplains, 
Military Family Life Consultants (MFLCs) and Family Advocacy Program staff. 
See attached support letters from our military consultants and collaborators. 
 

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26.0 References 
 
Almirall, D., et al., Designing a pilot sequential multiple assignment randomized trial for 
developing an adaptive treatment strategy. Stat Med, 2012. 31(17): p. 1887-902. 
 
Kasari, C., et al., Communication interventions for minimally verbal children with 
autism: a sequential multiple assignment randomized trial. J Am Acad Child Adolesc 
Psychiatry, 2014.53(6): p. 635-46. 
 
Thall, P.F., et al., Adaptive therapy for androgen-independent prostate cancer: a 
randomized selection trial of four regimens. J Natl Cancer Inst, 2007. 99(21): p. 1613-22. 
 
Murphy, S.A., et al., Developing adaptive treatment strategies in substance abuse 
research. Drug Alcohol Depend, 2007. 88 Suppl 2: p. S24-30. 
 
August, G.J., T.F. Piehler, and M.L. Bloomquist, Being "SMART" About Adolescent 
Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion 
Agency. J Clin Child Adolesc Psychol, 2014: p. 1-15. 
 

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Domain 
Measure 
Location 
Number 
of Items 
Time to 
Complete 
Parents 
Parenting sense of control 
PLOC 
In home 
24 
5 minutes 
 
Parenting Practices 
APQ-22 
In home 
22 
5 minutes  
 
Deviant peer association 
PEERS 
In home 
18 
5 minutes 
 
Child internalizing and externalizing 
BASC-3 
In home 
160 
10 minutes 
 
Coping with children’s neg emotions CCNES 
In home 
72 
10 minutes 
 
PTSD supplement question 
Ever experienced trauma 
Either 
1 
1 minute 
 
PTSD 
PCL 
In home 
18 
5 minutes 
 
Context measures 
DRRI (Sections I&J Only) 
In home 
30 
5 minutes 
 
 
Total Time for In-Home Parent Survey Measures: 46 minutes 
 
Demographic questionnaire 
Assorted items 
Online 
 
5-10 minutes 
 
Couple adjustment 
DAS-7 
Online 
7 
2 minutes 
 
Mindfulness 
FFMQ 
Online 
39 
7 minutes 
 
Substance use 
AUDIT 
Online 
10 
1 minute 
 
Emotion regulation 
DERS 
Online 
36 
5 minutes 
 
Depression 
CESD 
Online 
20 
3 minutes 
 
Parenting support 
PSI/receipt of help 
Online 
48 
5 minutes 
 
Moral Injury 
MIES 
Online 
9 
2 minutes 
 
Parenting mindfulness 
IEM-P 
Either 
10 
2 minutes 
 
Parenting Identity 
DeGarmo Scale 
Either 
8 
2 minutes 
 
 
Total Time for Online Parent Survey Measures: 40 minutes 
Parent 
EF – Inhibitory Control 
NIH Toolbox – Flanker  
In home 
 
5 minutes 
 
Verbal Ability 
NIH Toolbox – Peabody Picture 
Vocabulary test 
In home 
 
5 minutes 
 
 
Total Time for IQ/EF tasks: 10-15 minutes 
Child 
Deviant peer association 
Describing friends 
In home 
44 
5-10 minutes 
 
Internalizing and externalizing 
BASC-3 
In home 
176 
10-25 min 

PROTOCOL TITLE: SMART optimization of a parenting program for active-duty families 
VERSION DATE: V10, June 2019  
 
Page 40 of 40 
Revised: June 2019 
 
 
Internalizing 
CDI 
In home 
10 
5 minutes 
 
PTSD-RI 
Combo of DSM-IV/V items 
In home 
52 
5-10 minutes 
 
 
Total Time for Child In Home Measures (minus PTSD): 45-50 minutes 
Teacher 
Deviant peer association 
TPRISK  
Online 
24 items 
5 minutes 
 
Internalizing and externalizing 
BASC-3 
Online 
139 
10-20 min 
 
 
Total Time for Teacher Measures: 15-25 minutes