Comparing Web, Group, and Telehealth Formats of a Military Parenting Program
Phase: NA
Conditions: Parenting
Sponsor: University of Minnesota

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
Parenting Program 
VERSION DATE: May 4, 2018 
 
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Revised: May 4, 2018 
PROTOCOL TITLE: 
Comparing Web, Group, and Telehealth Formats of a Military Parenting Program 
 
PRINCIPAL INVESTIGATOR or FACULTY ADVISOR: 
Abigail Gewirtz 
Institute of Translational Research  
612-624-1475 
agewirtz@umn.edu  
STUDENT INVESTIGATOR: NA 
 
VERSION NUMBER/DATE: 
V6, May 4, 2018 
 
 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
Parenting Program 
VERSION DATE: May 4, 2018 
 
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REVISION HISTORY 
 
Revision # 
Version Date Summary of Changes 
Consent 
Change? 
4 
9/12/2017 
IRB application (V4) transferred to 
protocol template for Ethos 
migration; incorporates all CIP that 
were submitted and approved after 
this original application and up 
until Ethos migration. 
NA 
5 
3/28/2018 
Updated process for 
Smartphone/Android application 
(App) 
NA 
6 
5/4/2018 
Addition of three measures (Life 
Events Checklist (LEC-5), Child 
Lifetime Events and DRRI-Section 
K 1 and 2) to be collected at time 
point 4 (T4). See updated attached 
measures list. 
NA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
Parenting Program 
VERSION DATE: May 4, 2018 
 
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Table of Contents 
After completing your protocol, right click on the Table of Contents below and select 
“Update Field.” If prompted, select “Update entire table.” This will automatically 
update the protocol sections and page numbers for you. Do this also each time you 
modify your protocol after initial approval. 
 
1.0 
Objectives ................................................................................................................ 6 
2.0 
Background .............................................................................................................. 9 
3.0 
Study Endpoints/Events/Outcomes ........................................................................ 10 
4.0 
Study Intervention(s)/Interaction(s) ....................................................................... 10 
5.0 
Procedures Involved............................................................................................... 12 
6.0 
Data Banking – NA ................................................................................................ 19 
7.0 
Sharing of Results with Participants – NA ............................................................ 19 
8.0 
Study Duration ....................................................................................................... 19 
9.0 
Study Population .................................................................................................... 19 
10.0 Vulnerable Populations .......................................................................................... 20 
11.0 Number of Participants .......................................................................................... 21 
12.0 Recruitment Methods ............................................................................................. 21 
13.0 Withdrawal of Participants .................................................................................... 24 
14.0 Risks to Participants ............................................................................................... 24 
15.0 Incomplete Disclosure or Deception ...................................................................... 29 
16.0 Potential Benefits to Participants ........................................................................... 29 
17.0 Data Management .................................................................................................. 29 
18.0 Confidentiality ....................................................................................................... 30 
19.0 Provisions to Monitor the Data to Ensure the Safety of Participants – NA ........... 33 
20.0 Provisions to Protect the Privacy Interests of Participants .................................... 33 
21.0 Compensation for Research-Related Injury ........................................................... 34 
22.0 Consent Process ..................................................................................................... 34 
23.0 Setting .................................................................................................................... 35 
24.0 Multi-Site Research ............................................................................................... 36 
25.0 Resources Available............................................................................................... 36 
26.0 References .............................................................................................................. 36 
 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
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ABBREVIATIONS/DEFINITIONS 
Include any abbreviations or definitions for key or technical terms you use in your 
protocol. 
 
 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
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STUDY SUMMARY 
 
Study Title 
Comparing Web, Group, and Telehealth Formats of a 
Military Parenting Program 
Study Design 
Randomized Control Trial 
Primary Objective 
Advance the research on family-based prevention of 
negative outcomes for reintegrating Operation 
Enduring Freedom/Operation Iraqi Freedom personnel 
by evaluating different formats of a parenting program, 
After Deployment, Adaptive parenting Tools 
(ADAPT).  
Secondary Objective(s) 
 
Primary Study Intervention 
or Interaction 
Delivery of three different formats (in-person, tele-
health and online) of ADAPT. 
Study Population 
National Guard and Reserve (former and present) 
personnel in MN and MI, and their families  
Sample Size (number of 
participants) 
360 
Study Duration for 
Individual Participants 
2 years  
 
 
 

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1.0 
Objectives 
1.1 Purpose:  
The overarching goal of this study is to advance research on family-based 
prevention of negative child outcomes for reintegrating Operation 
Enduring Freedom/Operation Iraqi Freedom personnel by evaluating 
different formats of a parenting program, After Deployment, Adaptive 
Parenting Tools/ADAPT. The ADAPT program is based upon the Parent 
Management Training-Oregon Model/PMTO, but adapted for military 
deployed families. We will examine which of three delivery formats of 
ADAPT is most effective at reducing youth risk behaviors associated with 
negative childhood outcomes by improving parenting, child, and parent 
adjustment.  There is a clear intent to benefit all subjects in this study 
(except surveyed teachers), including children.   
We will conduct a three-group, two-site randomized trial to test the 
comparative effectiveness of ADAPT delivery approaches. The study will 
randomly allocate 360 NGR families to one of three conditions: (i) group-
based web-enhanced ADAPT; (ii) individualized web-facilitated ADAPT; 
or (iii) self-directed web ADAPT. 
Thus, specific aims are as follows: 
1. Conduct a three-group, two-site randomized trial to test the comparative 
effectiveness of ADAPT delivery approaches 
a. Families will complete a pre-intervention baseline assessment and 
post-intervention follow-up assessments at 6, 12- and 24 months. 
2. Test the generalizability of ADAPT effectiveness across three delivery 
approaches using intent to treat (ITT) analyses 
a. Test the value-added impact of group-based delivery relative to 
facilitated and self-directed web approaches 
b. Comparative effectiveness will be tested by specifying a non-
equivalence hypothesis for group based and individualized facilitated 
relative to self-directed web only 
We hypothesize that (1) individualized web-facilitated parenting 
intervention will be equally effective as the group-based web-enhanced 
intervention, and (2) both individualized and group-based ADAPT will be 
more effective than a self-directed web-condition. Effective internet 
delivery methods will facilitate development of new approaches to engage 
military families separated by deployment, isolated by geographical 
location, and in need of strategies to deal with deployment and 
reintegration stressors, directly addressing limitations and barriers to 
access to evidence based prevention programs. 
 

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Analysis of Aim 1: ADAPT comparative effectiveness hypotheses will be 
tested using standard normal theory Analysis of Variance and multiple 
regression techniques in structural equation modeling (SEM) with a focus 
on growth curve analyses for follow up data. We will specify analyses to 
test Hypothesis 1: NGR families in both the ADAPT group-based 
condition and the ADAPT web-facilitated condition will show greater pre-
post improvements in observed parenting, and parent, child, and couple 
functioning relative to the self-directed web condition; and Hypothesis 2: 
ADAPT group-based condition will be equally effective as the 
individualized ADAPT web-facilitated condition. 
Analyses for Hypothesis 1 of Aim 1.  We will employ standard normal 
theory pre-post Analysis of Variance and structural equation modeling 
(SEM) growth curve analyses for the long-term follow up. For the 
immediate pre-post analyses we will conduct a 3 group by 2 repeated 
measures Analysis of Variance for parenting, child, and couple 
functioning constructs focusing on the comparison of change across the 
Group Based, Individualized Facilitated, and Self-directed ADAPT 
conditions. The study randomly allocates 360 NGR families across the 
three conditions (n = 120 per group). For the 6-month assessment, we 
estimate a projected 5% attrition rate and over the 24-month follow up we 
expect roughly 15% attrition. In two prior PMTO randomized trials with 
intensive multiple-method family assessments, family retention was 88% 
and 86%, respectively, at 30-month follow-ups [2, 12]. In both of those 
studies, there were no differential rates of attrition between intervention 
and controls, there was less than 5% attrition by the immediate 6 month 
post-test assessment, and less than 15% attrition by the 24 month 
assessment. Using an alpha level of .05 and considering 5% attrition over 
the first 6 months, a pre-post design with 3 groups of 114, within subject 
SD = 1, and between groups SD = .71; the study is powered .81 to 
minimally detect a small group by time interaction effect (ES = .12), small 
time effect (ES = .15), and small group effect (ES = .21) for given 
parenting, child, couple or parent constructs. 
Follow Up Analyses. For the intent to treat (ITT) analyses of long term 
follow up, we will specify latent growth models (LGM) recommended for 
long term effectiveness designs involving maximum likelihood SEM. 
LGMs have become more standard because they more reliably assess 
change. Growth models combine individual and group levels of analysis, 
taking into account mean growth and individual variation. Fixed effects 
(e.g., random assignment to ADAPT, parent and child gender) and time-
varying random effects may be estimated using chronometric time 
weights. A model specifying an initial status latent variable (assessing 
variance in BL differences) and a linear slope latent variable (estimating 
individual differences in change over time), would be specified using 
factor weights of 1, 1, 1, 1, for the respective repeated measures, and 
factor weights of 0, 1, 2, and 4 for growth. The first step in LGM is to 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military 
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VERSION DATE: May 4, 2018 
 
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identify the model that best characterizes patterns of growth. We can also 
specify an additional nonlinear quadratic factor, a higher order polynomial 
function to capture any nonlinearity. Accelerated or decelerated change 
would be specified with loadings fixed at 0, 1, 4, and 16. A sequential set 
of models tests the latent variances and model fit across a random 
intercept, linear growth, and quadratic model to determine the optimal 
growth pattern.  The comparative effectiveness hypothesis for observed 
parenting is shown in Figure 2 as linear growth. Group Based and Web 
Facilitated will be contrasted to the Self-Directed omitted group. Analyses 
will test that the Group Based effect (β1 > 0) and the Web Facilitated (β2 
> 0) will show greater 2-year improvements relative to Self-Directed. For 
the LGM in Figure 2 we estimated power using Mplus Monte Carlo 
simulations with 1000 replications. An advantage of this approach is the 
ability to incorporate specific patterns of expected attrition over time. For 
the figure in Figure 3, contrasts for Group Based and Web Facilitated were 
fixed at a mean of .33 and variance of .22 representing the random 
allocation across groups. The latent initial status intercept and latent 
growth factors were specified reflecting a commonly observed ratio of 5:1 
for the variance components (Initial Status ѱ 2 = .5 and SD = .70; and 
Linear Growth ѱ2 = .1, SD = .31). The effect size (ES) is then the ratio of 
group contrast mean differences in the latent growth factor divided by the 
SD for growth. A sample size of 306 (cumulative attrition of 15% over 2 
years, specified as .05, .10 and .15 over time) obtained power of .98 
respectively to detect small effects (ES=.10) for β1 and β2 relative to Self-
Directed and likewise for child, couple, parent adjustment.  
Analyses for Hypothesis 2 of Aim 1.  To test whether the ADAPT Group 
Based and Web Facilitated have similar effects we will employ two 
related approaches to test whether (β1 = β2) for the paths shown in Figure 
2. First, using the same model specification shown in Figure 2, we will 
further specify equality constraints in the LGM model to directly compare 
the relative magnitude of β1 and β2. Second, we will conduct a one-sided 
non-inferiority test (i.e., a test of equivalence) for the intent to treat growth 
slope factor means and variances for the respective parenting, child, 
couple, and parent adjustment constructs; hypothesizing no differences 
between the Group Based and Web Facilitated conditions. We used the 
non-inferiority module in the Power Analysis and Sample Size program 
for the equivalence test of means using two one-sided tests for two groups 
of 102 (Group Based and Web Facilitated). The study is powered .82 
using a .05 one-sided alpha when the reference mean = 1 and the 
comparison mean = 1, and the range of difference still results in the 
conclusion of equal means when the comparison group is plus or minus a 
quarter of a standard deviation of the reference mean (± .25 SDs). Finally, 
we will also examine dosage, participation, and variation in fidelity as 
potential moderators of group intervention effects.  
 

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2.0 
Background 
2.1 Significance of Research Question/Purpose:  
Combat deployment and related challenges are family stressors, associated 
with more negative parent-child interactions, ineffective and coercive 
parenting practices and lower levels of parenting satisfaction (e.g. Glenn et 
al.,2002; Jordan et al., 1992; Samper, Taft, King, & King, 2004). 
Disrupted parenting practices are well-known predictors of risk for child 
adjustment difficulties that are precursors to youth substance use, 
including behavior problems, school failure, deviant peer association, and 
depression (Patterson & Fisher, 2002; Sanders, Cann, & Markie-Dadds, 
2003). These child adjustment problems can contribute to continuing 
parental stress, increasing parental distress, and further disrupting 
parenting (DeGarmo & Forgatch, 2004).   
2.2 Preliminary Data:  
With funding from NIH, the first adaptation of PMTO for military families was 
initiated by this research team, and is currently being evaluated in a randomized 
controlled trial/RCT of 400 reintegrating primarily National Guard and 
Reserve/NGR families with preliminary effectiveness.  Known as After 
Deployment, Adaptive Parenting Tools/ADAPT, the program is a 14-week group-
based parenting intervention with an online supplement. ADAPT addresses issues 
specific to deployment and combat stressors, enhances ecological validity by 
incorporating examples and materials relevant to NGR families, and addresses 
psychological and environmental barriers to accessing services. In addition to 
PMTO skills, ADAPT adds a mindfulness and emotion coaching component 
based on the hypothesis that the immediate reactivity and suppression of emotions 
learned on the battlefield may spill over at home following reintegration, leading 
to dys-regulated emotional interactions that increase family coercion. Preliminary 
data show improved parenting practices, mindfulness, parenting efficacy, and 
couple adjustment for ADAPT compared with controls (Gewirtz, 2013). The 
After Deployment, Adaptive Parenting Tools/ADAPT study is the only military 
parenting study of school-aged children to date with preliminary evidence from an 
RCT. We propose to address existing gaps in access to services by NGR families 
by testing the comparative effectiveness of different formats of this program 
including in-person, online, and telehealth. 
2.3 Existing Literature: 
PMTO is a well-established empirically supported intervention targeting highly 
stressed parents that applies Social Interaction Learning theory (SIL, Patterson, 
Chamberlain & Reid, 1982).  Similar to family stress and stress amplification 
models (e.g., Elder Jr, Van Nguyen, & Caspi, 1985), SIL posits that parenting 
mediates the effects of family stressors on child adjustment. That is, deployment 
and related stressors would be expected to impair social interactional patterns, 
leading to increases in coercion, decrements in positive parenting, and increased 
risk for child maladjustment.  PMTO interventions have demonstrated efficacy 

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and effectiveness, showing benefits for children including reductions in behavior 
problems that are precursors to substance use, actual substance use, and 
internalizing problems, as well as increases in social competence and school 
adjustment (for a comprehensive overview see Forgatch & Patterson, in press). 
Moreover, recent findings indicate that strengthening parenting practices 
contributes to improved outcomes for parents themselves (Patterson, Forgatch, & 
DeGarmo, 2010). 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome:  
This study is a three-group, two-site, randomized controlled effectiveness trial 
with baseline and three follow-up assessment points. 
ADAPT Intervention Delivery Conditions. Prior grant funding has enabled the 
development of two modes of ADAPT delivery: group-based (with web 
enhancement) and web-only (self-directed). Group-based ADAPT includes 14 
face-to-face parent group sessions with two facilitators plus access to the ADAPT 
web enhancement (7 mini-modules that consolidate skills learned in group). Web-
only ADAPT provides additional web materials for a total of 10 modules covering 
all the topics taught in group. The web products run on a dedicated site hosted 
through IRIS’ online service, using standard web platforms that can be accessed 
via computers, tablets, or smartphones. Each module contains the following: (a) 
Video-driven lessons, (b) Interactive assessments, (c) Interactive mastery 
exercises, (d) and Printable Resources. Activities in each module take 20-30 
minutes to complete, for total interactivity of up to 40 minutes. The goal is to 
provide an engaging learning experience that imparts knowledge, motivation, and 
skill acquisition using compelling storylines, modeling situations, right 
way/wrong way lessons, and interactive learning exercises (e.g., quizzes). In the 
facilitator-enhanced condition we propose to augment the web-only ADAPT by 
providing individual telehealth facilitation of the web program (i.e. Google 
Hangout, enabling an ADAPT facilitator to guide families through the program in 
weekly video call meetings). 
3.2 Secondary Endpoint(s)/Event(s)/Outcome(s): NA 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description:  
Group-based ADAPT. Groups will meet weekly (excluding holidays; we 
conservatively estimate 3 sessions/month) for 120 minutes, at a time convenient 
to participants (usually early evening). Dinner and childcare are provided, and 
each family is receives $10 per session to cover transportation costs. (c) Group 
content. Groups cover core ADAPT/PMTO topics: 1.Program introduction; 
identifying strengths in military families; reintegration-related stressors. 2. 
Promoting cooperation through use of effective parental directions. 3. Parents as 
effective teachers: teaching strategies using contingent positive encouragement. 4-
5. Observing emotions and regulating emotions: recognizing and regulating 

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emotions, specific emotions, differentiating between parents’ and children’s 
emotions; regulating emotions; strategies to cope with deployment- and combat-
related stressors (e.g., PTSD, injury, separation stressors, renegotiation of family 
roles). 6. Setting limits and 7. Following through: establishing family rules and 
strategies for use of negative sanctions that are consistent, contingent, mild, and 
non-corporal. 8. Communicating with children: active listening skills; family 
meetings, and responding to children’s anxiety; emotion coaching.  9. Family 
Problem Solving: strategies to anticipate and address stressors, problem family 
situations, and plan positive family activities. 10. Managing conflict: builds upon 
sessions 4, 5, 8, and 9 to manage family and other relationship conflicts; 11. 
Monitoring children’s activities: keeping children safe and engaged in well 
supervised prosocial activities; tracking children’s whereabouts, peers, 
transportation. 12. Promoting school success; incorporates material from sessions 
2, 3, 8, 9, and 11 with focus on positive involvement in academic development at 
home and at school; 13. Building skills: reinforces and integrates skills from 
earlier sessions with emphasis on emotional regulation, emotion coaching, 
decreasing coercive interactions and emphasizing positive parenting practices.14. 
Balancing work and play focuses on couple and family relationships and supports 
participants in developing future goals. Sessions begin with a 5-10 minute 
mindfulness practice; attention to deployment issues are addressed in each 
session. Home practice assignments reinforce skills learned in the group. 
Participants have access to the ADAPT website to reinforce and consolidate skills 
learned in group. Facilitators will offer referrals for other services as needed (e.g., 
PTSD) to VA and other mental health providers. 
ADAPT Self Directed Web. In the self-directed web-only ADAPT condition, 
participants have access to the full ADAPT website (10 modules, online 
discussion forum) but do not have access to a ‘live’ in-person facilitator. 
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 thank you gift card with 
directions to 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.  
ADAPT individualized web-facilitated.  This condition comprises access to the 
full ADAPT web program as described above, with augmentation of individual 
facilitator web support (i.e. the facilitator connects via Google Hangout). 
Facilitators meet with families at a mutually convenient time weekly (10-14 
weeks, approximately 3 sessions per month). Sessions cover the same topics as in 
the group condition, but the material is tailored for families and sessions are 
shorter (1 hr vs 2 hrs) to reflect the pace of teaching skills to individual families 

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vs. groups. The web program is used as a springboard for each individual session 
and as a reference for home practice assignments. For example, in session 2, 
‘Giving Effective Directions’, the facilitator introduces the family to effective and 
ineffective directions via role play (as in ADAPT groups), refers the family to the 
online skill video, and provides live (Hangout) role play practice with parents. 
The facilitator explains and shows parents the online home practice assignment. 
Facilitators will offer referrals for other services (e.g. individual therapy for 
PTSD) to VA and other community mental health providers, as needed. 
5.0 
Procedures Involved 
5.1 Study Design: 
This study is a three-group, randomized control effectiveness trial with baseline 
and three follow-up assessment points. 
5.2 Study Procedures:  
1. Eligible participants will complete a brief contact information form, followed 
by an online informed consent providing information about study risks, benefits 
and the possibility of being randomly assigned to one of three intervention 
conditions: group-based ADAPT (G), web-only/self-directed ADAPT (W), or 
individualized web-facilitated ADAPT (F).  In reintegrating families with two at-
home participating parents/caregivers, each will complete a separate informed 
consent. 
2. Consenting participants will be provided a contact number to speak to the PI or 
study coordinator with questions. Families requesting a telephone screening will 
be asked for verbal consent for the team to maintain contact through reminder 
emails and phone calls as needed to complete informed consent and BL online 
assessments. Informed consent may also be completed at the in-home assessment. 
3. Participants who submit informed consents will automatically be directed to log 
in to the BL assessment by providing their email and creating a password. 
Participants who lose their password can automatically retrieve it from the 
system. Upon logging in, participants will be given the online portion of the BL 
assessment. The BL online assessment includes self-report measures to be 
completed by each participating parent or caregiver. The assessment package 
takes approximately 45 minutes to complete; upon completion each participant is 
compensated $25 (per assessment completed; up to two per family). A 15-minute 
study orientation call and in-home assessment with project staff are scheduled. 
Families who do not complete the online assessment can complete the assessment 
by phone or during the home visit. In order to increase the T1 completion rate, 
families may be offered a $50 bonus for scheduling and keeping their 
appointment date and time. This would only be offered after multiple contacts and 
methods have been used to schedule the baseline assessment.  
 
4. In-home assessments will be conducted by pairs of well-trained graduate 
research assistants with experience conducting home assessments using similar 
measures [3]. Assessors will schedule home visits to complete child assent and 

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assessments with the target 5-12 year old child, and complete parent-child 
observational tasks, and adult measures (approximately 100 minutes total). 
Families who prefer assessment outside the home may go to the local UMN or 
UM project office. 
 
Note: Child care is offered to families for the siblings that are not participating in 
the research. In the event that child care staff are not available we will offer 
families a $30 gift card stipend to provide their own child care during the in-home 
assessment.  
 
5. Teachers will be contacted (at each time point) 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 study website to complete 
questionnaires. Teachers not responding will receive materials by mail, with 
follow-up calls. Teachers who do not want their compensation may choose to give 
the gift card back to ADAPT or to MCEC. 
 
6. Following BL assessment, participants are electronically given random 
assignment to the G, W, or F study conditions, with 120 families assigned to each 
condition. The group condition will be run in three cohorts, with 2 groups of up to 
10 families in each cohort of 20 families (up to 60 families in each of the two sites 
– i.e. 120 total, considerably more than we estimate will participate). In both 
online conditions, families may participate as they enter the study. However, 
given the necessity of running groups in cohorts and the need for equivalence in 
analysis, we will also assign individuals in the web conditions to a cohort. 
 
7. Participants in the Group (G) condition will be assigned to a 14-week ADAPT 
facilitator-led group. Groups will be organized as follows: (a) Orientation. The 
group facilitator will provide a telephone orientation to the program to: 1) provide 
program information, 2) address any potential barriers to participation, and/or 
concerns about group attendance, 3) provide information about features and limits 
to confidentiality within intervention groups, and 4) direct attention to the 
ADAPT website and the consent for intervention form. The facilitator will explain 
information will be confidential except when harm to self or others is expressed, 
or child maltreatment reporting is mandated. Facilitators will describe the 14 
week ADAPT group and the web-enhancement component, will encourage group 
participation of both parents/ caregivers in the home in 2-caregiver families, and 
will troubleshoot barriers to group participation. (b) Logistics and locations.  
Sessions will begin as soon as the group is full. Five to ten families (up to 20 
individuals) will participate in each group. Two groups will be offered in each 
cohort. Groups will be facilitated by trained ADAPT facilitators, all of whom 
have previously delivered successful ADAPT or PMTO groups for mothers and 
fathers with high retention and satisfaction. We are currently training a cohort of 
VA therapists, and Michigan community mental health professionals in ADAPT, 
and these individuals will join our current ADAPT facilitator team of 14 
individuals based in MN. The 14 week ADAPT group interventions will take 

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place at community locations in the Detroit, Ann Arbor, Twin Cities, and Duluth 
areas, convenient to participants. We have selected community locations (e.g., 
schools, libraries) rather than VA or Armories to reduce concerns about the 
stigma of services, to normalize the ADAPT groups as health promotion, and to 
ensure proximity to homes.  
 
8. Participants assigned to the web-only (W)/self-directed condition will be 
instructed to log in to the ADAPT website. The website will offer a short (10 
minute) introduction to the program, as well as an informed consent form to 
participate. Then, participants will be given access to the ADAPT dashboard 
(program content list) and instructions on going through the components.  
 
9. Participants in the facilitator-enhanced (F) condition, will be have an ADAPT 
facilitator who will provide a telephone orientation to the program. Orientation 
calls will 1) provide program information, 2) address any potential barriers to 
participation, 3) provide information about features and limits to confidentiality, 
and 4) direct attention to the ADAPT website and the consent for intervention 
form. During this call, the facilitator will show parents how to log in to the 
ADAPT website. The website will offer a short (10 minute) introduction to the 
program, and an informed consent form to participate in the program that parents 
complete and submit online. The facilitator will inform participants that 
information is confidential except when harm to self or others is expressed, or 
child maltreatment reporting is mandated. Facilitators will describe the 14 week 
ADAPT program and the website, encourage participation of both 
parents/caregivers in the home in 2-caregiver families. Throughout the 14-week 
program, participants use the ADAPT website to complete and submit home 
practice assignments, and view materials online. As PMTO topics are introduced 
in the individual telehealth session, facilitators will show participants clips of the 
relevant online module to maintain and support learning. Participants whose 
spouses, or other caregivers are not present, are encouraged to go online between 
sessions, and can share material with other family members.  
 
10. The modules will be accessible to all participants in all conditions for a six-
month period from the start of the program. Parents may log on as often as they 
wish. 
 
11. Six months post BL (after all conditions are completed), all participants will 
be contacted by email and given an online link to the T2 assessments on the study 
website.  The assessment package takes each adult approximately 45 minutes to 
complete; upon completion participants are each compensated $25 (per 
assessment package completed; up to two per family). If a participant has not 
accessed the assessment within three days of the reminder email, a research 
assistant will follow up by phone at regular intervals. The same procedures are 
repeated for T3 (12 months post BL) and T4 (24 months post BL). If at any point 
during the study the participant family loses access to internet service, study staff 
will provide internet access at the in-home assessments so the online surveys can 

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be completed during the baseline or follow-up, or study staff will provide funds 
for the family to travel to a local library, University, etc. to gain computer access. 
Sources of Materials 
• Research material obtained from human subjects will consist of data collected 
specifically for this study.  
The data will include: 
1. 
Web-based questionnaires filled out by families 
2. 
Observational coding data based on videotaped parent-child interaction 
tasks completed by families 
3. 
Short questionnaire packets filled out by families and teachers 
4. 
Short surveys and web conference calls completed by expert panel 
members. 
5. 
Audio and video tape of parent’s response to KidVid (video of parenting 
tasks) 
Measures and Assessments: 
There are 4 assessments: Time 1- baseline (BL, prior to start of the intervention), 
Time 2 - six months post BL (post-intervention, given 4-5 month intervention at 3 
sessions/month, allowing for holidays, etc), Time 3- 12 months following BL, and 
Time 4, 24 months after BL. Assessments are weighted to be gathered in the first 
year, (BL, 6, and 12 months) to gauge intervention effects immediately at posttest 
(i.e., T2) and at T3, which is when parenting and teacher report outcomes 
indicated change in prior studies. All measures (i.e., child, parent, and teacher 
report, and direct observations) will be gathered annually (T1, T3, T4), ensuring 
that teachers are different at each assessment.  At T2, only parent report data will 
be gathered, online, (no in-home assessment) to minimize participant burden in 
Year 1, and because in prior studies observed parenting and teacher report 
outcomes indicated change at 12 months, while parent report indicated some 
change immediately posttest. Child self-report measures will be gathered (and 
were standardized with) children over age 8. Measures are summarized below: 
Parenting practices: (i) Observations. Parent(s) and child participate in a Family 
Interaction Task (FIT) comprising five separate tasks lasting a total of 30-45 
minutes. We have successfully used the FIT in our current ADAPT and prior 
PMTO studies with less than 5% refusals. Coder ratings yield reliable and valid 
measures of parenting practices with short- and long-term predictive validity for 
child and parent outcomes. Tasks include planning a family activity, two, 5-
minute problem-solving tasks to resolve current conflict issues; three 
game/teaching tasks, discussion of an emotional deployment cycle issue from 
Deployment Issues Checklist; and a monitoring task. Families are debriefed to 
address any concerns or questions.  
Parent-child interactions are scored using validated Coder Impressions. The 
ratings yield three primary constructs: positive parenting (family problem-solving, 

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skill encouragement, positive involvement, monitoring), coercive parenting (inept 
discipline/non-contingent parenting) and emotion socialization. Scale scores yield 
reliable Cronbach alphas (ranging from .74-.92) and interrater reliabilities in the 
70% range [12-13]. (ii) Self-report. Alabama Parenting Questionnaire. The APQ 
is a widely measure of parenting practices, with three subscales: Positive 
Parenting, Inconsistent Discipline and Poor Supervision. The 9-item scale has 
been validated in military and community samples, and has validity in 
distinguishing parents of children with and without behavior disorders.   
Child adjustment and substance use. Child adjustment will be assessed with the 
Behavioral Assessment Scale for Children (BASC-2; teacher, parent, and child 
self-report, a system assessing broad domains of externalizing problems, 
internalizing problems, and adaptive skills. Items are rated on a 4-point scale. 
Gender-specific normative scores are provided in the form of T-scores. Parents 
use the parent version of the BASC2 (BASC2-PRS; (alphas = .80-.87); teachers 
use the Teacher Report Form (BASC2-TRS; alphas = .85-.89). Child intentions 
and use of substances will be assessed using self-report for children in 5th grade 
and up, given sensitivity of questions, and given data suggesting that some 
children begin experimenting with substances at this age: in a study of 2300 
students, 16.1% of 5th graders, and 29.4% of 6th graders reported ever having 
used alcohol. Tobacco use will be assessed with 6 items reflecting tobacco use 
behavior (ever taken a puff, smoked a whole cigarette, current smoking, α=.84) 
and intentions to smoke; α=.78 [17]. Alcohol Use Intentions and Behavior Scale. 
This 9-item scale measures alcohol use in the past year, month, week, heavy 
drinking (5+ drinks in past 2 weeks), ever having been drunk, and intentions to 
drink if offered by a friend, in the next month, in high school and as an adult 
(scale range 9-49; α=.82). The combined scale and two subscales (Alcohol Use 
Behavior and Alcohol Use Intentions) have adequate internal consistency and 
test-retest reliability. Child distress will be measured using the Children’s 
Depression Inventory [19], a 27-item symptom-oriented summative index (e.g., "I 
am sad," "nobody loves me") that has been repeatedly shown to correlate highly 
with similar measures of depression and to distinguish between clinical and non-
clinical samples. Since the CDI is designed to be sensitive to change over time, 
test-retest reliability varies between .38 and .87 depending on the sample and the 
time interval being used. PTSD Reaction Index is a 20-item child interview 
assessing posttraumatic 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. Child peer adjustment will be 
measured using a 16-item scale assessing loneliness and dissatisfaction with peer 
relations. Items include "I have nobody to talk to," "I don't have any friends," and 
"It's hard to get other kids to like me." The Describing Friends is a measure of 
deviant peer association  – a summative index of five items scored true of false. 
Items are child reports of friends’ deviant behavior (e.g., my friends get into 
fights, clown around, get into trouble, do not like schoolwork, find schoolwork 
too hard). Childhood exposure to stressful and traumatic events will be collected 
using the Children Lifetime Events questionnaire previously and successfully 
used in the original ADAPT study. These questions will be collected at T4 only.  

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Parent/caregiver adjustment:  Post-Traumatic Stress Checklist; (17 items; alphas = 
.94) is a clinically validated, self-report screening tool assessing presence and 
severity of PTSD symptoms as defined by the Diagnostic and Statistical Manual 
of Mental Disorders Fourth Edition (DSM-IV). Respondents rate each PTSD 
symptom in the past month using a 5-point scale. Center for Epidemiologic 
Studies Depression Scale assesses depressive mood, motor and somatic 
difficulties and has been validated in national health surveys. Items are on a 4-
point scale indicating symptom frequency over the past week. Higher scores 
indicate greater impairment; total scores of 16 or more indicate a “depressive 
case” (Eaton et al., 2004). Additional stressful and traumatic lifetime events will 
be collected using the LEC-5. The LEC-5 assesses exposure to 16 events known 
to potentially result in PTSD or distress and includes one additional item 
assessing any other extraordinarily stressful event not captured in the first 16 
items.  Alcohol Use Disorders Identification Test/AUDIT is a self-report measure 
developed by the World Health Organization as a reliable screen for excessive 
drinking, validated in over two decades with multinational samples and deemed 
effective for early identification in military populations. Cut-off scores of 8 show 
adequate sensitivity; scores between 9-10 are suggested for heavy drinking 
populations (e.g., veterans). Parent mindfulness is assessed using the Five Facet 
Mindfulness Questionnaire/FFMQ, a 39-item questionnaire with five subscales 
(observing, acting with awareness, non-judging, and non-reactivity). Questions 
are on a 5-point Likert scale; α = .72-.92. Difficulties in Emotion 
Regulation/DERS is a 36-item questionnaire assessing six domains of adult 
emotion dys-regulation: non-acceptance, avoidance, difficulties in impulse 
control, lack of emotional clarity, and awareness. Items are on a 5-point Likert 
scale (α = .94). Working memory: Operational Span (OSPAN) requires 
individuals to remember an unrelated sequence of 3-7 letters while solving 
arithmetic problems; total OSPAN working memory is the sum letters recalled in 
correct sequence. Data with military personnel show change following 
intervention. 
Parenting stress and support: Parenting Stress Index-Short Form  (36 items, 
alphas>.90), assesses extent to which parents feel burdened by caretaking, and 
satisfaction with their relationship with their child. Receipt of Help (5 items), 
developed for the National Survey of Families and Households, assesses the 
numbers of persons available for practical help (e.g., babysitting, transportation); 
one or less indicates very low support.  
Participant satisfaction with intervention uses two 10-item measures: (i) Group 
satisfaction questionnaire completed at the end of each session. A principal 
components factor analysis of the 10 parent ratings of satisfaction (e.g., info 
provided was helpful, leader seemed to understand me, enjoyed group) obtained a 
single factor solution for intervention group (eigenvalue = 5.60 explaining 56% of 
the variance) (α = .91). (ii) An online user satisfaction measure will be completed 
at the end of each online module to assess 1) stimulation, 2) comprehension, 3) 
acceptability, 4) ownership, 5) persuasiveness, and 6) support.   

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Context Measures:  Demographic information include: gender, age, racial and 
ethnic identity for parents/children; employment, income, date(s) and numbers of 
deployment. Deployments will be assessed from three questions to obtain 
information about the extent of respondents’ deployment history.  Combat 
exposure will be measured with the Deployment Risk and Resilience Inventory 
(DRRI), an ecologically valid instrument for assessing risk and resilience factors 
among military personnel participating in recent and current deployments. Extent 
and nature of combat injury (5 items) will be assessed using an adapted 
assessment from the National Veterans Readjustment Study designed for 
OEF/OIF/OND veterans. In addition, section K 1 and 2 from the DRRI-2 will be 
administered to collect information about general and sexual harassment. This 
information will be collected at T4 only.  
An ADAPT4U Smart Phone App has been created for study participants who 
have an Android phone and are participating in the ADAPT4U study. This App is 
free by downloading from the App store and will be used voluntarily by study 
participants. Study participants are given a username and password to access the 
App. This information is de-indentified to the engineer managing the App. Only 
research staff will have access to identifying information and data collected 
through the App. When study participants log in they are asked to give consent to 
their data being collected by research staff and if they agree, to allow access to 
their App usage data for uploading to the University of Minnesota's server. If 
study participants do not agree to this, then the data will be uploaded to the 
University of Minnesota's server when their phone becomes connected to WiFi. 
The App has observing exercises, already presented in the ADAPT4U curriculum 
that can be used individually for home practice. They are: Mindful Eating, Ten 
Deep Breaths, Sitting Observing, Body Scan, Notice 5 Things, Drop Anchor, 
Leaves on A Stream, Bell Ringing, Hexaflexercise, Wisdom, Loving Kindness, 
Self-Compassion, and Stretching. 
To begin, study participants select the observing activity they want to practice. 
The App collects data on three questions before study participants begin the 
observing activity. They are: (1) How do you feel right now, (2) I argued or had 
conflict with my children or spouse in the past 6 hours, and (3) How much awake 
time have you spent with your children today so far. Study participants practice 
the observing activity by listening to the guided audio and/or viewing still 
pictures. After completing the activity they answer a final question (How do you 
feel right now?). Data is tracked regarding selected activities, frequency of 
practice, and responses to the pre and post questions. Study participants that use 
the App will be put into a monthly drawing for a $50 gift card. The greater the 
usage, the more chances they have to win the gift card. 
 
Some Smart Phone Application users may be asked to participate in a short 
interview (via phone or email) about their use of the App to help improve it for 
other users and for the development of other versions of the App (i.e. for I-
phones). The purpose of the interview is for program improvement only. This 
would be a one-time phone call lasting no more than 10-15 minutes with study 
participants who have used the App during the course of the study. Participants 

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will be emailed first to ask if they would be willing to answer some questions and 
when is a good time to call. Participants who are interested, but do not have time 
for a call, may be emailed the questions and asked to respond in that manner. 
Study participants will be given a $5 gift card for their one time participation in 
this interview. The goal would be to obtain feedback from at least 10 study 
participants. Note: See list of interview questions. 
 
5.3 Follow-Up:  
There are 4 assessments: Time 1- baseline (BL, prior to start of the intervention), 
Time 2 - six months post BL (post-intervention, given 4-5 month intervention at 3 
sessions/month, allowing for holidays, etc), Time 3- 12 months following BL, and 
Time 4, 24 months after BL. Assessments are weighted to be gathered in the first 
year, (BL, 6, and 12 months) to gauge intervention effects immediately at posttest 
(i.e., T2) and at T3, which is when parenting and teacher report outcomes 
indicated change in prior studies. All measures (i.e., child, parent, and teacher 
report, and direct observations) will be gathered annually (T1, T3, T4), ensuring 
that teachers are different at each assessment.  At T2, only parent report data will 
be gathered, online, (no in-home assessment) to minimize participant burden in 
Year 1, and because in prior studies observed parenting and teacher report 
outcomes indicated change at 12 months, while parent report indicated some 
change immediately posttest. Child self-report measures will be gathered (and 
were standardized with) 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. 
• December 31, 2017 
• May 31, 2019  
 
9.0 
Study Population 
9.1 Inclusion Criteria:  
Inclusion criteria are: (a) one parent has returned from deployment to OIF or OEF 
or stateside deployment in support of the Global War On Terrorism, (b) at least 
one child ages 5-12 in their custody and living with parent(s) in the home, and (c) 
high speed internet access at home (a MN study indicates that 97% deployed 
families have internet, with 70% using internet daily; Sayer et al., 2009). 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 analyses. Participants must live within an hour’s 

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travel time of Grand Rapids, Kalamazoo, Battle Creek or Selfridge, MI, the Twin 
Cities Metro area, St. Cloud or Duluth, MN, agree to randomization, and indicate 
willingness to interact with study materials and complete assessment batteries. 
9.2 Exclusion Criteria: 
Exclusion criteria include: (a) active psychosis, (b) an open child protection case 
for abuse or neglect in the family, (c) a serious child mental health diagnosis, (d) 
families who piloted material or participated in or are currently participating in 
the original ADAPT RCT. MN ARNG data indicate that fewer than 10% families 
would be excluded based on a-c, above (personal correspondence, Polusny). 
There is no reason to exclude women of childbearing potential. There will be no 
exclusion of racial or ethnic groups. 
9.3 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: 
Child Participants: 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.  
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).  Research staff will ask both the parent and child, separately and directly, 

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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.  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. 
Families will be provided with a copy of all consent forms they have signed. 
The following consent forms will be obtained from participants: 
a. Adult consent for participation in the clinical study (all family adults screened 
for participation in the clinical study)  
b. Parental consent for child’s participation in baseline and follow-up assessments 
(all parents of children in the study) 
c. Child Assent Form for participation in baseline and follow-up assessments (all 
children in study) 
d. Adult Consent to release observational assessment video data (all families) 
e. Teacher consent to participate in study (teachers of targeted child only) 
11.0 Number of Participants 
11.1 Number of Participants to be Consented: 630 
12.0 Recruitment Methods 
12.1 Recruitment Process:  
Recruitment flyers promoting the study will be distributed to our partners (NG, 
VA, M-SPAN). In addition, the PI has been invited by the MN ARNG to present 
at reintegration workshops which are mandatory for all soldiers returning from 
OEF/OIF deployment, and flyers will be handed out there. Flyers provide the 
phone and email contact information for the researchers, and the study site URL. 
The website guides parents to a brief explanation of the project, and a description 
of project confidentiality and its limits. Refer a friend post cards will be 
distributed to previous ADAPT study participants and current participants (as 
recruitment occurs). A recruitment/outreach booth will be set-up at the MN State 
Fair on Military Appreciation Day.  
Interested participants will be directed to an anonymous online screening 
instrument. This screen determines eligibility based on the above stated inclusion 
and exclusion criteria. Eligible 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 either an intervention (E) group or SAU comparison group.  
In reintegrating families with two at-home participating parents/caregivers, each 
will complete a separate informed consent. 

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Eligible participants will next complete a brief contact information form, followed 
by an online informed consent providing information about study risks, benefits 
and the possibility of being randomly assigned to one of three intervention 
conditions: group-based ADAPT (G), web-only/self-directed ADAPT (W), or 
individualized web-facilitated ADAPT (F).  In reintegrating families with two at-
home participating parents/caregivers, each will complete a separate informed 
consent. 
Consenting participants will be provided a contact number to speak to the PI or 
study coordinator with questions. Families requesting a telephone screening will 
be asked for verbal consent for the team to maintain contact through reminder 
emails and phone calls as needed to complete informed consent and BL online 
assessments. Informed consent may also be completed at the in-home assessment. 
Participants who submit informed consents will automatically be directed to log 
in to the BL assessment by providing their email and creating a password. 
Attrition and Enhancing retention:  We expect attrition to be 5-20%, based on 
current study data, and have calculated power accordingly. 
 
Assessors in all conditions will use retention tools successful in this and other 
stressed populations: 1) Families give contact information for themselves and 3 
friends/family members. 2) Parents receive pre-stamped cards with study address 
and receive $20 for providing their new address. 3) We provide study updates in 
newsletters, and bi-yearly mailings. We will use evidence-based strategies for 
enhancing retention. To encourage assessment completion we will compensate 
participants. To enhance participation in group (G) activities, we will hold two 
drawings at each session: group start for timeliness, group end for home practice 
completers, for small prizes (e.g. chocolate; journals; stress balls). In W and F 
conditions, participants will receive small online gift cards for participation and 
online completion ($10 per module completed). We will hold groups at 
convenient times for families (e.g, early evening hours), include meals for 
participants, and onsite childcare. Transportation stipends and free parking will be 
provided. If increasing recruitment numbers become a challenge, we will offer a 
refer a friend bonus of a $5 gift card and/or put the referrer and referee into a 
drawing for a $100 gift card.  
 
12.2 Source of Participants:  
Military (current or former) and their families who self-identify and live in within 
an hour’s travel time of Grand Rapids, Kalamazoo, Battle Creek or Selfridge, MI, 
the Twin Cities Metro area, St. Cloud or Duluth, MN.   
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 

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contact will be made by site coordinator on each installation only after 
participants express interest and provide their contact information. 
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. 
12.5 Payment:  
Subjects will be compensated utilizing Target (or similar) gift cards for 
assessment activities as follows: 
Effectiveness trial participants (N=360 families) will be paid $50 for in-home 
assessments at baseline and 12 months, and  $100 at 24 months post-baseline; 
children will be provided a small gift valued at $5. Each adult completing an 
online assessment (at baseline, 6, 12, 24 months), up to 2 adults per family, will 
be compensated $25 per assessment.  2 parent families who complete all surveys 
and in-home assessments can make up to $400 and 1 parent families can make up 
to $300. 
Families randomly assigned to the face-to-face group intervention (N= 120 
families) will be compensated $10 for each group session attended to offset travel 
costs, as well as an additional $5 when they complete at least two online 
assignments per module (14 maximum). Small prizes will be distributed at each 
group session for attendance and homework completion. Full participation would 
entail 14 sessions and result in a $210 incentive per family. 
Families randomly assigned to the online-facilitated intervention (N= 120 
families) will be compensated $5 per one-hour session with a facilitator, as well 
as an additional $5 when they complete at least two online assignments per 
module (140 maximum). Full participation would entail 140 sessions and result in 
a $1400 incentive per family. 
Families randomly assigned to the online-only intervention (N= 120 families) will 
be compensated $5 for each parent who completes at least two online assignments 
per module (140 maximum). Full participation would entail 140 sessions for each 
parent and result in a $1400 incentive per family. 
2 parent families have the potential to be compensated up to $610, and single 
parent families have the potential to be compensated up to $510. 
Teachers will be compensated $15 for completing yearly assessments (at baseline, 
12, and 24 months) 
Compensation will be provided along the way as subjects complete each in-home 
assessment and online surveys, and each week as they complete either the in-
person groups or the online modules. 
 

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Subjects will be compensated for all of the assessments, surveys, and group 
sessions they attend. 
 
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 
14.1 Foreseeable Risks:  
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 below. 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 NG, 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 

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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. 
 
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 
study website to complete online informed consent and study questionnaires. 
Teachers not responding will receive materials by mail with follow-up calls.  
 
Effectiveness Trial Family Participants:  
• We will create and distribute recruitment flyers to our partners (MN NG, MI 
NG), providing a study website URL and phone number. We will recruit families 
in close collaboration with the MN, MI, ND, and WI NG, by: (a) postings on the 
NG websites, (b) flyers and pamphlets at armories and announcements via email, 
(c) attending NG family support groups, family readiness academies, and Yellow 
Ribbon family reintegration training.  
 
• To manage study participation and administer online measures, we use a secure 
web site (Qualtrics, 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.  
 
• Interested participants will be directed to an anonymous online screening 
instrument. This screen determines eligibility based on the inclusion criteria 
mentioned above.  To be eligible for the study, families must agree to random 
assignment to experimental or control conditions, be willing and able to complete 
assessment and intervention, and live within the catchment area.  See 
Inclusion/Exclusion Criteria for eligibility guidelines.   
 
• 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 three conditions.  Families will be assured that no services or relationship 

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with the NG or the University of Minnesota or University of Michigan will 
change or be adversely affected regardless of whether or not they choose to 
participate in the study.   
 
• The voluntary nature of participation and the ability to withdraw from the 
project at any time without penalty will be emphasized. In reintegrating families 
with two at-home participating parents/caregivers, each will complete a separate 
informed consent. 
 
• 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. 
 
• Child Participants: 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.  
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).  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.  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. 
 
Families will be provided with a copy of all consent forms they have signed. 
The following consent forms will be obtained from participants: 
 
a. Adult consent for participation in the clinical study (all family adults screened 
for participation in the clinical study)  
b. Parental consent for child’s participation in baseline and follow-up assessments 
(all parents of children in the study) 
c. Child Assent Form for participation in baseline and follow-up assessments (all 
children in study) 
d. Adult Consent to release observational assessment video data (all families) 
e. Teacher consent to participate in study ( teachers of targeted child only) 

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Planned procedures for protecting against or minimizing potential risks, including 
risks to privacy of individuals or confidentiality of data, and assess their likely 
effectiveness.  
 
• Potential risk #1 (discomfort with assessment procedures) and #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. 
 
• 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. 
 
• Potential risk #4 (violation of confidentiality): Safeguards. Extensive procedures 
are in place to prevent confidentiality violation and errors resulting from data 
processing. We will complete and submit an application for a Certificate of 
Confidentiality to provide further protection of our study participants and our 
data. 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. 

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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.  
 
• 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 or, for children an assent 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. 
 
The anticipated potential adversity inherent in assessment is limited to those 
situations described above and is addressed by the timely intervention of a 
licensed clinical psychologist skilled in risk assessment and mandatory reporting 
requirements.  
 
We have never had a staff safety issue while in a subject’s home and have done 
more than 500 in-home assessments to date. In our assessment tech training, our 
techs are given a manual with instructions for dealing with different situations, 
and we do discuss this issue so all of our techs know what to do in case of an 
emergency.  
 
As a part of the ongoing statistical analyses conducted to evaluate the 
effectiveness of the prevention trial, the experimental and control groups will be 
routinely compared on several dimensions, including the occurrence of the type of 
adverse events described above. With any significant group difference, the 
relevant covariates will be thoroughly examined in order to understand more 
completely the relationship between the variables of interest and potential effects 
of the intervention. The results of our analyses, including the occurrence of 
adverse events, will be reported both to our IRB and to NIDA through annual 
progress reports. We will also report adverse events to others, as directed by our 
IRB or NIDA Program Official.  
 
Reporting Procedure for Serious Unanticipated Adverse Events 
In the event of an unanticipated serious adverse event, the project PI will ensure 
that these events are reported to the NIDA Program Official within 24 hours by 
phone, fax, and/or email and will submit a written report to the Program Official 
no more than two days later. The project staff will also utilize the following 
reporting procedures:  
1. When the grant staff and/or PI become aware of a serious adverse event, 
reporting requirements must be implemented in a timely manner.  

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2. PI completes a University of Minnesota "Adverse Event Reporting Form" and 
submits the form to the Human Subjects Officer at the U of Minnesota.  
3. The Human Subjects officer immediately distributes the form to the following 
individuals or groups as required: Center Administrator, Center Management 
Committee, and Center IRB Officials.  
4. The Human Subjects Officer will convene an expedited meeting of the IRB 
either on site or via telephone. The IRB, with the input of the PI will review the 
study protocol and determine what further action to take based on the best 
interests of the participants and of the research.  
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:  
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.  Families will be compensated for 
their participation in assessments.  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:  
Descriptive analyses will be computed to determine the usability and 
acceptability of the delivery formats. We will examine family 
demographics, included age and gender of parent(s) and child(ren), as well 
as family structure. We will also compute descriptive analyses on the 
recruitment data, including the number and percentage of families 
expressing interest in the study, time to recruit families, the percentage of 
families screened who meet inclusion criteria. We will also examine 
retention data including weekly attendance, participants completing home 
practice assignments, as well as their reasons for absences or drop out.  
Complex long-term follow up analyses will also be computed. We will 
employ standard normal theory pre-post Analysis of Variance and 

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structural equation modeling (SEM) growth curve analyses. For the 
immediate prepost analyses we will conduct a 3 group by 2 repeated 
measures Analysis of Variance for parenting, child, and couple 
functioning constructs focusing on the comparison of change across the 
Group Based, Individualized Facilitated, and Self-directed ADAPT 
conditions. 
For the intent to treat (ITT) analyses of long term follow up, we will specify latent 
growth models (LGM) recommended for long term effectiveness designs [110] 
involving maximum likelihood SEM. Fixed effects (e.g., random assignment to 
ADAPT, parent and child gender) and time varying random effects may be 
estimated using chronometric time weights. A model specifying an initial status 
latent variable (assessing variance in BL differences) and a linear slope latent 
variable (estimating individual differences in change over time), would be 
specified using factor weights of 1, 1, 1, 1, for the respective repeated measures, 
and factor weights of 0, 1, 2, and 4 for growth. The first step in LGM is to identify 
the model that best characterizes patterns of growth. We can also specify an 
additional nonlinear quadratic factor, a higher order polynomial function to 
capture any nonlinearity. Accelerated or decelerated change would be specified 
with loadings fixed at 0, 1, 4, and 16. A sequential set of models tests the latent 
variances and model fit across a random intercept, linear growth, and quadratic 
model to determine the optimal growth pattern [113]. 
17.2 Power Analysis:  
sing an alpha level of .05 and considering 5% attrition over the first 6 months, a 
pre-post design with 3 groups of 114, within subject SD = 1, and between groups 
SD = .71; the study is powered .81 to minimally detect a small group by time 
interaction effect (ES = .12), small time effect (ES = .15), and small group effect 
(ES = .21) for given parenting, child, couple or parent constructs. 
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, 

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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.  
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 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 (Secure 
Sockets Layer) and 40, 56, or 128-bit Public Key Encryption. All data collection 
is performed using the Secure Sockets Layer (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 U of O 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.  

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All University of Minnesota, U OF O, ISII and IRIS Media 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. 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. IRIS Media has developed a self-directed 
training program for its employees that includes the videotape entitled “Protecting 
Human Subjects,” and utilizes the web-based training program from the Office of 
Human Research Protections. 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. Finally, the PI will apply for a Certificate of 
Confidentiality 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. 
 
All data will be stored in digital form on secure University of Minnesota servers.  
Access to files is password protected. Most data will be stored electronically, but 
some situations may require the use of paper forms  
 
Certificate of Confidentiality has been obtained to provide further protection of 
our study participants and our data. 
 
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 

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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. 
 
Breaking of confidentiality: There is the risk that we may learn that a child has 
been abused, neglected, or endangered and need to report it to child protective 
services. Thus, we will fully inform parents of the limits of confidentiality, both 
verbally and in writing. Given that the intervention we will be offering teaches 
non-abusive parenting strategies, we believe that the potential benefits in this area 
outweigh the risks. Project staff will be properly trained to identify signs of 
potential child abuse, neglect, or child endangerment, and will report any 
suspicions immediately to the Principal Investigator. Suspicions of child abuse, 
neglect, or endangerment will be reported to child protective services in 
accordance with Minnesota law, and the parents will be told of the report. In 
addition, those who present an imminent threat of harm to themselves or others 
will be reported to the proper authorities. Project staff will also be properly 
trained in responding to parents who are experiencing significant life difficulties 
and require additional professional assistance. The statement of informed consent 
will include the following statement: “It is possible that you may experience 
serious life difficulties that are beyond the ability of the ADAPT program to help 
you with. This program is not a substitute for professional help for serious 
difficulties you might be having. If you feel you are having an emergency 
situation, please seek outside professional help. If you are experiencing serious 
difficulties, please let us know [project staff email and phone provided] and we 
will work with you to find resources in your community that can help you.” Staff 
will be equipped with specific guidelines and a referral list for referring parents to 
specialized treatment for PTSD, substance abuse, depression, domestic violence, 
other mental illness, and similar problems beyond the scope of ADAPT. 
Procedures to prevent the violation of confidentiality in accordance with reporting 
requirements are limited by the mandatory nature of these requirements. Subjects 
are informed in the consent document that staff must report to authorities 1) 
physical injury to any child caused by other than accidental means, as required by 
Minnesota Statutes; and 2) information from a study participant which leads staff 
to believe a person is in imminent danger of physical harm. Staff will inform 
parents or guardians if, in the judgment of the professional staff, their child (under 
18) is in imminent danger of trying to kill him/herself.  
 
19.0 Provisions to Monitor the Data to Ensure the Safety of 
Participants – NA 
 
20.0 Provisions to Protect the Privacy Interests of Participants 

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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 
convenient to participants (i.e. libraries, community centers). As participants are 
recruited we will determine optimum group locations. For example, given the 
prevalence of ARNG families in Stillwater, we anticipate that one location will be 
a library or community center in Stillwater. In each location we will rent a private 
room with no capacity for those outside to overhear or see what is being said. The 
University of Minnesota project office in the Department of Family Social 
Science will be used as a default location for assessments in the event that any 
family requests not to have a home visit assessment 
20.2 Access to Participants: NA 
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: NA 
21.2 Contract Language: NA 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained):  
Initial consent is obtained online.  The consent form will be divided to be easily 
read on separate screens without the needs to scroll.  Participants will need to 
check a box indicating that they have read that part of the consent form before 
they can proceed to the next screen of the consent form.  On the last screen, 
participants will need to check a box saying that they have read the form, asked 
questions, and understand what they are being asked to participate in before they 
click  the "agree to participate" button.  During the online consent, participants 
will all be offered the opportunity (i) for a phone call to complete the consent 
process, or (ii) to complete the consent process at the start of the in-home (i.e. in 
person) baseline assessment. In addition, contact information for researchers 
(phone and email) is provided on the website and the consent document. 
Additionally, assent from minor participants will be obtained at the first in-home 
visit. Subjects who are randomized to the experimental (intervention) condition 
will complete an additional consent to participate in the program and for 
videotaping of the intervention. This additional consent will be gathered during 
the first group session for those randomized to in-person groups, or online for 
those randomized to individualized, web-facilitated ADAPT. 
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): NA 
22.3 Non-English Speaking Participants: NA 

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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 be conducted at the following locations: participants’ 
homes, neutral community location, University of Minnesota 
(ADAPT offices), and at the Michigan ADAPT office.  
• Recruitment will take place in the following ways: Recruitment 
flyers promoting the study will be distributed to our partners (NG, 
VA, M-SPAN). In addition, the PI has been invited by the MN 
ARNG to present at reintegration workshops which are mandatory 
for all soldiers returning from OEF/OIF deployment, and flyers 
will be handed out there. Flyers provide the phone and email 
contact information for the researchers, and the study site URL. 
The website guides parents to a brief explanation of the project, 
and a description of project confidentiality and its limits. Refer a 
friend post cards will be distributed to previous ADAPT study 
participants and current participants (as recruitment occurs). A 
recruitment/outreach booth will be set-up at the MN State Fair on 
Military Appreciation Day.  
Interested participants will be directed to an anonymous online 
screening instrument. This screen determines eligibility based on 
the above stated inclusion and exclusion criteria. Eligible 
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 either an intervention (E) group or 
SAU comparison group.  In reintegrating families with two at-

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home participating parents/caregivers, each will complete a 
separate informed consent. 
24.0 Multi-Site Research 
24.1 Study-Wide Number of Participants: 360 
24.2 Study-Wide Recruitment Methods: Recruitment methods for both MN and 
MI are described earlier in protocol. 
24.3 Study-Wide Recruitment Materials: Recruitment materials are described 
earlier in the protocol.  
24.4 Communication Among Sites:  
• The Project Manager 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 Project Manager at the U of MN has weekly one on one meetings 
with participating site. 
• Participating site has a Project Coordinator that have access to the U of 
MN secure server where all applicable study documents are maintained and 
available.  
• Second site has the most current version of the protocol, consent 
document(s), and, when applicable, HIPAA authorization. 
• Engaged participating site 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:  
• The Project Manager at the U of MN has weekly one on one 
meetings with participating site. 
• Site Coordinator is part of weekly team call.  
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 advisement on data management issues. 
26.0 References 
 
 

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ADAPT4U MEASURES 
KEY: 
OL = Collected online prior to the interview 
IH = Collected during the in-home interview 
 
Items 
T1 
T2 
T3 
T4 
Measures - Parents 
 
 
OL 
IH 
OL 
IH 
OL 
IH 
OL 
IH 
Demographics (vary slightly by time point) 
 
x 
 
x 
N/A 
x 
 
x 
 
Dyadic Adjustment Scale (DAS-7) 
7 
x 
 
x 
N/A 
x 
 
x 
 
Five Facet Mindfulness Questionnaire (FFMQ) 
39 
x 
 
x 
N/A 
x 
 
x 
 
The Alcohol Use Disorders Identification Test (AUDIT) 
10 
x 
 
x 
N/A 
x 
 
x 
 
Difficulties in Emotion Regulation Scale (DERS) 
36 
x 
 
x 
N/A 
x 
 
x 
 
Center for Epidemiologic Studies Depression Scale (CES-D) 
20 
x 
 
x 
N/A 
x 
 
x 
 
ODS Interpersonal Support Evaluation List (ISEL) 
16 
x 
 
x 
N/A 
x 
 
x 
 
Life Events Checklist (LEC-5) 
17 
x 
 
 
N/A 
 
 
x 
 
The List of Threatening Experiences (LTE) 
12 
x 
 
 
N/A 
x 
 
x 
 
Military Organization (Sheila’s Questions) 
6 
x 
 
x 
N/A 
x 
 
x 
 
Child Lifetime Events 
19 
 
 
 
 
 
 
x 
 
Deployment Risk and Resilience Inventory – 2 (DRRI-2) Section K (number of questions dependent on 
exposure to military context and deployment) 
 
16-64 
 
 
 
 
 
 
x 
 
PTSD Checklist - Military (PCL-M)  (parents who were deployed/mobilized in support of GWOT) 
18 
 
x 
x 
N/A 
 
x 
 
x 
PTSD Checklist – Civilian (PCL-C) – (parents who were not deployed/mobilized in support of GWOT) 
17 
 
x 
x 
N/A 
 
x 
 
x 
Deployment Risk and Resilience Inventory (DRRI) – Sections I & J (Deployed Parent Only) 
30 
 
x 
 
N/A 
 
x 
 
x 
Deployment Risk and Resilience Inventory – 2 (DRRI-2) – Items 1, 2, 5, 6 from Section I (parents 
who were deployed/mobilized in support of GWOT) 
4 
 
x 
 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) PRS-P (parents of children age 5) 
134 
 
x 
x 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) PRS-C (parents of children ages 6-11) 
160 
 
x 
x 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) PRS-A (parents of children 12 and older) 
150 
 
x 
x 
N/A 
 
x 
 
x 
Alabama Parenting Questionnaire – short (APQ) 
9 
 
x 
x 
 
 
x 
 
x 
Coping with Children’s Negative Emotions Scale (CCNES) 
72 
 
x 
x 
N/A 
 
x 
 
x 
Parent Locus of Control – short (PLOC) 
24 
 
x 
x 
N/A 
 
x 
 
x 
Wechsler Abbreviated Scale of Intelligence – 2 (WASI-2) – vocabulary and matrix reasoning only 
61 
 
x 
 
N/A 
 
 
 
 
Operation Span Task (OSPAN) – working memory 
N/A 
 
x 
 
N/A 
 
x 
 
x 
Family Interaction Tasks 
N/A 
 
x 
 
N/A 
 
x 
 
x 

PROTOCOL TITLE: Comparing Web, Group, and Telehealth Formats of a Military Parenting Program 
VERSION DATE: May 4, 2018 
 
Page 38 of 38 
Revised: May 4, 2018 
 
 
 
Items 
T1 
T2 
T3 
T4 
Measures - Child 
 
 
OL 
IH 
OL 
IH 
OL 
IH 
OL 
IH 
DADS Loneliness & Social Dissatisfaction Scale (LONE) administered to children between 4-7 
24 
 
x 
 
N/A 
 
x 
 
x 
DADS Loneliness & Social Dissatisfaction Scale-Y (LONE-Y) administered to children 8 and older 
24 
 
x 
 
N/A 
 
x 
 
x 
Child Depression Inventory – short version (CDI) administered to children 7 and older 
10 
 
x 
 
N/A 
 
x 
 
x 
DADS Describing Friends (DESS) -  administered to children between 4-7 
25 
 
x 
 
N/A 
 
x 
 
x 
DADS  Describing Friends (DESS) – administered to children 8 and older 
44 
 
x 
 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) – SRP-I (administered to children 5-7) 
65 
 
x 
 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) – SRP-C (administered to children 8-11) 
139 
 
x 
 
N/A 
 
x 
 
x 
Behavioral Assessment System for Children – 2 (BASC) – SRP-A (administered to children 12 and older) 
176 
 
x 
 
N/A 
 
x 
 
x 
The American Drug and Alcohol Survey (ADAS) & 8 supplemental questions (administered to children 10+ ) 
88 
 
x 
 
N/A 
 
x 
 
x 
Wechsler Abbreviated Scale of Intelligence – 2 (WASI-2) – vocabulary and matrix reasoning only 
61 
 
x 
 
N/A 
 
 
 
 
Family Interaction Tasks 
N/A 
 
x 
 
N/A 
 
x 
 
x 
 
Items 
T1 
T2 
T3 
T4 
Measures - Teacher 
 
OL 
IH 
OL 
IH 
OL 
IH 
OL 
IH 
Behavioral Assessment System for Children – 2 (BASC) PRS-P (administered to teachers of kids age 5) 
100 
x 
 
 
N/A 
x 
 
x 
 
Behavioral Assessment System for Children – 2 (BASC) – TRS-C (administered to teachers of kids age 6-11) 
139 
x 
 
 
N/A 
x 
 
x 
 
Behavioral Assessment System for Children – 2 (BASC) – TRS-A (administered to teachers of kids age 12+) 
139 
x 
 
 
N/A 
x 
 
x