Adaptation, Refinement, and Open Trial of Parent Training for Veterans With PTSD
Phase: NA
Conditions: Parenting Behaviors and PTSD Symptoms
Sponsor: VA Office of Research and Development

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Parenting Strength at Home- Parents Pilot 
Protocol 
NCT03403153 
Document date 3/29/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Central Texas VA Healthcare System research protocol. 
Title: Adaptation, Refinement, and Open Trial of Parent Training for Veterans with 
PTSD 
“Strength at Home – Parents Pilot” 
Sponsor: VHA RR&D  
Principal Investigator: Suzannah Creech 
Version Date: 03.29.2022 
 
Key Personnel: Central Texas VA Healthcare System, Temple, TX and the VHA 
VISN 17 Center of Excellence for Research on Returning War Veterans, Waco, TX 
site 
Suzannah Creech, Ph.D. 
  
Psychologist, Behavioral Sciences Core  
 
VHA VISN 17 COE 
Associate Professor (Research) 
Department of Psychiatry 
Dell Medical School, UT Austin 
 
 
Collaborators: 
Dr. Casey Taft (Co-I); National Center for PTSD, VA Boston Healthcare System  
Dr. Jordan Braciszweski (Co-I); Henry Ford Healthcare System (On contract) 
Dr. Shelley Riggs (Co-I); University of North Texas (on IPA) 
 
Appendices:  
1. 
Study Measures 
2. 
Recruitment Flyers 
3. 
Telephone Scripts (veteran and partner) 
4. 
Recruitment Letters 
 
 
 
 
 
 
 
 

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Study Overview: Symptoms of posttraumatic stress disorder (PTSD) after deployment 
have been shown to adversely impact family and close relationship functioning, 
including parent-child relationships1-4. About 31% of U.S. Veterans are parents to 
children under the age of 185. In addition, a study of over 100,000 records of Iraq and 
Afghanistan Veterans indicated those with dependent children were 40% more likely to 
carry a diagnosis of PTSD compared to those without children6. Despite these large 
numbers and the known association between PTSD and parenting problems, there are 
no empirically validated parenting interventions within the VHA that address the unique 
needs of Veteran parents with PTSD7, nor is there evidence that existing 
treatments for PTSD improve family functioning8,9.This gap in both research and 
practice is significant given that parent-child functioning is a large component of 
recovery and reintegration into the community. Difficulties with parenting and the 
parent-child relationship are a vital influence on overall family functioning and quality of 
life. It follows logically that an intervention that improves parenting will have a 
significant downstream impact on overall family and close relationship 
functioning and the Veteran’s quality of life. 
This proposal will conduct the research necessary to adapt, refine, and conduct an 
open trial of Strength at Home – Parents (SAHP) -  the new intervention incorporates 
the core clinical components of the empirically validated Strength at Home (SAH) 
interventions for improved family functioning among Veterans11-13 and targets key 
parenting behaviors and interpersonal relationship skills that can be impaired 
when a parent suffers from PTSD. 
Given that parenting challenges are not typically addressed within VHA10,14, one reason 
prior national pilot efforts may have had trouble with enrollment and retention is a 
failure to address motivation and goal setting at the outset. It can be difficult for clients 
to be ready to change a problem when few resources have historically been available 
to address it. Therefore this proposal will pilot the feasibility of including a pre-treatment 
Motivational Interviewing Assessment (MIA15) to assist Veterans with PTSD in 
strengthening and building motivation to change their parenting behaviors. The MIA 
can result in higher rates of treatment retention during the first 4 weeks of treatment 
compared to treatment as usual16. Assessment approaches such as MIA that are 
personalized and collaborative have been shown to have a positive and clinically 
meaningful impact on treatment17. 
1) Aim 1 (completed): Refine and Pilot Test intervention for Veteran Feedback. 
Obtain and incorporate expert clinician and Veteran feedback on credibility, 
acceptability, and satisfaction with the intervention to ensure Veteran-friendly manual, 
materials, and processes. Aim 1 will be accomplished through two rounds of expert 
panel review of the treatment/MIA manual and two rounds of pilot testing of the 
treatment for Veteran feedback in 16 female and 16 male Veterans. 
 
2) Aim 2 (ongoing): Open Trial for Feasibility. Evaluate feasibility of study 
recruitment, retention, assessment procedures and proposed methods of the 
intervention. Preliminary examination of whether intervention results in improvements 
to parenting behaviors, parenting satisfaction and overall family functioning. Aim 2 will 

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be accomplished through an open trial of the final intervention and MIA procedures in 
3-5 groups of female Veterans (n = 24-40) and 3-5 groups of male Veterans (n = 24-40; 
total N = 48-80), with collateral partner assessment of outcomes where possible.  
 
A. Background and Significance 
A1. Prevalence of PTSD among veteran parents. Approximately 31% of Veterans 
(population 20 million) have at least one minor child living with them5 and half of all 
service members who deployed as part of the military operations in Iraq (Operation Iraqi 
Freedom; OIF; Operation New Dawn; OND) and Afghanistan (Operation Enduring 
Freedom; OEF) are parents18. Recent estimates of the rate of posttraumatic stress 
disorder (PTSD) among returning Veterans seeking care at the Veterans Health 
Administration (VHA) have suggested it may be as high as 23%19. A study of the 
administrative records of over 100,000 OEF/OIF Veterans indicated those with 
dependent children were 40% more likely to carry a diagnosis of PTSD6 and parent 
status is associated with higher PTSD symptom severity20. These statistics are alarming 
because a large body of research has also found that a diagnosis of PTSD is highly 
disruptive to the parent-child relationship as well as impairing family functioning1-4. 
Difficulties with family functioning undermine recovery and overall quality of life. 
 
A2. PTSD and family functioning share a bidirectional association. Family 
functioning is an umbrella term encompassing intimate relationships, parent child 
functioning, and the functioning of the larger “family” system. A compelling line of 
research indicates that family functioning difficulties are 
magnified and co-occur with PTSD symptoms in Veteran 
and military populations1-3. These difficulties range from 
intimate relationship dissatisfaction and overall family 
dysfunction to increased rates of intimate partner 
violence21. A growing literature also suggests that specific 
family processes such as avoidance and accommodation 
may be important contributors to the development and 
maintenance of PTSD22. Evidence also links family functioning to PTSD treatment 
engagement and response23-25. In sum, PTSD and family functioning appear to be 
reciprocally related, and therefore attention to family functioning may have great benefit 
for Veteran recovery. Unfortunately, existing treatments for PTSD do not appear to 
improve family functioning8,9, therefore adjunctive and novel treatment approaches are 
needed. 
 
A3. Addressing parenting as part of PTSD treatment. The need for direct attention to 
family functioning in addition to treatment for PTSD is highlighted by prior findings 
indicating that poorer family functioning predicts higher PTSD symptoms after 
treatment25, therefore those with family functioning problems may have benefited less 
from PTSD treatment in the first place. In addition, gold standard treatments for PTSD 
do not include family functioning modules. Finally, families are systems and a pattern of 
interactions may have become stable over a long period, thus even when PTSD remits, 
direct intervention may be required to improve family functioning. Increases in PTSD 
symptoms over the year following combat deployment are associated with poorer 

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parenting behaviors4. Several studies describe a strong association between PTSD 
symptoms and Veterans’ reports of increased parenting stress and decreased 
satisfaction with parenting26-28. The hyperarousal and avoidance/numbing symptoms of 
PTSD are particularly deleterious to parenting26,29. Research has also found that 
Veterans are greatly interested in family focused services that promote family 
involvement in their care30. In one study, more than 75% of Veterans referred for mental 
health evaluations at VHA reported difficulties in their romantic relationships or with their 
children31. Another study found the majority of Veteran parents surveyed were 
concerned about child rearing and felt that parenting was more stressful after 
deployment32. Taken together, PTSD appears to be associated with parenting 
difficulties, and Veterans report an interest in family focused care that includes 
interventions directed at improving parenting skills10.  
 
A4. Family-centered care at VHA. VA’s transition to increased emphasis on family 
centered care began in 2004, after the President’s New Freedom Commission on 
Mental Health made this a priority. Prior to that time, mental health services at VHA 
were focused on individual treatment models (to the exclusion of the family system). 
VA’s transition to family-centered care was bolstered by decades of research indicating 
that family systems and individual mental health are reciprocally related and recognition 
that family functioning is a critical component of recovery. Policy changes secondary to 
the passage of P.L. 110-387 (The Veterans Mental Health and Other Care Improvement 
Act) allowed the expansion of marital and family therapy services at VHA. Thus, the last 
decade has seen a transformation in VA culture culminating in large scale dissemination 
of evidence-based family and couples’ therapies, with an emphasis on providing these 
services to Veterans with PTSD47. Yet no parenting training program is currently 
available nationally. 
 
Appeals to address parenting issues within VA are growing and they are now being 
voiced by Veterans10, researchers14,48-50, policy makers51, and clinicians alike (see 
Preliminary Studies). The VA mandate specifies that family services are offered in 
service of the Veteran’s treatment plan, therefore, parenting treatment focused on child 
behavior problems and that include dyadic parent-child models are best provided 
through community partners. However, recent data from a national, random sample of 
all OEF/OIF veterans who had returned through 2009 indicated that 2/3 of Veterans with 
probable PTSD had sought treatment, and most had done so at the VA52. Limited 
funding and limited community expertise with Veterans in general, and in areas such as 
military related PTSD specifically, will likely continue to drive Veterans to the VA47. 
Given that the VA has recognized family centered care in all other domains of family 
functioning, work to develop a parent training program that meets the unique needs of 
Veterans and VHA clinicians is critical. 
 
A5. Need for a new intervention developed with and for Veterans. First, there are 
no evidence-based parent training programs that address the specific parenting 
behaviors and family dynamics that are likely to be impaired by PTSD symptoms (e.g. 
positive parenting, emotion regulation, avoidance, communication). Our pilot data 
indicated that PTSD symptoms explain greater variance in child psychosocial 

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functioning than parenting behaviors, which indicates that community treatments that 
address only parenting will not be sufficient in this population. Second, most evidence-
based parenting programs for civilians are delivered in parent-child dyads and have an 
emphasis on child difficulties - a model that is not consistent with the VHA mandate. 
Third, interventions that do exist for improving parenting in military families were 
developed and tested to help families recover from deployment separation and stress. 
They were not designed to address the unique parenting and family dynamics that 
continue to be impacted by PTSD symptoms many years after military deployment. In 
2014 PI Creech published a systematic review evaluating findings from 50 studies on 
Veterans/active duty military and parenting7. This review revealed that growth in 
research on parenting and Veterans has centered around deployment separation with 
almost no attention to the impact of post-deployment mental health problems on 
parenting. In sum, a brief treatment to improve the aspects of parenting and family 
functioning that are specifically impacted by PTSD symptoms is needed, but to be 
feasible and effective it must also be developed for delivery within the VHA system, and 
with Veteran input.  
 
A6. Theoretical Frameworks. The theoretical frameworks informing SAHP are the 
Cognitive-Behavioral Interpersonal Theory of PTSD (C-BIT56) and the Military Family 
Attachment Network model46. Dekel & Monson’s C-BIT posits that specific cognitive, 
behavioral and emotional processes impact the development and maintenance of PTSD 
and impair family functioning. Within this model, avoidance and accommodation refer to 
behaviors through which PTSD avoidance symptoms are negatively reinforced thereby 
maintaining trauma-related distress. Avoidance behaviors impact the family system by 
reducing positive family activities. Cognitive processes and thematic content refer to 
maladaptive schema about the world and past experiences and disruptions to core 
themes such as power, trust, control and intimacy57. These cognitive processes are 
theorized to impact family closeness by promoting avoidance behaviors, disrupting 
expressed emotions and intimacy, and impairing communication. Emotional 
disturbances such as blunted positive emotions and increased anger, shame, guilt and 
sadness are thought to further impair family processes58. Candice Monson, C-BIT 
developer, is an expert consultant on this proposal. 
  
The Riggs & Riggs Military Family Attachment Network Model is a developmental-
contextual theory that posits disruptions to attachment and a lack of clarity in family 
roles (e.g., parent-child role-reversal) are other mechanisms through which PTSD 
symptoms impact family functioning46. This theory argues attachment relationships and 
key family processes (e.g., belief systems, communication, organization) underlie the 
risk and resilience processes that influence post-deployment outcomes for service 
members and their families. Within this theory, attachment to significant others and 
family interaction patterns impact and are impacted by PTSD. Insecure attachment has 
been frequently associated with PTSD symptoms59. This model specifies that child 
functioning is determined by the extent to which PTSD symptoms impact parenting 
behaviors, parent-child attachment, family roles and communication patterns, and the 
level of violence and hostility in the home. Dr. Shelley Riggs, a developer of this theory, 
is a Co-I on this proposal. 

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A7. Motivational Interviewing Assessment. In order to proactively address enrollment 
and retention issues that some parenting programs at VA have reported, the intake 
assessment that occurs prior to treatment is conducted as a Motivational Interviewing 
Assessment (MIA). Parenting challenges are not part of standard VHA mental health 
assessments14, therefore the pre-treatment assessment and interview that will occur 
prior to treatment may be the first time the Veteran is directly asked about their 
parenting and their interest in receiving such services. It can be difficult for clients to be 
ready to change a problem when few resources have historically been available to 
address it. Therefore we argue that directly targeting goal setting and motivation for 
change may be necessary to facilitate success in the intervention. Rather than 
conducting a standard clinical assessment, methodologies such as MIA are consistent 
with recent calls in the assessment field that psychological assessment can and should 
be conducted as a therapeutic intervention in its own right, as opposed to serving only 
as a necessary precursor to treatment. The process of conducting a psychological 
assessment in a collaborative and personalized manner combined with feedback is 
called therapeutic assessment 75. A meta-analysis of 17 studies indicated therapeutic 
assessment has a positive and clinically meaningful impact on treatment 17. 
Consistent with the principles of therapeutic assessment, motivational Interviewing (MI) 
was developed as a therapeutic strategy in recognition that clients present to treatment 
at different levels of readiness for change76. The Motivational Interviewing Assessment 
(MIA) is an outcome of the National Institute on Drug Abuse’s (NIDA) Clinical Trials 
Network protocol in which one MIA session (lasting roughly 1.5 hours) resulted in higher 
rates of treatment retention during the first 4 weeks of treatment compared to treatment 
as usual16. MIA procedures call for use of a standardized and structured clinical 
assessment that is “sandwiched” between two 20-minute client-centered MI 
interventions. The MIA was selected because (1) its prior efficacy in improving 
treatment engagement, (2) data indicates it can be easily implemented by clinicians 
given proper training and supervision, and (3) we believe it will result in a therapeutic 
assessment process that has value to the Veteran. Dr. Jordan Braciszewski (Co-I) is an 
expert in MI and the MIA and he will provide training to study staff in both MI more 
generally and in the pre-treatment MIA. He will also work with the study team to develop 
and standardize the MIA assessment procedures for use in the future randomized 
clinical trial. During the open trial we will pilot the feasibility and acceptability of MIA 
prior to beginning treatment. Within the MIA, participants will identify their major goals 
for improving their parent-child functioning. Following MI mechanisms for change, we 
will also help participants identify their desire, ability, need, and reasons for change and 
we will share feedback with the Veteran on how they are doing based on the 
assessment measures they completed. Change talk, an MI term for a person’s mention 
or discussion of their desires, ability, need and reason for change will be identified 
during the MIA and participants will be prompted with their individual change talk 
throughout treatment. 
 
 

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B. 
Study Methods 
B1. Our primary objective is to adapt, refine, and conduct an open trial of the 
Strength at Home-Parents (SAHP) intervention for Veteran parents with PTSD. 
The outcome of this study will be a treatment manual that is designed specifically for 
the capabilities and organizational constraints of VA clinicians, treatment materials 
designed specifically for Veterans with PTSD, and refined assessment, recruitment, 
and retention procedures. This research will address feasibility and acceptability by 
incorporating Veteran and expert clinician feedback into treatment refinement. Positive 
evidence that the refined SAHP intervention and assessment procedures are feasible 
for delivery within the VHA will lead to a second merit application to test the hypothesis 
that relative to a control condition, SAHP improves parenting behaviors, parenting 
satisfaction and family functioning. This objective will be fulfilled by accomplishing the 
following aims: 
 
Aim 1: Refine and Pilot Test SAHP for Veteran Feedback (completed). Obtain and 
incorporate expert clinician and Veteran feedback on credibility, acceptability, and 
satisfaction with the intervention to ensure Veteran-friendly SAHP manual, materials, 
and processes. Aim 1 will be accomplished through two rounds of expert panel review 
of the treatment/MIA manual and two rounds of pilot testing of the treatment for Veteran 
feedback in 16 female and 16 male Veterans.  
 
Aim 2: Open Trial of the Refined SAHP Treatment for Feasibility (ongoing). 
Evaluate feasibility of study recruitment, retention, assessment procedures and 
proposed methods of the SAHP intervention. Preliminary examination of whether SAHP 
results in improvements to parenting behaviors, parenting satisfaction and overall 
family functioning. Aim 2 will be accomplished through an open trial of the final SAHP 
intervention and MIA procedures in 3-5 groups of female Veterans (n = 24-40) and 3-5 
groups of male Veterans (n = 24-40; total N = 48-80), with collateral partner assessment of 
outcomes where possible. 
 
Aim 1 was completed in January of 2020. In response to the COVID-19 pandemic 
the remainder of Aim 2 study activities will be completed remotely, and the 
protocol was edited to reflect these changes. Discrepancies between the protocol 
pre/post-COVID are clearly noted throughout the document.  
 
Pre-COVID: In-Person groups and Assessments: This research will take place at the 
VISN 17 Center of Excellence for Research on Returning War Veterans in Waco, TX 
(CoE), the Olin Teague Veterans’ Medical Center in Temple, TX and the Austin 
Outpatient Clinic in Austin, TX.    
 
Post-COVID: Remote groups and Assessments: This research will be conducted 
remotely, and all assessment and treatment sessions will be completed through Central 
Texas VA-approved video technology platforms. Study assessment measures obtained 
at all timepoints (intake,treatment, post-treatment) will be completed through Qualtrics 
(as described on page 23). Prior to the start of assessment and intervention sessions 

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participants will be asked to provide their phone number and location, so they can be 
located if technological or safety issues were to arise.     
 
Pre-COVID: Procedures for obtaining informed consent 
Consent to participate in the study will be obtained during the first in-person assessment 
session. Veterans will read the consent documents and study staff obtaining consent 
will discuss discomforts/risks and potential benefits associated with the study. Any 
questions arising during the consent process will be answered.   
 
Post-COVID: Procedures for obtaining informed consent:  
Consent to participate in this study will be obtained by sending participants two signed 
copies of informed consent documents through the US Postal Service. The participant 
will read and sign consent documents, and mail one set of documents back to the study 
team located at the VHA VISN 17 Center of Excellence in Waco, TX using a pre-
addressed envelope. Study staff obtaining consent will contact participants by phone to 
discuss discomforts/risks and potential benefits associated with the study. Any 
questions arising during the consent process will be answered. Veterans will be given 
another opportunity to ask questions and give verbal consent before the first 
assessment session.  
 
Following RSD best guidance for obtaining informed consent through electronic 
methods, the following electronic methods for obtaining informed consent may be 
offered to veterans:  
1) Rights Management Services (RMS): Secure Transmission Using 
Encrypted Email with Return of Wet Signatures. The Azure RMS VA cloud-
based protection service may be used to securely transmit IRB-approved 
informed consent forms. Azure RMS uses encryption and authorization policies 
to help secure VA documents and emails containing sensitive data. 
2) MyHealtheVet: Secure Transmission Using Encrypted Email with Return of 
Wet Signatures. MyHealtheVet may be used to send and return secure VA 
research informed consent forms (scanned or picture). MyHealtheVet provides 
encryption through secure messaging for compliance with FIPS 140-2 policy. 
Additionally, the MyHealtheVet enrollment process supports verifying a subject’s 
identity before allowing access to the application for increased authentication. 
3) DocuSign Transmitting Informed Consent Forms and Obtaining Digital 
Signatures. DocuSign can be used for the purpose of sending and signing digital 
documents to patients for their signatures.  
 
Similarly to the procedures outlined above, staff obtaining electronic consent will 
first contact participants by phone to discuss discomforts/risks and potential 
benefits associated with the study. Any questions arising during the consent 
process will be answered. Veterans will be given another opportunity to ask 
questions and give verbal consent before the first assessment session.  
 
B2. Veteran Inclusion Criteria: 
1) Age 18 years and older. 

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2) English speaking and able to provide written informed consent 
 
3) Current parent to a child between the ages of 3 and 12. If the parent has more than 
one child within the target group, they will choose one of their children to be the index 
child for the purposes of SAHP (though we expect skills learned will translate to other 
children in the family). The child must reside with the Veteran or spend at least an 
average of two days per week with the Veteran. 
 
4) Screen positive for elevated PTSD symptoms on the PTSD checklist for DSM 5 
(PCL-580). The PCL-5 is a 20 item self-report measure of PTSD symptoms in the past 
month. Items are rated on a 5 point Likert scale (0 = not at all, 4= extremely) and 
participants endorse symptoms based on “a very stressful experience.” Items are 
summed with higher scores reflecting greater symptomatology. The measure evidences 
good reliability (Internal consistency = .96; test-retest = .84), discriminant and 
convergent validity81 and takes 5-10 min. to complete.  
 
5) Screen positive (above the 85th percentile) for parent-child functioning problems 
based on Parenting Stress Index- Short Form; PSI-SF. All three subscales and the total 
stress scale on the short-form are highly correlated with those on the long-form (.97-
.99), and is expected to take respondents about 10 minutes to complete82. The total 
stress scale can successfully differentiate between different levels of risk for parent-
child functioning problems and has strong convergent validity 83,84. High Cronbach’s 
alpha scores have been reported across all scales, ranging from .88 to .9584. 
 
B3. Exclusion Criteria: The intent of exclusion criteria for this study is to ensure study 
participants can provide informed consent and understand assessments/group 
materials, detect and provide referrals for urgent treatment of suicidality, substance 
dependence or psychosis, and protect the group environment so that individuals who 
might be disruptive to the group process due to unmanaged symptoms of psychosis or 
inability to attend the group free from intoxicants are not enrolled. Therefore, at the 
intake assessment we will screen for the following conditions:  
 
1) Major neurocognitive disorder, including due to TBI. The adapted Ohio State 
Traumatic Brain Injury Identification Method (OSU TBI-ID 85), is a 3-5 min. clinician 
administered interview for lifetime history of TBI. The OSU TBI-ID is a recommended 
common data element by NIH and evidences good- excellent reliability and validity85,86. 
The OSU TBI-ID will be used to identify severe TBI as defined as a score of 5. The 
participant’s medical record may also be used for secondary verification in the case of 
TBI. For those scoring a 5, further referral and screening for comprehension ability will 
be recommended to determine exclusion (as the intent is to identify individuals who may 
not understand or comprehend study materials). 
 
2) Untreated/poorly managed psychosis or substance dependence. The Mini-
International Diagnostic Interview (MINI;87), is a structured diagnostic interview that can 
be completed in less than 10 minutes. It is one of the most widely used diagnostic 

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interviews and evidences psychometric properties that are like more complex and 
lengthier measures88. The psychotic disorders and substance dependence subscales of 
the MINI will be used to screen for DSM-V criteria for current psychosis and substance 
dependence. Participants meeting the diagnostic criteria above will be asked about their 
current treatment and if needed, the PI (licensed clinical psychologist) will speak with 
them regarding their current treatment plan and interest in referrals. Those not engaged 
in treatment (diagnosis without ongoing medication management or psychotherapy) 
and/or evidencing need for referral to detox (e.g. symptoms of withdrawal), and/or 
evidencing symptoms that interfere with the intake assessment will be excluded and 
referred for treatment. Where possible, a warm handoff will always be provided.  
Participants will be welcomed back to the study once stabilized. 
 
3) Current suicide risk. The Beck Depression Inventory-II (BDI-II, 89), a 21-item self-
report measure of depression symptoms (5 min. to complete), will be used to assess for 
suicide risk as defined as a score of 2 or more on the BDI-II suicide item89. The BDI-II 
suicide item evidences a moderate correlation with the other scales of suicidal ideation 
in clinical samples, and has predictive validity90. Follow-up risk-assessment will be 
provided by the PI who is a licensed clinical psychologist. Individuals will be eligible 
after crisis intervention has been received.  
 
Veterans will be asked if they have a partner (current or former) who participates in co-
parenting with them. If affirmative, they will be asked to complete consent to partner 
contact and release of information form so that the study team can offer the partner a 
chance to participate in a phone or web-based assessment. This will not be required for 
study participation, and the study team will make clear to both the partner and the 
Veteran that no information will be shared between them regarding what the other 
person said or their scores on assessment measures. 
 
B4. Partner Inclusion Criteria: 
One goal of the proposed research is to determine whether collateral report of parent-
child functioning is feasible, as this is a best practice in family functioning research. At 
the baseline assessment, Veterans will be asked to complete a consent for partner 
contact and release of information form to allow study staff to contact the partner. If the 
Veteran agrees, partners will be called and offered the chance to complete a brief 
assessment at pre-and post-treatment. Partners are eligible to participate in the phone 
interview if they are over 18 (assessed verbally) and give verbal assent to participate (or 
agree to participate using the online assessment system). 
 
B5. Aim 1 (Months 0-18). Number of Subjects: 32. 
Obtain and incorporate expert clinician and Veteran feedback on credibility, 
acceptability, and satisfaction with the intervention to ensure Veteran-friendly 
SAHP manual, materials, and processes. Aim 1 will be accomplished through two 
rounds of expert panel review of the treatment/MIA manual and two rounds of pilot 
testing of the treatment/MIA for Veteran feedback (see Figure 1). First, the SAHP 
manual will be reviewed by a panel of expert clinicians who will provide feedback. 
Second, the revised SAHP manual will be piloted for Veteran feedback in 1 group of 

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women Veterans (n = 8) and 1 group of men Veterans (n=8). Third, the expert panel will 
convene again for consensus decision making regarding the Veteran feedback and 
additional adaptation of the SAHP manual. They will also review and provide feedback 
on the MIA manual and forms at this time. Finally, the revised manuals will be piloted a 
second time in 1 group of women Veterans (n = 8) and 1 group of men Veterans (n = 8) 
to ensure that revisions improved Veteran satisfaction with the treatment. Total N for 
Aim 1 is 32 Veterans.  
 
B6. Aim 1 Procedure for intervention refinement: 
Expert Panel 1: The first panel review will be a pre-assessment and refinement of 
materials. SAHP materials will be disseminated in month 1. Consultants will review and 
provide written feedback on the SAHP manual and they will be convened for a tele-
conference in month 3 for a consensus discussion of needed modifications based on 
their considerable expertise and with consideration for effective presentation of material 
and ease of use by VHA clinicians. The manual will be revised accordingly.  
 
Pilot Group 1: Veteran feedback (see measures and data 
sources) will be obtained through a pilot trial of SAHP in which 
they will assess the acceptability and credibility of SAHP 
strategies/content after each session. Investigators and facilitators 
will review session procedures and will use a template to make 
detailed notes after each module on phrasing, clarity, and 
participant engagement with material. There will be two pilot 
groups: 1 in women and 1 in men.  
 
Expert Panel 2: The Veteran feedback from the first pilot round 
will be incorporated into a revised treatment manual during a 
second panel review. The panel will be provided with a summary 
of Veteran feedback and proposed manual revisions. Expert 
consultants will review and provide written feedback on the 
proposed revisions to the SAHP manual, and they will convene 
again by teleconference (month 12) for a consensus discussion of 
needed modifications. During the second panel the expert 
consultants will also evaluate and provide feedback on the MIA 
manual and forms. Veteran feedback on the MIA will not be 
assessed until the Open trial (Aim 2) because staff will still be 
training and achieving competence in MIA throughout Aim 1 (see 
Aim 1 MIA training). PI Creech and Co-I’s Riggs, Taft and 
Braciszewski will make final revisions to the SAHP and MIA 
manual according to this feedback.  
 
Pilot Group 2: The revised SAHP treatment will be piloted for 
Veteran feedback a second time to ensure revisions improve 
credibility, acceptability and satisfaction. As in pilot group 2 there 
will be two pilot groups held at this stage: 1 in women and 1 in men. Veteran feedback 

14 
 
will be used to make any final modifications to the treatment manual prior to the open 
trial. 
 
B7. Aim 1 Procedure for pilot groups: The project coordinator and Research 
Technician will administer all assessment materials to Veteran participants. The PI and 
post-doctoral fellows will facilitate treatment groups. 
 
Recruitment: Recruitment will use 2 main strategies: 1) Direct recruitment at local 
events, provider referrals, and flyers posted. 2) The study analyst will utilize VA 
administrative databases to request a list of all OEF/OIF/OND Veterans in our 
catchment area who have screened positive for PTSD on the Primary Care-PTSD 
Screen or who have a diagnosis of PTSD in their problem list. These Veterans will 
receive a letter informing them of the study and providing an opportunity to opt out of 
future contact. 
 
Following standard VA procedures and data pull approval processes, the study analyst 
will pull the contact information of all Veterans in the Central TX VA catchment area with 
PTSD in their problem list, with dependents where possible, and without the exclusion 
criteria in their problem list. This will result in a large data pull, from which we will 
randomly select two batches to receive letters notifying them of the study and that they 
may receive a call. As one of the study aims is to measure the feasibility of recruiting 
veterans in the target group, we do not know how many veterans will truly meet 
inclusion criteria and how many will be interested. Starting with the larger group allows 
us the ability to estimate our needs better in the future, while also enhancing likelihood 
of recruiting success. 
  
Eligibility screening: Those Veterans who are interested in participating will complete 
inclusion eligibility screening by telephone (15-20 minutes). Those who are eligible and 
interested based on the phone screen will be scheduled for an intake assessment 
(MIA).  
 
Participant Remuneration: $50 pre- and post-assessment, $10 per post-intervention 
assessment for a total of $180. The $10 per post-intervention assessment is not 
reimbursement for participating in the intervention, but for time spent completing 
measures after each session. Partners will receive $20 for time spent completing each 
of 2 phone/web-based assessments. 
 
Measures and Data sources for Pilot Groups (see Appendix for copies of measures): 
Credibility, acceptability, and satisfaction will be assessed with 4 measures. 1) The 
Credibility/Expectancy Questionnaire (CEQ93) will measure intervention credibility after 
each session. This measure has high internal consistency and test-re-test reliability93. 
Four questions on an 8-point Likert scale inquire about the logical nature of the 
intervention, willingness to recommend it to others, and expectations for the success of 
the intervention. Items are summed and scored, with higher scores representing greater 
credibility (possible range 0-32). 2) The Client Satisfaction Questionnaire-8 (CSQ94) 
assesses acceptability post-treatment. Eight items are scored on a 4-point scale 

15 
 
inquiring about quality of services, treatment satisfaction, and willingness to recommend 
the treatment to others. Ratings are summed, with higher scores representing greater 
acceptability ratings (possible range 4-32). This measure is commonly used in both 
clinical trials and program evaluation, and has been shown to correlate with treatment 
attendance and outcomes. It takes approximately three minutes to complete. 
Evaluations of the measure found it to be reliable, with high coefficient alphas (.83-.93) 
to support internal consistency, and that it evidences positive construct validity with 
other measures of satisfaction. Where available, mean CSQ ratings can also be 
compared against norms from other studies in similar populations 94. 3) SAHP specific 
satisfaction questionnaire: Veteran feedback will be elicited after sessions using an 
open-ended measure to assess satisfaction with SAHP strategies and content. 
Satisfaction will be evaluated via Veteran ratings of how helpful the session was, how 
helpful the homework was (0 = ‘‘not at all helpful,’’ 8 = ‘‘definitely helpful’’), whether they 
learned anything during the session, and which components of each session were 
helpful or unhelpful. A modified version of this form will evaluate satisfaction with the 
MIA during the open trial. 4) Clinician notes after sessions will document phrasing and 
clarity of materials, and participant engagement with material. Clinicians will complete a 
template after each session documenting how role plays, examples, and language was 
received, any suggesting any changes. 
 
Aim 1 Analysis Plan: Credibility ratings (CEQ) will be averaged to determine overall 
ratings for each session. Acceptability ratings (CSQ) will be averaged to determine 
overall acceptability and satisfaction for the intervention. The item-level and overall 
means on the CEQ/CSQ will be examined in concert with feedback from the open-
ended SAHP specific questionnaires to guide further refinements to the treatment 
manual. Specifically, matrix displays will be used to organize and examine the 
qualitative and quantitative feedback from Veterans92. Matrix displays allow for within-
case analyses (i.e., comparing a participant’s satisfaction with different sessions) as 
well between-case analyses (i.e., comparing satisfaction for a session across groups) 
and comparisons with the quantitative data (CEQ, CSQ). A matrix format for entering 
and displaying data, which may include words, phrases, or direct quotes, will be based 
on the open-ended questions, with each of the primary topics (e.g., satisfaction with 
material, comments on practice assignments, intervention acceptability, etc.) having a 
separate matrix to identify common themes and concepts of importance. The analysis 
will guide adaptations to the intervention manuals. Data will be summarized for 
presentation to the expert panel that will evaluate additional refinements to the 
treatment manual. If major changes are made to the intervention in response to 
feedback from pilot 1, we will also examine whether there are changes in credibility and 
acceptability ratings from pilot 1 to pilot 2. 
 
Motivational Interviewing Assessment (pre-treatment): The study assessor will be the 
post-doctoral associate and may include other CoE trainees (fellows and interns). The 
pre-treatment assessment will be conducted as a MIA which sandwiches two 20 min MI 
sessions around a structured clinical intake.  
 

16 
 
Aim 1 MIA training: Throughout aim 1, study assessors will be developing their MI skills 
and the focus will be on attaining MI competency. During this phase a project specific 
MIA protocol and manual will be developed and tested for use in the pilot and open trial 
and the future RCT. Dr. Braciszewski (CO-I) will provide centralized training in MI and 
the MIA to study staff beginning with a two-day training, followed by intensive fidelity 
coding and coaching. Dr. Braciszewski will collaborate with the study team members to 
draft the assessment protocol and manual and will provide ongoing consultation and 
training to staff in MI and the MIA for both assurance of training goals and fidelity to the 
model during the pilot and open trial. 
 
 

17 
 
 
Table 2: Research Timeline  
 
Yr 1 
Yr 2 
Yr 3 
Quarters 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Pre-Award Activities (completed) 
 
 
 
 
 
 
 
• 
IRB Application and staff hiring 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Motivational Interviewing Assessment Training (completed) 
 
 
 
 
 
 
 
• 
2 day MIA training 
 
X 
 
 
 
 
 
 
 
 
 
 
 
• 
Staff test out for MIA competency 
 
 
X 
 
 
 
 
 
 
 
 
 
 
• 
SAHP/MIA protocol complete 
 
 
X 
 
 
 
 
 
 
 
 
 
 
• 
All staff rated competent on MIA 
 
 
 
X 
 
 
 
 
 
 
 
 
 
• 
Expert panel review of MIA protocol 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
• 
MIA manual and forms finalized 
 
 
 
 
 
 
X 
 
 
 
 
 
 
Aim 1) Refine and Pilot test SAHP (completed) 
 
 
 
 
 
 
 
• 
Panel review of treatment manual  
 
X 
 
 
 
 
 
 
 
 
 
 
 
• 
Refine Manual 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
• 
Recruitment 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
• 
Pilot groups (n = 8 men and 8 
women) 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
• 
2nd Panel review/Refine manual  
 
 
X 
X 
 
 
 
 
 
 
 
• 
Pilot groups (n = 8 men and 8 
women) 
 
 
X 
X 
X 
 
 
 
 
 
 
• 
Finalize treatment manual 
 
 
 
X 
X 
 
 
 
 
 
 
Aim 2) Open Trial and Feasibility evaluation (ongoing) 
 
 
 
 
 
 
 
• 
Recruitment 
 
 
 
 
 
 
X 
X 
 
 
 
 
 
• 
Pilot groups (n = 24-30 men; 24-30 
women) 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
 
• 
Analysis of findings 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
• 
Dissemination of Results 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
• 
Application for IIR for clinical trial 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
 
B8. Aim 2 (Months 18-36) (N = 48-60 Veterans; N=48-60 partner phone 
assessments) 
Evaluate feasibility of study recruitment, retention, assessment procedures and 
proposed methods of the SAHP intervention. Aim 2 will be accomplished through an 
open trial of the final SAHP intervention in 3-5 groups of female Veterans (n = 24-30) 
and 3-5 groups of male Veterans (n = 24-30; total N = 48-60). Research questions to be 
answered include: 1) feasibility of group modality, viability of gender specific 
cohorts/recruitment of women, timing and location of group sessions, and barriers to 
participation, 2) Veteran perceptions of/satisfaction with MIA, proposed RCT outcomes 
measures, and collateral partner report of parent-child functioning, 3) Feasibility of MIA 
as evidenced by clinician experiences using the MIA and clinician fidelity ratings 
throughout the open trial. MIA fidelity coding will be conducted by Dr. Braciszewski. 
Feasibility of collateral partner report of parent-child functioning. 4) Preliminary test of 
whether SAHP results in improvements to parenting behaviors, parenting satisfaction 
and family functioning. 
 
 

18 
 
  
B9. Procedures: All group procedures including recruitment, eligibility screening, 
inclusion and exclusion criteria for Aim 2 are the same as described above in Aim 1, 
with one exception – groups may now be facilitated by one facilitator (PI or post-doctoral 
fellow). 
 
Measures and Data sources: Feasibility and acceptability will be assessed with three 
measures: 1) Number and rates of Veterans contacted, screened, assessed, enrolled, 
retained; 2) Veteran reasons for opting out or dropping out. 3) Veteran ratings of their 
satisfaction with treatment (CSQ; SAHP satisfaction). Feasibility and satisfaction with 
the pre-treatment MIA will be evaluated using the Client Evaluation of Motivational 
Interviewing Scale (CEMI97) and a study specific post-assessment feedback form that 
will assess for satisfaction (see appendix). The CEMI is an 11-item self-report measure 
of client perceptions of clinicians’ use of MI during their session. Internal consistency is 
high across the two factors (a = .88, relational; a = .91, technical) 97,98. Evaluations of 
CEMI validity found that client’s experiences of clinician MI fidelity was generally 
consistent with other measures99. MIA fidelity ratings based on the MIA Interview Rating 
Guide15 will be provided by Dr. Braciszewski to determine feasibility of clinicians 
providing MIA. Feasibility of collateral partner report of parent-child functioning will be 
determined based on the number of Veterans with a partner who could complete 
collateral report, the number who consent to partner contact, and data completion rates 
for this aspect of the study. 
 
Five measures will be used as a preliminary assessment of treatment outcomes and a 
sixth measure will be used to understand co-morbidity in the study sample. These 
measures will be completed at intake and after session 8. In the case of drop-out, the 
post-treatment assessment will be scheduled within one week of what would have been 
session 8 and this will be done in person or over the phone.  1) The Parenting Stress 
Index, 4th edition (PSI100) is a 120-item measure on a five-point Likert scale yielding a 
parent and child domain scale measuring stress related to parent and child 
characteristics including relevant subscales. The PSI includes a scale examining 
support from a parenting partner. The PSI has high reliability coefficients (a = .75-.88), 
high internal consistency (a = .96), and high test-retest reliability. The measure has 
been validated across a variety of population, and takes 10 min. to complete. 82 2) The 
Alabama Parenting Questionnaire (APQ101), contains 42 items examining positive and 
negative discipline and other parenting practices and takes 10 min. to complete. The 
measure evidences satisfactory reliability (a = .80-.92), and discriminant and convergent 
validity102. The parent report converges well with concurrent observational ratings of 
parenting103. 3) The 12-item general family functioning scale of the Family Assessment 
Device (FAD104) measures general family functioning and consists of statements about 
family functioning that respondents answer via a 4-point Likert scale and takes 5 min. to 
complete. Responses are added together, then divided by twelve to give a mean score 
ranging from one to four. The FAD has high Cronbach’s alpha (.86), and split-half 
reliability (.83)105. Consistency between responses to the 12-item FAD, and related 
family variables provides validity evidence106. 4) The Pediatric Symptom Checklist 
(PSC106) measures parents’ impressions of their child’s psychosocial functioning and 

19 
 
takes 5 min. to complete. Parents complete 35 items reflecting a range of emotional and 
behavioral problems (e.g., “has trouble sleeping” or “feels sad, unhappy”) that are 
scored on a 3-point scale reflecting the rating that best fits their child (0 = never, 
1=sometimes, 2 = often). Items are averaged to create a total scale. Higher scores 
reflect greater psychosocial problems/impairment. The psychometric properties of the 
PSC have been established across diverse populations of children107,108 and it has been 
validated in military populations109,110. 5) The Parenting Scale (PS; 111), a 30-item 
measure of parenting practices will also be completed. The PS has demonstrated 
adequate internal consistency and reliability, and correlates well with observational 
measures of dysfunctional discipline and child misbehavior.  Demographics will be 
collected (5 min.). 6) The Personality Assessment Screener (PAS 112) is a brief, 5 
minute 22-item screener that is adapted from the larger response item Personality 
Assessment Inventory (PAI). It will be used to screen for the presence of co-morbid 
disorders. Items are scored with higher scores ranging from mild to marked risk 
(possible range 15-23)112,113. The Personality Assessment Observer (PAS-O112) is 
designed as a parallel assessment to address the 22 corresponding items that the 
Veteran answered on the (PAS). It will be obtained through the spouse or partner of the 
Veteran and will help validate the Veterans’ (PAS) results. 
 
Feasibility of collateral partner assessment: Where possible, a co-parent will be asked 
to complete the PSI, the PSC, PAS-O and demographics in order to examine whether it 
will be feasible to gather external evaluation of parent-child functioning at intake and 
post-treatment. This will be conducted via phone or web-based assessment. 
Aim 2 Analysis Plan. The combination of the data collected will allow us to evaluate 
whether there is sufficient evidence to scale up to an RCT. Feasibility, acceptability and 
satisfaction: Descriptive statistics, including means, standard deviation, numbers, and 
percentages will be used to summarize feasibility and acceptability variables as the 
measures are continuous and there is no validated cut-off. Participant attendance at 
sessions exceeding 70% will indicate feasibility about timing and location of the group. 
Numbers of Veterans screened, assessed and enrolled vs. the number contacted will be 
examined to calculate a screening to enrollment ratio that will guide the timeline and 
costs for the future RCT and help evaluate overall feasibility and efficacy of recruitment 
strategies. At each stage, we will also assess reasons for opting out or dropping out to 
evaluate the barriers to participating and the feasibility of the proposed methods. A 
recruitment milestone of 8 Veterans (one cohort) enrolled within a 3-month period is 
necessary to meet the study goals and a good estimate of the feasibility and viability of 
scaling up recruitment for the planned RCT. Veteran satisfaction and feedback on the 
pre-treatment MIA as well as rating of interview fidelity on the MIA will be used to 
determine whether there is preliminary evidence that that the MIA is feasible and 
satisfactory. Veteran willingness to sign a release for partner contact, and number of 
successfully completed partner assessments will help determine the feasibility of 
collateral partner assessment of parent-child functioning in the RCT. Preliminary 
effectiveness: As formal significance testing is not the goal of this study, we will test for 
a signal that SAHP results in changes to the Veteran-reported primary outcomes at p < 
.10. Outcome analyses will be conducted following both Intention-to-treat and per 
protocol principles. That is, first, we will examine pre-to post-treatment changes in the 

20 
 
primary treatment outcomes for all individuals assessed (ITT). Second, we will examine 
pre-to post-treatment changes in the primary treatment outcomes from all Veterans 
completing the group. Outcomes will be analyzed using one-way within-subjects’ 
ANOVA (i.e., repeated measures) to assess change from pre- to post-intervention at p < 
.10. Analyses will also evaluate differences between Veterans who do and do not 
complete Time 2 data. The goal of partner reported outcomes is to determine whether it 
will be feasible to gather these data. If successful, we will look for a signal that SAHP 
results in changes in the partner-reported outcomes, particularly changes in the support 
from parenting partner scale of the PSI. 
 
 
Schedule of Assessments 
  
 
Phone 
Screen 
Baseline Weekly 
Post-
treatment 
  
  
  
SAHP 
SAHP 
SAHP 
SAHP 
Measure Purpose 
Reasons for opting out or 
dropping out 
X 
X 
X 
X 
Feasibility  
Eligibility/Clinical Scales 
PCL-5 
X 
X 
  
  
  
X 
Eligibility/ Exploratory 
PSI-SF 
X 
  
  
  
Eligibility 
OSU TBI ID 
  
X 
  
  
Eligibility 
MINI 
  
X 
  
  
Eligibility 
BDI-II 
  
X 
  
 X 
Eligibility/Exploratory 
AIM I 
(completed) 
CEQ 
  
  
X        
  
Treatment Credibility 
SAHP Specific 
  
  
X 
  
Treatment 
Satisfaction 
Clinician notes 
  
  
X 
  
Exploratory  
AIM II  
(ongoing ) 
SAHP Satisfaction 
  
  
  
X 
Primary Outcome 
CEMI 
  
X 
 
x 
Feasibility Satisfaction 
PSI- Partner 
  
X  
 
X 
Preliminary Outcomes 
PSC- Partner 
  
X 
 
X 
Preliminary Outcomes 
PAS-O 
 
X 
 
X 
Preliminary Outcomes 
CSQ 
  
  
  
X 
Primary Outcome 

21 
 
AIM I (completed) & 
AIM II (ongoing) 
 
PSI 
 
  
 
X 
 
 
X 
 
Preliminary Outcomes 
APQ/APQ-PR 
  
X 
 
X 
Preliminary Outcomes 
FAD 
  
X 
 
X 
Preliminary Outcomes 
PSC 
  
X 
 
X 
Preliminary Outcomes 
PS 
 
X 
 
X 
Preliminary Outcomes 
PAS 
 
X 
 
X 
Preliminary Outcomes 
*Measure Names: PSI-SF (Parenting Stress Index), OSU TBI ID (Ohio State University Traumatic 
Brain Injury), MINI (Mini International Diagnostic Interview), BDI II (Beck Depression Inventory), CEQ 
(Credibility and Expectancy Questionnaire), CSQ (Client Satisfaction Questionnaire), SAHP Specific 
(Satisfaction questionnaire), CEMI (Client Evaluation and Interviewing Scale), PSI (Parenting Stress 
Index), APQ (Alabama Parenting Questionnaire), FAD (Family Assessment Device), PSC (Pediatric 
Symptom Checklist). PS (Parenting Scale). PAS/PAS-O (Personality Assessment Screener/Other) 
D. Data Management 
D1. Identifiers: A study ID number will be used to identify each participant and their 
partner across assessments.  
D2. Identifiers/linking data: A password protected master participant tracking 
spreadsheet will contain the linking information that matches the unique participant IDs 
to participant names. This spreadsheet will reside only on the secure research S drive. 
Other PHI such as participant addresses and phone numbers (for follow-up contact), 
and date of participation will be contained in the master tracker. This information will 
only be accessible to PI Creech and her research staff that is approved to work on the 
study. The Master tracker will be kept separately from study databases on the Central 
Texas secure research (S) drive. The paper files will be stored in locked file cabinet in a 
locked room at the VHA VISN 17 Center of Excellence in Waco, TX 
D3. Confidentiality: No participant will be identified in any publications or presentations 
arising from this study. Records will be maintained in accordance with the Department 
of Veterans Affairs Record Control Schedule 10-1. It may be necessary or required for 
the study investigators to break confidentiality and release personal identifiers and 
health information when mandated by law. For example, state law requires health care 
workers to report any suspected abuse or neglect of a child, or person 65 years or 
older, or an adult with disabilities to the Texas Department of Family and Protective 
Services.  
A Certificate of Confidentiality will be obtained from the National Institutes of Health 
prior to the commencement of research. The purpose of this certificate is to protect the 
identity of research subjects participating in studies that collect sensitive information. No 
information about participants will be released without their permission or where 
required by law (such as the examples given above).   
All employees who are to handle data will be trained in confidentiality policies and 
procedures. If theft, loss, or other unauthorized access of sensitive data and non-
compliance with security controls occur, study staff has been instructed to follow the 
CTVHCS standard operating procedure on incidence reporting. 

22 
 
Post-COVID: Prior to starting treatment and assessment sessions participants will be 
asked to confirm that confidentiality can be maintained at their location. Following 
confirmation, remote treatment and assessment sessions will be locked to maintain 
confidentiality. Only non-public facing VA-approved video technology platforms will be 
used for assessment and treatment sessions, and all available privacy and encryption 
modes will be enabled.  
 
D4. Delineation of research tasks performed by VA and collaborators: 
Collaborators (as listed on p.1) are those individuals who are involved in specific 
aspects of the study (for example, drafting the treatment and assessment manual as 
described in Aim 1, “procedures for intervention refinement”), but who have no 
participant contact or contact with study data. 
All participant contact activities will take place remotely via VA-approved video 
technology (Post-COVID) or place on the Austin, Temple or Waco campuses of 
CTVHCS (Pre-COVID) or via a telephone call between a study staff member and a 
participant. Participants will complete self-report study measures on Qualtrics (as 
described on pp. 23). Participant contact only occurs between CTVHCS participants 
and IRB approved individuals listed as key personnel or study staff. 
D5. Primary users of the study dataset: are those individuals listed as key personnel 
or who are on the study staff list and are those individuals who will conduct pre-
specified analyses consistent with the study’s hypotheses and its primary, secondary 
and exploratory aims as described in the aims and analysis plan. 
D6. Disposition of the data: Paper files containing identifiers will be kept in locked file 
cabinets in a locked room at the Center of Excellence in Waco, TX. Questionnaire data 
will be kept separately from data containing identifiers. Only approved study staff will 
have access to the files. Electronic data will be stored on the secure VA password-
protected server with access restricted to research staff.  These records will be 
maintained and retained in accordance with the Department of Veterans Affairs Record 
Control Schedule 10-1. 
D7. Incident Reporting: Any incidents affecting the security of the data such as theft, 
loss, or unauthorized access of sensitive data will be reported to the ISO and PO per 
VA regulations. 
D8. Data Use and Transfer within CTVHCS: Only IRB approved personnel on the 
study staff list will have access to the data collected in this study. Access to the study 
data will be terminated when personnel are no longer part of the research team. This 
study will recruit participants across the Central Texas VA Healthcare System. The 
recordings during intake assessments will be saved directly to the secure S drive. All 
original audio recordings are saved directly to the S drive. 
Pre-COVID:The primary repository of paper files generated by the study is the VHA 
VISN 17 COE. Data to be transported to the COE includes: consent documents and 
measures completed after each session and at post-treatment. Study data collected at 
the Temple or Austin campus (post-session and post-treatment measures and consent 

23 
 
documents) will be transported to the approved data storage location at the Waco 
Campus where it will be uploaded to the secure research S drive. Personally-identifying 
information (e.g. Informed Consent Form with name and date of consent) will be kept in 
a separate locked carrying case from the data during transport. No other paper data is 
collected as part of this study.  
Post-COVID: All assessment measures will be collected on the web-based survey 
application Qualtrics, and will be stored on a FIPS 140-2 compliant server. 
D9. Coding of Recording Motivational Interviews: Recordings of the pre-treatment 
motivational interviews will be sent to Dr. Jordan Braciszewski, Henry Ford Healthcare 
System, for fidelity coding and feedback. Both the informed consent document (p. 5, 
item 1 informs participants this will occur) and the study HIPPA authorization document 
(p. 2, disclosure) describe this for participants. The interviewers will minimize 
verbalizations of PHI during the interviews, and files will be saved with code numbers 
only and password protected, however, it will not be possible to remove all PHI given 
that voice recordings themselves are PHI. The recordings will be encrypted and saved 
in a manner approved by the Central Texas Privacy Officer and Information Security 
Officer. Following completion of the applicable procedures documented in protocol 
section D11 and working in collaboration with the Central Texas Privacy Officer and 
Information Security Officer, a VA Materials Transport Agreement (MTA) will be 
completed and the recordings will be sent via an approved, secure chain of custody 
method (UPS) from Dr. Creech directly to Dr. Braciszewski. Once the interviews are 
coded, Dr. Braciszewski will return them using the same secure chain of custody 
method. Original copies will remain at VA. 
D10. Records destruction information:  "All paper AND electronic documentation 
containing confidential, personally identifiable information, protected health information, 
and any other sensitive information will be disposed/destroyed per current VA 
regulations at the time of disposal/destruction of documentation." 
D11. Records retention information:  "The required records, including the 
investigator's research records, must be retained until disposition instructions are 
approved by the National Archives and Records Administration and are published in 
VHA's Records Control Schedule (RCS 10-1)." All de-identified data will be managed in 
accordance with the VHA Handbook 1605.1 APPENDIX B. 
All original data will be stored at VA. 
D12. Reporting: Any incidents involving theft or loss of data or storage media, 
unauthorized access of sensitive data or storage devices or non-compliance with 
security controls will be immediately reported to the IRB chair, Privacy Officer and 
Information Security Officer. 
D13. Data Analysis Software: Data will be analyzed using the software programs R, 
SPSS and MPLUS that are already owned by the VA either using local copies of the 
software or through VA Informatics and Computing Infrastructure (VINCI).  
E. VINCI 

24 
 
E. VINCI: VINCI is a major informatics initiative of the Department of Veterans Affairs 
(VA) that provides a secure, central analytic platform for performing research and 
supporting clinical operations activities. It is a partnership between the VA Office of 
Information Technology (OI&T) and the Veterans Health Administration Office of 
Research and Development (VHA ORD). VINCI includes a cluster of servers for 
securely hosting suites of databases integrated from select national VA data sources. 
VINCI servers for data, applications and virtual sessions are physically located at the 
VA Austin Information Technology Center (AITC), located in Austin, Texas. This secure 
enclave with 105 high-performance servers and 1.5 petabytes of high-speed data 
storage has multiple layers of security and disaster recovery to prevent data loss. 
To ensure the protection of Veteran data, VINCI maintains compliance with the 
guidelines set forth by Veterans Health Administration (VHA) Handbook 1200.12, Use of 
Data and Data Repositories in VHA Research, and all other applicable VA and VHA 
policies and regulations. In addition, VINCI has undergone all security certification 
activities in support of obtaining an Authorization to Operate (ATO). Access to VINCI 
resources are approved in accordance with the requirements of National Data Systems 
(NDS), VHA Handbook 1200.12, Use of Data and Data Repositories in VHA Research, 
and all other applicable VA and VHA policies and regulations. All data transferred from 
VINCI is subject to audit for compliance. 
VA-credentialed research or operations staff are granted access to study-specific data 
along with tools for analysis and reporting in the secure, virtual working environment 
through a certified VHA network computer within the VA.  If not working within a VA or 
VHA hosted office environment containing VA network access, researchers may apply 
for and then access VINCI through an approved Virtual Private Network (VPN) and 
Remote Desktop application. The remote computing environment enables data analysis 
to be performed directly on VINCI servers, offering several advantages: uniform security 
standards for access; a common point of entry for all investigators who use the data; 
tools for analysis and reporting; tighter and more consistent control of data quality; and 
the ability to standardize and update terminology and format as technology and 
methodology improve. 
Only study team personnel explicitly authorized by data stewards will have access to 
project data. The study principal investigator has the responsibility for security of study. 
VINCI data managers and VA OI&T personnel not under the purview of the study 
principal investigator control the servers, network, processors, firewall and software in 
the VINCI environment, including access rights granted to study personnel. 
When study personnel are no longer part of the research team, the study principal 
investigator will amend the data access request to terminate that person’s access to all 
study data and notify the VA Information Security Officer of such action. No sensitive 
patient data may be shared with anyone who does not have a VA appointment. All study 
team personnel with access to sensitive patient data must stay current on required VA 
information security and privacy policy trainings. 
Study data stored on VINCI servers is located at the Austin Information Technology 
Center, 1615 Woodward St., Austin, TX 78772-0001. The specific server where the data 

25 
 
are stored within the VINCI environment will be chosen by VINCI personnel. The server 
name and location within the Austin Information Technology Center may be changed at 
any time at the discretion of VINCI personnel. 
Data from measurements collected at intake, treatment and post-treatment may be 
captured by secure, web-based survey application Qualtrics. Qualtrics has been 
approved by the VA as a secure data collection tool, and is considered equivalent to 
being behind the VA firewall. Within Qualtrics all web-based information is encrypted. 
Qualtrics stores all data on a FIPS 140-2 compliant server. Qualtrics is flexible enough 
to be used for a variety of types of research, and provides an intuitive interface for 
participants to complete surveys without an experimenter present. The survey will be 
created as an anonymous survey, such that no IP address, names, emails, or any other 
identifying information will be collected at the time of participation. Qualtrics is currently 
used by other research studies within the Central Texas VA Healthcare System, 
including the large-scale Project SERVE (Protocol #: 00390). 
F. Data Safety and Monitoring 
F1. Safety monitoring plan 
Any breach of data or procedure will be reported immediately to the ISO, privacy officer 
and IRB. If any participant safety issues arise during the group sessions (participant 
discloses suicidal ideation or in intoxicated), the participant will be assisted in obtaining 
immediate medical attention and this will be reported to the IRB chair. All adverse 
events will be reported to the IRB within 24 hours of notification.  
 
Monitoring of safety and data quality in the proposed study will be the responsibility of 
all personnel on the project, with primary responsibility and supervision by the PI. The 
Institutional Review Board at the Central Texas VA HCS will approve the Statement of 
Informed Consent for the study and this board provides oversight of data and safety 
issues. The study protocol will be approved prior to soliciting or consenting any 
participants. Any incidents that involve a breach of this plan or serious accident/injury 
will be reported to the IRB chair at CTVHCS. Potential, albeit minimally likely, include 
distress resulting from the study assessments, coercion through compensation, and 
breach of confidentiality. 
 
In the case of an Adverse Effect (AE) or a Serious Adverse Effect (SAE), a written 
report of the AE or SAE will be prepared for submission to the IRB. Any such AEs or 
SAEs will be presented to the IRB within 24 hours of notification. The report of such AEs 
or SAEs will include whether they were expected or unexpected, a rating of severity of 
the event, a brief narrative summary of the event, a determination of whether a causal 
relationship existed between the study procedures and the event, whether the informed 
consent should be changed as a result of the event, and whether all enrolled 
participants should be notified of the event. All team meetings will begin by asking 
whether any adverse events have occurred and the team will regularly review the 
criteria for AEs and SAEs. 
 

26 
 
 All required personnel proposed for this project will have the required human subjects 
and confidentiality training, including information about maintaining data integrity and 
security so that data quality and health information are protected.  
 
All other identifying information (e.g., signed consent forms) will be stored separately 
from the research questionnaires. Separate locked, secure files will be used to store 
study materials for each participant to ensure confidentiality and safety. Methods for 
obtaining electronic informed consent forms are compliant with Department of Veterans 
Affairs (VA) Directive 6500, “VA Cybersecurity Program” and FIPS 140-2. Identity 
masking subject numbers assigned to each participant will be the only means by which 
collected information is labeled. Each participant will have his or her own. The only list 
that will link the names of the participants with their subject numbers will be kept in a 
secure, password-protected computer account accessible only to the PI and IRB 
approved personnel on the study staff list. Study results will be presented and/or 
published in a fashion to ensure that participants cannot be identified. 
G. Risks/Benefits Assessment: 
G1. Foreseeable risks: There are three major areas of low to moderate risk associated 
with participation in the proposed study: 1) In any research study there is risk to 
confidentiality and loss of privacy if identifying study data were to be hacked or 
breached. 2) When discussing PTSD symptoms or problems with parenting or family 
and relationship functioning, participants may become emotionally upset and distressed. 
3) Some participants may feel coerced into participating in the research if compensation 
is too high. 
Data and safety monitoring will take place to assure the safety of subjects. All 
participants will be reminded that their participation is voluntary and that they can 
withdraw at any time without penalty. Additionally, the risks described above will be 
minimized by the following procedures:  
1. Confidentiality. We will take all necessary steps to protect patient privacy and 
confidentiality, in accordance with VA regulations and other applicable laws. We have 
undertaken several steps to ensure confidentiality and data security. First, we will 
eliminate any identifying information on study surveys and we will use unique numeric 
identifiers to label and track participant measures completed over the course of the 
study. Second, all data storage devices, including computers and servers, will be VA 
issued and monitored by VA information management services. Only study personnel 
authorized by the Principal Investigator (PI) will have access to the data, and the file 
server is protected from the internet by a firewall. Third, participant files will be stored in 
separate locked filing cabinets in a secure data storage room. Each participant will have 
their own subject number, and these numbers will be the only means by which subject 
information is identified. Subject numbers will mask identity. One list will be kept that will 
link the names of the participants with their subject numbers. Fourth, audio-recorded 
MIA sessions will be mailed to Dr. Braciszeski at Henry Ford using a secure chain of 
custody and they will be mailed back using the same method. The recordings will be 
encrypted and saved on a password protected manner, following procedures approved 
by the local ISO and PO. Fidelity ratings will not include subject information but only 

27 
 
interviewer information for the purpose of rating fidelity and providing coaching. Fifth, all 
electronic recordings from the MIA sessions will be stored electronically until such time 
as they need to be sent to Dr. Braciszewski. Data will be stored on a protected VHA 
server that is behind the firewall. Access to the server is limited to system administrators 
and project personnel will have access to the data. Results will only be reported in 
aggregate so no individual can be identified. Post- COVID: Sixth, all assessment and 
intervention sessions will be completed using non-public facing VA-approved video 
technology. Prior to the start of every session participants will be asked if confidentiality 
can be maintained at their location, and once confidentiality is confirmed sessions will 
be locked.  All available encryption and privacy modes will be enabled.  
2. Emotional distress. The primary risk in this study is that participants may become 
emotionally upset when discussing PTSD symptoms or family functioning problems. 
Participants will be made aware of what to expect during study procedures prior to their 
participation, and will be informed in the consent form that the procedures may 
potentially lead to more distress. Participants will also be informed that they may 
discontinue their participation at any time. At the end of participant’s assessment 
sessions, each participant will be debriefed individually to ensure that they are not 
emotionally distressed. Licensed psychologists will be available always if a participant is 
or becomes emotionally distressed. In addition, appropriate treatment referrals will be 
made for study participants when necessary, and participants will be made aware of 
resources available to them. 
If the participant volunteers information regarding self-harm at any point during the 
study (including during telephone screening), safety issues will be formally assessed 
and in conjunction with the Central Texas Suicide Prevention Coordinators. If 
imminently suicidal or homicidal, the participant will be evaluated for hospitalization per 
standard Medical Center procedures. This would involve a planned psychiatric 
evaluation in the ER, and participants will be instructed to come to the ER. If the 
participant is unwilling to seek care the police would be called. These procedures have 
been in place for other ongoing studies and have been approved by the IRB.  All 
adverse events will immediately be reported to the IRB. 
As needed, partners will be offered hotline numbers and local mental health resources, 
which can be given over the phone or mailed. For more serious concerns regarding risk 
for self or other harm, the partner will be offered a chance to talk the study PI for a 
safety assessment, and if necessary, will be encouraged to go to their local ER or the 
police will be called for a safety check. We do not expect this to occur since the partner 
call is brief, scripted and does not inquire into the partner’s mental health. Never-the-
less, all staff conducting these calls will be trained in safety procedures. 
Due to our focus on improving parenting, the study team recognizes this may enhance 
concerns about child abuse or neglect. Participants who are justice-involved due to past 
concerns about child abuse or neglect will still be eligible for the study; however, they 
will be informed that the treatment will not meet criteria for any court-mandated 
treatment. All participants will also be informed at the beginning of every new contact 
(screening, interview, and group) that all members of the study staff are mandated 
reporters of any child abuse or neglect so that it will not be a surprise if this occurs (in 

28 
 
addition to being mandated reporters of elder abuse or intention to hurt oneself or 
someone else). Veterans will be encouraged to let study staff know if they have 
concerns regarding this issue. Though the study protocol and assessments do not 
measure child abuse, all study staff will be trained in procedures for what to do should 
they become aware of child abuse or any other mandated reporting issue. 
3. Coercion through Compensation. A human subjects concern is whether the 
financial compensation is too high and therefore coercive to participants. That is, there 
is a concern that high reimbursement may coerce normally unwilling participants to 
participate in the study. The typical compensation rate used at the research site for 
research study participants and those in the current study is $25 per hour, a rate that 
aims to compensate for the cost of resultant travel (applies to Pre-COVID only) and 
child care, but does not constitute undue inducement. We believe that this proposed 
reimbursement fairly compensates participants for their lost work time and for taking 
time out of their schedules to participate. Therefore, we have proposed to compensate 
Veterans participants at the rate of $50 for each pre and post assessment, and $10 for 
time completing measures after each intervention session, for a total of $180. Partners 
will be compensated $20 each for their time completing two phone assessments. 
We will minimize the risk of potential coercion by following standard procedures for 
obtaining informed consent. We will begin this process by having participants read 
consent documents and taking time during the intake for the screening phase and the 
trial phase to clarify the nature of the study and possible alternatives upfront. Prior to 
enrolling participants in the research, we will fully explain the study procedures, risks, 
benefits, and alternatives. Participants will be reminded that study participation is 
voluntary and that refusing to participate or withdrawing from the study at any time will 
not impact in any way their relationship to the Central Texas VA or any other VAMC, or 
existing services they receive within the community Veterans will have the opportunity 
to discuss any uncomfortable feelings with the assessment or intervention with the 
research assistant who will be available during both the assessment and intervention. 
The Veteran will also be informed that the veteran’s well-being and safety takes priority 
over research considerations. Furthermore, the veteran will be informed that should 
they experience any problems, they should report them to the research assistant or to 
the principal investigator of this study. All reimbursements for participating will be 
commensurate with participants’ time required for participating in the research. 
G2. Referral to treatment and counseling during the study. No referral, or 
counseling will be withheld in any way at any time during the study. If participants 
request referrals, or it becomes clear they may benefit from a referral, study staff will 
facilitate this process. 
G3. Potential Benefits of the Proposed Research to the Subjects and Others.There 
are no assured benefits but several potential benefits from participation in the proposed 
project. First, although discussing PTSD, parenting difficulties and family functioning 
may potentially lead to some emotional distress, this is also likely to be experienced as 
educational and possibly therapeutic for some participants. Participants will have the 
opportunity to learn more about problems they may be experiencing but poorly 
understand, and may gain a better understanding of their relationships through study 

29 
 
participation. Therefore, for some, the proposed project may assist in the patient’s 
education and self-awareness. Participants may also experience a sense of relief 
through these study procedures, because they may not have discussed such issues 
with a therapist previously. Furthermore, the intervention itself may improve parent-child 
functioning, and overall family functioning which may also be of considerable value. 
G4. Importance of Knowledge to be Gained Despite known bidirectional links 
between PTSD symptoms and family functioning impairment, including parent child 
functioning, there is no evidence-based intervention built specifically for VHA that seeks 
to improve parenting in Veterans who are diagnosed with PTSD. The knowledge that 
may be gained from this study will fill a gap in knowledge about evidence-based parent 
training for Veterans with PTSD. This research may also lead to an effective and 
evidence-based intervention to improve the lives of Veterans and their family members. 

30 
 
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