Strength At Home- Parents Pilot (SAHP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03403153|
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : March 11, 2019
The overall goal of this work is to adapt, refine, and conduct an open trial of a parent-training intervention for Veterans with posttraumatic stress disorder (PTSD) symptoms using feedback from Veterans, VA clinicians, and expert consultants as key stakeholders. PTSD symptoms are associated with parent-child functioning difficulties, which are also an important determinant of quality of life and functional recovery. This project will examine the feasibility and acceptability of an evidence-based group intervention to improve parenting behaviors, parenting satisfaction, and family functioning in Veteran parents with PTSD symptoms and who have children between the ages of 3 and 12.
This intervention is derived from an existing evidence-based intervention to improve Veteran relationship functioning (Strength at Home; SAH), and it is informed by the Cognitive Behavioral Theory of Interpersonal Functioning and the Military Family Attachment frameworks for the association between PTSD and family functioning problems. The intervention also includes a pre-treatment Motivational Interviewing Assessment (MIA) to assist Veterans in strengthening and building motivation to change their parenting behaviors. The goals and change talk identified in the pre-treatment MIA are then referred to throughout the treatment. Groups are gender-specific, meaning that the investigators will pilot the treatment in separate groups of women and men Veterans.
|Condition or disease||Intervention/treatment||Phase|
|Parenting Behaviors and PTSD Symptoms||Behavioral: SAHP||Not Applicable|
Symptoms of posttraumatic stress disorder (PTSD) after deployment have been shown to adversely impact family and close relationship functioning, including parent-child relationships. About 31% of U.S. Veterans are parents to children under the age of 18. 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 children. 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 PTSD, nor is there evidence that existing treatments for PTSD improve family functioning. 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 Veterans 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 VHA, 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 usual. Assessment approaches such as MIA that are personalized and collaborative have been shown to have a positive and clinically meaningful impact on treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is examining the feasibility and acceptability of an intervention to improve parent-child functioning. It will also conduct a preliminary test for movement in target outcomes.|
|Masking:||None (Open Label)|
|Official Title:||Adaptation, Refinement, and Open Trial of Parent Training for Veterans With PTSD|
|Actual Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
Pilot and Open Trial
All Participants will complete the 8-week parenting support intervention and will provide satisfaction and acceptability ratings of the intervention. In the pilot trial, participants will make these ratings after each session, in the open trial the ratings will be made pre and post intervention.
Aim 1: To obtain and incorporate expert clinician and Veteran feedback on credibility, acceptability, and satisfaction with the intervention to ensure Veteran-friendly intervention manual, materials, and processes. Aim 1 will be accomplished through two rounds of expert panel review of treatment/MIA manual and two rounds of pilot testing of the treatment for Veteran Feedback in 16 female and 16 male Veterans.
Aim 2: To evaluate feasibility of study recruitment, retention, assessment procedures and proposed methods of the intervention. Preliminary examination of whether the intervention results in improvements to parenting behaviors, parenting satisfaction and overall family functioning.
- Client Satisfaction Questionnaire-8 (CSQ) [ Time Frame: eight week ]The Client Satisfaction Questionnaire-8 (CSQ) assesses acceptability post-treatment. Eight items are scored on a 4-point scale 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.
- Strength at Home Parents Specific Satisfaction Questionnaire [ Time Frame: eight week ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403153
|Contact: Suzannah K Creech, PhD||(254) 297-3025||Suzannah.Creech@va.gov|
|Contact: Kathryn Roe, BA||(254) 297-3167||Kathryn.Roe@va.gov|
|United States, Texas|
|Austin Information Technology Center, Austin, TX||Not yet recruiting|
|Austin, Texas, United States, 78772|
|Contact: Suzannah K Creech, PhD 254-297-3025|
|Central Texas Veterans Health Care System, Temple, TX||Recruiting|
|Temple, Texas, United States, 76504|
|Contact: Suzannah K Creech, PhD 254-297-3025 Suzannah.Creech@va.gov|
|Principal Investigator: Suzannah K. Creech, PhD|
|Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX||Not yet recruiting|
|Waco, Texas, United States, 76711|
|Contact: Suzannah K Creech, PhD 254-297-3025|
|Principal Investigator:||Suzannah K. Creech, PhD||Central Texas Veterans Health Care System, Temple, TX|