Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03403153 |
| Other study ID # |
D2421-R |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
April 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
