Strength at Home - Parents RCT
Randomized Clinical Trial of Parent Training for Veterans With PTSD Symptoms (Strength at Home - Parents RCT)
1 other identifier
interventional
200
1 country
1
Brief Summary
The goal of this clinical trial is to compare the effect of the Strength at Home Parents intervention to treatment as usual in veterans enrolled for care at VA facilities in VISN 17 on parenting stress and parenting behaviors. The participant population will have elevated PTSD symptoms and parent-child functioning difficulties with an index child between the ages of 3-12. The main question\[s\]it aims to answer are: • Does Strength at Home Parents improve parenting stress and parenting behaviors in comparison to a no-treatment control condition? • Are gains maintained over time and is there a gender difference in efficacy? Participants will complete 4 online assessments, and if randomized to the intervention group they will complete an 8 week tele-health group program. If randomized to the control group participants will receive a link to the VA parenting resources website and any referrals they would like to have. Researchers will compare Strength at Home Parents to VA treatment as usual see if the group intervention improves parenting stress and behaviors above and beyond the existing resources.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
March 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
April 24, 2024
April 1, 2024
5.1 years
March 6, 2024
April 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Time 2: 8-16 weeks
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Time 3: 16-24 weeks
Parenting Stress Index total score
The Parenting Stress Index, 4th edition (PSI) has 120 items scored on a 5-point scale, yielding a parent and child domain scale measuring stress related to parent and child characteristics. These scale scores are combined to yield a total stress score.
Time 4: 24-32 weeks
Secondary Outcomes (6)
Laxness subscale on the Parenting Scale
Time 2: 8-16 weeks
Laxness subscale on the Parenting Scale
Time 3: 16-24 weeks
Laxness subscale on the Parenting Scale
Time 4: 24-32 weeks
Over reactivity subscale on the Parenting scale
Time 2: 8-16 weeks
Over reactivity subscale on the Parenting scale
Time 3: 16-24 weeks
- +1 more secondary outcomes
Other Outcomes (9)
PTSD Symptom Checklist score
Time 2: 8-16 weeks
PTSD Symptom Checklist score
Time 3: 16-24 weeks
PTSD Symptom Checklist score
Time 4: 24-32 weeks
- +6 more other outcomes
Study Arms (2)
Strength at Home Parents
EXPERIMENTALVA treatment as usual
ACTIVE COMPARATORInterventions
Strength at Home parents is an 8 week trauma-informed and cognitive behavioral tele-health group intervention that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military Veterans with post-traumatic stress disorder symptoms
VA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting .
Eligibility Criteria
You may not qualify if:
- Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VISN 17 Center of Excellencelead
- United States Department of Defensecollaborator
- University of Texas at Austincollaborator
Study Sites (1)
Central Texas Veterans Healthcare System
Temple, Texas, 76504, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Psychologist
Study Record Dates
First Submitted
March 6, 2024
First Posted
March 13, 2024
Study Start
March 30, 2024
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
April 24, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- will become available per NDA policy which is subject to change; data will be shared with authorized users upon publication or 1-2 years after the grant end date specified on the first Notice of Award, as defined in the applicable Data Sharing Terms and Conditions.
- Access Criteria
- Per NIMH NDA in addition Data access requires sponsorship by an Institution on behalf of Recipient
A de-identified copy of study data will be shared on a yearly basis to the National Institute of Mental Health Data Archive registry (e.g., National Institute of Mental Health (NIMH) data archive (NDA)).