Strength at Home - Parents RCT

Not Applicable

• Conditions: Parent-Child Relations
• Interventions: Behavioral: VA treatment as usual; Behavioral: Strength at Home Parents

• Registration Number: NCT06309329
• Lead Sponsor: VISN 17 Center of Excellence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Study Start: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Eligible participants are veterans enrolled in any VA VISN 17 facility who meet the following inclusion criteria: Current parent to a child between the ages of 3 and 12 (the index child), who resides with the participant or spends at least two days per week with the participant, elevated PTSD symptoms and Parent-child functioning problems.

Exclusion Criteria

Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VA treatment as usual	VA treatment as usual	-
Strength at Home Parents	Strength at Home Parents	-

Primary Outcome Measures

Name	Time	Method
Parenting Stress Index total score	Time 4: 24-32 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Laxness subscale on the Parenting Scale	Time 4: 24-32 weeks	The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline
Over reactivity subscale on the Parenting scale	Time 4: 24-32 weeks	The over reactivity scale (10 items) measures use of emotional, harsh discipline

Trial Locations

Locations (1)

Central Texas Veterans Healthcare System; 🇺🇸 Temple, Texas, United States