Clinical trial NCT06309329: Strength at Home - Parents RCT
Official title: Randomized Clinical Trial of Parent Training for Veterans With PTSD Symptoms (Strength at Home - Parents RCT)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parent-Child Relations
Lead sponsor: VISN 17 Center of Excellence
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: University of Texas at Austin
First posted: 2024-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: Parenting Stress Index total score
timeFrame: Time 2: 8-16 weeks
measure: Parenting Stress Index total score
timeFrame: Time 3: 16-24 weeks
measure: Parenting Stress Index total score
timeFrame: Time 4: 24-32 weeks
Secondary outcomes:
measure: Laxness subscale on the Parenting Scale
timeFrame: Time 2: 8-16 weeks
measure: Laxness subscale on the Parenting Scale
timeFrame: Time 3: 16-24 weeks
measure: Laxness subscale on the Parenting Scale
timeFrame: Time 4: 24-32 weeks
measure: Over reactivity subscale on the Parenting scale
timeFrame: Time 2: 8-16 weeks
measure: Over reactivity subscale on the Parenting scale
timeFrame: Time 3: 16-24 weeks
measure: Over reactivity subscale on the Parenting scale
timeFrame: Time 4: 24-32 weeks
Other outcomes:
measure: PTSD Symptom Checklist score
timeFrame: Time 2: 8-16 weeks
measure: PTSD Symptom Checklist score
timeFrame: Time 3: 16-24 weeks
measure: PTSD Symptom Checklist score
timeFrame: Time 4: 24-32 weeks
measure: Quick Inventory of Depressive Symptoms
timeFrame: Time 1: 8-16 weeks
measure: Quick Inventory of Depressive Symptoms
timeFrame: Time 2: 16-24 weeks
measure: Quick Inventory of Depressive Symptoms
timeFrame: Time 3: 24-32 weeks
measure: Total Family Problems Score
timeFrame: Time 2: 8-16 weeks
measure: Total Family Problems Score
timeFrame: Time 3: 16-24 weeks
measure: Total Family Problems Score
timeFrame: Time 4: 24-32 weeks
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Healthcare System
state: Texas
Study officials:
References: