Strength at Home - Parents RCT

Randomized Clinical Trial of Parent Training for Veterans With PTSD Symptoms (Strength at Home - Parents RCT)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parent-Child Relations
• Intervention / Treatment: Behavioral: Strength at Home Parents; Behavioral: VA treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76504
      • Central Texas Veterans Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength at Home Parents	Behavioral: Strength at Home Parents; 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
Active Comparator: VA treatment as usual	Behavioral: VA treatment as usual; VA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laxness subscale on the Parenting Scale	The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline	Time 2: 8-16 weeks
Laxness subscale on the Parenting Scale	The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline	Time 3: 16-24 weeks
Laxness subscale on the Parenting Scale	The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline	Time 4: 24-32 weeks
Over reactivity subscale on the Parenting scale	The over reactivity scale (10 items) measures use of emotional, harsh discipline	Time 2: 8-16 weeks
Over reactivity subscale on the Parenting scale	The over reactivity scale (10 items) measures use of emotional, harsh discipline	Time 3: 16-24 weeks
Over reactivity subscale on the Parenting scale	The over reactivity scale (10 items) measures use of emotional, harsh discipline	Time 4: 24-32 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Symptom Checklist score	We will measure PTSD with the PTSD Checklist for DSM-5; PCL-5, a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms.	Time 2: 8-16 weeks
PTSD Symptom Checklist score	We will measure PTSD with the PTSD Checklist for DSM-5; PCL-5, a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms.	Time 3: 16-24 weeks
PTSD Symptom Checklist score	We will measure PTSD with the PTSD Checklist for DSM-5; PCL-5, a 20-item measure on a 5-point scale assessing PTSD symptom severity. Scores range from 0 to 80 with higher scores reflecting increased endorsement of PTSD symptoms.	Time 4: 24-32 weeks
Quick Inventory of Depressive Symptoms	We will use the Quick Inventory of Depressive Symptoms (QIDS). The QIDS includes 16 items that capture the severity of nine depressive symptoms in the last 7 days.	Time 1: 8-16 weeks
Quick Inventory of Depressive Symptoms	We will use the Quick Inventory of Depressive Symptoms (QIDS). The QIDS includes 16 items that capture the severity of nine depressive symptoms in the last 7 days.	Time 2: 16-24 weeks
Quick Inventory of Depressive Symptoms	We will use the Quick Inventory of Depressive Symptoms (QIDS). The QIDS includes 16 items that capture the severity of nine depressive symptoms in the last 7 days.	Time 3: 24-32 weeks
Total Family Problems Score	The Systematic Clinical Outcome Routine Evaluation (SCORE-15) Index of Family Functioning and Change is a 15-item, self-administered instrument that assesses family problems and includes subscales for family strengths, family difficulties, and family communication. Each item is rated on a 5-point scale where 1 = Describes us: Very well and 5 = Describes us: Not at all. The scores from all individual items can be added together into a total family problem score.	Time 2: 8-16 weeks
Total Family Problems Score	The Systematic Clinical Outcome Routine Evaluation (SCORE-15) Index of Family Functioning and Change is a 15-item, self-administered instrument that assesses family problems and includes subscales for family strengths, family difficulties, and family communication. Each item is rated on a 5-point scale where 1 = Describes us: Very well and 5 = Describes us: Not at all. The scores from all individual items can be added together into a total family problem score.	Time 3: 16-24 weeks
Total Family Problems Score	The Systematic Clinical Outcome Routine Evaluation (SCORE-15) Index of Family Functioning and Change is a 15-item, self-administered instrument that assesses family problems and includes subscales for family strengths, family difficulties, and family communication. Each item is rated on a 5-point scale where 1 = Describes us: Very well and 5 = Describes us: Not at all. The scores from all individual items can be added together into a total family problem score.	Time 4: 24-32 weeks

Collaborators and Investigators

• Sponsor: VISN 17 Center of Excellence
• Collaborators: United States Department of Defense; University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1770023-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)).
• IPD Sharing 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.
• IPD Sharing Access Criteria: Per NIMH NDA in addition Data access requires sponsorship by an Institution on behalf of Recipient
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No