Strength at Home - Parents RCT

Parent-Child Relations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06309329
• Other study ID #: 1770023-2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: May 2029

Study information

• Verified date: April 2024
• Source: VISN 17 Center of Excellence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: May 2029
• Est. primary completion date: May 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Parent-Child Relations

Intervention

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
• VA treatment as usual
VA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting .

Locations

Country	Name	City	State
United States	Central Texas Veterans Healthcare System	Temple	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VISN 17 Center of Excellence	United States Department of Defense, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

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