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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| University of Texas at Austin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength at Home Parents | Experimental |
| |
| VA treatment as usual | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength at Home Parents | Behavioral | 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 |
| 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 |
| 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 |
| 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 |
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 .
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Texas Veterans Healthcare System | Temple | Texas | 76504 | United States |
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)).
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.
Per NIMH NDA in addition Data access requires sponsorship by an Institution on behalf of Recipient
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| VA treatment as usual | Behavioral | VA treatment as usual includes referral to the online resources at veterantraining.va.gov/parenting . |
|
| 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 |
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 |