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Enrolling by Invitation

NCT Number: NCT06309329

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.

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Key information

Conditions

Parent-Child Relations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Texas Veterans Healthcare System

Temple, Texas, 76504, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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

VA treatment as usual

Behavioral

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

Primary outcomes

  1. Parenting Stress Index total score

    Time frame: Time 2: 8-16 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.

  2. Parenting Stress Index total score

    Time frame: Time 3: 16-24 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.

  3. Parenting Stress Index total score

    Time frame: 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 outcomes

  1. Laxness subscale on the Parenting Scale

    Time frame: Time 2: 8-16 weeks

    The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline

  2. Laxness subscale on the Parenting Scale

    Time frame: Time 3: 16-24 weeks

    The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline

  3. Laxness subscale on the Parenting Scale

    Time frame: Time 4: 24-32 weeks

    The laxness scale is comprised of 11 items measuring permissive, inconsistent discipline

  4. Over reactivity subscale on the Parenting scale

    Time frame: Time 2: 8-16 weeks

    The over reactivity scale (10 items) measures use of emotional, harsh discipline

  5. Over reactivity subscale on the Parenting scale

    Time frame: Time 3: 16-24 weeks

    The over reactivity scale (10 items) measures use of emotional, harsh discipline

  6. Over reactivity subscale on the Parenting scale

    Time frame: Time 4: 24-32 weeks

    The over reactivity scale (10 items) measures use of emotional, harsh discipline

Other outcomes

  1. PTSD Symptom Checklist score

    Time frame: Time 2: 8-16 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.

  2. PTSD Symptom Checklist score

    Time frame: Time 3: 16-24 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.

  3. PTSD Symptom Checklist score

    Time frame: 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.

  4. Quick Inventory of Depressive Symptoms

    Time frame: Time 1: 8-16 weeks

    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.

  5. Quick Inventory of Depressive Symptoms

    Time frame: Time 2: 16-24 weeks

    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.

  6. Quick Inventory of Depressive Symptoms

    Time frame: Time 3: 24-32 weeks

    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.

  7. Total Family Problems Score

    Time frame: Time 2: 8-16 weeks

    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.

  8. Total Family Problems Score

    Time frame: Time 3: 16-24 weeks

    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.

  9. Total Family Problems Score

    Time frame: Time 4: 24-32 weeks

    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.

Sponsors and collaborators

Lead sponsor

VISN 17 Center of Excellence

Fed

Collaborators

  • United States Department of Defense
  • University of Texas at Austin

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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