Strength at Home - Parents RCT

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Parenting Stress Index total score [Срок оценки: Time 2: 8-16 weeks]
• Parenting Stress Index total score [Срок оценки: Time 3: 16-24 weeks]
• Parenting Stress Index total score [Срок оценки: Time 4: 24-32 weeks]

Вторичные конечные точки (6)

• Laxness subscale on the Parenting Scale [Срок оценки: Time 2: 8-16 weeks]
• Laxness subscale on the Parenting Scale [Срок оценки: Time 3: 16-24 weeks]
• Laxness subscale on the Parenting Scale [Срок оценки: Time 4: 24-32 weeks]
• Over reactivity subscale on the Parenting scale [Срок оценки: Time 2: 8-16 weeks]
• Over reactivity subscale on the Parenting scale [Срок оценки: Time 3: 16-24 weeks]
• Over reactivity subscale on the Parenting scale [Срок оценки: Time 4: 24-32 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

Major neurocognitive disorder likely to impact comprehension of material, including severe TBI .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Central Texas Veterans Healthcare System — Temple

Идентификаторы

NCT: NCT06309329 · 1770023-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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