ACT Dad's Power: Feasibility RCT for Fathers of Children With Special Needs

Официальное название

ACT Dad's Power: A Feasibility Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) for Fathers of Children With Special Needs in Improving Their Psychological Flexibility and Mental Health

Обзор

Objective: (1) To examine the feasibility of proceeding to a future definitive RCT of ACT in Hong Kong Chinese fathers rearing children with special needs. (2) To calculate the effect sizes of the intervention on fathers' psychological flexibility, shame, guilt, and quality of life (QoL) at the 6-month follow-up. (3) To calculate the potential efficacy of the intervention. Methods: A 2-arm feasibility randomised controlled trail will be conducted on 50 fathers of children with special needs. 25 participants will be allocated into the intervention group to attend 6 weekly 45-60 minute sessions of ACT with VR. 25 participants will be allocated to the control group receiving 6 weekly 45-60 minute sessions of health talks and simple social support. Outcome and measurement: Primary outcomes are screening rate, eligibility rate, consent rate, randomization rate, attendance rate, adherence rate, retention rate, completion rate, missing data, and adverse events. Secondary outcomes are the effect sizes and preliminary efficacy of the intervention on psychological flexibility, shame, guilt, depressive symptoms, and QoL at T4. Both groups will be required to fill in a set of questionnaires at the start of intervention (T1), post-intervention (T2), 3 (T3), and 6 months (T4) after the end of intervention. They will also be invited to join semi-structure interviews at T2. Data analysis: Descriptive statistics, mixed between-within-participants analysis of variance, and content analysis will be used.

Вмешательства

• Поведенческое VR-based ACT
  Participants in the intervention group will be invited to attend 6 weekly sessions of ACT with VR. Each session will last approximately 45-60 minutes.
• Поведенческое Health Talks and Simple Social Support
  Participants in the control group will receive 6 weekly sessions of health talks and simple social support to mimic the time and attention spent on the intervention group.

Первичные конечные точки

• Screening rate [Срок оценки: During the recruitment period (up to 10 months)]
• Eligibility rate [Срок оценки: During the recruitment period (up to 10 months)]
• Consent rate [Срок оценки: During the recruitment period (up to 10 months)]
• Randomization rate [Срок оценки: T1 (start of intervention)]
• Attendance rate [Срок оценки: T2 (post-intervention at 6 weeks)]
• Retention rate [Срок оценки: T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)]
• Adherence rate [Срок оценки: T2 (post-intervention at 6 weeks)]
• Complete rate [Срок оценки: T1 (start of intervention) , T2 (post-intervention at 6 weeks), T3 (3 months after intervention), T4 (6 months after intervention)]
• Proportion of missing data [Срок оценки: T4 (6 months after intervention)]
• Adverse events [Срок оценки: T4 (6 months after intervention)]

Вторичные конечные точки (5)

• Psychological flexibility [Срок оценки: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
• Shame [Срок оценки: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
• Guilt [Срок оценки: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
• Depressive symptoms [Срок оценки: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]
• Quality of life (QoL) [Срок оценки: T1 (at the start of intervention), T4 (at 6 months after the end of intervention)]

Критерии участия

Критерии включения

• (1) who are the biological fathers of children aged 2 to 12 years
• (2) with a child having a formal diagnosis of a developmental disability, including autism spectrum disorder, attention deficit/hyperactivity disorder, intellectual disability, or related neurodevelopmental conditions
• (3) who are able to speak Cantonese and read Chinese

Критерии исключения

• (1) who are currently undergoing psychotherapies
• (2) with physical or cognitive impairment and learning problems as identified from NGO or related medical records
• (3) who exhibit a high risk of serious mental illnesses screened using the Kessler Psychological Distress Scale , with a score of ≥13

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07459010 · ACT Dad's Power

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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