Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China

Обзор

The goal of this waitlist-controlled randomized pilot trial is to premilinariliy learn if the CPG-CA internvention, a group psychoeducational intervention for family caregivers of children and adolescents with emotional and behavioral disorders, works to relieve caregiver burden among family caregivers of children and adolescents with emotional and behavioral disorders in China. It will also learn about the acceptability of the CPG-CA intervention. The main questions it aims to answer are: Does the CPG-CA intervention relieve caregiver burden among family caregivers of children and adolescents with emotional and behavioral disorders in China? Is the CPG-CA intervention acceptable to family caregivers of children and adolescents with emotional and behavioral disorders in China? Researchers will compare the CPG-CA intervention to care-as-usual to see if the CPG-CA internvention works to relieve caregiver burden among family caregivers of children and adolescents with emotional and behavioral disorders in China. Participants will receive the CPG-CA intervention or care-as-usual for 12 weeks.

Подробное описание

In China, most children and adolescents with emotional and behavioral disorders (E/BDs) are living with families. With an extreme scarcity of child and adolescent mental health care resources in China, the primary caregiving responsibility for children and adolescents with E/BDs is laid on families. However, caregiving for children and adolescents with E/BDs could be challenging, and family caregivers of children and adolescents with E/BDs often describe their caregiving experiences as exhausting and burdensome.

To date, very few interventions in China have been designed to relieve caregiver burden among family caregivers of children and adolescents with E/BDs. Therefore, this study aims to conduct a randomized, wait-list controlled pilot trial to preliminarily evaluate the feasibility and effectiveness of the CPG-CA intervention, a group psychoeducational intervention for family caregivers of children and adolescents with E/BDs, in reducing caregiver burden among family caregivers of children and adolescents with E/BDs in China. This pilot trial will lay the groundwork for a major trial that will be conducted in future studies.

Вмешательства

• Поведенческое Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)
  The CPG-CA intervention is a group psychoeducational internvention for family caregivers of children and adolescents with E/BDs in China. It will consist of 10 to 15 family caregivers of children and adolescents with E/BDs, meeting once a week for 1.5 to 2 hours per session, for a total of 12 sessions over a 3-month period. The sessions will cover the following themes: (1) knowledge about child and adolescent emotional and behavioral disorders; (2) coping skills for common emotional and behavior

Первичные конечные точки

• Caregiver burden [Срок оценки: Baseline (T0) and 3 months (T1)]

Вторичные конечные точки (12)

• Caregiver burden [Срок оценки: Baseline (T0) and 6 months (T2)]
• Caregiver burden [Срок оценки: Baseline (T0) and 9 months (T3)]
• Depression [Срок оценки: Baseline (T0) and 3 months (T1)]
• Depression [Срок оценки: Baseline (T0) and 6 months (T2)]
• Depression [Срок оценки: Baseline (T0) and 9 months (T3)]
• Anxiety [Срок оценки: Baseline (T0) and 3 months (T1)]
• Anxiety [Срок оценки: Baseline (T0) and 6 months (T2)]
• Anxiety [Срок оценки: Baseline (T0) and 9 months (T3)]
• Illness perception [Срок оценки: Baseline (T0) and 3 months (T1)]
• Illness perception [Срок оценки: Baseline (T0) and 6 months (T2)]
• Illness perception [Срок оценки: Baseline (T0) and 9 months (T3)]
• Coping style [Срок оценки: Baseline (T0) and 3 months (T1)]

Критерии участия

Критерии включения

• Family caregivers of children and adolescents under the age of 18 with emotional and behavioral disorders;
• The child or adolescent must have a confirmed diagnosis of an emotional or behavioral disorder, including: emotional and behavioral disorders with onset usually occurring in childhood and adolescence, mood disorders, depressive disorders, bipolar disorder, anxiety disorders, attention-deficit/hyperactivity disorder (ADHD), conduct disorder, oppositional defiant disorder, obsessive-compulsive disorder (OCD), eating disorders, schizophrenia, and addictive disorders;
• Providing care for a child or adolescent with an emotional or behavioral disorder for at least three months;
• Aged 18 or older;
• Able to provide informed consent.

Критерии исключения

• Caregivers of children and adolescents with neurodevelopmental disorders (e.g., autism, intellectual disability);
• Paid caregivers;
• Caregivers with severe physical illnesses or mental disorders;
• Caregivers under the age of 18;
• Those unable to provide informed consent;
• Caregivers who are simultaneously participating in other support groups for family caregivers of children and adolescents with emotional and behavioral disorders.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Mental Health Center — Шанхай

Идентификаторы

NCT: NCT06900465 · 2023-73

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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