Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Caregiver burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
The intervention group will first receive the CPG-CA intervention.
干预措施: Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA) (Behavioral)
Waitlist control group
The waitlist control group will receive the CPG-CA intervention after the intervention group. During the waiting period, the waitlist control group will receive care as usual.
结局指标
主要结局
Caregiver burden
时间窗: Baseline (T0) and 3 months (T1)
Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
次要结局
- Depression(Baseline (T0) and 9 months (T3))
- Coping style(Baseline (T0) and 9 months (T3))
- Social support(Baseline (T0) and 9 months (T3))
- Positive caregiving experiences(Baseline (T0) and 9 months (T3))
- Feeling of mastery(Baseline (T0) and 9 months (T3))
- Feeling of hope(Baseline (T0) and 9 months (T3))
- Self-stigma(Baseline (T0) and 9 months (T2))
- Caregiver burden(Baseline (T0) and 9 months (T3))
- Anxiety(Baseline (T0) and 9 months (T3))
- Illness perception(Baseline (T0) and 9 months (T3))
- Depression(Baseline (T0) and 3 months (T1))
- Depression(Baseline (T0) and 6 months (T2))
- Anxiety(Baseline (T0) and 3 months (T1))
- Anxiety(Baseline (T0) and 6 months (T2))
- Illness perception(Baseline (T0) and 3 months (T1))
- Caregiver burden(Baseline (T0) and 6 months (T2))
- Illness perception(Baseline (T0) and 6 months (T2))
- Coping style(Baseline (T0) and 3 months (T1))
- Coping style(Baseline (T0) and 6 months (T2))
- Social support(Baseline (T0) and 3 months (T1))
- Social support(Baseline (T0) and 6 months (T2))
- Positive caregiving experiences(Baseline (T0) and 3 months (T1))
- Positive caregiving experiences(Baseline (T0) and 6 months (T2))
- Feeling of hope(Baseline (T0) and 3 months (T1))
- Feeling of hope(Baseline (T0) and 6 months (T2))
- Feeling of mastery(Baseline (T0) and 3 months (T1))
- Feeling of mastery(Baseline (T0) and 6 months (T2))
- Self-stigma(Baseline (T0) and 3 months (T1))
- Self-stigma(Baseline (T0) and 6 months (T2))
研究者
Hao YAO
Attending Psychiatrist
Shanghai Mental Health Center