Clinical trial NCT06900465: Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China
Official title: Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional and Behavioral Disorders in Children and Adolescents
Keywords: Pilot trial
Emotional and behavioral disorder
Child and adolescent
Psychoeducation
China
Psychosocial intervention
Caregiver
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study will be a waitlist-controlled randomized pilot trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Family caregivers of children and adolescents under the age of 18 with emotional and behavioral disorders;
2. 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;
3. Providing care for a child or adolescent with an emotional or behavioral disorder for at least three months;
4. Aged 18 or older;
5. Able to provide informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Caregiver burden
timeFrame: Baseline (T0) and 3 months (T1)
Secondary outcomes:
measure: Caregiver burden
timeFrame: Baseline (T0) and 6 months (T2)
measure: Caregiver burden
timeFrame: Baseline (T0) and 9 months (T3)
measure: Depression
timeFrame: Baseline (T0) and 3 months (T1)
measure: Depression
timeFrame: Baseline (T0) and 6 months (T2)
measure: Depression
timeFrame: Baseline (T0) and 9 months (T3)
measure: Anxiety
timeFrame: Baseline (T0) and 3 months (T1)
measure: Anxiety
timeFrame: Baseline (T0) and 6 months (T2)
measure: Anxiety
timeFrame: Baseline (T0) and 9 months (T3)
measure: Illness perception
timeFrame: Baseline (T0) and 3 months (T1)
measure: Illness perception
timeFrame: Baseline (T0) and 6 months (T2)
measure: Illness perception
timeFrame: Baseline (T0) and 9 months (T3)
measure: Coping style
timeFrame: Baseline (T0) and 3 months (T1)
measure: Coping style
timeFrame: Baseline (T0) and 6 months (T2)
measure: Coping style
timeFrame: Baseline (T0) and 9 months (T3)
measure: Social support
timeFrame: Baseline (T0) and 3 months (T1)
measure: Social support
timeFrame: Baseline (T0) and 6 months (T2)
measure: Social support
timeFrame: Baseline (T0) and 9 months (T3)
measure: Positive caregiving experiences
timeFrame: Baseline (T0) and 3 months (T1)
measure: Positive caregiving experiences
timeFrame: Baseline (T0) and 6 months (T2)
measure: Positive caregiving experiences
timeFrame: Baseline (T0) and 9 months (T3)
measure: Feeling of hope
timeFrame: Baseline (T0) and 3 months (T1)
measure: Feeling of hope
timeFrame: Baseline (T0) and 6 months (T2)
measure: Feeling of hope
timeFrame: Baseline (T0) and 9 months (T3)
measure: Feeling of mastery
timeFrame: Baseline (T0) and 3 months (T1)
measure: Feeling of mastery
timeFrame: Baseline (T0) and 6 months (T2)
measure: Feeling of mastery
timeFrame: Baseline (T0) and 9 months (T3)
measure: Self-stigma
timeFrame: Baseline (T0) and 3 months (T1)
measure: Self-stigma
timeFrame: Baseline (T0) and 6 months (T2)
measure: Self-stigma
timeFrame: Baseline (T0) and 9 months (T2)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References: