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

Not Applicable

Not yet recruiting

• Conditions: Emotional and Behavioral Disorders in Children and Adolescents

• Registration Number: NCT06900465
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-06-01
• Primary Completion: 2025-10-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Caregiver burden	Baseline (T0) and 3 months (T1)	Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).

Secondary Outcome Measures

Name	Time	Method
Coping style	Baseline (T0) and 9 months (T3)	Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).
Social support	Baseline (T0) and 9 months (T3)	Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).
Positive caregiving experiences	Baseline (T0) and 9 months (T3)	Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).
Feeling of mastery	Baseline (T0) and 9 months (T3)	Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).
Feeling of hope	Baseline (T0) and 9 months (T3)	Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).
Self-stigma	Baseline (T0) and 9 months (T2)	Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).
Caregiver burden	Baseline (T0) and 9 months (T3)	Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
Depression	Baseline (T0) and 9 months (T3)	Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).
Anxiety	Baseline (T0) and 9 months (T3)	Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).
Illness perception	Baseline (T0) and 9 months (T3)	Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China