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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Emotional and Behavioral Disorders in Children and Adolescents
• Intervention / Treatment: Behavioral: Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Yao, MD, MPH; Phone Number: +86 18817301628; Email: haoyao@vip.163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center
      • Contact: Hao Yao, MD, MPH; Phone Number: +86 18817301628; Email: haoyao@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will first receive the CPG-CA intervention.	Behavioral: 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 behavioral problems in children and adolescents; (3) problem-solving skills; (4) communication skills with children and adolescents; (5) positive parenting techniques; and (6) self-care techniques. A variety of facilitation techniques will be used in the intervention, including didactic teaching, group discussion, role-playing, and homework assignment.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver burden	Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).	Baseline (T0) and 6 months (T2)
Caregiver burden	Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).	Baseline (T0) and 9 months (T3)
Depression	Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).	Baseline (T0) and 3 months (T1)
Depression	Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).	Baseline (T0) and 6 months (T2)
Depression	Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).	Baseline (T0) and 9 months (T3)
Anxiety	Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).	Baseline (T0) and 3 months (T1)
Anxiety	Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).	Baseline (T0) and 6 months (T2)
Anxiety	Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).	Baseline (T0) and 9 months (T3)
Illness perception	Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).	Baseline (T0) and 3 months (T1)
Illness perception	Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).	Baseline (T0) and 6 months (T2)
Illness perception	Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).	Baseline (T0) and 9 months (T3)
Coping style	Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).	Baseline (T0) and 3 months (T1)
Coping style	Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).	Baseline (T0) and 6 months (T2)
Coping style	Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).	Baseline (T0) and 9 months (T3)
Social support	Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).	Baseline (T0) and 3 months (T1)
Social support	Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).	Baseline (T0) and 6 months (T2)
Social support	Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).	Baseline (T0) and 9 months (T3)
Positive caregiving experiences	Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).	Baseline (T0) and 3 months (T1)
Positive caregiving experiences	Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).	Baseline (T0) and 6 months (T2)
Positive caregiving experiences	Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).	Baseline (T0) and 9 months (T3)
Feeling of hope	Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).	Baseline (T0) and 3 months (T1)
Feeling of hope	Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).	Baseline (T0) and 6 months (T2)
Feeling of hope	Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).	Baseline (T0) and 9 months (T3)
Feeling of mastery	Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).	Baseline (T0) and 3 months (T1)
Feeling of mastery	Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).	Baseline (T0) and 6 months (T2)
Feeling of mastery	Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).	Baseline (T0) and 9 months (T3)
Self-stigma	Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).	Baseline (T0) and 3 months (T1)
Self-stigma	Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).	Baseline (T0) and 6 months (T2)
Self-stigma	Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).	Baseline (T0) and 9 months (T2)

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: China; Caregiver; Psychoeducation; Pilot trial; Psychosocial intervention; Emotional and behavioral disorder; Child and adolescent
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 2023-73

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to protect participants' privacy, IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No