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Not yet recruiting NCT06900465

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

No phase Interventional Emotional and Behavioral Disorders in Children and Adolescents

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA).
Who it may be relevant to
Registry conditions: Emotional and Behavioral Disorders in Children and Adolescents. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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 behavior

Primary outcome measures

  • Caregiver burden [Time frame: Baseline (T0) and 3 months (T1)]
Secondary outcome measures (12)
  • Caregiver burden [Time frame: Baseline (T0) and 6 months (T2)]
  • Caregiver burden [Time frame: Baseline (T0) and 9 months (T3)]
  • Depression [Time frame: Baseline (T0) and 3 months (T1)]
  • Depression [Time frame: Baseline (T0) and 6 months (T2)]
  • Depression [Time frame: Baseline (T0) and 9 months (T3)]
  • Anxiety [Time frame: Baseline (T0) and 3 months (T1)]
  • Anxiety [Time frame: Baseline (T0) and 6 months (T2)]
  • Anxiety [Time frame: Baseline (T0) and 9 months (T3)]
  • Illness perception [Time frame: Baseline (T0) and 3 months (T1)]
  • Illness perception [Time frame: Baseline (T0) and 6 months (T2)]
  • Illness perception [Time frame: Baseline (T0) and 9 months (T3)]
  • Coping style [Time frame: Baseline (T0) and 3 months (T1)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Mental Health Center — Shanghai

Identifiers

NCT: NCT06900465 · 2023-73

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗