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NCT Number: NCT06900465

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.

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Key information

Conditions

Emotional and Behavioral Disorders in Children and Adolescents Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)

Behavioral

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.

Primary outcomes

  1. Caregiver burden

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).

Secondary outcomes

  1. Caregiver burden

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).

  2. Caregiver burden

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).

  3. Depression

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).

  4. Depression

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).

  5. Depression

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).

  6. Anxiety

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).

  7. Anxiety

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).

  8. Anxiety

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).

  9. Illness perception

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).

  10. Illness perception

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).

  11. Illness perception

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).

  12. Coping style

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).

  13. Coping style

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).

  14. Coping style

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).

  15. Social support

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).

  16. Social support

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).

  17. Social support

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).

  18. Positive caregiving experiences

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).

  19. Positive caregiving experiences

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).

  20. Positive caregiving experiences

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).

  21. Feeling of hope

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).

  22. Feeling of hope

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).

  23. Feeling of hope

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).

  24. Feeling of mastery

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).

  25. Feeling of mastery

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).

  26. Feeling of mastery

    Time frame: Baseline (T0) and 9 months (T3)

    Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).

  27. Self-stigma

    Time frame: Baseline (T0) and 3 months (T1)

    Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).

  28. Self-stigma

    Time frame: Baseline (T0) and 6 months (T2)

    Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).

  29. Self-stigma

    Time frame: Baseline (T0) and 9 months (T2)

    Participants' self-stigma will be assessed using the stigma sub-scale of the Experiences of Caregiving Inventory (ECI).

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Yao, MD, MPH

CONTACT

[email protected]

+86 18817301628

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 28, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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