Emotional and Behavioral Disorders in Children and AdolescentsNCT06900465
Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China
A study testing Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA) in people with Emotional and Behavioral Disorders in Children and Adolescents, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional and Behavioral Disorders in Children and Adolescents
- What is being tested?
- Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Hao Yao, MD, MPH, +86 18817301628, haoyao@vip.163.com
About this study
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?
Read more
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.
Read the 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.
- Being tested
- Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)
- Keywords
- Pilot trial, Emotional and behavioral disorder, Child and adolescent, Psychoeducation, China, Psychosocial intervention, Caregiver
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will first receive the CPG-CA intervention. Receives: Behavioral: Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA) |
| Waitlist control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden
Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
Measured: Baseline (T0) and 3 months (T1)
Secondary outcomes (29)
Caregiver burden
Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
Measured: Baseline (T0) and 6 months (T2)
Caregiver burden
Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
Measured: Baseline (T0) and 9 months (T3)
Depression
Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).
Measured: Baseline (T0) and 3 months (T1)
Depression
Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).
Measured: Baseline (T0) and 6 months (T2)
Depression
Participants' depression will be assessed using the Patient Health Questionnaire (PHQ).
Measured: Baseline (T0) and 9 months (T3)
Anxiety
Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).
Measured: Baseline (T0) and 3 months (T1)
Anxiety
Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).
Measured: Baseline (T0) and 6 months (T2)
Anxiety
Participants' anxiety will be assessed using the Generalized Anxiety Disorder Scale (GAD).
Measured: Baseline (T0) and 9 months (T3)
Illness perception
Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).
Measured: Baseline (T0) and 3 months (T1)
Illness perception
Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).
Measured: Baseline (T0) and 6 months (T2)
Illness perception
Participants' illness perception will be assessed using the Brief Illness Perception Questionnaire (BIPQ).
Measured: Baseline (T0) and 9 months (T3)
Coping style
Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).
Measured: Baseline (T0) and 3 months (T1)
Coping style
Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).
Measured: Baseline (T0) and 6 months (T2)
Coping style
Participants' coping style will be assessed using the Simplified Coping Style Questionnaire (SCSQ).
Measured: Baseline (T0) and 9 months (T3)
Social support
Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).
Measured: Baseline (T0) and 3 months (T1)
Social support
Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).
Measured: Baseline (T0) and 6 months (T2)
Social support
Participants' social support will be assessed using the Oslo Social Support Scale (OSSS).
Measured: Baseline (T0) and 9 months (T3)
Positive caregiving experiences
Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).
Measured: Baseline (T0) and 3 months (T1)
Positive caregiving experiences
Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).
Measured: Baseline (T0) and 6 months (T2)
Positive caregiving experiences
Participants' positive caregiving experiences will be assessed using the Positive Aspect of Caregiving scale (PAC).
Measured: Baseline (T0) and 9 months (T3)
Feeling of hope
Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).
Measured: Baseline (T0) and 3 months (T1)
Feeling of hope
Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).
Measured: Baseline (T0) and 6 months (T2)
Feeling of hope
Participants' feeling of hope will be assessed using the Herth Hope Index (HHI).
Measured: Baseline (T0) and 9 months (T3)
Feeling of mastery
Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).
Measured: Baseline (T0) and 3 months (T1)
Feeling of mastery
Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).
Measured: Baseline (T0) and 6 months (T2)
Feeling of mastery
Participants' feeling of mastery will be assessed using the Pearlin Mastery Scale (PMS).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (T0) and 9 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional and Behavioral Disorders in Children and AdolescentsStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a waitlist-controlled randomized pilot trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao YAO, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900465
- Sponsor's protocol ID
- 2023-73
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect participants' privacy, IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of a Psychoeducation Group for Family Caregivers of Children and Adolescents With Emotional and Behavioral Disorders (CPG-CA) in China
- ClinicalTrials.gov ID
- NCT06900465
- Acronym / sponsor ID
- 2023-73
- Keywords
- Pilot trial, Emotional and behavioral disorder, Child and adolescent, Psychoeducation, China, Psychosocial intervention, Caregiver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a waitlist-controlled randomized pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA)The intervention group will first receive the CPG-CA intervention. |
| Waitlist control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention group |
Primary outcome
Caregiver burden
Time frame: Baseline (T0) and 3 months (T1)
Participants' caregiver burden will be assessed using the Zarit Burden Interview (ZBI).
29 secondary outcomes
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)
Coping style
Time frame: Baseline (T0) and 6 months (T2)
Coping style
Time frame: Baseline (T0) and 9 months (T3)
Social support
Time frame: Baseline (T0) and 3 months (T1)
Social support
Time frame: Baseline (T0) and 6 months (T2)
Social support
Time frame: Baseline (T0) and 9 months (T3)
Positive caregiving experiences
Time frame: Baseline (T0) and 3 months (T1)
Positive caregiving experiences
Time frame: Baseline (T0) and 6 months (T2)
Positive caregiving experiences
Time frame: Baseline (T0) and 9 months (T3)
Feeling of hope
Time frame: Baseline (T0) and 3 months (T1)
Feeling of hope
Time frame: Baseline (T0) and 6 months (T2)
Feeling of hope
Time frame: Baseline (T0) and 9 months (T3)
Feeling of mastery
Time frame: Baseline (T0) and 3 months (T1)
Feeling of mastery
Time frame: Baseline (T0) and 6 months (T2)
Feeling of mastery
Time frame: Baseline (T0) and 9 months (T3)
Self-stigma
Time frame: Baseline (T0) and 3 months (T1)
Self-stigma
Time frame: Baseline (T0) and 6 months (T2)
Self-stigma
Time frame: Baseline (T0) and 9 months (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. In order to protect participants' privacy, IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Psychoeducation Group for Children and Adolescents with Emotional and Behavioral Disorders (CPG-CA) in people with Emotional and Behavioral Disorders in Children and Adolescents, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Yao, MD, MPH (+86 18817301628, haoyao@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver burden (time frame: Baseline (T0) and 3 months (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.