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Emotional DisorderNCT07138417

Compassion-Based Family Intervention for Adolescents

A study testing Compassion-Based Family Intervention in people with Emotional Disorder, run by Beijing HuiLongGuan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Adolescents with emotional disorders often experience psychological distress that may also affect their parents, creating bidirectional stress within the family. This randomized waitlist-controlled trial will evaluate a 6-week compassion-based family intervention involving adolescents and their parents. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Emotional Disorder
What is being tested?
Compassion-Based Family Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Aug 2025to Jul 2027
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • the adolescent is aged 12-18 years
  • for the adolescent, required scores at enrollment: at least one of the following criteria is met (i) 17-item Hamilton Depression Rating Scale (HAMD-17) (Hamilton, 1960) total score ≥17 and ≤30, (ii) Hamilton Anxiety Rating Scale (HAMA) (Hamilton, 1959) total score ≥18 and ≤29; and in addition, the HAMD-17 item 3 (suicide) score must be ≤ 2
  • at least one parent is willing to participate
  • the adolescent has normal auditory and visual perception abilities and intellectual functioning
  • the participating parent has normal reading and writing ability
  • the adolescent has no history of manic episodes

Who cannot join

  • the adolescent presents with psychotic symptoms, bipolar disorder, or schizophrenia
  • the parent suffers from a mental illness or psychological disorder
  • the adolescent or their parent has a history of substance abuse
  • the adolescent or their parent has a severe neurological disorder or major physical disease
  • the adolescent or their parent is assessed as having high suicide risk

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongmei Wang, Ph.D contact

+86 132 4190 1959

wangdm@psych.ac.cn

China1 site, 1 recruiting
  • Hefei Fourth People's Hospital (Anhui Mental Health Center; Affiliated Psychological Hospital of Anhui Medical University)

    Hefei, Anhui, 230022

    Xiangyang Zhang, Ph.D, 86-10-62710644, zhangxy99@mail.tsinghua.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Compassion-Based Family Intervention for Adolescents With Emotional Disorders and Their Parents: A Randomized Waitlist-Controlled Trial

Adolescents with emotional disorders often experience psychological distress that may also affect their parents, creating bidirectional stress within the family. This randomized waitlist-controlled trial will evaluate a 6-week compassion-based family intervention involving adolescents and their parents. A total of 60 parent-adolescent dyads will be randomly assigned to either an intervention group or a waitlist control group. The primary outcomes are adolescents' depressive and anxiety symptoms. Secondary outcomes include broader psychological and family-related measures. Parent-child neural and physiological synchrony will also be explored using fNIRS hyperscanning and wearable devices. Assessments will be conducted at baseline, post-intervention, and 3-month and 6-month follow-ups.

Read the detailed description

This is a parallel-group, randomized waitlist-controlled trial with a 1:1 allocation ratio. A total of 60 parent-adolescent dyads, including adolescents aged 12-18 years with emotional disorders and one participating parent, will be recruited from the Fourth People's Hospital of Hefei, China. After baseline assessment, dyads will be randomly assigned to either the intervention group (IG) or the waitlist control group (WL) using a computer-generated randomization sequence (SAS 9.4 PROC PLAN). The allocation sequence will be prepared by an independent researcher who is not involved in participant recruitment, enrollment, intervention delivery, or outcome assessment. Participants will not be explicitly informed of their group allocation; however, complete participant blinding cannot be guaranteed because the timing of intervention initiation differs between groups. Outcome assessors will remain blinded to group allocation.

The IG will receive a 6-week compassion-based family intervention consisting of weekly 120-minute sessions. The program includes separate sessions for parents and adolescents during the first three weeks and joint family sessions during the final three weeks. The WL will receive no study intervention during the 6-week waiting period and will subsequently receive the same intervention.

Assessments will be conducted at baseline, post-intervention, and 3-month and 6-month follow-ups. The primary outcomes are adolescents' depressive symptoms, assessed using the Children's Depression Inventory (CDI), and anxiety symptoms, assessed using the Beck Anxiety Inventory (BAI). Secondary outcomes include compassion-related, parenting, parent-child relationship, emotional, and other family-related psychological measures. Parent-child neural and physiological synchrony assessed using fNIRS hyperscanning and wearable devices will be examined as exploratory mechanistic outcomes.

Primary efficacy analyses will follow the intention-to-treat principle and compare changes from baseline to post-intervention between the IG and WL using linear mixed models. Bonferroni correction will be applied across the two primary outcomes, while the Benjamini-Hochberg false discovery rate procedure will be used for secondary outcomes. Follow-up analyses will examine the maintenance of intervention-related changes, and fNIRS and HRV outcomes will be analyzed separately as exploratory outcomes with correction for multiple comparisons.

The study has been approved by the Ethics Committee of the Institute of Psychology, Chinese Academy of Sciences (approval number H25123).

Being tested
Compassion-Based Family Intervention
Keywords
Emotional disorder, adolescents, compassion, parents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion-Based Family InterventionOther

    A 6-week program (120 minutes weekly) combining theoretical content and group activities, with additional home practice (emotion diaries and meditation). Content focuses on cultivating self-compassion and compassion for others, developing inward awareness and outward observation, improving perspective-taking and communication skills, and managing conflict within the family. Weekly themes: Week 1 "Setting Sail Together, Understanding Love in Thought and Action"; Week 2 "Inward Awareness, Resonance of Body and Mind"; Week 3 "Outward Observation, Seeing One Another Clearly"; Week 4 "Shifting Perspectives, Bridging Boundaries"; Week 5 "Perspective-Taking, Managing Conflict"; Week 6 "Harnessing Compassion, Bringing Love Home."

Study groups in NCT07138417
Study groupRoleWhat they receive
Compassion-based family intervention groupExperimentalParticipants receive a 6-week compassion-based family intervention (one 120-min session per week).
Receives: Other: Compassion-Based Family Intervention
Waiting list control groupNo interventionParticipants receive no intervention during the 6-week waiting period and then receive the same intervention after the waiting period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Children's depression levels

    Children's depression levels will be assessed using the Children's Depression Inventory (CDI). The total score of 27 items will be calculated, with each item scored from 0 to 2. Higher scores indicate more severe depressive symptoms.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  2. Children's anxiety levels

    Children's anxiety levels will be assessed using the Beck Anxiety Inventory (BAI). The total score of 21 items will be calculated, with each item scored from 0 to 3. Higher scores indicate more severe anxiety.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

Secondary outcomes (13)
  1. Self-Compassion

    The self-compassion levels of both parents and adolescents will be assessed using the Self-Compassion Scale (SCS). The mean score (ranging from 1 to 5 per item) will be calculated. Higher scores indicate greater self-compassion.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  2. Fears of Compassion

    The fear of compassion levels of both parents and adolescents will be assessed using the Fears of Compassion Scales (FCS). The total score of the three subscales (ranging from 0 to 4 per item) of Fear of Compassion for Self, Fear of Compassion for Others, and Fear of Receiving Compassion from Others will be calculated. Higher scores indicate greater fear of compassion.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  3. Perceived emotional synchrony

    The emotional synchrony of both parents and adolescents will be assessed using the Perceived Emotional Synchrony Scale (PESS). The mean score of the two subscales (ranging from 1 to 7 per item) of Emotional Communion and Felt Unity will be calculated. Higher scores indicate greater perceived emotional synchrony.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  4. Parenting stress

    Parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF). The total score of 36 items will be calculated, with each item scored from 1 to 5. Higher scores indicate greater parenting stress.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  5. Parenting styles

    Parenting styles will be assessed using the Parenting Scale-7 (PS-7) and the Egna Minnen Beträffande Uppfostran (EMBU), Swedish for "My Memories of Upbringing", from the perspectives of parents and adolescents, respectively. For the PS-7, the mean score (ranging from 1 to 7 per item) will be calculated. Lower scores indicate better parenting behavior. For the EMBU, the total scores of the subscales Rejection, Emotional Warmth, and Overprotection will be calculated. Higher Rejection and Overprotection scores indicate worse outcomes, whereas higher Emotional Warmth scores indicate better outcomes.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  6. Parent-child relationships

    The parent-child relationship will be assessed using Child-Parent Relationship Scale, 30-item version (CPRS-30) and the Remembered Relationship with Parents, 10-item scale (RRP-10) from the perspectives of parents and adolescents, respectively. For the CPRS-30, the mean scores of the three subscales (ranging from 1 to 5 per item) for Closeness, Conflict, and Dependence will be calculated. Higher Closeness indicates a better relationship, whereas higher Conflict and higher Dependence indicate worse outcomes. For the RRP-10, the total score of the 10 items (ranging from 0 to 4 per item) will be calculated. Higher scores indicate more negative remembered relationships with parents.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  7. Parental Burnout

    Parental burnout will be assessed using the Parental Burnout Assessment (PBA). The total score of the 23 items (ranging from 0 to 6 per item) including four dimensions (exhaustion in one's parental role, contrast with previous parental self, feelings of being fed up with one's parental role, and emotional distancing from one's children) will be calculated. Higher scores indicate greater parental burnout.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  8. Parental self-stigmatization

    Parental self-stigmatization will be assessed using the Self-Stigma in Relatives of people with Mental Illness Scale (SSRMI). The mean score of the 30 items (ranging from 1 to 5 per item) will be calculated. Higher scores indicate greater self-stigma among parents.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  9. Perceived Criticism

    The parent's perceived criticism will be assessed using the Perceived Criticism Measure (PCM). The PCM criticism item is rated on a scale ranging from 1 (not at all) to 10 (very critical). Higher scores indicate greater perceived criticism.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  10. Adolescents' expressed emotion

    The expressed emotion of adolescents will be assessed using the Concise Chinese Level of Expressed Emotion Scale (CCLEES). The mean score of the 12 items (ranging from 1 to 4 per item) will be calculated. Higher scores indicate higher expressed emotion.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  11. Family Expressiveness

    The family expressiveness of both parents and adolescents will be assessed using the Family Expressiveness Questionnaire (FEQ). The mean score of the 20 items (ranging from 1 to 9 per item) will be calculated. Higher scores indicate more frequent family emotional expressiveness; when reporting Positive and Negative Expressiveness subscales, higher Positive Expressiveness scores are considered better, whereas higher Negative Expressiveness scores are considered worse.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  12. Emotion Regulation

    The emotion regulation of both parents and adolescents will be assessed using the Emotion Regulation Questionnaire-Short Form (ERQ-S), a 6-item version. The mean score of the two subscales (ranging from 1 to 7 per item) of Cognitive Reappraisal (4 items) and Expressive Suppression (2 items) will be calculated. Higher Cognitive Reappraisal scores indicate more frequent use of cognitive reappraisal, whereas higher Expressive Suppression scores indicate more frequent use of expressive suppression.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

  13. Nonclinging to Ego

    Nonclinging to ego in both parents and adolescents will be assessed using the Nonclinging to Ego Scale (NCES). The total score of the 33 items (ranging from 1 to 6 per item) will be calculated. Higher scores indicate greater nonattachment to self.

    Measured: baseline, immediately after the intervention, and 3, 6 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start30 Aug 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07138417
Sponsor's protocol ID
CASPsy8
Status last verified
Sep 2025
First submitted
30 Jul 2025
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The datasets generated and/or analyzed during the current study are not publicly available due to ethical restrictions (as they contain information that could compromise participant privacy), but will be available from the corresponding author upon reasonable request after completion of the study and approval by the ethics committee.

Questions about this trial

What is this clinical trial studying?

A study testing Compassion-Based Family Intervention in people with Emotional Disorder, run by Beijing HuiLongGuan Hospital 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. 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 Dongmei Wang, Ph.D (+86 132 4190 1959, wangdm@psych.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's depression levels (time frame: baseline, immediately after the intervention, and 3, 6 month follow-up). The study lists 2 primary outcomes in all. 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 30 Sep 2026.

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