ClinicalTrials.gg
RecruitingNCT07138417Updated Sep 30, 2026

Compassion-Based Family Intervention for Adolescents

An interventional study of Compassion-Based Family Intervention in Emotional Disorder, sponsored by Beijing HuiLongGuan Hospital. Recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Beijing HuiLongGuan Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Sep 30, 2026Eligibility revisedPrimary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Emotional Disorder

Keywords

  • Emotional disorder
  • adolescents
  • compassion
  • parents
03

In context

Lead sponsor

Beijing HuiLongGuan Hospital is the lead sponsor of 22 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 30, 2026. See what changed

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Compassion-based family intervention group

    Participants receive a 6-week compassion-based family intervention (one 120-min session per week).

    Other: Compassion-Based Family Intervention

  • No intervention
    Waiting list control group

    Participants receive no intervention during the 6-week waiting period and then receive the same intervention after the waiting period.

Interventions

  • OtherCompassion-Based Family Intervention

    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."

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. Parent-child neural synchrony (fNIRS hyperscanning)

    The fNIRS measures are designated as exploratory mechanistic outcomes to investigate potential intervention-related changes in parent-child neural synchrony. Wavelet transform coherence (WTC) will be computed from oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) signals measured during the emotional video co-viewing task. WTC values in the 0.02-0.1 Hz frequency band will be used to quantify brain-to-brain synchrony. Higher coherence indicates stronger neural synchrony.

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

  2. Parent-child physiological synchrony (HRV)

    The HRV measures are designated as exploratory mechanistic outcomes to investigate potential intervention-related changes in parent-child physiological synchrony. HRV metrics will be derived from inter-beat interval recordings obtained using Huawei Band 8 wearable devices. Parent-child physiological synchrony will be quantified using the cross-correlation function applied to the HRV time series for each parent-child dyad.

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

07

Study locations

1 of 1 sites recruiting
  • Hefei Fourth People's Hospital (Anhui Mental Health Center; Affiliated Psychological Hospital of Anhui Medical University)
    Hefei, Anhui 230022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
2 inclusion criteria edited
What changed in the criteria
Inclusion criteria
  • Editedfor 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 score of HAMD-17 (suicide) score must be ≤ 2
  • Editedthe adolescent has normal auditory and visual perception abilities and intellectual levelfunctioning
Sep 30, 2026
Primary outcomes
6 removed, 2 description edited
What changed in the outcomes
  • RemovedPerceived emotional synchronyTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedSelf-CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedFears of CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedParenting StressTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedParent-child neural synchrony (fNIRS hyperscanning)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedHeart rate variability (HRV)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • DescriptionChildren's anxiety levels: how it is measured was reworded
  • DescriptionChildren's depression levels: how it is measured was reworded
Sep 30, 2026
Secondary outcomes
1 edited, 7 added, 3 removed, 7 description edited
What changed in the outcomes
  • EditedParent-child relationships in parents' viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • AddedSelf-CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • AddedFears of CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • AddedPerceived emotional synchronyTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • AddedParenting stressTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • AddedAdolescents' expressed emotionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedParenting styles in children's viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedParent-child relationships in children's viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • RemovedConcise Chinese Level of Expressed EmotionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • DescriptionEmotion Regulation: how it is measured was reworded
  • DescriptionFamily Expressiveness: how it is measured was reworded
  • DescriptionNonclinging to Ego: how it is measured was reworded
  • DescriptionParental Burnout: how it is measured was reworded
  • DescriptionParental self-stigmatization: how it is measured was reworded
  • DescriptionParenting styles: how it is measured was reworded
  • DescriptionPerceived Criticism: how it is measured was reworded
  • Addedother outcomeParent-child neural synchrony (fNIRS hyperscanning)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
  • Addedother outcomeParent-child physiological synchrony (HRV)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Eligibility 2 inclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • Editedfor 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 score of HAMD-17 (suicide) score must be ≤ 2
    • Editedthe adolescent has normal auditory and visual perception abilities and intellectual levelfunctioning
    Primary outcomes 6 removed, 2 description edited
    What changed in the outcomes
    • RemovedPerceived emotional synchronyTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedSelf-CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedFears of CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedParenting StressTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedParent-child neural synchrony (fNIRS hyperscanning)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedHeart rate variability (HRV)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • DescriptionChildren's anxiety levels: how it is measured was reworded
    • DescriptionChildren's depression levels: how it is measured was reworded
    Secondary outcomes 1 edited, 7 added, 3 removed, 7 description edited
    What changed in the outcomes
    • EditedParent-child relationships in parents' viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • AddedSelf-CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • AddedFears of CompassionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • AddedPerceived emotional synchronyTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • AddedParenting stressTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • AddedAdolescents' expressed emotionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedParenting styles in children's viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedParent-child relationships in children's viewTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • RemovedConcise Chinese Level of Expressed EmotionTime frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • DescriptionEmotion Regulation: how it is measured was reworded
    • DescriptionFamily Expressiveness: how it is measured was reworded
    • DescriptionNonclinging to Ego: how it is measured was reworded
    • DescriptionParental Burnout: how it is measured was reworded
    • DescriptionParental self-stigmatization: how it is measured was reworded
    • DescriptionParenting styles: how it is measured was reworded
    • DescriptionPerceived Criticism: how it is measured was reworded
    • Addedother outcomeParent-child neural synchrony (fNIRS hyperscanning)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    • Addedother outcomeParent-child physiological synchrony (HRV)Time frame: baseline, immediately after the intervention, and 3, 6 month follow-up
    + 4 other changes: description, design details, contact details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07138417
Lead sponsor
Beijing HuiLongGuan Hospital
Responsible party
Xiang Yang Zhang (Professor, Beijing HuiLongGuan Hospital) — Principal investigator
First posted
Aug 22, 2025
Start date
Aug 30, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Dongmei Wang, Ph.D
Contact
wangdm@psych.ac.cn
+86 132 4190 1959
Dongmei Wang, Ph.D
principal investigator · Institute of Psychology, Chinese Academy of Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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