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NCT Number: NCT07138417

Compassion-Based Family Intervention for Adolescents

Adolescents with emotional disorders (such as depression or anxiety) often experience distress that also affects their parents, creating a cycle of stress within the family. This study tests a new compassion-based family intervention designed to help both adolescents and their parents. The program includes six weekly sessions (120 minutes each). The study will recruit 60 parent-adolescent dyads. Half will receive the intervention immediately; the other half will wait 6 weeks before receiving it. We will measure changes in depression, anxiety, parenting stress, family relationships, and - using brain imaging (fNIRS) and heart rate monitors - how the intervention affects parent-child emotional and physiological synchrony. Assessments will take place before the intervention, right after, and at 3-month and 6-month follow-ups. The goal is to see whether this family-focused compassion program can improve mental health for both adolescents and their parents.

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Key information

Conditions

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hefei Fourth People's Hospital (Anhui Mental Health Center; Affiliated Psychological Hospital of Anhui Medical University)

Hefei, Anhui, 230022, China

Location status: Recruiting

Location contact

Xiangyang Zhang, Ph.D

CONTACT

[email protected]

86-10-62710644

About this study

This is a parallel-group, randomized waitlist-controlled trial with a 1:1 allocation ratio. A total of 60 parent-adolescent dyads (adolescents aged 12-18 years with emotional disorder symptoms, and one parent each) will be recruited from the Fourth People's Hospital of Hefei, China. After baseline assessment, dyads are randomly assigned to either the intervention group (IG) or the waiting-list control group (WL) using a computer-generated randomization sequence (SAS 9.4 PROC PLAN). Allocation concealment is maintained by an independent researcher who is not involved in recruitment, enrolment, intervention delivery, or outcome assessment. Outcome assessors and data analysts are blinded to group assignment. Due to the behavioral nature of the intervention, participants are not blinded to their group; however, they are unaware of the specific study hypotheses regarding allocation.

Intervention: The IG receives a 6-week compassion-based family intervention delivered in weekly 120-min sessions. Each session follows a progressive thematic structure (weeks 1-6). Participants also complete daily home practice (emotion diaries and meditation). The WL receives no intervention during the 6-week waiting period, after which they are offered the same intervention.

Assessments: Data are collected at four time points: baseline (t1), post-intervention (t2, week 6), 3-month follow-up (t3), and 6-month follow-up (t4). Primary outcomes include psychological measures (self-compassion, fears of compassion, perceived emotional synchrony, parenting stress, adolescent depression and anxiety), as well as neuroimaging (fNIRS hyperscanning) and physiological (heart rate variability) measures of parent-child synchrony. Secondary outcomes cover additional family relationship and parental well-being indicators.

Sample size: Calculated using G*Power 3.1.9.7 for repeated-measures ANOVA (within-between interaction) with power = 0.95, medium effect size f = 0.25, α = 0.05, 2 groups, 4 measurements, correlation = 0.5, and nonsphericity correction = 1. The required total is 36 dyads. Allowing for a 40% dropout rate, we aim to recruit 60 dyads.

Statistical analysis: Primary analyses follow the intention-to-treat (ITT) principle. Linear mixed models (LMM) will be applied to each outcome, including group (IG, WL), time (t1, t2, t3, t4), and the group×time interaction as fixed effects, with participant as a random effect and baseline scores as covariates. Missing data will be handled using multiple imputation (assuming missing at random). For fNIRS data, wavelet transform coherence (WTC) in the 0.02-0.1Hz band will be computed and compared between groups. HRV synchrony will be assessed via cross-correlation functions. Secondary outcomes and exploratory correlation analyses will be conducted with appropriate multiplicity adjustments.

Ethics and dissemination: The trial protocol has been approved by the Ethics Committee of the Institute of Psychology, Chinese Academy of Sciences (approval number H25123). Results will be reported in accordance with the CONSORT 2025 statement, regardless of the direction of findings.

Who can participate

Healthy volunteers accepted: No

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

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 item 3 score of HAMD-17 (suicide) must be ≤2
  • at least one parent is willing to participate
  • the adolescent has normal auditory and visual perception abilities and intellectual level
  • the participating parent has normal reading and writing ability
  • the adolescent has no history of manic episodes

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

Treatment and study plan

Compassion-Based Family Intervention

Other

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."

Primary outcomes

  1. Perceived emotional synchrony

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

    Using the score of Perceived Emotional Synchrony Scale to assess perceived emotional synchrony of parents and children respectively.

    Perceived emotional synchrony scale (16-item version): items rated 1-7; the investigators report mean subscale scores (range 1-7) for Emotional Communion (items 1, 4, 5, 7, 8, 11, 14, 15) and Felt Unity (items 2, 3, 6, 9, 10, 12, 13, 16). Higher scores indicate greater perceived emotional synchrony (better outcome).

  2. Self-Compassion

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

    Using the Self-Compassion Scale to assess self-compassion levels of parents and children respectively.

    Self-Compassion Scale (SCS): 26 items rated 1-5; the investigators report the mean score (range 1-5). Higher scores indicate greater self-compassion (better outcome).

  3. Fears of Compassion

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

    Using the Fears of Compassion Scales to assess fears of compassion levels of parents and children respectively.

    Fears of Compassion Scales (FCS): three subscales rated 0-4 - Fear of Compassion for Self (15 items; total 0-60), Fear of Compassion for Others (10 items; total 0-40), and Fear of Receiving Compassion from Others (13 items; total 0-52). Higher scores indicate greater fear of compassion (worse outcome).

  4. Parenting Stress

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

    Using the Parenting Stress Index-Short Form to assess parenting stress. Parenting Stress Index-Short Form (PSI-SF): 36 items rated 1-5; the investigators report the total score (range 36-180). Higher scores indicate greater parenting stress (worse outcome).

  5. Children's depression levels

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

    Using the Children's Depression Inventory scale to assess children's depression levels.

    Children's Depression Inventory (CDI): 27 items rated 0-2; the investigators report the total score (range 0-54). Higher scores indicate more severe depressive symptoms (worse outcome).

  6. Children's anxiety levels

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

    Using the Beck Anxiety Inventory to assess children's anxiety levels. Beck Anxiety Inventory (BAI): 21 items rated 0-3; the investigators report the total score (range 0-63). Higher scores indicate more severe anxiety (worse outcome).

  7. Parent-child neural synchrony (fNIRS hyperscanning)

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

    Wavelet transform coherence (WTC) was computed from oxy-hemoglobin (ΔHbO) and deoxy-hemoglobin (ΔHbR) signals measured by fNIRS during an emotional video task. The primary outcome is the WTC value in the 0.02-0.1 Hz frequency band, reflecting brain-to-brain synchrony. Higher coherence indicates stronger neural synchrony.

  8. Heart rate variability (HRV)

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

    Heart rate variability (HRV) metrics in parents and children were measured using wearable wristbands (Huawei Band 8) throughout both the emotional video task and group intervention sessions.

Secondary outcomes

  1. Parenting styles

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

    Using the Parenting Scale-7 to assess parenting styles. Parenting Scale-7 (PS-7): 7 items rated 1-7; the investigators report the mean score (range 1-7). Higher scores indicate more dysfunctional parenting practices (worse outcome).

  2. Parenting styles in children's view

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

    Using the Egna Minnen av Barndoms Uppfostran to assess the parenting styles in children's view.

    Egna Minnen av Barndoms Uppfostran (EMBU; "My Memories of Upbringing"), 21-item version: items rated 1-4; the investigators report summed subscale scores for Rejection (items 1, 4, 7, 12, 14, 19), Emotional Warmth (items 2, 6, 9, 11, 13, 17, 21), and Overprotection (items 3, 5, 8, 10, 15R, 16, 18, 20), with item 15 reverse-scored. Higher Rejection and Overprotection indicate worse outcomes, whereas higher Emotional Warmth indicates better outcomes.

  3. Parent-child relationships in parents' view

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

    Using the Child-Parent Relationship Scale, 30-item scale to assess the Parent-child relationships from the perspective of parents.

    Child-Parent Relationship Scale, 30-item version (CPRS): items rated 1-5; the investigators report mean subscale scores (range 1-5) for Closeness, Conflict, and Dependence. Higher Closeness indicates a better relationship (better outcome), whereas higher Conflict and higher Dependence indicate worse outcomes.

  4. Parent-child relationships in children's view

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

    Using the Remembered Relationship with Parents, 10-item scale to assess the Parent-child relationships from the perspective of children.

    Remembered Relationship with Parents, 10-item scale (RRP10): 10 items rated 0-4; the investigators report the total score (range 0-40). Higher scores indicate more negative remembered relationships with parents (worse outcome).

  5. Nonclinging to Ego

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

    Using the Nonclinging to Ego Scale to assess nonclinging to ego levels of parents and children respectively.

    Nonclinging to Ego Scale (NES): 33 items rated 1-6; the investigators report the total score (range 33-198). Higher scores indicate greater nonattachment to self (better outcome).

  6. Parental self-stigmatization

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

    Using the Self-Stigma in Relatives of people with Mental Illness Scale to assess the parental self-stigmatization.

    Self-Stigma in Relatives of people with Mental Illness Scale (SSRMI): 30 items rated 1-5; the investigators report the mean score (range 1-5). Higher scores indicate greater self-stigma among relatives (worse outcome).

  7. Perceived Criticism

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

    Using the Perceived Criticism Measure to assess the parent' perceived criticism levels.

    Perceived Criticism Measure (PCM): items rated 1-10; the investigators report the mean score (range 1-10). Higher scores indicate greater perceived criticism (worse outcome).

  8. Family Expressiveness

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

    Using the Family Expressiveness Questionnaire to assess the family expressiveness.

    Family Expressiveness Questionnaire (FEQ): 20 items rated 1-9; the investigators report the mean score (range 1-9). Higher scores indicate more frequent family emotional expressiveness; when reporting Positive vs. Negative Expressiveness subscales, higher Positive is considered better and higher Negative is considered worse.

  9. Emotion Regulation

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

    Using the Emotion Regulation Questionnaire, 6-item version to assess the emotion regulation levels of parents and children respectively.

    Emotion Regulation Questionnaire, 6-item version (ERQ-6): items rated 1-7; the investigators report mean subscale scores (range 1-7) for Cognitive Reappraisal (4 items) and Expressive Suppression (2 items). Higher Reappraisal indicates more frequent use of cognitive reappraisal (typically better outcome), whereas higher Suppression indicates more frequent use of expressive suppression (typically worse outcome).

  10. Concise Chinese Level of Expressed Emotion

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

    Using the Concise Chinese Level of Expressed Emotion Scale to assess the concise Chinese level of expressed emotion of children.

    Concise Chinese Level of Expressed Emotion Scale (CCLEES): 12 items rated 1-4; the investigators report the mean score (range 1-4). Higher scores indicate higher expressed emotion (typically associated with worse outcomes).

  11. Parental Burnout

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

    Using the Parental Burnout Assessment to assess the parental burnout level. Parental Burnout Assessment (PBA): 23 items rated 0-6; the investigators report the total score (range 0-138). Higher scores indicate greater parental burnout (worse outcome).

Study contacts

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

Dongmei Wang, Ph.D

CONTACT

[email protected]

+86 132 4190 1959

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
May 8, 2026

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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