NCT07138417

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Aug 2025Jul 2027

First Submitted

Initial submission to the registry

July 30, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 6, 2026

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

July 30, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

Emotional disorderadolescentscompassionparents

Outcome Measures

Primary Outcomes (8)

  • Perceived emotional synchrony

    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).

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

  • Self-Compassion

    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).

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

  • Fears of Compassion

    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).

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

  • Parenting Stress

    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).

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

  • Children's depression levels

    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).

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

  • Children's anxiety levels

    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).

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

  • Parent-child neural synchrony (fNIRS hyperscanning)

    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.

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

  • Heart rate variability (HRV)

    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.

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

Secondary Outcomes (11)

  • Parenting styles

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

  • Parenting styles in children's view

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

  • Parent-child relationships in parents' view

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

  • Parent-child relationships in children's view

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

  • Nonclinging to Ego

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

  • +6 more secondary outcomes

Study Arms (2)

Compassion-based family intervention group

EXPERIMENTAL

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

Other: Compassion-Based Family Intervention

Waiting list control group

NO INTERVENTION

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

Interventions

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, compassion for others, emotion awareness, communication skills, and conflict management.

Compassion-based family intervention group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hefei, Anhui, 230022, China

RECRUITING

Study Officials

  • Dongmei Wang, Ph.D

    Institute of Psychology, Chinese Academy of Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Wang, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 30, 2025

First Posted

August 22, 2025

Study Start

August 30, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

May 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Data with be available on request

Locations