Compassion-Based Family Intervention for Adolescents With Emotional Disorders and Their Parents: A Randomized Waitlist-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Parent-child neural synchrony (fNIRS hyperscanning)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Waiting list control group
Participants receive no intervention during the 6-week waiting period and then receive the same intervention after the waiting period.
Compassion-based family intervention group
Participants receive a 6-week compassion-based family intervention (one 120-min session per week).
干预措施: Compassion-Based Family Intervention (Other)
结局指标
主要结局
Parent-child neural synchrony (fNIRS hyperscanning)
时间窗: 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.
Perceived emotional synchrony
时间窗: 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).
Self-Compassion
时间窗: 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).
Fears of Compassion
时间窗: 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).
Parenting Stress
时间窗: 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).
Children's depression levels
时间窗: 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).
Children's anxiety levels
时间窗: 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).
Oxy-hemoglobin concentration change (ΔHbO)
时间窗: baseline, immediately after the intervention, and 3, 6 month follow-up
Functional near-infrared spectroscopy (fNIRS) hyperscanning was employed to measure wavelet transform coherence (WTC) between parents and children during an emotional video task. The primary signals of interest were the concentration changes of oxy-hemoglobin (ΔHbO) and deoxy-hemoglobin (ΔHbR). ΔHbO and ΔHbR signals were preprocessed before WTC analysis. The WTC frequency band was set at 0.02-0.10 Hz to assess brain signal synchrony in time-frequency domains, providing higher sensitivity than traditional correlation coefficients. Higher coherence values indicated stronger neural synchrony.
Deoxy-hemoglobin concentration change (ΔHbR)
时间窗: baseline, immediately after the intervention, and 3, 6 month follow-up
Functional near-infrared spectroscopy (fNIRS) hyperscanning was employed to measure wavelet transform coherence (WTC) between parents and children during an emotional video task. The primary signals of interest were the concentration changes of oxy-hemoglobin (ΔHbO) and deoxy-hemoglobin (ΔHbR). ΔHbO and ΔHbR signals were preprocessed before WTC analysis. The WTC frequency band was set at 0.02-0.10 Hz to assess brain signal synchrony in time-frequency domains, providing higher sensitivity than traditional correlation coefficients. Higher coherence values indicated stronger neural synchrony.
Heart rate variability (HRV)
时间窗: 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.
次要结局
- Parental self-stigmatization(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)
- 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)
- Nonclinging to Ego(baseline, immediately after the intervention, and 3, 6 month follow-up)
- Parental self-stigmatization(baseline, immediately after the intervention, and 1, 3, 6 month follow-up)
- Perceived Criticism(baseline, immediately after the intervention, and 3, 6 month follow-up)
- Family Expressiveness(baseline, immediately after the intervention, and 3, 6 month follow-up)
- Emotion Regulation(baseline, immediately after the intervention, and 3, 6 month follow-up)
- Concise Chinese Level of Expressed Emotion(baseline, immediately after the intervention, and 3, 6 month follow-up)
- Parental Burnout(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)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital