Compassion-Based Family Intervention for Adolescents
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Compassion-Based Family Intervention.
- Кому может быть актуально
- Состояния в реестре: Emotional Disorder. Базовые параметры: 12 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Compassion-Based Family Intervention for Adolescents With Emotional Disorders and Their Parents: A Randomized Waitlist-Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Compassion-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, Resonanc
Первичные конечные точки
- Perceived emotional synchrony [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Self-Compassion [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Fears of Compassion [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parenting Stress [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Children's depression levels [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Children's anxiety levels [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parent-child neural synchrony (fNIRS hyperscanning) [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Heart rate variability (HRV) [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
Вторичные конечные точки (11)
- Parenting styles [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parenting styles in children's view [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parent-child relationships in parents' view [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parent-child relationships in children's view [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Nonclinging to Ego [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parental self-stigmatization [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Perceived Criticism [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Family Expressiveness [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Emotion Regulation [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Concise Chinese Level of Expressed Emotion [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
- Parental Burnout [Срок оценки: baseline, immediately after the intervention, and 3, 6 month follow-up]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Hefei Fourth People's Hospital (Anhui Mental Health Center; Affiliated Psychological Hospi — Хэфэй
Идентификаторы
NCT: NCT07138417 · CASPsy8