Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences: A Multi-Center Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Alexithymia
研究概览
简要总结
The study aims to examine the effectiveness of joint parent-adolescent intervention in improving the mental health outcomes of participants, specifically by reducing symptoms of depression, anxiety, and PTSD, as measured by the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder-7 scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). Adolescents will be recruited from middle schools and randomly assigned to one of three groups: (a) psychoeducation, (b) psychoeducation + emotional skills enhancement, or (c) psychoeducation + emotional skills enhancement + positive childhood experience promotion. The school-based intervention will consist of 4-8 sessions, with assessments conducted at baseline, post-treatment, and a 3-month follow-up. Investigators will conduct multilevel models (MLMs) and structural equation models (SEMs) to investigate the impact of Adverse Childhood Experiences (ACEs), Positive Childhood Experiences (PCEs), alexithymia, and emotion regulation abilities on mental health outcomes in adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Middle school students studying in school and their parents
- •Capable of hearing, speaking, reading, and writing
排除标准
- •High suicidal risks
- •Severe mental disorders
结局指标
主要结局
Alexithymia
时间窗: baseline, post treatment(1 month), 3 month after post treatment
A 36-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 36 to 180). A higher score represents more severe alexithymia.
PTSD for adolescents
时间窗: baseline, post treatment(1 month), 3 month after post treatment
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
Emotion awareness
时间窗: baseline, post treatment(1 month), 3 month after post treatment
A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, and total scores vary from 30 to 90). A higher score represents better emotion awareness.
Emotion regulation
时间窗: baseline, post treatment(1 month), 3 month after post treatment
An 18-item cognitive emotion regulation questionnaire measures the ability of emotion regulation on a 5-point Likert scale (1 to 5, and total scores vary from 18 to 90). A higher score represents better emotion regulation.
Depression
时间窗: baseline, post treatment(1 month), 3 month after post treatment
The 9-item patient health questionnaire (PHQ-9) for adults (score from 0 to 3, and total score varies from 0 to 27). A higher score represents worse depression symptoms.
Generalized anxiety disorder
时间窗: baseline, post treatment(1 month), 3 month after post treatment
The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.
次要结局
- Irritability(baseline, post treatment(1 month), 3 month after post treatment)
- Resilience(baseline, post treatment(1 month), 3 month after post treatment)
- Seeking for help(baseline, post treatment(1 month), 3 month after post treatment)
- Insomnia Severity(baseline, post treatment(1 month), 3 month after post treatment)
研究者
Yinyin Zang, PhD
Principal Investigator
Peking University