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临床试验/NCT07115186
NCT07115186招募中不适用

Enhancing Stress Resilience and Coping Skills Among Adolescents in Rural China Through School-Based Psychological Interventions: A Cluster Randomized Controlled Trial

Peking University2 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2025年5月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
850
试验地点
2
主要终点
PTSD for adolescents

研究概览

简要总结

This study aims to evaluate the effectiveness of school-based psychological interventions in improving stress resilience and coping skills among adolescents in rural China. The intervention seeks to reduce stress-related mental health symptoms, including depression, anxiety, and post-traumatic stress, measured using validated instruments such as the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). (See Appendix for full scale descriptions.)

Participants will be recruited from rural middle schools and randomly assigned to either an intervention group or a wait-list control group. The intervention consists of four sessions delivered over one week. Assessments will be conducted at baseline, immediately after the intervention, and again at a 3-month and 6-month follow-ups.

Researchers will use multilevel modeling (MLM) and structural equation modeling (SEM) to examine potential mediators and moderators of intervention effects, including emotion recognition, alexithymia, and coping strategies. indings are expected to provide evidence on the effectiveness and mechanisms of an existing, school-based psychological intervention tailored to the needs of adolescents in underserved rural settings.

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

入选标准

  • Currently enrolled middle school students attending regular school classes
  • Sufficient functional capacity in hearing, speaking, reading, and writing to participate in intervention activities and assessments.

排除标准

  • Individuals assessed to be at high risk of suicide, based on screening or clinical judgment
  • Diagnosis of severe mental disorders (e.g., psychotic disorders, severe mood disorders) that would interfere with participation or require more intensive clinical care

结局指标

主要结局

PTSD for adolescents

时间窗: baseline, post treatment (2 weeks after baseline), 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.

Depression

时间窗: baseline, post treatment (2 weeks after baseline), 3 month after post treatment

The 9-item patient health questionnaire (PHQ-9) for adults (score ranges from 0 to 3, and the total score varies from 0 to 27). A higher score indicates worse depression symptoms.

Insomnia Severity

时间窗: baseline, post treatment (2 weeks after baseline), 3 month after post treatment

The severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep disturbance (score from 0 to 4, and total score vary from 0 to 32). Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity.

Alexithymia

时间窗: baseline, post treatment (2 weeks after baseline), 3 month after post treatment

A 22-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 22 to 110). A higher score represents more severe alexithymia.

Generalized anxiety disorder

时间窗: baseline, post treatment (2 weeks after baseline), 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.

Emotion awareness

时间窗: baseline, post treatment (2 weeks after baseline), 3 month after post treatment

A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, with total scores ranging from 30 to 90). A higher score indicates better emotion awareness.

次要结局

  • Subjective Happiness Scale(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Frustration(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Resilience(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Self-esteem(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Irritability(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Cognitive emotion regulation(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)
  • Game Addiction Scale(baseline, post treatment (2 weeks after baseline), 3 month after post treatment)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yinyin Zang, PhD

Principal Investigator

Peking University

研究点 (2)

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