このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Trauma-Informed School Intervention for Adolescent Mental Health and Self-Injury Prevention in China (TISI-China)

2026年5月6日 更新者:WU Han

Development and Implementation of a Psychosocial Adaptive Capacity Enhancement Program for Adolescents With Childhood Household Dysfunction

This study evaluated a school-based psychosocial adaptive capacity enhancement program for Chinese adolescents. The program was developed to support students who may have experienced childhood household dysfunction or other adverse childhood experiences, while being delivered as a universal school-based mental health education program.

The intervention aimed to improve students' psychosocial skills, including emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The study assessed whether the program was associated with improvements in adolescent mental health and psychosocial adaptation, including symptoms of depression and anxiety, rumination, dissociative experiences, resilience, behavioral difficulties, and non-suicidal self-injury-related thoughts and behaviors.

Participants were students from collaborating middle schools, high schools, and vocational secondary schools in Hongjiang, Hunan Province, China. Students in the intervention group received the structured school-based psychosocial program, while students in the control group continued their usual school education and routine mental health education. Outcomes were measured using self-report questionnaires at baseline and follow-up assessments.

This study was conducted as an international collaborative project, with ethical approval obtained in Japan and China. The intervention and data collection were conducted in China, and the Japanese research team was mainly responsible for study design, data management, statistical analysis, and manuscript preparation.

調査の概要

研究の種類

介入

入学 (実際)

5787

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Hunan
      • Huaihua、Hunan、中国、413507
        • Hongjiang Furong Middle School

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

Students enrolled in participating middle schools, high schools, or vocational secondary schools in Hongjiang, Hunan Province, China Adolescents aged approximately 12 to 18 years Students who were able to understand and complete self-report questionnaires Students who provided assent or consent to participate Students whose parent, guardian, or appropriate custodian provided informed consent Students who were expected to remain enrolled at the participating school during the intervention and follow-up period

Exclusion Criteria:

Students with severe psychiatric disorders, developmental disorders, or cognitive impairment that made it difficult to complete questionnaires or participate in the intervention Students who were unable to understand the study explanation or complete self-report measures Students for whom assent/consent from the student or informed consent from a parent, guardian, or appropriate custodian could not be obtained Students who transferred school, withdrew from school, had long-term absence, or were otherwise unable to complete follow-up assessments Students who withdrew from the study during the study period, either by their own decision or by the decision of their parent, guardian, or appropriate custodian

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:School-Based Psychosocial Intervention
Participants in this arm received a structured school-based psychosocial adaptive capacity enhancement program. The program was informed by childhood household dysfunction, adverse childhood experiences, trauma-informed principles, and life-skills education. It included modules on emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The program was delivered in routine school settings by trained school mental health staff or psychologists under the guidance of the research team.
The intervention is a structured school-based psychosocial adaptive capacity enhancement program for adolescents. It was developed based on trauma-informed principles related to childhood household dysfunction and adverse childhood experiences, life-skills education, and psychosocial competence enhancement. The program aims to support students' mental health and psychosocial adaptation by strengthening emotional awareness, emotion regulation, stress coping, self-understanding, interpersonal communication, peer support, resilience, and mental health literacy. The program was delivered in routine school settings by trained school mental health staff or psychologists under the guidance of the research team. Students in the control arm continued usual school education and routine mental health education and did not receive this structured program during the study period.16-session version: The program consisted of 16 sessions, delivered once weekly, approximately 45 minutes per session.
介入なし:Usual School Education Control
Participants in this arm continued usual school education, routine class management, and standard school mental health education activities. They did not receive the structured psychosocial adaptive capacity enhancement program developed for this study during the study period. They could continue to access existing school counseling, homeroom teacher support, and routine campus mental health services as usual. Outcomes were assessed at the same time points as in the intervention arm.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Depressive Symptoms
時間枠:Baseline and post-intervention after 16 weeks
Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report scale assessing depressive symptom severity, with higher scores indicating more severe depressive symptoms. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Anxiety Symptoms
時間枠:Baseline and post-intervention after 16 weeks
Anxiety symptoms were assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity. Higher scores indicate more severe anxiety symptoms. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Borderline Personality Features
時間枠:Baseline and post-intervention after 16 weeks
Borderline personality features were assessed using the Borderline Personality Features Scale (BPFS), a self-report measure of borderline personality features. Higher scores indicate greater levels of borderline personality features. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Non-Suicidal Self-Injury Thoughts
時間枠:Baseline and post-intervention after 16 weeks
Non-suicidal self-injury thoughts were assessed using self-report items on the frequency of NSSI-related thoughts during the past month. Higher values indicate more frequent NSSI thoughts. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Non-Suicidal Self-Injury Behaviors
時間枠:Baseline and post-intervention after 16 weeks
Non-suicidal self-injury behaviors were assessed using self-report items on the frequency of NSSI actions during the past month. Higher values indicate more frequent NSSI behaviors. The primary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Behavioral Difficulties
時間枠:Baseline and post-intervention after 16 weeks
Behavioral difficulties were assessed using the Strengths and Difficulties Questionnaire (SDQ). The SDQ is a self-report measure of emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Higher difficulty scores indicate greater behavioral and emotional difficulties. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Dissociative Experiences
時間枠:Baseline and post-intervention after 16 weeks
Dissociative experiences were assessed using the Adolescent Dissociative Experiences Scale-II (A-DES-II), a self-report measure of dissociative symptoms among adolescents. Higher scores indicate greater levels of dissociative experiences. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Peer Victimization
時間枠:Baseline and post-intervention after 16 weeks
Peer victimization was assessed using the Multidimensional Peer Victimisation Scale (MPVS), a self-report measure of different forms of peer victimization. Higher scores indicate greater exposure to peer victimization. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Prosocial Behavior
時間枠:Baseline and post-intervention after 16 weeks
Prosocial behavior was assessed using the prosocial behavior subscale of the Strengths and Difficulties Questionnaire (SDQ). Higher scores indicate greater prosocial behavior. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks
Change in Resilience
時間枠:Baseline and post-intervention after 16 weeks
Resilience was assessed using the Connor-Davidson Resilience Scale-10 (CD-RISC-10), a 10-item self-report measure of psychological resilience. Higher scores indicate greater resilience. The secondary analysis evaluated the between-group difference in change from baseline to post-intervention.
Baseline and post-intervention after 16 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年11月10日

一次修了 (実際)

2026年4月30日

研究の完了 (実際)

2026年5月5日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月13日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025245NI

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する