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。

Integrated Motivational Interviewing and Rational Emotive Behavior Therapy Intervention for Non-Suicidal Self-Injury Among Malaysian Primary School Students: A Feasibility Trial Protocol (MIND-SET)

2026年5月31日 更新者:Charles A/L Ganaprakasam、Universiti Utara Malaysia

The Feasibility and Preliminary Effects of an Integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) Intervention on Non-Suicidal Self-Injury, Emotional Dysregulation, and Readiness for Change Among Malaysian Primary School Students: A Trial Protocol

This study aims to evaluate the feasibility and preliminary effects of the MIND-SET Intervention Module, an integrated Motivational Interviewing and Rational Emotive Behavior Therapy (MI-REBT) intervention, among Malaysian primary school students involved in Non-Suicidal Self-Injury (NSSI) behaviour. The module is designed to reduce self-injurious behaviour, improve emotional regulation, and enhance readiness for change among 12-year-old students in school settings. This study will use a quasi-experimental design involving three groups: a MIND-SET intervention group, a PRISMA Mental Health Module group, and a treatment-as-usual group. Data will be collected at pre-intervention, post-intervention, and follow-up stages using validated psychological instruments. The findings are expected to support the development of culturally responsive, school-based mental health interventions for children involved in NSSI behaviour in Malaysia.

調査の概要

詳細な説明

Non-Suicidal Self-Injury (NSSI) among children and adolescents is an increasingly important mental health concern worldwide, including in Malaysia. NSSI refers to deliberate self-injurious behaviour without suicidal intent and is often associated with emotional distress, maladaptive coping, emotional dysregulation, and interpersonal difficulties. These concerns highlight the need for early, structured, and school-based intervention, particularly among primary school students who may have limited emotional regulation and help-seeking skills.

Despite increasing attention to NSSI, culturally appropriate intervention modules for Malaysian primary school students remain limited. Many existing interventions are developed within Western contexts and may not fully address the developmental, emotional, family, school, and sociocultural needs of Malaysian children. Therefore, this study introduces the MIND-SET Intervention Module, which integrates Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) to support emotional regulation, cognitive restructuring, and readiness for behavioural change among students involved in NSSI behaviour.

MI is incorporated to enhance readiness for change, reduce ambivalence, and strengthen intrinsic motivation toward healthier coping behaviours. REBT is used to help participants identify irrational beliefs, challenge maladaptive thinking patterns, and develop healthier emotional and behavioural responses. The integration of MI and REBT is expected to provide a structured, supportive, and developmentally appropriate intervention for school counselling settings.

This study will employ a quasi-experimental pre-test, post-test, and follow-up design involving three groups. Approximately 105 primary school students aged 12 years from selected schools in Kedah, Malaysia, will participate in the study. Participants will be identified through school mental health screening and NSSI-related assessment procedures. The treatment group will receive the MIND-SET Intervention Module through structured group counselling sessions. The active comparator group will receive the PRISMA Mental Health Module developed by the Ministry of Education Malaysia. The treatment-as-usual group will continue receiving routine school support and normal school activities without participating in any structured intervention module during the study period.

Data will be collected at three time points: pre-intervention, post-intervention, and follow-up assessment. The study will evaluate changes in NSSI frequency, emotional dysregulation, and readiness for change using validated psychological instruments. Quantitative data analysis will be conducted to examine the feasibility and preliminary effects of the intervention across the three groups.

The findings are expected to contribute to the development of evidence-informed and culturally responsive school-based mental health interventions for Malaysian children. In addition, this study may provide practical guidance for school counsellors, educators, and policymakers in strengthening early intervention efforts related to emotional wellbeing and self-injurious behaviour among primary school students

研究の種類

介入

入学 (推定)

105

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。

研究連絡先

研究場所

    • Kedah
      • Kulim、Kedah、マレーシア、09000
        • Selected Primary Schools in Kulim District
        • コンタクト:
        • コンタクト:
          • Research Ethics Committee Universiti Utara Malaysia
          • 電話番号:604-9285299
          • メール:ahsgservices@uum.edu.my
        • 主任研究者:
          • Charles Ganaprakasam
        • 副調査官:
          • Siti Rozaina Kamsani
        • 副調査官:
          • Nabisah Ibrahim

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

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Primary school students aged 12 years old.
  • Students identified with Non-Suicidal Self-Injury (NSSI) behaviour through school mental health screening and assessment procedures.
  • Able to understand and participate in group counselling sessions.
  • Written informed consent obtained from parents or guardians.
  • Assent obtained from participating students.

Exclusion Criteria:

  • Students currently receiving intensive psychiatric treatment or psychological -intervention for severe mental health conditions.
  • Students identified with active suicidal intent requiring immediate clinical intervention.
  • Students with severe cognitive or developmental impairments that may interfere with participation in group intervention activities.
  • Students who are unable to attend the scheduled intervention sessions consistently.

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:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:MIND-SET Intervention Group
Participants in this group will receive the MIND-SET intervention module integrating Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) approaches through structured group counselling sessions conducted in school settings.
A structured school-based intervention module integrating Motivational Interviewing (MI) and Rational Emotive Behavior Therapy (REBT) approaches to reduce Non-Suicidal Self-Injury behaviour, improve emotional regulation, and enhance readiness for change among Malaysian primary school students through group counselling sessions.
アクティブコンパレータ:Standard School Counselling Group
Participants in this group will receive the PRISMA Mental Health Module developed by the Ministry of Education Malaysia (KPM), which represents the standard structured mental health intervention currently implemented in schools.
A structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students.
介入なし:Treatment as Usual Group
Participants in this group will continue receiving routine school support and normal school activities without participating in any structured intervention module during the study period.

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 Non-Suicidal Self-Injury Frequency
時間枠:Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Measured using the translated version of the Six-Item Non-Suicidal Self-Injury Instrument (Prinstein et al., 2010). The instrument consists of the frequency of self-injury behavior using a 5-point scale: 0 (never), 1 (1-2 times), 2 (3-5 times), 3 (6-9 times), and 4 (10 times or more). Scores range from 0 to 4 per item. A higher score indicates a higher frequency of non-suicidal self-injury behavior (worse outcome).
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in Emotional Dysregulation
時間枠:Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Measured using the Malay version of the Difficulties in Emotion Regulation Scale-18 (DERS-18), originally developed by Gratz and Roemer (2004). The instrument consists of 18 items, with each item rated on a 5-point scale ranging from 1 (almost never) to 5 (almost always). Total scores can range from a minimum of 18 to a maximum of 90. A higher total score indicates a greater level of emotional dysregulation, representing a worse outcome.
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Change in Readiness for Change
時間枠:Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).
Measured using the translated short version of the University of Rhode Island Change Assessment (URICA-S), developed and validated by Mander et al. (2017). The instrument contains 12 items mapping across four distinct subscales representing the Stages of Change framework: Precontemplation, Contemplation, Action, and Maintenance. Each item is rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Individual subscale scores range from 3 to 15. A composite Readiness to Change score is calculated by summing the Contemplation, Action, and Maintenance scores, and subtracting the Precontemplation score. Total composite scores range from a minimum of 4 to a maximum of 44, where higher scores indicate a greater readiness to change behavior (better outcome).
Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).

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。

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 (推定)

2026年8月1日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年12月1日

試験登録日

最初に提出

2026年5月23日

QC基準を満たした最初の提出物

2026年5月31日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4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31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

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

IPD プランの説明

The individual participant data (IPD) generated during this study involve highly sensitive psychological and behavioral information from primary school students, including Non-Suicidal Self-Injury (NSSI)-related data. Due to strict ethical considerations, participant confidentiality protection, and institutional data protection policies, individual participant data sets will not be made publicly available to external researchers.

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