NCT07627061

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Dec 2026

First Submitted

Initial submission to the registry

May 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 23, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Non-suicidal self-injuryNSSIPrimary school studentsChildrenEmotional dysregulationReadiness for changeMotivational InterviewingRational Emotive Behavior TherapySchool counsellingMalaysiaMIND-SET Intervention Module

Outcome Measures

Primary Outcomes (1)

  • Change in Non-Suicidal Self-Injury Frequency

    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).

Secondary Outcomes (2)

  • Change in Emotional Dysregulation

    Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).

  • Change in Readiness for Change

    Baseline (Week 0), 4 weeks after baseline (Week 4), and 16 weeks after baseline (Week 16).

Study Arms (3)

MIND-SET Intervention Group

EXPERIMENTAL

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.

Behavioral: MIND-SET Intervention Module

Standard School Counselling Group

ACTIVE COMPARATOR

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.

Behavioral: PRISMA Mental Health Module

Treatment as Usual Group

NO INTERVENTION

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.

Interventions

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.

MIND-SET Intervention Group

A structured school-based mental health intervention module developed by the Ministry of Education Malaysia (KPM) implemented as the standard care benchmark for students.

Standard School Counselling Group

Eligibility Criteria

Age12 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selected Primary Schools in Kulim District

Kulim, Kedah, 09000, Malaysia

Location

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Charles Ganaprakasam

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This study uses an open-label design because participants and facilitators will be aware of the intervention received during the implementation of the school-based counselling module.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned into three groups consisting of one treatment group and two control groups. The treatment group will receive the MIND-SET intervention module integrating Motivational Interviewing and Rational Emotive Behavior Therapy approaches, while the control groups will receive standard school counselling intervention or no intervention. Outcomes will be assessed across pre-test, post-test, and follow-up phases.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate / Principal Investigator

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 4, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations