Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism

NCT06591130 | Active Not Recruiting DMC

• 1 other identifier: OAR-ASD-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this feasibility randomized controlled trial is to assess the feasibility and acceptability of Youth Culturally Adapted Manually Assisted brief psychological intervention (YCMAP) in young people with autism in Pakistan. In a rater-blind, 2-arm, multi-site, feasibility randomized controlled trial (RCT), participants will be randomized either to 1) YCMAP added to the Treatment as Usual (TAU) or 2) TAU alone. Participants in the Y-CMAP arm will receive 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. Assessments will be conducted at baseline and at 3 months.

Conditions

Autism Spectrum Disorder; Self Harm

Keywords

Autism; Self harm; Youth suicidality

Outcome Measures

Primary Outcomes (2)

• Intervention feasibility

  Data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants and retain 70%.

  Baseline to 12 weeks

• Intervention acceptability

  Acceptability will be assessed using data on attendance. The criterion for acceptability is the mean attendance rate of \>70% of sessions.

  Baseline to 12 weeks

Secondary Outcomes (8)

• Suicide Attempt and Self-Harm

  Baseline to 12 weeks

• Beck Scale for Suicide Ideation

  Baseline to 12 weeks

• Card sort Task for Self-harm Behavior

  Baseline to 12 weeks

• Beck Hopelessness Scale

  Baseline to 12 weeks

• Autistic Depression Assessment Tool - Adult

  Baseline to 12 weeks

Study Arms (2)

Y-CMAP + TAU

EXPERIMENTAL

Behavioral: Youth culturally adapted manual assisted psychological intervention (Y-CMAP)

TAU alone

NO INTERVENTION

Treatment as usual (TAU) will include standard routine care that participants could potentially be receiving by their treating GP, or from autism centers, such as behavioral therapy, psychoeducation, occupational therapy, sports therapy, and art therapy. We will maintain a detailed record of each participant's routine care.

Interventions

Youth culturally adapted manual assisted psychological intervention (Y-CMAP) BEHAVIORAL

YCMAP (Youth culturally adapted manual assisted psychological intervention) is based on CBT principles. It comprises of 8-10 sessions delivered individually over 3 months (weekly for 1 month then fortnightly), lasting for 60 minutes. The intervention includes psycho-education and a comprehensive cognitive behavioural assessment of the self-harm attempt using virtual stories of four young people. Therapists and young person choose from a list of techniques those which are most relevant to the young person's problems. Therapy is therefore adapted to fit with the young person's problems and primarily utilises problem solving, CBT, and dialectical therapy strategies to bring about change. To help determine the most appropriate coping strategy a coping tree is designed. Training in assertiveness and anger management are offered to help the young person to develop resilience to cope with stress.

Y-CMAP + TAU

Eligibility Criteria

• Age: 14 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 14-24 years
• History of self-harm and/or possible suicidal behavior
• Able to engage in assessment and intervention
• Ability to provide informed consent

You may not qualify if:

• Young people with autism with limited receptive and expressive language skills that would prevent engagement
• With any chronic medical disorder or physical condition (including communicable diseases such as Tuberculosis) that would prevent participation in assessments and or intervention.
• Not willing to participate.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Pakistan Centre for Autism

Karachi, Sindh, 75300, Pakistan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Self-Injurious Behavior; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Nasim Chaudhry, FRCPsych

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion: February 15, 2026
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)