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

Pakistan Institute of Living and Learning

Status: Not yet enrolling

Conditions: Autism Spectrum Disorder; Self Harm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06591130

OAR-ASD-002

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18-24 years
• History of self-harm and/or possible suicidal behavior
• Able to engage in assessment and intervention
• Ability to provide informed consent

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Y-CMAP + TAU

Experimental group

Treatment:

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

TAU alone

No Intervention group

Description:

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.