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

NCT ID: NCT06591130

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Y-CMAP + TAU

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

TAU alone

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasim Chaudhry, FRCPsych

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Central Contacts

Nadia Shafique, PhD

Role: CONTACT

nadiashafique17@gmail.com

+1 (425) 525-8418

Nusrat Husain, MD

Role: CONTACT

nusrat.husain@manchester.ac.uk

Other Identifiers

OAR-ASD-002

Identifier Type: -

Identifier Source: org_study_id