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

A Pilot Trial of a Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autism Spectrum Disorder; Self Harm
• Intervention / Treatment: Behavioral: Youth culturally adapted manual assisted psychological intervention (Y-CMAP)

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75300
      • Pakistan Centre for Autism

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Y-CMAP + TAU	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicide Attempt and Self-Harm	This consists of four questions measuring the previous suicide attempt and the presence of self-harm. The scale was taken from the original Self-Harm Questionnaire.	Baseline to 12 weeks
Beck Scale for Suicide Ideation	A 19-item instrument for detecting and measuring the current intensity of patient-specific attitude, behavior, and specificity of patient thoughts to kill him/ herself during the past week.	Baseline to 12 weeks
Card sort Task for Self-harm Behavior	117 cards related to thoughts, feelings, events, behaviours and self-harm supports/services	Baseline to 12 weeks
Beck Hopelessness Scale	This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.	Baseline to 12 weeks
Autistic Depression Assessment Tool - Adult	It has 21 items capturing depression symptoms in the past 14 days. The Autistic Depression Assessment Tool - Adult has staged questions for each symptom: 1) the presence (yes/no) of the difficulty in the past 14 days; 2) if present, the length of time the difficulty has been experienced for over the past 14 days (from 1-3 days (1) to 12-14 days (4)); and 3) the impact of the symptom on everyday functioning (from "Never" (0) to "Extremely" (4)). Answering "no" to a difficulty is scored 0, length of time is scored from 1-4, and impact from 1-4. Scores across the sections are summed to obtain individual item scores from 0-8, with total scores ranging from 0-168, with higher scores indicating a greater number / impact of depressive symptoms in the past 14 days.	Baseline to 12 weeks
Kessler Psychological Distress Scale	The Kessler Psychological Distress Scale is a simple measure of psychological distress. The scale involves 10 questions about emotional states each with a five-level response scale. The measure can be used as a brief screen to identify levels of distress. Each item is scored from one 'none of the time' to five 'all of the time'. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.	Baseline to 12 weeks
Euro-Qol-5 Dimensions scale	It's a standardised instrument to measure participants' health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression)	Baseline to 12 weeks
Childhood Autism Rating Scale-2	CARS-2 is an observational, standardized assessment tool to identify and measure the severity of autism spectrum disorder (ASD) in children. Rating relies on information being gathered by observing the child and from the parents. CARS is a 15-item scale with a cutoff score of 28, measuring fifteen different behaviors indicative of ASD on a point rating scale. A systematic review and meta-analysis on CARS indicate its internal consistency of 0.90 across all items (Brignell et al., 2019). The CARS-2 was administered by trained clinicians and used as evidence to support the clinical diagnosis of ASD.	Baseline

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Investigators: Principal Investigator: Nasim Chaudhry, FRCPsych, Pakistan Institute of Living and Learning

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): February 15, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Autism; Self harm; Youth suicidality
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Autistic Disorder; Self-Injurious Behavior
• Other Study ID Numbers: OAR-ASD-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No