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Completed

NCT Number: NCT06591130

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.

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Key information

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Centre for Autism

Karachi, Sindh, 75300, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Intervention feasibility

    Time frame: Baseline to 12 weeks

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

  2. Intervention acceptability

    Time frame: Baseline to 12 weeks

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

Secondary outcomes

  1. Suicide Attempt and Self-Harm

    Time frame: Baseline to 12 weeks

    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.

  2. Beck Scale for Suicide Ideation

    Time frame: Baseline to 12 weeks

    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.

  3. Card sort Task for Self-harm Behavior

    Time frame: Baseline to 12 weeks

    117 cards related to thoughts, feelings, events, behaviours and self-harm supports/services

  4. Beck Hopelessness Scale

    Time frame: Baseline to 12 weeks

    This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.

  5. Autistic Depression Assessment Tool - Adult

    Time frame: Baseline to 12 weeks

    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.

  6. Kessler Psychological Distress Scale

    Time frame: Baseline to 12 weeks

    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.

  7. Euro-Qol-5 Dimensions scale

    Time frame: Baseline to 12 weeks

    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)

  8. Childhood Autism Rating Scale-2

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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