Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
- Conditions
- Autism Spectrum DisorderSelf Harm
- Interventions
- Behavioral: Youth culturally adapted manual assisted psychological intervention (Y-CMAP)
- Registration Number
- NCT06591130
- Lead Sponsor
- Pakistan Institute of Living and Learning
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Y-CMAP + TAU Youth culturally adapted manual assisted psychological intervention (Y-CMAP) -
- Primary Outcome Measures
Name Time Method Intervention feasibility 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%.
Intervention acceptability 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 Outcome Measures
Name Time Method Suicide Attempt and Self-Harm 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.
Beck Scale for Suicide Ideation 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.
Card sort Task for Self-harm Behavior Baseline to 12 weeks 117 cards related to thoughts, feelings, events, behaviours and self-harm supports/services
Beck Hopelessness Scale Baseline to 12 weeks This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Autistic Depression Assessment Tool - Adult 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.
Kessler Psychological Distress Scale 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.
Euro-Qol-5 Dimensions scale 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)
Autism Diagnostic Observation Schedule Baseline Autism Diagnostic Observation Schedule is a semi-structured, standardized assessment measuring social interaction, communication, play, and imaginative use of materials for individuals suspected of experiencing ASD. It consists of four different modules as per the age and expressive language, from preverbal children to verbally proficient adults. Behaviours are coded in the areas of social communication, social relatedness, play and imagination, and restricted interests and repetitive behaviours. Internal consistency ranges from 0.47 to 0.94 for all domains and modules ranges from 0.47 to 0.94.