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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
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.
Pakistan Centre for Autism
Karachi, Sindh, Pakistan
Intervention feasibility
Data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants and retain 70%.
Time frame: 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.
Time frame: Baseline to 12 weeks
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.
Time frame: 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.
Time frame: Baseline to 12 weeks
Card sort Task for Self-harm Behavior
117 cards related to thoughts, feelings, events, behaviours and self-harm supports/services
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Baseline
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