Autism Spectrum DisorderNCT06591130
Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
A study testing Youth culturally adapted manual assisted psychological intervention (Y-CMAP) in people with Autism Spectrum Disorder and Self Harm, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 24 years
- Conditions the study is for
- Autism Spectrum Disorder, Self Harm
- What is being tested?
- Youth culturally adapted manual assisted psychological intervention (Y-CMAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder, Self Harm
- Being tested
- Youth culturally adapted manual assisted psychological intervention (Y-CMAP)
- Keywords
- Autism, Self harm, Youth suicidality
- Medical subject headings
- Autism Spectrum Disorder, Self-Injurious Behavior, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth culturally adapted manual assisted psychological intervention (Y-CMAP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Y-CMAP + TAU | Experimental | Not described Receives: Behavioral: Youth culturally adapted manual assisted psychological intervention (Y-CMAP) |
| TAU alone | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility
Data on recruitment and retention rates. The success criterion of feasibility will be to recruit > 50% of eligible participants and retain 70%.
Measured: 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.
Measured: Baseline to 12 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: Baseline to 12 weeks
Card sort Task for Self-harm Behavior
117 cards related to thoughts, feelings, events, behaviours and self-harm supports/services
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nasim Chaudhry, FRCPsych, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591130
- Sponsor's protocol ID
- OAR-ASD-002
- Status last verified
- Jun 2026
- First submitted
- 16 Aug 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of a Culturally Adapted Intervention to Prevent Self-harm in Young People With Autism
- ClinicalTrials.gov ID
- NCT06591130
- Acronym / sponsor ID
- OAR-ASD-002
- Conditions
- Autism Spectrum Disorder, Self Harm
- Keywords
- Autism, Self harm, Youth suicidality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-CMAP + TAU | Experimental | Behavioral: Youth culturally adapted manual assisted psychological intervention (Y-CMAP) |
| TAU alone | No intervention | –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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Y-CMAP + TAU |
Primary outcome
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%.
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.
8 secondary outcomes
Suicide Attempt and Self-Harm
Time frame: Baseline to 12 weeks
Beck Scale for Suicide Ideation
Time frame: Baseline to 12 weeks
Card sort Task for Self-harm Behavior
Time frame: Baseline to 12 weeks
Beck Hopelessness Scale
Time frame: Baseline to 12 weeks
Autistic Depression Assessment Tool - Adult
Time frame: Baseline to 12 weeks
Kessler Psychological Distress Scale
Time frame: Baseline to 12 weeks
Euro-Qol-5 Dimensions scale
Time frame: Baseline to 12 weeks
Childhood Autism Rating Scale-2
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasim Chaudhry, FRCPsych principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth culturally adapted manual assisted psychological intervention (Y-CMAP) in people with Autism Spectrum Disorder and Self Harm, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.