Self HarmNCT04131179
Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)
A study testing Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in people with Self Harm, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
Trial summary
To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Self Harm
- What is being tested?
- Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 3 sitesPakistan
- Study dates
- 5 Nov 2019to 28 Feb 2023
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients age 12-18 years presenting to the participating GPs, emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
- History of recent self-harm. Recent self-harm is defined as self-harm occurring within the last 3 months (from the initial identification of a potential participant).
- Participants living within the catchment area of the participating practices and hospitals.
- Not needing inpatient psychiatric treatment.
Who cannot join
- Severe mental illness (such as Psychotic disorder) as Self-harm commonly co- occurs with other mental health difficulties.
- Conditions limiting engagement with assessment or intervention, including developmental and communication disorders, intellectual disabilities and autistic spectrum disorders.
- Temporary resident unlikely to be available for follow up.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Karachi Site
Karachi, Sindh
Lahore Site
Lahore, 540000
Rawalpindi Site
Rawalpindi, 46300
About this study
Official title: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm
To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm
Read the detailed description
Globally suicide is the second leading cause of death in young people 15-29 years of age. A recent review indicated that the reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an under estimate since suicide data from many Low and Middle Income Countries (LMICs) is lacking. There is little official data on suicide from Pakistan, where suicide and self-harm remains as criminal act and socially, religiously condemned. However, there is accumulating evidence that both self-harm and suicide rates have been increasing in Pakistan.
This is the first RCT of a psychological intervention for self-harm in children and young people in Pakistan. It follows from the work of "Multicentre RCT to evaluate the clinical and cost effectiveness of culturally adapted manual assisted psychological intervention"(CMAP) trial currently taking place in adults who have self-harmed in Pakistan, by evaluating whether a similar intervention, adapted for children and adolescents, could be clinically and cost effective.
- Conditions
- Self Harm
- Being tested
- Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)
- Keywords
- Self-harm, adolescents, adaptation, problem solving, LMICs
- Medical subject headings
- Self-Injurious Behavior
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 Therapy (Y-CMAP)Behavioural
Also called Psychosocial Intervention
Y-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), including 8-10 sessions delivered over three months.
This intervention includes evaluation of the self-harm attempt, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking,relapse prevention strategies and training on anger management and assertiveness.
| Study group | Role | What they receive |
|---|---|---|
| Youth culturally adapted therapy (Y-CMAP) | Experimental | Youth Culturally adapted manual assisted (Y-CMAP) psychological therapy Receives: Behavioral: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) |
| Treatment as Usual | No intervention | TAU will be standard routine care delivered by local medical, psychiatric and primary care services according to clinical judgement. A record will be kept of any treatment received by each participant. Assessment will be done at 3rd,6th,9th and 12 month after randomization along with TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Attempt Self Injury Interview SASII
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII). Higher number on repetition indicates worse outcome and vice versa
Measured: Change in scores from baseline to 12th months
Secondary outcomes (6)
Beck Scale for Suicidal ideation (BSI)
Suicidal ideation will be assessed with the Beck Scale for Suicide Ideation (BSS; Beck \& Steer, 1991), a 19-item self-report questionnaire, measuring the intensity and frequency of suicidal thoughts within the past week. Minimum total score is 0 and maximum total score can be 38. Higher scores indicate worse outcome.
Measured: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Beck Hopelessness Scale
This is a 20 items scale measuring hopelessness. Higher scores on the scale indicate greater severity of hopelessness. Minimum total score on this scale can be 0 and maximum total score can be 20, with higher levels of hopelessness indicated by higher scores on the scale.
Measured: [Time Frame: Baseline,3rd,6th,9th and 12th months]
Psychological Distress Scale
It's a 10 item scale measuring emotional states with a 5 level response scale. The maximum score is 50 indicating severe distress, and the minimum score is 10 indicating no distress.
Measured: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
EuroQol-5 Dimensions (EQ5-D)
A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression).
Measured: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Client Satisfaction Questionnaire (CSQ).
The participants will rate their satisfaction with treatment by using the CSQ. The total score ranges from 8 to 32. Higher scores indicate higher level of satisfaction.
Measured: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Client Services Receipt Inventory CSRI
We will collect information on the use of health services (including the informal sector such as faith healers/Imams)
Measured: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start5 Nov 2019
- Primary completion8 Sep 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Self HarmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Prof. Nusrat Husain, MD, Principal investigator, University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131179
- Sponsor's protocol ID
- PILL-YCMAP-001
- Status last verified
- Mar 2023
- First submitted
- 16 Oct 2019
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linehan MM, Comtois KA, Brown MZ, Heard HL, Wagner A. Suicide Attempt Self-Injury Interview (SASII): development, reliability, and validity of a scale to assess suicide attempts and intentional self-injury. Psychol Assess. 2006 Sep;18(3):303-12. doi: 10.1037/1040-3590.18.3.303.
PubMed 16953733Beck, A. T., & Steer, R. A. (1991). BSI, Beck scale for suicide ideation: manual: Psychological Corporation.
Beck, A., & Steer, R. J. S. A., TX: Psychological Corporation. (1988). Manual for the Beck hopelessness scale
Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
PubMed 10158943Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust N Z J Public Health. 2001 Dec;25(6):494-7. doi: 10.1111/j.1467-842x.2001.tb00310.x.
PubMed 11824981Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963Beecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.
Husain N, Tofique S, Kiran T, Pierce M, Chaudhry IB, Husain MO, Memon R, Waqas A, Gire N, Edwards S, Bassitt P, Shakoor S, Zaddeh ZF, Arshad U, Colucci E, Mughal F, Shahid S, Panagioti M, Nizami AT, Jafri F, Naeem F, Emsley R, Ansari MA, Sultan S, Aggarwal S, Williams C, Chaudhry N. Effectiveness of YCMAP (youth culturally adapted manual assisted problem solving) intervention in adolescents after self-harm in Pakistan: multicentre, randomised controlled trial. BMJ. 2025 Sep 12;390:e083272. doi: 10.1136/bmj-2024-083272.
PubMed 40940081Husain N, Tofique S, Chaudhry IB, Kiran T, Taylor P, Williams C, Memon R, Aggarwal S, Alvi MH, Ananiadou S, Ansari MA, Aseem S, Beck A, Alam S, Colucci E, Davidson K, Edwards S, Emsley R, Green J, Gumber A, Hawton K, Jafri F, Khaliq A, Mason T, Mcreath A, Minhas A, Naeem F, Naqvi HA, Noureen A, Panagioti M, Patel A, Poppleton A, Shiri T, Simic M, Sultan S, Nizami AT, Zadeh Z, Zafar SN, Chaudhry N. Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial. BMJ Open. 2022 May 13;12(5):e056301. doi: 10.1136/bmjopen-2021-056301.
PubMed 35568489Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
PubMed 33677832
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm
- ClinicalTrials.gov ID
- NCT04131179
- Acronym / sponsor ID
- PILL-YCMAP-001
- Conditions
- Self Harm
- Keywords
- Self-harm, adolescents, adaptation, problem solving, LMICs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 18 Oct 2019 (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.
To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm
Detailed description
Globally suicide is the second leading cause of death in young people 15-29 years of age. A recent review indicated that the reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an under estimate since suicide data from many Low and Middle Income Countries (LMICs) is lacking. There is little official data on suicide from Pakistan, where suicide and self-harm remains as criminal act and socially, religiously condemned. However, there is accumulating evidence that both self-harm and suicide rates have been increasing in Pakistan.
This is the first RCT of a psychological intervention for self-harm in children and young people in Pakistan. It follows from the work of "Multicentre RCT to evaluate the clinical and cost effectiveness of culturally adapted manual assisted psychological intervention"(CMAP) trial currently taking place in adults who have self-harmed in Pakistan, by evaluating whether a similar intervention, adapted for children and adolescents, could be clinically and cost effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth culturally adapted therapy (Y-CMAP) | Experimental | Behavioral: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)Youth Culturally adapted manual assisted (Y-CMAP) psychological therapy |
| Treatment as Usual | No intervention | –TAU will be standard routine care delivered by local medical, psychiatric and primary care services according to clinical judgement. A record will be kept of any treatment received by each participant. Assessment will be done at 3rd,6th,9th and 12 month after randomization along with TAU |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients age 12-18 years presenting to the participating GPs, emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
- History of recent self-harm. Recent self-harm is defined as self-harm occurring within the last 3 months (from the initial identification of a potential participant).
- Participants living within the catchment area of the participating practices and hospitals.
- Not needing inpatient psychiatric treatment.
Key exclusion criteria (3 listed)
- Severe mental illness (such as Psychotic disorder) as Self-harm commonly co- occurs with other mental health difficulties.
- Conditions limiting engagement with assessment or intervention, including developmental and communication disorders, intellectual disabilities and autistic spectrum disorders.
- Temporary resident unlikely to be available for follow up.
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 Therapy (Y-CMAP)Also: Psychosocial InterventionY-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), including 8-10 sessions delivered over three months. This intervention includes evaluation of the self-harm attempt, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking,relapse prevention strategies and training on anger management and assertiveness. | Behavioural | Youth culturally adapted therapy (Y-CMAP) |
Primary outcome
Suicide Attempt Self Injury Interview SASII
Time frame: Change in scores from baseline to 12th months
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII). Higher number on repetition indicates worse outcome and vice versa
6 secondary outcomes
Beck Scale for Suicidal ideation (BSI)
Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Beck Hopelessness Scale
Time frame: [Time Frame: Baseline,3rd,6th,9th and 12th months]
Psychological Distress Scale
Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
EuroQol-5 Dimensions (EQ5-D)
Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Client Satisfaction Questionnaire (CSQ).
Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Client Services Receipt Inventory CSRI
Time frame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
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 3 Apr 2023.
- Background: PubMed 16953733Linehan MM, Comtois KA, Brown MZ, Heard HL, Wagner A. Suicide Attempt Self-Injury Interview (SASII): development, reliability, and validity of a scale to assess suicide attempts and intentional self-injury. Psychol Assess. 2006 Sep;18(3):303-12. doi: 10.1037/1040-3590.18.3.303.
- BackgroundBeck, A. T., & Steer, R. A. (1991). BSI, Beck scale for suicide ideation: manual: Psychological Corporation.
- BackgroundBeck, A., & Steer, R. J. S. A., TX: Psychological Corporation. (1988). Manual for the Beck hopelessness scale
- Background: PubMed 10158943Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
- Background: PubMed 11824981Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust N Z J Public Health. 2001 Dec;25(6):494-7. doi: 10.1111/j.1467-842x.2001.tb00310.x.
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- BackgroundBeecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.
- Derived from this study: PubMed 40940081Husain N, Tofique S, Kiran T, Pierce M, Chaudhry IB, Husain MO, Memon R, Waqas A, Gire N, Edwards S, Bassitt P, Shakoor S, Zaddeh ZF, Arshad U, Colucci E, Mughal F, Shahid S, Panagioti M, Nizami AT, Jafri F, Naeem F, Emsley R, Ansari MA, Sultan S, Aggarwal S, Williams C, Chaudhry N. Effectiveness of YCMAP (youth culturally adapted manual assisted problem solving) intervention in adolescents after self-harm in Pakistan: multicentre, randomised controlled trial. BMJ. 2025 Sep 12;390:e083272. doi: 10.1136/bmj-2024-083272.
- Derived from this study: PubMed 35568489Husain N, Tofique S, Chaudhry IB, Kiran T, Taylor P, Williams C, Memon R, Aggarwal S, Alvi MH, Ananiadou S, Ansari MA, Aseem S, Beck A, Alam S, Colucci E, Davidson K, Edwards S, Emsley R, Green J, Gumber A, Hawton K, Jafri F, Khaliq A, Mason T, Mcreath A, Minhas A, Naeem F, Naqvi HA, Noureen A, Panagioti M, Patel A, Poppleton A, Shiri T, Simic M, Sultan S, Nizami AT, Zadeh Z, Zafar SN, Chaudhry N. Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial. BMJ Open. 2022 May 13;12(5):e056301. doi: 10.1136/bmjopen-2021-056301.
- Derived from this study: PubMed 33677832Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Pakistan Institute of Living and LearningLink provided by the sponsor.
- 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.
Prof. Nusrat Husain, MD principal investigator
University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)
3 sites 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 Therapy (Y-CMAP) in people with Self Harm, run by Pakistan Institute of Living and Learning at 3 sites 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Suicide Attempt Self Injury Interview SASII (time frame: Change in scores from baseline to 12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131179, which also lists 10 linked publications.
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 3 Apr 2023.