Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)

NCT ID: NCT04131179

Last Updated: 2023-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 684 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2023-02-28

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Youth culturally adapted therapy (Y-CMAP)

Youth Culturally adapted manual assisted (Y-CMAP) psychological therapy

Group Type: EXPERIMENTAL

Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)

Intervention Type: BEHAVIORAL

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.

Treatment as Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychosocial Intervention

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Nusrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)

Locations

Karachi Site

Karachi, Sindh, Pakistan

Lahore Site

Lahore, , Pakistan

Rawalpindi Site

Rawalpindi, , Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

PMID: 16953733 (View on PubMed)

Beck, A. T., & Steer, R. A. (1991). BSI, Beck scale for suicide ideation: manual: Psychological Corporation.

Reference Type: BACKGROUND

Beck, A., & Steer, R. J. S. A., TX: Psychological Corporation. (1988). Manual for the Beck hopelessness scale

Reference Type: BACKGROUND

Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.

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PMID: 10158943 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 10259963 (View on PubMed)

Beecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.

Reference Type: BACKGROUND

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.

Reference Type: DERIVED

PMID: 40940081 (View on PubMed)

Husain 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.

Reference Type: DERIVED

PMID: 35568489 (View on PubMed)

Witt 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.

Reference Type: DERIVED

PMID: 33677832 (View on PubMed)

Related Links

http://pill.org.pk

Pakistan Institute of Living and Learning

Other Identifiers

PILL-YCMAP-001

Identifier Type: -

Identifier Source: org_study_id