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

NCT04131179 | Completed DMC

• 1 other identifier: PILL-YCMAP-001
• Study Type: interventional
• Target: 684
• Locations: 1 country
• Sites: 3

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

Conditions

Self Harm

Keywords

Self-harm, adolescents, adaptation, problem solving, LMICs

Outcome Measures

Primary Outcomes (1)

• 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

  Change in scores from baseline to 12th months

Secondary Outcomes (6)

• Beck Scale for Suicidal ideation (BSI)

  Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

• Beck Hopelessness Scale

  [Time Frame: Baseline,3rd,6th,9th and 12th months]

• Psychological Distress Scale

  Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

• EuroQol-5 Dimensions (EQ5-D)

  Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

• Client Satisfaction Questionnaire (CSQ).

  Change in scores from Baseline to 3rd, 6th, 9th and 12th month.

Study Arms (2)

Youth culturally adapted therapy (Y-CMAP)

EXPERIMENTAL

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

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

Interventions

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

Also known as: Psychosocial Intervention

Youth culturally adapted therapy (Y-CMAP)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead
• University of Manchester: collaborator

Study Sites (3)

Karachi Site

Karachi, Sindh, Pakistan

Location

Lahore Site

Lahore, 540000, Pakistan

Location

Rawalpindi Site

Rawalpindi, 46300, Pakistan

Location

Related Publications (10)

• 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.

  PMID: 16953733 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 10158943 BACKGROUND

• Andrews 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.

  PMID: 11824981 BACKGROUND

• Attkisson 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.

  PMID: 10259963 BACKGROUND

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

  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.

  PMID: 40940081 DERIVED

• 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.

  PMID: 35568489 DERIVED

• 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.

  PMID: 33677832 DERIVED

Related Links

• Pakistan Institute of Living and Learning

MeSH Terms

Conditions

Self-Injurious Behavior

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prof. Nusrat Husain, MD

  University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: November 5, 2019
• Primary Completion: September 8, 2022
• Study Completion: February 28, 2023
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)