CClinicalTrials.gg
CompletedNCT04131179Updated Apr 3, 2023

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

An interventional study of Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Self Harm, sponsored by Pakistan Institute of Living and Learning. Completed at 3 sites in Pakistan. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-03.

Sponsored by Pakistan Institute of Living and Learning · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
684
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Self Harm

Keywords

  • Self-harm, adolescents, adaptation, problem solving, LMICs
03

In context

Self-Injurious Behavior

249 studies on the registry are indexed under Self-Injurious Behavior; 92 are open to participants now.

This study's enrollment of 684 is above the median of 66 across 212 interventional studies indexed under Self-Injurious Behavior.

Browse Self-Injurious Behavior studies →

Lead sponsor

Pakistan Institute of Living and Learning is the lead sponsor of 59 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
684 participants (actual)

Study arms

  • Experimental
    Youth culturally adapted therapy (Y-CMAP)

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

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

  • No intervention
    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

Interventions

  • BehavioralYouth 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.

    Also known as: Psychosocial Intervention

06

What researchers measure

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

    Time frame: Change in scores from baseline to 12th months

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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.

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

  6. Client Services Receipt Inventory CSRI

    We will collect information on the use of health services (including the informal sector such as faith healers/Imams)

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

07

Study locations

3 sites
  • Karachi Site
    Karachi, Sindh, Pakistan
  • Lahore Site
    Lahore, 540000, Pakistan
  • Rawalpindi Site
    Rawalpindi, 46300, Pakistan
08

References and documents

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 16953733 ↗
  • Beck, 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 10158943 ↗
  • 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. PubMed 11824981 ↗
  • 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. PubMed 10259963 ↗
  • Beecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.
  • 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. PubMed 35568489 ↗
  • 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. PubMed 33677832 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04131179
Lead sponsor
Pakistan Institute of Living and Learning
Collaborators
University of Manchester
Responsible party
Sponsor
First posted
Oct 18, 2019
Start date
Nov 5, 2019
Primary completion
Sep 8, 2022
Completion
Feb 28, 2023
Last update
Apr 3, 2023

Study contacts

Prof. Nusrat Husain, MD
principal investigator · University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion