Clinical trial NCT04131179: Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)
Official title: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Harm
Keywords: Self-harm, adolescents, adaptation, problem solving, LMICs
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
Collaborators: name: University of Manchester
First posted: 2019-10-18
Enrollment: 684
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Suicide Attempt Self Injury Interview SASII
timeFrame: Change in scores from baseline to 12th months
Secondary outcomes:
measure: Beck Scale for Suicidal ideation (BSI)
timeFrame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
measure: Beck Hopelessness Scale
timeFrame: [Time Frame: Baseline,3rd,6th,9th and 12th months]
measure: Psychological Distress Scale
timeFrame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
measure: EuroQol-5 Dimensions (EQ5-D)
timeFrame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
measure: Client Satisfaction Questionnaire (CSQ).
timeFrame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
measure: Client Services Receipt Inventory CSRI
timeFrame: Change in scores from Baseline to 3rd, 6th, 9th and 12th month.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Karachi Site
state: Sindh
city: Lahore
country: Pakistan
facility: Lahore Site
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Site
Study officials:
affiliation: University of Manchester (OTHER SPONSOR_RESPONSIBLE PARTY)
name: Prof. Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Beck, A. T., & Steer, R. A. (1991). BSI, Beck scale for suicide ideation: manual: Psychological Corporation.
citation: Beck, A., & Steer, R. J. S. A., TX: Psychological Corporation. (1988). Manual for the Beck hopelessness scale
citation: Brooks R. EuroQol: the current state of play. Health Policy. 1996 Jul;37(1):53-72. doi: 10.1016/0168-8510(96)00822-6.
citation: 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.
citation: 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.
citation: Beecham, J., & Knapp, M. J. M. m. h. n. (2001). Costing psychiatric interventions. 2, 200-224.
citation: 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.
citation: 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.