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

Study Overview
=================
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.

Official Title
-----------------
Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP) in Adolescents Pakistani Patients With a History of Self Harm

Conditions
-----------------
Self Harm

Intervention / Treatment
-----------------
* Behavioral: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Youth culturally adapted therapy (Y-CMAP)<br>Youth Culturally adapted manual assisted (Y-CMAP) psychological therapy | Behavioral: Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)<br>* 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.<br>* Other names: Psychosocial Intervention;|
| No Intervention: Treatment as Usual<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | [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. | 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). | 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. | 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) | Change in scores from Baseline to 3rd, 6th, 9th and 12th month. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self-harm, adolescents, adaptation, problem solving, LMICs