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

Pakistan Institute of Living and Learning

Status: Completed

Conditions: Self Harm

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04131179

PILL-YCMAP-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 684 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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684 participants in 2 patient groups

Youth culturally adapted therapy (Y-CMAP)

Experimental group

Description:

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

Treatment:

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

Treatment as Usual

No Intervention group

Description:

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