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Clinical Trials/NCT04131179
NCT04131179
Completed
Not Applicable

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

Pakistan Institute of Living and Learning3 sites in 1 country684 target enrollmentNovember 5, 2019
ConditionsSelf Harm

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Self Harm
Sponsor
Pakistan Institute of Living and Learning
Enrollment
684
Locations
3
Primary Endpoint
Suicide Attempt Self Injury Interview SASII
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2019
End Date
February 28, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Suicide Attempt Self Injury Interview SASII

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

Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII). Higher number on repetition indicates worse outcome and vice versa

Secondary Outcomes

  • Client Services Receipt Inventory CSRI(Change in scores from Baseline to 3rd, 6th, 9th and 12th month.)
  • Beck Scale for Suicidal ideation (BSI)(Change in scores from Baseline to 3rd, 6th, 9th and 12th month.)
  • 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.)
  • Beck Hopelessness Scale([Time Frame: Baseline,3rd,6th,9th and 12th months])
  • Client Satisfaction Questionnaire (CSQ).(Change in scores from Baseline to 3rd, 6th, 9th and 12th month.)

Study Sites (3)

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