跳至主要内容
临床试验/NCT04131179
NCT04131179已完成不适用

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

Pakistan Institute of Living and Learning5 个研究点 分布在 1 个国家目标入组 684 人开始时间: 2019年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
684
试验地点
5
主要终点
Suicide Attempt Self Injury Interview SASII

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Suicide Attempt Self Injury Interview SASII

时间窗: 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

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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