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临床试验/NCT06155838
NCT06155838已完成不适用

Reducing Depression and Anxiety Among Teens in Multan, Pakistan: a Cluster Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年11月27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
450
试验地点
1
主要终点
Aga Khan University Anxiety and Depression Scale (AKUADS-25)

研究概览

简要总结

The objective of this clinical trial is to assess the efficacy of the Early Adolescent Skills for Emotions (EASE) program, a school-based, non-specialist psychosocial intervention developed by the WHO for LMICs, in alleviating Anxiety and Depression among teens aged 13-19. The primary inquiries it seeks to address include:

Does the EASE intervention effectively reduce anxiety and depression scores 12 weeks after implementation?

  • Can the EASE intervention enhance quality of life, improve problem-solving skills, and increase perceived emotional support?
  • Is the EASE intervention beneficial for enhancing the psychological well-being of parents and fostering positive parent-teen relationships?

详细描述

Background:

Anxiety and depression significantly impact global adolescent mental health, with 1 in 4 adolescents requiring immediate attention. Many mental health disorders emerge in late childhood and early adolescence, worsening the burden on youth and later in life. In severe cases, suicide can occur at an alarming rate of one person every 40 seconds. In Pakistan, with a large population of 220 million, 50% aged between 12-25, the rates of anxiety and depression among adolescents are concerning. A recent study of 400 high school adolescents (15-18 years) in Pakistan revealed a prevalence of around 53% for anxiety and depression. Early preventive interventions like cognitive behaviour therapy and interpersonal therapy can empower adolescents to manage these issues, but accessing mental health services conveniently remains a challenge. Engaging mainstream academic institutions for early intervention in schools is crucial to combat anxiety, depression, and suicidal thoughts among adolescents in Pakistan.

Introduction:

Anxiety and depression pose significant psychological distress and mental health challenges for adolescents worldwide, highlighting the need for evidence-based psychological interventions tailored to teens. This study aims to assess the effectiveness of a school-based psychosocial intervention, the Early Adolescent Skills for Emotions (EASE) program developed by the WHO, in reducing psychosocial distress among adolescents aged 13-19.

Method and Analysis:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Teens aged 13-19 years
  • Living with parents/primary caregivers
  • Enrolled in public middle and high schools of Multan, Southern Punjab, Pakistan
  • Teens Assent - agreed and signed by teen
  • Informed consent from parents- agreed and signed by parents

排除标准

  • Teens part of a dysfunctional family
  • Psychiatric issues
  • Physical and sensory disorder diagnosis.

结局指标

主要结局

Aga Khan University Anxiety and Depression Scale (AKUADS-25)

时间窗: at 12 weeks' post-intervention

AKUADS will be used to assess anxiety and depression affecting the target population. Items score ranges from 0-3 (0= never, 1=sometime, 2=mostly, 3=always) for each question item hence the total score of the tool is 0-75. The higher the score the more anxiety and depression will be severe with the cut score of 19.

次要结局

  • The Kessler Psychological Distress Scale -10 (K-10)(at 12 weeks' post-intervention)
  • Strengths and Difficulty Questionnaire(at 12 weeks' post- intervention)
  • The Perceived Emotional/Personal Support Scale ( PEPSS)(at 12 weeks' post- intervention)
  • The Social Problem-Solving Inventory-Revised Short Form- 25(at 12 weeks' post- intervention)
  • Parent-rated Pediatric Quality of Life (PedsQL).(at 12 weeks' post- intervention)
  • Parenting practices(at 12 weeks' post- intervention)
  • The Psychological Sense of School Membership(at 12 weeks' post- intervention)
  • Moderating Factors(T1, T2, T3)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lubna Ghazal

PhD student

Aga Khan University

研究点 (1)

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