NCT06155838

Reducing Depression and Anxiety Among Teens

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Accepted

Summary

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?

Detailed description

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: A two-parallel-arm, single-blinded, cluster randomized controlled trial will be conducted in Multan, Pakistan's school settings. Eight eligible public school clusters will be randomly allocated in a 1:1 ratio to the control arm (n=4) and intervention arm (n=4). The trial will recruit 450 adolescents (56 students from each school) experiencing psychosocial distress between April and May 2023. In the intervention arm, teens will receive the EASE program over 7 weeks, featuring psychoeducation, stress management, behavioural activation, problem-solving, and relapse prevention. Teachers will be trained in active listening, quality time spent, and the use of praise to assist their students. A qualitative study will explore facilitating and challenging factors related to intervention in low-resource school settings. Ethical Approval: Ethical approval has been obtained from the Ethics Committee of the School of Nursing at Shandong University, Jinan, China.

Conditions

• Anxiety
• Depression

Interventions

Type	Name	Description
OTHER	"Early Adolescent Skills for Emotions (EASE)	Weekly Schedule for Teen's and their parents Sessions: Over the course of 7 sessions, with one session per week lasting 90 minutes, the following core components will be covered: Week 1: Exploring My Feelings Week 2: Learning to Calm Week 3 \& 4: Learning CBT- Restructuring My Thinking, Changing Feelings and My Actions \& Managing My Emotions and Issues Week 5 \& 6: Fostering Independent Problem-Solving Skills and Seeking Help Week 7: Relapse Prevention 2.0 For parents/ guardians Week 3 Psychoeducation (to develop skills to be able to identify, listen, better respond and provide comfort to teens when they are overwhelmed by anxiety and depression). Week 4 Positive parenting strategies Week 5 Parents/ guardians Self-care

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2023-12-05
• Last updated: 2025-02-03

Locations

1 site across 1 country: Pakistan