Clinical trial NCT06155838: Reducing Depression and Anxiety Among Teens
Official title: Reducing Depression and Anxiety Among Teens in Multan, Pakistan: a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Shandong University
First posted: 2023-12-05
Enrollment: 450
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Aga Khan University Anxiety and Depression Scale (AKUADS-25)
timeFrame: at 12 weeks' post-intervention
Secondary outcomes:
measure: The Kessler Psychological Distress Scale -10 (K-10)
timeFrame: at 12 weeks' post-intervention
measure: The Perceived Emotional/Personal Support Scale ( PEPSS)
timeFrame: at 12 weeks' post- intervention
measure: The Social Problem-Solving Inventory-Revised Short Form- 25
timeFrame: at 12 weeks' post- intervention
measure: Parent-rated Pediatric Quality of Life (PedsQL).
timeFrame: at 12 weeks' post- intervention
measure: Parenting practices
timeFrame: at 12 weeks' post- intervention
measure: The Psychological Sense of School Membership
timeFrame: at 12 weeks' post- intervention
measure: Strengths and Difficulty Questionnaire
timeFrame: at 12 weeks' post- intervention
measure: Moderating Factors
timeFrame: T1, T2, T3
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Office of the Chief Executive Officer, District Education Authority, Multan
state: Punjab
Study officials:
affiliation: Aga Khan University
name: Lubna Ghazal
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong University - China
name: Coa Fenglin
role: STUDY_CHAIR
affiliation: Shandong University - China
name: Cui Naixue
role: STUDY_DIRECTOR
References: