Reducing Depression and Anxiety Among Teens

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

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?

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression; Anxiety
• Intervention / Treatment: Other: "Early Adolescent Skills for Emotions (EASE)

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Multān, Punjab, Pakistan
      • Office of the Chief Executive Officer, District Education Authority, Multan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Teens aged 13-16 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EASE Intervention; The intervention consists of four fundamental themes that have empirical support, structured across seven group sessions for adolescents and three group sessions for their parents or guardians. The sessions for teenagers will be conducted in person, spanning seven weeks with one session per week, each lasting 90 minutes. Similarly, three sessions are scheduled for parents. In accordance with WHO guidelines (2016), the intervention will be administered by non-specialist co-facilitators(class teachers) who possess at least 16 years of education (undergraduate degree). These co-facilitators will undergo a ten-day training program, demonstrating mock sessions as part of this training. During the intervention delivery, they will also benefit from weekly supervision provided by a specialist, who will be a graduate psychologist or trained nurse in mental health.	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
No Intervention: control/ wait list; Throughout the study, participants in the control group will continue to receive standard treatment. Nevertheless, following the conclusion of the trial, all control group participants will undergo the EASE intervention over a seven-week period, which will also involve three sessions for their parents and guardians. This approach ensures that the control group is not placed at a disadvantage, in alignment with ethical principles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aga Khan University Anxiety and Depression Scale (AKUADS-25)	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.	at 12 weeks' post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Kessler Psychological Distress Scale -10 (K-10)	K-10 will assess psychological distress among teens and parents. It will be measured on a scale from five to one (5=all of the time; 4= Most of the time; 3 some of the time; 2= A little of the time; 1= none of the time). The scores range from 6 to 30, by summing the individual items, total scores are calculated. The higher scores indicate high psychological distress.	at 12 weeks' post-intervention
The Perceived Emotional/Personal Support Scale ( PEPSS)	The Perceived Emotional/Personal Support Scale ( PEPSS) measures the perceived emotional support. On a four-point scale - hardly at all 4 to very much 1. The higher scores show a lack of perceived support.	at 12 weeks' post- intervention
The Social Problem-Solving Inventory-Revised Short Form- 25	it measures problem-solving skills in a situation. The total score of this scale varies between 0 and 20 points. The highest scores correspond to better social problem-solving abilities.	at 12 weeks' post- intervention
Parent-rated Pediatric Quality of Life (PedsQL).	This tool will be utilized to assess the child's quality of life (health-related). This tool measures a child's quality of health on a points Likert scale ranging from 'no problem= 1' to 'almost always a problem= 4'. "Items are then reverse-scored and linearly transformed to a 0-100 so that higher scores indicate better quality of life.	at 12 weeks' post- intervention

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: Shandong University
• Investigators: Principal Investigator: Lubna Ghazal, Aga Khan University; Study Chair: Coa Fenglin, Shandong University - China; Study Director: Cui Naixue, Shandong University - China

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: AgaKhanUGhazalet.al(2023)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No