Reducing Depression and Anxiety Among Teens

NCT ID: NCT06155838

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-03-31

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.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

"Early Adolescent Skills for Emotions (EASE)

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong University

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Lubna Ghazal

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lubna Ghazal

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Coa Fenglin

Role: STUDY_CHAIR

Shandong University - China

Cui Naixue

Role: STUDY_DIRECTOR

Shandong University - China

Locations

Office of the Chief Executive Officer, District Education Authority, Multan

Multan Khurd, Punjab Province, Pakistan

Countries

Pakistan

References

Ghazal L, Cui N, Cao F. To evaluate the EASE intervention for reducing anxiety and depression among adolescents in Pakistan: a protocol for a mixed methods study, including a cluster-randomised controlled trial. BMJ Open. 2025 Mar 22;15(3):e086393. doi: 10.1136/bmjopen-2024-086393.

Reference Type: DERIVED

PMID: 40122537 (View on PubMed)

Other Identifiers

AgaKhanUGhazalet.al(2023)

Identifier Type: -

Identifier Source: org_study_id