Reducing Depression and Anxiety Among Teens

NCT06155838 | Completed DMC

• 1 other identifier: AgaKhanUGhazalet.al(2023)
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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?

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• The Kessler Psychological Distress Scale -10 (K-10)

  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

Study Arms (2)

EASE Intervention

EXPERIMENTAL

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)

control/ wait list

NO INTERVENTION

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.

Interventions

"Early Adolescent Skills for Emotions (EASE) 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

EASE Intervention

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• Shandong University: collaborator

Study Sites (1)

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

Multan Khurd, Punjab Province, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 40122537 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lubna Ghazal

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Coa Fenglin

  Shandong University - China

  STUDY CHAIR

• Cui Naixue

  Shandong University - China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: December 5, 2023
• Study Start: November 27, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: June 2026- December 2026
• Access Criteria: Anyone with a reasonable reason

Locations

PA (1)