ABC School Intervention Among Ugandan Adolescents

NCT ID: NCT06957925

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-12

Study Completion Date

2024-05-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school. Adolescents from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction: Schools can be pivotal in addressing mental health challenges, especially in low-income settings like Uganda. However, randomized controlled trials tailored to cultural and contextual factors are scarce. This pilot cluster-randomized trial examines the impact of a culturally sensitive Act-Belong-Commit (ACT) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among Ugandan adolescents attending secondary school.

Methods: A total of 2,598 adolescents (1,295 intervention; 1,303 control; 1,199 boys \[46.1%\]; mean age 16.3 ± 1.0 years) from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led ACT intervention or a care-as-usual control. Anxiety (GAD-7) and depression (PHQ-9-A) were measured at baseline and immediately post-intervention. Childhood trauma (CTQ-SF), self-reported health, wealth, and food security were assessed at baseline. Linear mixed modeling was used to evaluate intervention effects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

PARALLEL

pilot cluster-randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Masked for group allocation

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABC

Group Type EXPERIMENTAL

educational

Intervention Type BEHAVIORAL

Teachers were provided with a manual that could be implemented in a flexible way adapted to the local context of the school consisting of six sessions. The manual assisted teachers to prepare students for success in understanding what is a good mental health (session 1), how to optimize and maintain good mental health, with a particular focus on being mentally, spiritually, socially and physically active including coping with stressors via breathing exercises and progressive muscle relaxation techniques (session 2), physical activity participation (session 3) and sleep hygiene measures (session 4), the importance of belongingness and commitment (session 5), and how to seek support including peer support, community engagement and existing local services (session 6). The first 6 sessions were facilitated by the teacher, and the next 6 by peers.

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

educational

Teachers were provided with a manual that could be implemented in a flexible way adapted to the local context of the school consisting of six sessions. The manual assisted teachers to prepare students for success in understanding what is a good mental health (session 1), how to optimize and maintain good mental health, with a particular focus on being mentally, spiritually, socially and physically active including coping with stressors via breathing exercises and progressive muscle relaxation techniques (session 2), physical activity participation (session 3) and sleep hygiene measures (session 4), the importance of belongingness and commitment (session 5), and how to seek support including peer support, community engagement and existing local services (session 6). The first 6 sessions were facilitated by the teacher, and the next 6 by peers.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All students aged 14 to 17 years in the four schools were screened for depression and anxiety using the Patient Health Questionnaire - 9 (PHQ-9) (Spitzer et al., 1999) and Generalized Anxiety Disorder - 7 (GAD-7) (Spitzer et al., 2006) as part of school health screening service embedded within the study.

Exclusion Criteria

* None
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Davy Vancampfort

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School

Gulu, , Uganda

Site Status

School

Masaka, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUREC 0501-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.