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Completed

NCT Number: NCT06957925

ABC School Intervention Among Ugandan Adolescents

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Deafness, Autosomal Dominant 20 Depression Depression Disorders Mental Disorders Motor Activity

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School, Gulu, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational

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.

Primary outcomes

  1. Patient Health Questionnaire -9

    Time frame: 2 weeks

  2. Generalized Anxiety Disorder - 7

    Time frame: 2 weeks

Secondary outcomes

  1. Patient Health Questionnaire -9

    Time frame: 2 weeks

    Item 9: suicidal ideation

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

A Cultural-sensitive Act-Belong-Commit-based School Intervention Reduces the Burden of Anxiety and Depression in Adolescents: a Pilot Cluster-randomized Trial From Uganda

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 6, 2025
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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