Brave Heart Intervention and Mental Health Outcomes Among Young People in Sierra Leone

NCT07853092 | Completed

• 2 other identifiers: SLESRC No - 015/03/2025BEING-2504-73418
• Study Type: interventional
• Target: 2,244
• Locations: 1 country
• Sites: 1

Brief Summary

Young people in Sierra Leone face a growing crisis of substance use and mental health struggles, but the country has very few mental health professionals to help them, only a handful of psychiatrists and no psychologists for a population of over 8 million. At the same time, use of a synthetic drug known as "kush" has risen sharply among adolescents and young adults, and hospital admissions related to it have increased dramatically in recent years. The Brave Heart Intervention is a research study testing a different way of getting help to young people: instead of relying only on scarce specialists, the study trains teachers and community leaders to deliver substance use prevention education and basic mental health support themselves. This approach, known as "task-shifting," has worked well in other under-resourced settings and aims to make prevention services available in places, schools and neighborhoods, that young people already spend time in. The study will take place in Freetown, the capital of Sierra Leone. Forty secondary schools and four communities will take part. Half will receive the Brave Heart Intervention (the "intervention group") and half will continue with usual practice for now (the "control group"), with schools and communities assigned to each group by chance, similar to a coin flip. This design allows researchers to fairly compare outcomes between the two groups. The intervention itself combines three elements: sessions that teach young people to recognize and manage difficult emotions and thoughts (drawing on cognitive-behavioral techniques), training in practical life and digital skills, and work with local leaders and policymakers to support drug prevention efforts over the long term. Teachers and community leaders receive training and ongoing supervision so they can deliver these sessions safely and effectively. Participants are young people aged 10 to 24, along with the teachers and community leaders who help deliver the program. The study will measure whether young people's ability to refuse or resist substance use improves, whether their overall mental well-being and life satisfaction improve, whether their knowledge about substance use and mental health increases, and whether their confidence in handling life's challenges (self-efficacy) and everyday life skills, such as communication, problem-solving, and coping with stress, improve. The study will also ask teachers and community leaders about their own knowledge and confidence in delivering this kind of support, and will explore, through group discussions and interviews, how practical, acceptable, and sustainable this approach feels to the people involved. By testing whether trained non-specialists can safely and effectively deliver mental health and substance use prevention support, this study aims to help identify a scalable model that could be adapted more broadly across Sierra Leone and similar low-resource settings, where specialist care is difficult to access.

Conditions

Substance-related Disorders; Mental Health Literacy; Adolescent Health; Substance Use Disorder (SUD)

Keywords

Substance use disorder; Task-shifting; Mental health literacy; Adolescents; Young People; School-based intervention; Drug Abstinence; Mental Health; Cluster randomized trial

Outcome Measures

Primary Outcomes (3)

• Change in Substance Use Refusal Skills (DASES)

  Substance use refusal skills will be assessed using the Drug Abstinence Self-Efficacy Scale (DASES), which measures participants' confidence in refusing substance use across various situations. A clinically meaningful improvement is defined as a 3-point increase in refusal skills score from baseline to endline, compared between intervention and control arms.

  Baseline, pre-intervention; 1 month after the intervention

• Change in Mental Well-being (WHO-5 Well-Being Index)

  Mental well-being will be assessed using the WHO-5 Well-Being Index, which measures subjective well-being over the previous two weeks on a scale from 0 to 100. A clinically meaningful improvement is defined as a greater than 50% increase in well-being score from baseline to endline, compared between intervention and control arms.

  Baseline, pre-intervention; 1 month after the intervention

• Change in Knowledge of SUD Prevention and Mental Health Literacy (MHLQ)

  Knowledge of substance use disorder prevention and mental health literacy will be assessed using the Mental Health Literacy Questionnaire (MHLQ). A clinically meaningful improvement is defined as a greater than 50% increase in knowledge score from baseline to endline, compared between intervention and control arms.

  Baseline, pre-intervention; 1 month after the intervention

Secondary Outcomes (1)

• Teacher and Community Leader Knowledge of SUD Prevention and Mental Health Literacy

  Baseline, pre-training; 3 weeks after training

Study Arms (2)

Brave Heart Intervention Arm

EXPERIMENTAL

Participants in 20 intervention secondary schools and 2 intervention communities in Freetown, Sierra Leone receive the Brave Heart Intervention. Trained teachers (in schools) and trained community leaders, including individuals with lived experience of substance use disorder (in communities), deliver a structured curriculum combining cognitive-behavioral psychoeducation, life and digital skills training (supported by the SIMBIHealth mobile application), and community/policy engagement activities. The intervention is delivered over the study period to groups of young people aged 10-24, with the aim of improving substance use refusal skills, mental well-being, knowledge of substance use disorder (SUD) prevention and mental health literacy, self-efficacy, and life skills. Teachers and community leaders also receive training and supervision to build their own capacity to deliver the intervention.

Behavioral: Brave Heart Intervention

Control Arm

NO INTERVENTION

Participants in 20 control secondary schools and 2 control communities in Freetown, Sierra Leone continue with usual school and community practice during the study period, without receiving the Brave Heart Intervention curriculum. No structured substance use disorder prevention or mental health literacy program is delivered to this arm by the study team. Control participants complete the same baseline and endline assessments as the intervention arm.

Interventions

Brave Heart Intervention BEHAVIORAL

Task-Shifting SUD Prevention and Mental Health Literacy Program

Also known as: Brave Heart Intervention Programme

Brave Heart Intervention Arm

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Schools:
• Located in Freetown, Sierra Leone Willing to participate in the intervention Willing to allocate time for the intervention as required Willing to sign a Memorandum of Understanding, data sharing agreement, and provide relevant documentation to the research team
• Students and Young People in the Community:
• Aged 10-24 years Willing to participate in the intervention and provide written assent/informed consent, or written informed consent from a parent or guardian where applicable Enrolled in a selected secondary school or residing in a selected community

You may not qualify if:

• Not enrolled in a selected secondary school and not residing in a selected community Unwilling or unable to provide written informed consent/assent (or, for minors, unable to obtain parental/guardian consent) Schools or communities unwilling to sign the required Memorandum of Understanding or data sharing agreement

Sponsors & Collaborators

• Slum and Rural Health Initiative: lead
• Grand Challenges Canada: collaborator

Study Sites (1)

40 secondary schools and 4 community groups drawn from the East End, Central, and West End regions

Freetown, Sierra Leone

Location

MeSH Terms

Conditions

Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Isaac I Olufadewa, Ph.D

  Slum and Rural Health Initiative, Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster randomized controlled trial with parallel assignment. Twenty secondary schools (stratified by Western Urban/Western Rural location) and two communities are randomized to the intervention arm; twenty schools and two communities are randomized to the control arm. Randomization occurs at the cluster level (school/community) rather than the individual level, since the intervention is delivered to intact groups of students or community youth by trained teachers or community leaders. This design reduces contamination between arms that could occur if intervention and control participants shared the same school or community environment. Intervention and control clusters are followed concurrently, with outcomes assessed at baseline and endline and compared using mixed-effects multilevel regression models accounting for clustering.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: October 1, 2026
• Study Start: July 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

SI (1)