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Substance-related DisordersNCT07853092

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

A study testing Brave Heart Intervention in people with Substance-related Disorders and Mental Health Literacy, run by Slum and Rural Health Initiative at 1 site in Sierra Leone.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 24 yearsHealthy volunteers can take part
What is being tested?
Brave Heart Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,244 participants
Where
1 siteSierra Leone
Study dates
1 Jul 2025to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sierra Leone1 site
  • 40 secondary schools and 4 community groups drawn from the East End, Central, and West End regions

    Freetown

Other trials in Sierra Leone

About this study

Official title: Assessing the Impact of the Brave Heart Intervention on Mental Health Literacy, Well-Being and Drug Abstinence Self-Efficacy Among Young People in Sierra Leone

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.

Read more

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.

Read the detailed description

Substance use disorders (SUDs) and poor mental health literacy are major contributors to disability among young people worldwide, with roughly half of adult mental disorders emerging before age 14 and three-quarters before age 24. Sierra Leone, a post-conflict, low-income country with a median age of 19, faces a particularly severe version of this burden. The national mental health workforce consists of only a small number of psychiatrists and no psychologists for a population exceeding 8 million, and mental health care is centralized in a single, chronically underfunded psychiatric hospital in Freetown. Over the past several years, the country has seen a sharp rise in use of "kush," a synthetic cannabinoid-like substance, among adolescents and young adults, with drug-related hospital admissions increasing dramatically since 2020. Existing national drug policy is oriented toward punitive enforcement rather than prevention, and no structured, evidence-based SUD prevention or mental health literacy programs currently operate at scale in Sierra Leonean schools or communities.

Given the shortage of specialist providers, this study tests a task-shifting model: delegating delivery of a structured prevention curriculum to trained non-specialists, secondary school teachers and community leaders, who are themselves supervised and equipped through a standardized training program. Task-shifting approaches have shown feasibility and effectiveness in other low-resource global health contexts, including for mental health service delivery, but have not been rigorously evaluated for SUD prevention and mental health literacy promotion in Sierra Leone specifically.

The Brave Heart Intervention integrates three components delivered jointly: (1) structured psychoeducation and cognitive-behavioral techniques aimed at helping young people recognize and manage risk factors for substance use and mental health difficulties; (2) life skills and digital skills training intended to strengthen coping capacity, resilience, and future economic opportunity, partly delivered through a mobile health application (SIMBIHealth); and (3) community and policy engagement activities intended to build local ownership and support sustained, systemic uptake of prevention practices beyond the trial period.

This is a cluster randomized controlled trial. Randomization occurs at the cluster level, schools and communities, rather than individuals, to reflect the way the intervention is naturally delivered (to intact groups of students within a school, or community members within a defined community) and to reduce contamination between intervention and control participants who share the same social environment. Twenty secondary schools and two communities are allocated to the intervention arm, and twenty schools and two communities to the control arm, drawn from Freetown's Western Urban and Western Rural areas to capture both urban and semi-urban/rural variation.

Within intervention schools, teachers are trained and then deliver the curriculum to groups of students; within intervention communities, trained community members (with preference given to individuals with lived experience of substance use disorder) deliver the curriculum to youth participants. Data are collected from young people (ages 10-24), as well as from the teachers and community leaders who deliver the intervention, using validated quantitative instruments administered electronically at baseline and endline, alongside qualitative focus group discussions and in-depth interviews conducted with a purposive subset of participants at both timepoints. Quantitative analysis will use mixed-effects multilevel regression models to account for clustering by school/community while comparing change scores between intervention and control arms; qualitative data will be analyzed using thematic content analysis with dual coding and inter-coder reliability checks. A parallel policy analysis will assess baseline adoption of SUD- and mental-health-relevant policies in participating schools and communities.

The study is grounded in the Government of Sierra Leone's Education Sector Plan, which identifies student mental health and well-being as a strategic priority, and is intended to generate evidence on whether a task-shifted, school- and community-based prevention model is a feasible, acceptable, and effective way to extend SUD prevention and mental health support to young people in settings where specialist care is largely inaccessible.

Being tested
Brave Heart Intervention
Keywords
Substance use disorder, Task-shifting, Mental health literacy, Adolescents, Young People, School-based intervention, Drug Abstinence, Mental Health, Cluster randomized trial
Medical subject headings
Substance-Related Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brave Heart InterventionBehavioural

    Also called Brave Heart Intervention Programme

    Task-Shifting SUD Prevention and Mental Health Literacy Program

Study groups in NCT07853092
Study groupRoleWhat they receive
Brave Heart Intervention ArmExperimentalParticipants 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.
Receives: Behavioral: Brave Heart Intervention
Control ArmNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, pre-intervention; 1 month after the intervention

  2. 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.

    Measured: Baseline, pre-intervention; 1 month after the intervention

  3. 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.

    Measured: Baseline, pre-intervention; 1 month after the intervention

Secondary outcomes (1)
  1. Teacher and Community Leader Knowledge of SUD Prevention and Mental Health Literacy

    Knowledge of substance use disorder prevention and mental health literacy among teachers and community leaders delivering the intervention will be assessed using a knowledge questionnaire administered at baseline and endline, to evaluate change in knowledge following training.

    Measured: Baseline, pre-training; 3 weeks after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Jul 2025
  3. Primary completion28 Feb 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
2,244 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07853092
Sponsor's protocol ID
SLESRC No - 015/03/2025
Other IDs
BEING-2504-73418
Status last verified
Sep 2026
First submitted
26 Aug 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Brave Heart Intervention in people with Substance-related Disorders and Mental Health Literacy, run by Slum and Rural Health Initiative at 1 site in Sierra Leone.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Substance Use Refusal Skills (DASES) (time frame: Baseline, pre-intervention; 1 month after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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