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

28 de septiembre de 2026 actualizado por: Slum and Rural Health Initiative

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.

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2244

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

10 años a 24 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Brave Heart Intervention Arm

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.

Task-Shifting SUD Prevention and Mental Health Literacy Program

Otros nombres:
  • Brave Heart Intervention Programme
Sin intervención: Control Arm

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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Substance Use Refusal Skills (DASES)
Periodo de tiempo: Baseline, pre-intervention; 1 month after the intervention

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)
Periodo de tiempo: Baseline, pre-intervention; 1 month after the intervention

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)
Periodo de tiempo: Baseline, pre-intervention; 1 month after the intervention

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Teacher and Community Leader Knowledge of SUD Prevention and Mental Health Literacy
Periodo de tiempo: Baseline, pre-training; 3 weeks after training

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.

Baseline, pre-training; 3 weeks after training

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Isaac I Olufadewa, Ph.D, Slum and Rural Health Initiative, Ibadan, Nigeria

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2025

Finalización primaria (Actual)

28 de febrero de 2026

Finalización del estudio (Actual)

30 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

26 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Publicado por primera vez (Actual)

1 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • SLESRC No - 015/03/2025
  • BEING-2504-73418 (Otro número de subvención/financiamiento: Grand Challenges Canada)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .