- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07853092
Brave Heart Intervention and Mental Health Outcomes Among Young People in Sierra Leone
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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-
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Freetown, Sierra Leone
- 40 secondary schools and 4 community groups drawn from the East End, Central, and West End regions
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: 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
Muut nimet:
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Ei väliintuloa: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Substance Use Refusal Skills (DASES)
Aikaikkuna: Baseline, pre-intervention; 1 month after the intervention
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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
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Change in Mental Well-being (WHO-5 Well-Being Index)
Aikaikkuna: Baseline, pre-intervention; 1 month after the intervention
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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
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Change in Knowledge of SUD Prevention and Mental Health Literacy (MHLQ)
Aikaikkuna: Baseline, pre-intervention; 1 month after the intervention
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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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Teacher and Community Leader Knowledge of SUD Prevention and Mental Health Literacy
Aikaikkuna: Baseline, pre-training; 3 weeks after training
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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
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Isaac I Olufadewa, Ph.D, Slum and Rural Health Initiative, Ibadan, Nigeria
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SLESRC No - 015/03/2025
- BEING-2504-73418 (Muu apuraha/rahoitusnumero: Grand Challenges Canada)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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