THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility) (THRIVE-Belize)
3 luglio 2026 aggiornato da: Mario Morales, University of Arizona
THRIVE-Belize: A Single-School Mixed-Methods Feasibility Trial of a Multi-Component Life-Skills Curriculum for Adolescent Health Promotion at Toledo Community College, Belize
THRIVE-Belize is a school-based program being developed to support the health and well-being of adolescents in the Toledo District of southern Belize. The program covers seven topics: communication and emotional regulation, healthy expressions of masculinity, sexual and reproductive health, healthy relationships, mental and physical health, substance use prevention, and environmental health.
Before testing whether the program works, the research team needs to learn whether students, teachers, parents, school staff, and community members find it acceptable, appropriate, and practical to deliver at Toledo Community College. This study (Phase I) does not deliver the program to anyone. Instead, it gathers feedback through surveys, focus groups, and interviews with about 280 participants across these five groups.
The information collected will be used to refine the program and decide whether to move forward to a future pilot study. No medical or educational intervention is given to participants in this phase.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
280
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Mario Morales, PhD
- Numero di telefono: 520-645-5878
- Email: mariomorales@arizona.edu
Backup dei contatti dello studio
- Nome: Gabriela Valdez, PhD
- Numero di telefono: 520-626-6530
- Email: gvaldez@arizona.edu
Luoghi di studio
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Toledo District
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Punta Gorda, Toledo District, Belize, 454V+3CH
- Toledo Community College
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Contatto:
- Shaunna Arnold Sanchez
- Numero di telefono: 501 + 722-2101
- Email: tccpg@btl.net
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Adolescents aged 12-18 (Forms 1-4) and adult stakeholders (teachers, parents/guardians, principal and administrative staff, and community stakeholders) at one secondary school in the Toledo District, Belize.
Descrizione
Inclusion Criteria:
- Students: enrolled at Toledo Community College in Forms 1-4; ages 12-18 years; able to read and comprehend English at grade level; provides written assent; has active written parental/guardian consent
- Teachers: currently employed at TCC; teaches students in Forms 1-4; provides written informed consent
- Parents/Guardians: parent or legal guardian of an eligible TCC student; age 18 years or older; able to communicate in English, Spanish, or Q'eqchi'-Mopan Maya; provides written informed consent
- School Principal and Administrative Staff: currently serving as principal or administrative staff at TCC; provides written informed consent
- Community Stakeholders: recognized expertise in adolescent health, education, or youth services (e.g., healthcare providers, religious leaders, village council members, youth organization leaders); resident of Toledo District, Belize; provides written informed consent
Exclusion Criteria:
- Cognitive or developmental limitations preventing informed assent or participation (students)
- Declines to participate (students or parents/guardians)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Students
TCC students in Forms 1-4, ages 12-18, providing feedback on the proposed curriculum via surveys, focus groups, and interviews.
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Teachers
TCC teachers assigned to Forms 1-4, providing feedback via surveys, focus groups, and interviews.
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Parents/Guardians
Parents or legal guardians of eligible TCC students, providing feedback via surveys, focus groups, and interviews.
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School Principal and Administrative Staff
TCC principal and administrative staff, providing feedback via surveys and interviews.
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Community Stakeholders
Toledo District community members with expertise in adolescent health, education, or youth services, providing feedback via surveys and interviews.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Acceptability of the proposed intervention (AIM)
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Mean score on the adapted 4-item Acceptability of Intervention Measure (AIM), 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree).
A mean score of 4.0 or higher indicates acceptability.
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Single timepoint at post-assessment data collection (study months 1-2)
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Appropriateness of the proposed intervention (IAM)
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Mean score on the adapted 4-item Intervention Appropriateness Measure (IAM), 5-point Likert scale.
A mean score of 4.0 or higher indicates appropriateness.
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Single timepoint at post-assessment data collection (study months 1-2)
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Feasibility of the proposed intervention (FIM)
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Mean score on the adapted 4-item Feasibility of Intervention Measure (FIM), 5-point Likert scale.
A mean score of 4.0 or higher indicates feasibility.
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Single timepoint at post-assessment data collection (study months 1-2)
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Adoption and organizational readiness
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Proportion of stakeholders expressing intent to support or participate in the proposed intervention, supplemented by qualitative themes related to readiness and barriers from focus groups and interviews.
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Single timepoint at post-assessment data collection (study months 1-2)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Recruitment and consent feasibility
Lasso di tempo: Throughout the recruitment period (study months 1-2)
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Consent/assent rates (target: at least 60%), retention rates, and reasons for non-participation.
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Throughout the recruitment period (study months 1-2)
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Measurement feasibility and respondent burden
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Survey completion rates (target: at least 90%), item-level missingness, and participant-reported comprehension of instruments.
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Single timepoint at post-assessment data collection (study months 1-2)
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Facilitator and delivery feasibility
Lasso di tempo: Single timepoint at post-assessment data collection (study months 1-2)
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Qualitative assessment of teacher capacity, willingness to deliver the curriculum (target: at least 60% willing), training needs, and scheduling constraints.
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Single timepoint at post-assessment data collection (study months 1-2)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available.
- Shinde S, Weiss HA, Varghese B, Khandeparkar P, Pereira B, Sharma A, Gupta R, Ross DA, Patton G, Patel V. Promoting school climate and health outcomes with the SEHER multi-component secondary school intervention in Bihar, India: a cluster-randomised controlled trial. Lancet. 2018 Dec 8;392(10163):2465-2477. doi: 10.1016/S0140-6736(18)31615-5. Epub 2018 Nov 22.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
1 settembre 2026
Completamento dello studio (Stimato)
1 settembre 2026
Date di iscrizione allo studio
Primo inviato
29 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 luglio 2026
Primo Inserito (Effettivo)
7 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY00007955
- MOHW/IRB/2026/002 (Altro identificatore: Belize Ministry of Health and Wellness IRB)
- GEN/21/26(112) VOL. III (Altro identificatore: Belize Ministry of Education (MOECST))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
No public release of individual participant data (IPD) is planned due to the small sample size and potential for re-identification in a single-school setting.
De-identified aggregate data may be made available upon reasonable request following primary publication, subject to University of Arizona IRB approval, Belize Ministry of Health and Wellness IRB approval, and a formal data sharing agreement.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .