THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility) (THRIVE-Belize)
3. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Studietype
Observasjonsmessig
Registrering (Antatt)
280
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mario Morales, PhD
- Telefonnummer: 520-645-5878
- E-post: mariomorales@arizona.edu
Studer Kontakt Backup
- Navn: Gabriela Valdez, PhD
- Telefonnummer: 520-626-6530
- E-post: gvaldez@arizona.edu
Studiesteder
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Toledo District
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Punta Gorda, Toledo District, Belize, 454V+3CH
- Toledo Community College
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Ta kontakt med:
- Shaunna Arnold Sanchez
- Telefonnummer: 501 + 722-2101
- E-post: tccpg@btl.net
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptability of the proposed intervention (AIM)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment and consent feasibility
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. september 2026
Studiet fullført (Antatt)
1. september 2026
Datoer for studieregistrering
Først innsendt
29. juni 2026
Først innsendt som oppfylte QC-kriteriene
3. juli 2026
Først lagt ut (Faktiske)
7. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00007955
- MOHW/IRB/2026/002 (Annen identifikator: Belize Ministry of Health and Wellness IRB)
- GEN/21/26(112) VOL. III (Annen identifikator: Belize Ministry of Education (MOECST))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .