THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility) (THRIVE-Belize)
3. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
280
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Mario Morales, PhD
- Telefonnummer: 520-645-5878
- E-Mail: mariomorales@arizona.edu
Studieren Sie die Kontaktsicherung
- Name: Gabriela Valdez, PhD
- Telefonnummer: 520-626-6530
- E-Mail: gvaldez@arizona.edu
Studienorte
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Toledo District
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Punta Gorda, Toledo District, Belize, 454V+3CH
- Toledo Community College
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Kontakt:
- Shaunna Arnold Sanchez
- Telefonnummer: 501 + 722-2101
- E-Mail: tccpg@btl.net
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Acceptability of the proposed intervention (AIM)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Recruitment and consent feasibility
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juli 2026
Primärer Abschluss (Geschätzt)
1. September 2026
Studienabschluss (Geschätzt)
1. September 2026
Studienanmeldedaten
Zuerst eingereicht
29. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
3. Juli 2026
Zuerst gepostet (Tatsächlich)
7. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY00007955
- MOHW/IRB/2026/002 (Andere Kennung: Belize Ministry of Health and Wellness IRB)
- GEN/21/26(112) VOL. III (Andere Kennung: Belize Ministry of Education (MOECST))
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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