THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility)

Официальное название

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

Обзор

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.

Первичные конечные точки

• Acceptability of the proposed intervention (AIM) [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]
• Appropriateness of the proposed intervention (IAM) [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]
• Feasibility of the proposed intervention (FIM) [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]
• Adoption and organizational readiness [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]

Вторичные конечные точки (3)

• Recruitment and consent feasibility [Срок оценки: Throughout the recruitment period (study months 1-2)]
• Measurement feasibility and respondent burden [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]
• Facilitator and delivery feasibility [Срок оценки: Single timepoint at post-assessment data collection (study months 1-2)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Cognitive or developmental limitations preventing informed assent or participation (students)
• Declines to participate (students or parents/guardians)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Belize · 1 центр

• Toledo Community College — Punta Gorda

Публикации

• 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. PMID 23295957
• 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. PMID 27777223
• 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. PMID 30473365
• 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. PMID 27174304

Идентификаторы

NCT: NCT07687199 · STUDY00007955 · MOHW/IRB/2026/002 · GEN/21/26(112) VOL. III

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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