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

NCT07687199 | Not Yet Recruiting

• 3 other identifiers: STUDY00007955MOHW/IRB/2026/002GEN/21/26(112) VOL. III
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Behavior; Adolescence; Feasibility Studies

Keywords

feasibility study; school-based intervention; life skills; adolescents; Belize; implementation science; acceptability

Outcome Measures

Primary Outcomes (4)

• Acceptability of the proposed intervention (AIM)

  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.

  Single timepoint at post-assessment data collection (study months 1-2)

• Appropriateness of the proposed intervention (IAM)

  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.

  Single timepoint at post-assessment data collection (study months 1-2)

• Feasibility of the proposed intervention (FIM)

  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.

  Single timepoint at post-assessment data collection (study months 1-2)

• Adoption and organizational readiness

  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.

  Single timepoint at post-assessment data collection (study months 1-2)

Secondary Outcomes (3)

• Recruitment and consent feasibility

  Throughout the recruitment period (study months 1-2)

• Measurement feasibility and respondent burden

  Single timepoint at post-assessment data collection (study months 1-2)

• Facilitator and delivery feasibility

  Single timepoint at post-assessment data collection (study months 1-2)

Study Arms (5)

Students

TCC students in Forms 1-4, ages 12-18, providing feedback on the proposed curriculum via surveys, focus groups, and interviews.

Teachers

TCC teachers assigned to Forms 1-4, providing feedback via surveys, focus groups, and interviews.

Parents/Guardians

Parents or legal guardians of eligible TCC students, providing feedback via surveys, focus groups, and interviews.

School Principal and Administrative Staff

TCC principal and administrative staff, providing feedback via surveys and interviews.

Community Stakeholders

Toledo District community members with expertise in adolescent health, education, or youth services, providing feedback via surveys and interviews.

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead
• Toledo Community College: collaborator
• Hillside Health Care: collaborator

Study Sites (1)

Toledo Community College

Punta Gorda, Toledo District, 454V+3CH, Belize

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 27174304 BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Mario Morales, PhD

CONTACT

520-645-5878; mariomorales@arizona.edu

Gabriela Valdez, PhD

CONTACT

520-626-6530; gvaldez@arizona.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)