ClinicalTrials.gg
Not yet recruitingNCT07687199THRIVE-BelizeUpdated Jul 7, 2026

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

An observational study in Health Behavior, Adolescence and Feasibility Studies, sponsored by University of Arizona. Not yet recruiting at 1 site in Belize. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Arizona · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
280
Ages
12 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Health Behavior
  • Adolescence
  • Feasibility Studies

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Keywords

  • feasibility study
  • school-based intervention
  • life skills
  • adolescents
  • Belize
  • implementation science
  • acceptability
03

In context

Health Behavior

967 studies on the registry are indexed under Health Behavior; 165 are open to participants now.

This study's planned enrollment of 280 is above the median of 219 across 131 observational studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

Exclusion Criteria:

  • Cognitive or developmental limitations preventing informed assent or participation (students)
  • Declines to participate (students or parents/guardians)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
280 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes

  1. Recruitment and consent feasibility

    Consent/assent rates (target: at least 60%), retention rates, and reasons for non-participation.

    Time frame: Throughout the recruitment period (study months 1-2)

  2. Measurement feasibility and respondent burden

    Survey completion rates (target: at least 90%), item-level missingness, and participant-reported comprehension of instruments.

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

  3. Facilitator and delivery feasibility

    Qualitative assessment of teacher capacity, willingness to deliver the curriculum (target: at least 60% willing), training needs, and scheduling constraints.

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

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Study locations

1 site
  • Toledo Community College
    Punta Gorda, Toledo District 454V+3CH, Belize
    • Shaunna Arnold Sanchez · Contacttccpg@btl.net · 501 + 722-2101
08

References and documents

Publications

  • 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. PubMed 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. PubMed 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. PubMed 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. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available. PubMed 27174304 ↗

Individual participant data

Plan to share: No — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07687199
Collaborators
Hillside Health Care, Toledo Community College
Responsible party
Mario Morales (Principal Investigator, University of Arizona) — Principal investigator
First posted
Jul 7, 2026
Start date
Jul 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jul 7, 2026

Study contacts

Mario Morales, PhD
Contact
mariomorales@arizona.edu
520-645-5878
Gabriela Valdez, PhD
Contact
gvaldez@arizona.edu
520-626-6530

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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