Health BehaviorTHRIVE-BelizeNCT07687199
THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility)
An observational study of Health Behavior and Adolescence, run by University of Arizona at 1 site in Belize.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Adolescence, Feasibility Studies
- How many people
- 280 participants
- Where
- 1 siteBelize
- Study dates
- Jul 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Cognitive or developmental limitations preventing informed assent or participation (students)
- Declines to participate (students or parents/guardians)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belize1 site
Toledo Community College
Punta Gorda, Toledo District, 454V+3CH
Shaunna Arnold Sanchez, 501 + 722-2101, tccpg@btl.net
About this study
Official title: 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.
- Conditions
- Health Behavior, Adolescence, Feasibility Studies
- Keywords
- feasibility study, school-based intervention, life skills, adolescents, Belize, implementation science, acceptability
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single timepoint at post-assessment data collection (study months 1-2)
Secondary outcomes (3)
Recruitment and consent feasibility
Consent/assent rates (target: at least 60%), retention rates, and reasons for non-participation.
Measured: Throughout the recruitment period (study months 1-2)
Measurement feasibility and respondent burden
Survey completion rates (target: at least 90%), item-level missingness, and participant-reported comprehension of instruments.
Measured: Single timepoint at post-assessment data collection (study months 1-2)
Facilitator and delivery feasibility
Qualitative assessment of teacher capacity, willingness to deliver the curriculum (target: at least 60% willing), training needs, and scheduling constraints.
Measured: Single timepoint at post-assessment data collection (study months 1-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Hillside Health Care, Toledo Community College
- Responsible party
- Principal investigator, Mario Morales, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687199
- Sponsor's protocol ID
- STUDY00007955
- Other IDs
- MOHW/IRB/2026/002, GEN/21/26(112) VOL. III
- Acronym
- THRIVE-Belize
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 23295957Eldridge 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 27777223Shinde 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 30473365Patton 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07687199
- Acronym / sponsor ID
- THRIVE-Belize / STUDY00007955
- Conditions
- Health Behavior, Adolescence, Feasibility Studies
- Keywords
- feasibility study, school-based intervention, life skills, adolescents, Belize, implementation science, acceptability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Hillside Health Care, Toledo Community College
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive or developmental limitations preventing informed assent or participation (students)
- Declines to participate (students or parents/guardians)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acceptability of the proposed intervention (AIM)
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
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.
Appropriateness of the proposed intervention (IAM)
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
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.
Feasibility of the proposed intervention (FIM)
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
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.
Adoption and organizational readiness
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
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.
3 secondary outcomes
Recruitment and consent feasibility
Time frame: Throughout the recruitment period (study months 1-2)
Measurement feasibility and respondent burden
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
Facilitator and delivery feasibility
Time frame: Single timepoint at post-assessment data collection (study months 1-2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 23295957Chan 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.
- Background: PubMed 27777223Eldridge 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.
- Background: PubMed 30473365Shinde 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.
- Background: PubMed 27174304Patton 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior and Adolescence, run by University of Arizona at 1 site in Belize.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belize. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Morales, PhD (520-645-5878, mariomorales@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the proposed intervention (AIM) (time frame: Single timepoint at post-assessment data collection (study months 1-2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07687199, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.