THRIVE-Belize: A School-Based Life-Skills Program to Support Teen Health in Toledo District, Belize (Feasibility) (THRIVE-Belize)
2026年7月3日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
280
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Mario Morales, PhD
- 電話番号：520-645-5878
- メール：mariomorales@arizona.edu
研究連絡先のバックアップ
- 名前：Gabriela Valdez, PhD
- 電話番号：520-626-6530
- メール：gvaldez@arizona.edu
研究場所
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Toledo District
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Punta Gorda、Toledo District、ベリーズ、454V+3CH
- Toledo Community College
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コンタクト：
- Shaunna Arnold Sanchez
- 電話番号：501 + 722-2101
- メール：tccpg@btl.net
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability of the proposed intervention (AIM)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Recruitment and consent feasibility
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年9月1日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年7月3日
最初の投稿 (実際)
2026年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年7月3日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00007955
- MOHW/IRB/2026/002 (その他の識別子：Belize Ministry of Health and Wellness IRB)
- GEN/21/26(112) VOL. III (その他の識別子：Belize Ministry of Education (MOECST))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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