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Completed

NCT Number: NCT05260996

Big Decisions - an Evaluation of a Comprehensive Sexual Health Curriculum Pilot in Ecuador During 2019

The purpose of this study is to assess the efficacy of the "Big Decisions" Adolescent sexual and reproductive health (ASRH) Curriculum via a pilot program with an educational experimental trial design.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
  • Student at COMIL High school in Riobamba(Control Site)
  • Student of 9th or 10th grade.

Exclusion criteria

  • Not a current student at the Liceo Policial High School in Riobamba, Ecuador(Pilot Site)
  • Not a current student at COMIL high school in Riobamba.(Control Site)
  • Not a student of 9th or 10th grade.

Treatment and study plan

Pilot Group

Other

12 Weeks, 1-1 Hour Session Per Week for 10 Total Curriculum Sessions,including 1 Week of Orientation and 1 Week of Debriefing/Program Graduation.

Primary outcomes

  1. Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.

    Time frame: Baseline

  2. Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.

    Time frame: week 12

  3. Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.

    Time frame: Baseline

  4. Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.

    Time frame: week 12

  5. Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.

    Time frame: Baseline

  6. Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.

    Time frame: week 12

  7. Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS)

    Time frame: Baseline

  8. Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS).

    Time frame: week 12

  9. Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.

    Time frame: Baseline

  10. Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.

    Time frame: week 12

  11. Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.

    Time frame: Baseline

  12. Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.

    Time frame: week 12

  13. Percentage of Surveys with 100% Completion of All Questions.

    Time frame: Baseline

    To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.

  14. Percentage of Surveys with 100% Completion of All Questions.

    Time frame: week 12

    To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.

  15. Percentage of Surveys with 100% Completion of All Questions.

    Time frame: week 16

    To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.

  16. Percentage of Surveys with 100% Completion of All Questions.

    Time frame: week 24

    To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.

  17. Number of students who abstain from participating in surveys

    Time frame: week 12

  18. Number of students who abstain from participating in surveys

    Time frame: week 16

  19. Number of students who abstain from participating in surveys

    Time frame: week 24

  20. Number of students who participate in surveys

    Time frame: week 12

  21. Number of students who participate in surveys

    Time frame: week 16

  22. Number of students who participate in surveys

    Time frame: week 24

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National University of Chimborazo, Riobamba Ecuador

Registry information

Official study title

Observational Studies About Implementing a Sexual Health Curriculum in Adolescents ( "Big Decisions") of the Canton Riobamba, Chimborazo - Ecuador

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.