Adolescent Sexual BehaviorNCT05260996
Big Decisions - an Evaluation of a Comprehensive Sexual Health Curriculum Pilot in Ecuador During 2019
A study testing Pilot Group in people with Adolescent Sexual Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Sexual Behavior
- What is being tested?
- Pilot Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2019to 2 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Observational Studies About Implementing a Sexual Health Curriculum in Adolescents ( "Big Decisions") of the Canton Riobamba, Chimborazo - Ecuador
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.
- Conditions
- Adolescent Sexual Behavior
- Being tested
- Pilot Group
- Keywords
- Adolescence, reproductive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Group | Experimental | Not described Receives: Other: Pilot Group |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Measured: Baseline
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Measured: week 12
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Measured: Baseline
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Measured: week 12
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Measured: Baseline
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Measured: week 12
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS)
Measured: Baseline
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS).
Measured: week 12
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Measured: Baseline
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Measured: week 12
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Measured: Baseline
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Measured: week 12
Percentage of Surveys with 100% Completion of All Questions.
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
Measured: Baseline
Percentage of Surveys with 100% Completion of All Questions.
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
Measured: week 12
Percentage of Surveys with 100% Completion of All Questions.
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
Measured: week 16
Percentage of Surveys with 100% Completion of All Questions.
To calculate this percentage, the number of surveys with 100% completion of all questions will be divided by the number of surveys administered.
Measured: week 24
Number of students who abstain from participating in surveys
Measured: week 12
Number of students who abstain from participating in surveys
Measured: week 16
Number of students who abstain from participating in surveys
Measured: week 24
Number of students who participate in surveys
Measured: week 12
Number of students who participate in surveys
Measured: week 16
Number of students who participate in surveys
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 Feb 2019
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Sexual BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Chimborazo, Riobamba Ecuador
- Responsible party
- Principal investigator, Garrett Kneese, The University of Texas Health Science Center, Houston
- Investigators
- Garrett Kneese, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260996
- Sponsor's protocol ID
- HSC-SPH-18-0979
- Status last verified
- Feb 2022
- First submitted
- 18 Feb 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies About Implementing a Sexual Health Curriculum in Adolescents ( "Big Decisions") of the Canton Riobamba, Chimborazo - Ecuador
- ClinicalTrials.gov ID
- NCT05260996
- Acronym / sponsor ID
- HSC-SPH-18-0979
- Conditions
- Adolescent Sexual Behavior
- Keywords
- Adolescence, reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National University of Chimborazo, Riobamba Ecuador
- Study start
- 9 Feb 2019 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 2 Mar 2022 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Group | Experimental | Other: Pilot Group |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot Group12 Weeks, 1-1 Hour Session Per Week for 10 Total Curriculum Sessions,including 1 Week of Orientation and 1 Week of Debriefing/Program Graduation. | Other | Pilot Group |
Primary outcome
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Time frame: Baseline
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale.
Time frame: week 12
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Time frame: Baseline
Qualitative perceptions surrounding gender as assessed by the Gender Equitable Men (GEM) Scale.
Time frame: week 12
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Time frame: Baseline
Qualitative perceptions surrounding gender as assessed by the Attitudes Toward Women Scale (AWSA) Scale.
Time frame: week 12
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS)
Time frame: Baseline
Qualitative perceptions surrounding relational norms as assessed by the Sexual Relationship Power Scale (SRPS).
Time frame: week 12
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Time frame: Baseline
Qualitative perceptions surrounding reproductive health knowledge as assessed by the Knowledge, Attitudes, and Practices (Sexual) (KAPS) survey.
Time frame: week 12
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Time frame: Baseline
Qualitative perceptions surrounding risk behaviors surrounding reproductive health as assessed by the Youth Risk Behavior Surveillance System (YRBSS) survey.
Time frame: week 12
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.
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.
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.
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.
Number of students who abstain from participating in surveys
Time frame: week 12
Number of students who abstain from participating in surveys
Time frame: week 16
Number of students who abstain from participating in surveys
Time frame: week 24
Number of students who participate in surveys
Time frame: week 12
Number of students who participate in surveys
Time frame: week 16
Number of students who participate in surveys
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Garrett Kneese principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Group in people with Adolescent Sexual Behavior, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 2 Mar 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative perceptions surrounding self-efficacy as assessed by the General Self-Efficacy Scale. (time frame: Baseline). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2022.