Teen Pregnancy PreventionNCT04508569
Evaluation of Big Decisions in Three South Texas School Districts
A study testing Big Decisions in people with Teen Pregnancy Prevention, run by Philliber Research & Evaluation at 1 site in United States.
Trial summary
An evaluation of a promising Teen Pregnancy Prevention Curriculum, Big Decisions, in ninth grade students in three high schools in South Texas. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Big Decisions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 15 Dec 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be in ninth grade and enrolled in a participating class at a participating high school
Who cannot join
- Lack of consent or assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Philliber Research and Evaluation
Accord, New York, 12404
About this study
Official title: Evaluation of the Big Decisions Teen Pregnancy Prevention Intervention in Three South Texas School Districts
An evaluation of a promising Teen Pregnancy Prevention Curriculum, Big Decisions, in ninth grade students in three high schools in South Texas.
Read the detailed description
Intervention Description Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.
Classroom teachers, who receive three days of training on the curriculum as well as ongoing technical assistance, deliver Big Decisions lessons to 9th grade students. The lessons take place during normally scheduled classes over the course of three to five weeks. Classes include health, biology, and English. The curriculum focuses on helping youth make good decisions about their sexual health. There are three key messages: (1) having sex with someone is a big decision, (2) abstinence is the most effective way to avoid both pregnancy and sexually transmitted infections, and (3) teens who have sex need to use latex condoms correctly every time to reduce the risk of HIV and sexually transmitted infections and use contraception to prevent pregnancy.
In addition to a classroom curriculum, Big Decisions also includes a parent component offered to all families. This includes two parent workshops, a parent workbook, and homework for parents and children. The parent workshop meets twice during the period of time when students receive the classroom curriculum. The workshops last for 90 minutes, are offered in both English and Spanish, and are facilitated by district coordinators and grantee staff.
Comparison Condition Youth Voices Comparison Condition Description Youth Voices is a benign comparison intervention that meets for two class sessions over three to five weeks. Classroom teachers deliver Youth Voices to 9th grade students. Teachers deliver sessions during regularly scheduled classes similar to Big Decisions. Students in Youth Voices participate in facilitated discussions about two of seven potential discussion topics (nutrition, physical fitness and exercise, tobacco and e-cigarettes, participation in sports, driver safety, environmental health, and safety at work). Students take a vote, and they discuss the two topics with the most votes during the sessions. Classroom teachers facilitate Youth Voices. Teachers are trained to deliver both Youth Voices and Big Decisions and can deliver both programs to different classes during the same implementation period.
Behavioral Outcomes Sexual initiation, condom use at last sex, birth control use at last sex, ever pregnant or gotten someone pregnant, sex in the past three months, sex without a condom in the past three months, sex without birth control in the past three months Non-behavioral Outcomes Intentions to have sex, intentions to use a condom, intentions to use birth control Sample and Setting HealthyFutures of Texas staff recruited four high schools from three rural and semi-rural school districts in Texas for participation in the study. The program targets 9th-grade students in each district for participation. Each high school identified one course required for 9th grade students for program delivery (for example, health, biology, English). To be eligible for participation, students must (1) be in 9th grade, (2) be enrolled in one of the courses identified for program delivery, (3) have parental consent, and (4) provide student assent. The evaluation expects to enroll 2,596 students from 178 classrooms.
Research Design and Data Collection This evaluation is a cluster randomized controlled trial. Classrooms are the unit of randomization. Two of the three school districts are implementing the program and evaluation once a year and the third school district, with two high schools, is implementing each quarter of the academic year. At the beginning of each round of implementation, parents provide consent for participation. Two weeks before implementation, students provide assent and take the baseline survey. The evaluator randomizes the participating classes the week before implementation.
Youth will be surveyed at baseline, immediately post-intervention, and at 12-month follow-up. Baseline and immediate post-test surveys will be given in the classroom. Surveys will be collected using a survey link or using paper versions of the survey. The 12-month follow-up survey will take place in small group settings at the school. Absent students will be surveyed in-person individually by the district coordinator, by phone, or over the web. Teachers, district coordinators, and research staff will collect data.
Data for an implementation study designed to assess fidelity, attendance, and quality will be collected through fidelity logs, observations, and attendance sheets.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Big Decisions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Big DecisionsBehavioural
Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.
| Study group | Role | What they receive |
|---|---|---|
| Big Decisions | Experimental | Not described Receives: Behavioral: Big Decisions |
| Youth Voices | Active comparator | Not described Receives: Behavioral: Big Decisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of condom or effective method of birth control last time you had sex
Did you use a condom or effective method of birth control the last time you had sex?
Measured: One year
Secondary outcomes (2)
intention to use condom or birth control
Do you intend to use a condom or effective method of birth control if you have sex
Measured: immediate post-test
Frequency of communication with parents about abstinence and sex
How often do you talk to your parent or guardian about abstinence or sex
Measured: immediate post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2016
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philliber Research & Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Futures of Texas, The Office of Adolescent Health, HHS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508569
- Sponsor's protocol ID
- Big Decisions
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 11 Aug 2020
- 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 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Big Decisions Teen Pregnancy Prevention Intervention in Three South Texas School Districts
- ClinicalTrials.gov ID
- NCT04508569
- Acronym / sponsor ID
- Big Decisions
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,170 participants (actual)
- Lead sponsor
- Philliber Research & EvaluationUniversity, hospital or other
- Collaborators
- Healthy Futures of Texas, The Office of Adolescent Health, HHS
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 11 Aug 2020 (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.
An evaluation of a promising Teen Pregnancy Prevention Curriculum, Big Decisions, in ninth grade students in three high schools in South Texas.
Detailed description
Intervention Description Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.
Classroom teachers, who receive three days of training on the curriculum as well as ongoing technical assistance, deliver Big Decisions lessons to 9th grade students. The lessons take place during normally scheduled classes over the course of three to five weeks. Classes include health, biology, and English. The curriculum focuses on helping youth make good decisions about their sexual health. There are three key messages: (1) having sex with someone is a big decision, (2) abstinence is the most effective way to avoid both pregnancy and sexually transmitted infections, and (3) teens who have sex need to use latex condoms correctly every time to reduce the risk of HIV and sexually transmitted infections and use contraception to prevent pregnancy.
In addition to a classroom curriculum, Big Decisions also includes a parent component offered to all families. This includes two parent workshops, a parent workbook, and homework for parents and children. The parent workshop meets twice during the period of time when students receive the classroom curriculum. The workshops last for 90 minutes, are offered in both English and Spanish, and are facilitated by district coordinators and grantee staff.
Comparison Condition Youth Voices Comparison Condition Description Youth Voices is a benign comparison intervention that meets for two class sessions over three to five weeks. Classroom teachers deliver Youth Voices to 9th grade students. Teachers deliver sessions during regularly scheduled classes similar to Big Decisions. Students in Youth Voices participate in facilitated discussions about two of seven potential discussion topics (nutrition, physical fitness and exercise, tobacco and e-cigarettes, participation in sports, driver safety, environmental health, and safety at work). Students take a vote, and they discuss the two topics with the most votes during the sessions. Classroom teachers facilitate Youth Voices. Teachers are trained to deliver both Youth Voices and Big Decisions and can deliver both programs to different classes during the same implementation period.
Behavioral Outcomes Sexual initiation, condom use at last sex, birth control use at last sex, ever pregnant or gotten someone pregnant, sex in the past three months, sex without a condom in the past three months, sex without birth control in the past three months Non-behavioral Outcomes Intentions to have sex, intentions to use a condom, intentions to use birth control Sample and Setting HealthyFutures of Texas staff recruited four high schools from three rural and semi-rural school districts in Texas for participation in the study. The program targets 9th-grade students in each district for participation. Each high school identified one course required for 9th grade students for program delivery (for example, health, biology, English). To be eligible for participation, students must (1) be in 9th grade, (2) be enrolled in one of the courses identified for program delivery, (3) have parental consent, and (4) provide student assent. The evaluation expects to enroll 2,596 students from 178 classrooms.
Research Design and Data Collection This evaluation is a cluster randomized controlled trial. Classrooms are the unit of randomization. Two of the three school districts are implementing the program and evaluation once a year and the third school district, with two high schools, is implementing each quarter of the academic year. At the beginning of each round of implementation, parents provide consent for participation. Two weeks before implementation, students provide assent and take the baseline survey. The evaluator randomizes the participating classes the week before implementation.
Youth will be surveyed at baseline, immediately post-intervention, and at 12-month follow-up. Baseline and immediate post-test surveys will be given in the classroom. Surveys will be collected using a survey link or using paper versions of the survey. The 12-month follow-up survey will take place in small group settings at the school. Absent students will be surveyed in-person individually by the district coordinator, by phone, or over the web. Teachers, district coordinators, and research staff will collect data.
Data for an implementation study designed to assess fidelity, attendance, and quality will be collected through fidelity logs, observations, and attendance sheets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Big Decisions | Experimental | Behavioral: Big Decisions |
| Youth Voices | Active comparator | Behavioral: Big Decisions |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Must be in ninth grade and enrolled in a participating class at a participating high school
Key exclusion criteria (1 listed)
- Lack of consent or assent
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 |
|---|---|---|
| Big DecisionsBig Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons. | Behavioural | Big Decisions, Youth Voices |
Primary outcome
Use of condom or effective method of birth control last time you had sex
Time frame: One year
Did you use a condom or effective method of birth control the last time you had sex?
2 secondary outcomes
intention to use condom or birth control
Time frame: immediate post-test
Frequency of communication with parents about abstinence and sex
Time frame: immediate post-test
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 11 Aug 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Big Decisions in people with Teen Pregnancy Prevention, run by Philliber Research & Evaluation 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 1 inclusion and 1 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 11 Aug 2020. 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?
Use of condom or effective method of birth control last time you had sex (time frame: One year). 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 11 Aug 2020.