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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT04508569
Study groupRoleWhat they receive
Big DecisionsExperimentalNot described
Receives: Behavioral: Big Decisions
Youth VoicesActive comparatorNot described
Receives: Behavioral: Big Decisions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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.

  1. First posted11 Aug 2020
  2. Study start1 Sep 2016
  3. Primary completion15 Dec 2019
  4. Study completion15 Dec 2019

Resources

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)
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

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.

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