Teen PregnancyNCT03729726
Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program
A study testing Future Foundation 2.0 PREIS Program in people with Teen Pregnancy and Pregnancy in Adolescence, run by Metis Associates, Inc. at 1 site in United States.
Trial summary
This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy, Pregnancy in Adolescence, Teen Pregnancy Prevention
- What is being tested?
- Future Foundation 2.0 PREIS Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to Oct 2021
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools: attending Woodland and McNair middle schools and projected to attend Banneker high school
- Grade level: Grades 6-8
- Race/ethnicity or tribe: 100% African American
- Gender: 34% male and 66% female (based on current make-up of Future Foundation youth)
- Risk characteristics: 93% of youth will come from low-income families (based on free lunch eligibility)
- Other characteristics: The majority of target youth will also exhibit academic need. 81% will be below proficiency in English language arts and 90% will score not proficient in math. All recruited subjects will be new to Future Foundation services.
Who cannot join
- Students who have already received Future Foundation services
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Future Foundation
East Point, Georgia, 30344
Qaadirah Abdur-Rahim
About this study
Official title: A Randomized Controlled Trial Study of the Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program
This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no condoms/contraceptives). FF will implement the 2.0 PREIS Program with three cohorts of African-American youth in the 6th to 8th grades. FF aims to recruit and enroll 400 students who are new to the program for Cohort 1, 150 new students for Cohort 2, and another 150 new students for Cohort 3. These cohorts of eligible students will come from grades 6-8 in Woodland and McNair middle schools and projected to attend Banneker high school. Random assignment will be an ongoing process throughout the project enrollment periods. By the end of the recruitment processes, a total of 700 students will be randomly assigned to either the treatment or the control group, resulting in 350 students in each condition. Each year, the FF 2.0 PREIS intervention model will offer year-round grant-funded services, including after-school, summer programming, and parent engagement activities. The 350 youth randomly assigned to the treatment group will be offered the FF 2.0 PREIS program (Cohort 1 will target 200 treatment youth from January 2018 through June 2018; Cohort 2 will target 75 treatment youth from August 2018 through May 2019; and Cohort 3 will serve 75 treatment youth from August 2019 through May 2020.), while the 350 students assigned to the control group may receive after school and/or summer programming from another community-based organization. The primary hypotheses for the RCT study are the following: significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in vaginal sex than their control group peers do by the time of the end of the program and also at the six-month follow-up; significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in recent unprotected sex significantly than the control group students do at the end of the program and also at the six-month follow-up; and significantly greater numbers of participants in the FF 2.0 PREIS intervention remain abstinent or report condom use during recent vaginal sexual activity than the control group students do at the end of the program and also at the six-month follow-up.
- Conditions
- Teen Pregnancy, Pregnancy in Adolescence, Teen Pregnancy Prevention, Pregnancy Prevention, Sexually Transmitted Diseases
- Being tested
- Future Foundation 2.0 PREIS Program
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Future Foundation 2.0 PREIS ProgramBehavioural
The Future Foundation 2.0 PREIS intervention model uses a placed-based collective impact framework to provide a comprehensive intervention model, including: academic support and college and career readiness services, evidence-based social emotional learning instruction to strengthen protective factors and promote healthy transitions to adulthood, and trauma-informed, medically accurate, and age appropriate sexual health education. Moreover, the 2.0 PREIS program model features a unique student advocacy component designed to ensure that youth and their families receive the wraparound supports necessary for their students to remain on track for school success.
| Study group | Role | What they receive |
|---|---|---|
| Future Foundation 2.0 PREIS Program | Experimental | The Future Foundation 2.0 PREIS intervention model will include: a mandatory school-year program that offers after-school programming 4 days a week, including 120 hours of education (direct instruction \& homework support), 30 hours of health (social emotional learning \& sexual health), and 15 hours of student advocacy; an optional, 4-week summer program that offers 120 hours of programming each summer, including 16 hours of health (social emotional learning - service learning), 104 hours of project-based learning and enrichment (project-based learning in STEM - 64 hours) and enrichment (i.e., field trips, career speakers, and arts and crafts opportunities- 40 hours); and an optional parent engagement program, which will offer monthly parent workshops and quarterly events. Receives: Behavioral: Future Foundation 2.0 PREIS Program |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post measure of ever having vaginal sex in the past 3 months
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Measured: 12 months after baseline
Post measure of risk of exposure to sexually transmitted infections in the past 3 months
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Measured: 12 months after baseline
Post measure of ever having unprotected vaginal sex in the past 3 months
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Measured: 12 months after baseline
Follow-up measure of ever having vaginal sex in the past 3 months
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Measured: 18 months after baseline
Follow up measure of risk of exposure to sexually transmitted infections in the past 3 months
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Measured: 18 months after baseline
Follow up measure of ever having unprotected vaginal sex in the past 3 months
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Measured: 18 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start11 May 2017
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen PregnancyStudies 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metis Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Future Foundation, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729726
- Sponsor's protocol ID
- MetisIRBFFPREIS05062017
- Status last verified
- Nov 2018
- First submitted
- 31 Oct 2018
- Last updated
- 5 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study of the Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program
- ClinicalTrials.gov ID
- NCT03729726
- Acronym / sponsor ID
- MetisIRBFFPREIS05062017
- Conditions
- Teen Pregnancy, Pregnancy in Adolescence, Teen Pregnancy Prevention, Pregnancy Prevention, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Metis Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services, Future Foundation, Inc.
- Study start
- 11 May 2017 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Nov 2018 (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.
This study uses a randomized controlled trial (RCT) design to evaluate the impacts of the Future Foundation (FF) 2.0 Personal Responsibility Education Innovative Strategies (PREIS) program on reducing students' sexual activity (vaginal), recent risking sexual activity without condom use, and unprotected sex (no condoms/contraceptives). FF will implement the 2.0 PREIS Program with three cohorts of African-American youth in the 6th to 8th grades. FF aims to recruit and enroll 400 students who are new to the program for Cohort 1, 150 new students for Cohort 2, and another 150 new students for Cohort 3. These cohorts of eligible students will come from grades 6-8 in Woodland and McNair middle schools and projected to attend Banneker high school. Random assignment will be an ongoing process throughout the project enrollment periods. By the end of the recruitment processes, a total of 700 students will be randomly assigned to either the treatment or the control group, resulting in 350 students in each condition. Each year, the FF 2.0 PREIS intervention model will offer year-round grant-funded services, including after-school, summer programming, and parent engagement activities. The 350 youth randomly assigned to the treatment group will be offered the FF 2.0 PREIS program (Cohort 1 will target 200 treatment youth from January 2018 through June 2018; Cohort 2 will target 75 treatment youth from August 2018 through May 2019; and Cohort 3 will serve 75 treatment youth from August 2019 through May 2020.), while the 350 students assigned to the control group may receive after school and/or summer programming from another community-based organization. The primary hypotheses for the RCT study are the following: significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in vaginal sex than their control group peers do by the time of the end of the program and also at the six-month follow-up; significantly fewer numbers of students in the FF 2.0 PREIS intervention engage in recent unprotected sex significantly than the control group students do at the end of the program and also at the six-month follow-up; and significantly greater numbers of participants in the FF 2.0 PREIS intervention remain abstinent or report condom use during recent vaginal sexual activity than the control group students do at the end of the program and also at the six-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Future Foundation 2.0 PREIS Program | Experimental | Behavioral: Future Foundation 2.0 PREIS ProgramThe Future Foundation 2.0 PREIS intervention model will include: a mandatory school-year program that offers after-school programming 4 days a week, including 120 hours of education (direct instruction \& homework support), 30 hours of health (social emotional learning \& sexual health), and 15 hours of student advocacy; an optional, 4-week summer program that offers 120 hours of programming each summer, including 16 hours of health (social emotional learning - service learning), 104 hours of project-based learning and enrichment (project-based learning in STEM - 64 hours) and enrichment (i.e., field trips, career speakers, and arts and crafts opportunities- 40 hours); and an optional parent engagement program, which will offer monthly parent workshops and quarterly events. |
| Control | No intervention | – |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Schools: attending Woodland and McNair middle schools and projected to attend Banneker high school
- Grade level: Grades 6-8
- Race/ethnicity or tribe: 100% African American
- Gender: 34% male and 66% female (based on current make-up of Future Foundation youth)
- Risk characteristics: 93% of youth will come from low-income families (based on free lunch eligibility)
Key exclusion criteria (1 listed)
- Students who have already received Future Foundation services
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 |
|---|---|---|
| Future Foundation 2.0 PREIS ProgramThe Future Foundation 2.0 PREIS intervention model uses a placed-based collective impact framework to provide a comprehensive intervention model, including: academic support and college and career readiness services, evidence-based social emotional learning instruction to strengthen protective factors and promote healthy transitions to adulthood, and trauma-informed, medically accurate, and age appropriate sexual health education. Moreover, the 2.0 PREIS program model features a unique student advocacy component designed to ensure that youth and their families receive the wraparound supports necessary for their students to remain on track for school success. | Behavioural | Future Foundation 2.0 PREIS Program |
Primary outcome
Post measure of ever having vaginal sex in the past 3 months
Time frame: 12 months after baseline
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Post measure of risk of exposure to sexually transmitted infections in the past 3 months
Time frame: 12 months after baseline
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Post measure of ever having unprotected vaginal sex in the past 3 months
Time frame: 12 months after baseline
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Follow-up measure of ever having vaginal sex in the past 3 months
Time frame: 18 months after baseline
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Follow up measure of risk of exposure to sexually transmitted infections in the past 3 months
Time frame: 18 months after baseline
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Follow up measure of ever having unprotected vaginal sex in the past 3 months
Time frame: 18 months after baseline
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Future Foundation 2.0 PREIS Program in people with Teen Pregnancy and Pregnancy in Adolescence, run by Metis Associates, Inc. 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 6 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: status not confirmed, as of the sponsor's last update on 5 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhu, Ph.D. (2124258833, jzhu@metisassoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post measure of ever having vaginal sex in the past 3 months (time frame: 12 months after baseline). The study lists 6 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 5 Nov 2018.