Recruiting

Observational Study

Sponsor:

Metis Associates, Inc.

Code:

NCT03729726

Conditions

Teen Pregnancy

Pregnancy in Adolescence

Teen Pregnancy Prevention

Pregnancy Prevention

Sexually Transmitted Diseases

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

Interventions

Future Foundation 2.0 PREIS Program

Study Details

Brief 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 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

Study ID

NCT03729726

Start date

May 11, 2017

Status verified date

Nov, 2018

Completion date

Oct, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Students who have already received Future Foundation services

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Future Foundation 2.0 PREIS Program

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.

no intervention: Control

Interventions

Future Foundation 2.0 PREIS Program

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.

Primary outcome measure

  • Post measure of ever having vaginal sex in the past 3 months [ Time Frame: 12 months after baseline ]
  • Post measure of risk of exposure to sexually transmitted infections in the past 3 months [ Time Frame: 12 months after baseline ]
  • Post measure of ever having unprotected vaginal sex in the past 3 months [ Time Frame: 12 months after baseline ]
  • Follow-up measure of ever having vaginal sex in the past 3 months [ Time Frame: 18 months after baseline ]
  • Follow up measure of risk of exposure to sexually transmitted infections in the past 3 months [ Time Frame: 18 months after baseline ]
  • Follow up measure of ever having unprotected vaginal sex in the past 3 months [ Time Frame: 18 months after baseline ]

Central Contacts and Locations

Central contacts

Jing Zhu, Ph.D.

2124258833jzhu@metisassoc.com

Locations

Future Foundation

Recruiting

East Point, Georgia, United States, 30344

More Information

Sponsor

Metis Associates, Inc.

Last update posted

Nov 5, 2018

Last verified

Nov, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Metis Associates, Inc. on 2018-11-05.