Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program

NCT ID: NCT03729726

Last Updated: 2018-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-11

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Teen Pregnancy Pregnancy in Adolescence Teen Pregnancy Prevention Pregnancy Prevention Sexually Transmitted Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Future Foundation 2.0 PREIS Program

Intervention Type BEHAVIORAL

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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Department of Health and Human Services

FED

Sponsor Role collaborator

Future Foundation, Inc.

UNKNOWN

Sponsor Role collaborator

Metis Associates, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Future Foundation

East Point, Georgia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jing Zhu, Ph.D.

Role: CONTACT

2124258833

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Qaadirah Abdur-Rahim

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MetisIRBFFPREIS05062017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PrEP for HBCUs (Study 2)
NCT03080597 COMPLETED NA
Evaluation of Stepping Stones
NCT06574217 RECRUITING NA