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

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.

Study Overview

• Status: Unknown
• Conditions: Sexually Transmitted Diseases; Pregnancy in Adolescence; Teen Pregnancy; Teen Pregnancy Prevention; Pregnancy Prevention
• Intervention / Treatment: Behavioral: Future Foundation 2.0 PREIS Program

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • East Point, Georgia, United States, 30344
      • Recruiting
      • Future Foundation
      • Contact: Qaadirah Abdur-Rahim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	18 months after baseline

Collaborators and Investigators

• Sponsor: Metis Associates, Inc.
• Collaborators: Department of Health and Human Services; Future Foundation, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: MetisIRBFFPREIS05062017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No