Clinical trial NCT03729726: Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program
Official title: A Randomized Controlled Trial Study of the Future Foundation 2.0 Personal Responsibility Education Innovative Strategies (PREIS) Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Teen Pregnancy
Pregnancy in Adolescence
Teen Pregnancy Prevention
Pregnancy Prevention
Sexually Transmitted Diseases
Lead sponsor: Metis Associates, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
name: Future Foundation, Inc.
First posted: 2018-11-05
Enrollment: 700
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post measure of ever having vaginal sex in the past 3 months
timeFrame: 12 months after baseline
measure: Post measure of risk of exposure to sexually transmitted infections in the past 3 months
timeFrame: 12 months after baseline
measure: Post measure of ever having unprotected vaginal sex in the past 3 months
timeFrame: 12 months after baseline
measure: Follow-up measure of ever having vaginal sex in the past 3 months
timeFrame: 18 months after baseline
measure: Follow up measure of risk of exposure to sexually transmitted infections in the past 3 months
timeFrame: 18 months after baseline
measure: Follow up measure of ever having unprotected vaginal sex in the past 3 months
timeFrame: 18 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: East Point
country: United States
facility: Future Foundation
state: Georgia
Study officials:
References: