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

Primary Purpose

Teen Pregnancy, Pregnancy in Adolescence, Teen Pregnancy Prevention

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Future Foundation 2.0 PREIS Program
Sponsored by
Metis Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Teen Pregnancy

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Future FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Future Foundation 2.0 PREIS Program

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2018
Last Updated
November 2, 2018
Sponsor
Metis Associates, Inc.
Collaborators
Department of Health and Human Services, Future Foundation, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03729726
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metis Associates, Inc.
Collaborators
Department of Health and Human Services, Future Foundation, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teen Pregnancy, Pregnancy in Adolescence, Teen Pregnancy Prevention, Pregnancy Prevention, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Future Foundation 2.0 PREIS Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Future Foundation 2.0 PREIS Program
Intervention Description
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 Information:
Title
Post measure of ever having vaginal sex in the past 3 months
Description
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Time Frame
12 months after baseline
Title
Post measure of risk of exposure to sexually transmitted infections in the past 3 months
Description
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Time Frame
12 months after baseline
Title
Post measure of ever having unprotected vaginal sex in the past 3 months
Description
A dichotomous measure collected at the end of the program based on self-report questionnaire.
Time Frame
12 months after baseline
Title
Follow-up measure of ever having vaginal sex in the past 3 months
Description
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Time Frame
18 months after baseline
Title
Follow up measure of risk of exposure to sexually transmitted infections in the past 3 months
Description
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Time Frame
18 months after baseline
Title
Follow up measure of ever having unprotected vaginal sex in the past 3 months
Description
A dichotomous measure collected six months after the end of program implementation based on self-report questionnaire.
Time Frame
18 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Zhu, Ph.D.
Phone
2124258833
Email
jzhu@metisassoc.com
Facility Information:
Facility Name
Future Foundation
City
East Point
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qaadirah Abdur-Rahim

12. IPD Sharing Statement

Learn more about this trial

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

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