Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS)

Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) in Houston TX

The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.

Study Overview

• Status: Unknown
• Conditions: Teen Pregnancy
• Intervention / Treatment: Other: DREAMS Curriculum

Detailed Description

The study is a an evaluation of the teen pregnancy prevention curriculum Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) through a random control trial. The evaluation will take place in high schools in the greater Houston area. Five cohorts of two classes each in ten HS schools will be used. Randomization will occur each semester for five semesters. Curriculum is ten modules in length delivered in 45 minute classes twice a week for five weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77036
      • Bee Busy Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age 13-19; enrolled in participating high school health class; passive consent received;

Exclusion Criteria:

Students who enrolled in classes post baseline. Students who had previously failed the HS course and was already exposed to DREAMS curriculum.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DREAMS; The experimental group will be exposed to the DREAMS curriculum including the supplemental technology based application.It is composed of 10 modules: Introduction; Self Exploration; Healthy Relationships; Adolescent Sexuality; Attitudes and Adolescent Sexual Activity; Consequences of Sex - HIV/STI; Consequences of Sex - Pregnancy; Managing Pressure to Engage in Sexual Activity through the Lens of Social Media; Financial Literacy; Careers; Post secondary Education; Wrap up and Close Out. The technology app will include curriculum support and additional resources. Students will have access to the mobile app after the in school programming ends. The intent is for students to have access to portions of the app that deal with self developed goals and progress monitoring for goals, and resource material. This is similar to a student having continued access to a textbook/other class materials.	Other: DREAMS Curriculum; Teen Pregnancy Prevention Curriculum as described in arm/group description.
Active Comparator: Non DREAMS; The control group experience will include health curriculum already adopted by the school district. Continued services as usual. The control group schools, for the most part, lack any formal pregnancy prevention services. All schools claim that lessons developed by the teachers meet the Texas Essential Knowledge Standards (TEKS). No outside services are provided to students and school based services are limited. The services offered at the schools is predominately abstinence based. Students attending the schools would need to initiate any services that are available within the community. The control group will not have access to the DREAMS curriculum or the technology-based application to enhance the DREAMS curriculum. The technology-based application will be a closed, password protected, system during the research trial.	Other: DREAMS Curriculum; Teen Pregnancy Prevention Curriculum as described in arm/group description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who had sex without a condom	Number of participants who had sex without a condom. The relative difference of condom usage during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.	immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who ever had sex	Number of participants who ever had sex. The relative difference of ever having sex (penile-vaginal sex acts) in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.	immediately post-intervention, 6-months and 12-months-post intervention
Number of penile-vaginal sex acts	Number of penile-vaginal sex acts. The relative difference of the number of penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.	immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who used other birth control methods	Number of participants who used other birth control methods. The relative difference of birth control methods (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.	immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who had an STI	Number of participants who had an STI. The relative difference of reported STI in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.	immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who increased knowledge concerning risks associated with unprotected sex	Number of participants who increased knowledge concerning risks associated with unprotected sex. The relative difference of knowledge gained in the intervention versus control group at immediately post-intervention.	immediately post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy	Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy. The relative difference of teenage pregnancies (among genders, ages, and race/ethnicity) in the intervention versus control group at 12-months post-intervention.	12-months-post intervention
Number of participants who had had a teenage pregnancy	Number of participants who had had a teenage pregnancy. The relative difference of teenage pregnancies in the intervention versus control group at 12-months post-intervention.	12-months-post intervention

Collaborators and Investigators

• Sponsor: Winter Rose Services, LLC
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2017
• Last Update Submitted That Met QC Criteria: October 10, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Prevention; Teen Pregnancy; Behavior Modification; Positive Youth Development; School Based Intervention; Financial Literacy; College and Career Readiness; Age 13-19
• Other Study ID Numbers: 00004955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

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