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DREAMS for Teenage Pregnancy (DREAMS Trial)
N/A
Waitlist Available
Research Sponsored by Winter Rose Services, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 13-19; enrolled in participating high school health class; passive consent received;
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-intervention, 6-months and 12-months-post intervention
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-intervention, 6-months and 12-months-post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-intervention, 6-months and 12-months-post intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who ever had sex
Number of participants who had an STI
Number of participants who had sex without a condom
+3 moreSecondary study objectives
Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Number of participants who had had a teenage pregnancy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DREAMSExperimental Treatment1 Intervention
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.
Group II: Non DREAMSActive Control1 Intervention
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.
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Who is running the clinical trial?
Winter Rose Services, LLCLead Sponsor
Department of Health and Human ServicesFED
231 Previous Clinical Trials
933,529 Total Patients Enrolled
1 Trials studying Teenage Pregnancy
508 Patients Enrolled for Teenage Pregnancy
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