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

Sponsor
Winter Rose Services, LLC (Other)
Overall Status
Unknown status
CT.gov ID
NCT03311061
Collaborator
Department of Health and Human Services (U.S. Fed)
2,000
1
2
35.7
56.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: DREAMS Curriculum
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups of participants. group A will receive the DREAMS Curriculum intervention. Group B (Control group) will receive curriculum already in place at school.Two groups of participants. group A will receive the DREAMS Curriculum intervention. Group B (Control group) will receive curriculum already in place at school.
Masking:
Single (Participant)
Masking Description:
Students are masked through
Primary Purpose:
Prevention
Official Title:
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) in Houston TX
Actual Study Start Date :
Oct 10, 2017
Anticipated Primary Completion Date :
Sep 30, 2020
Anticipated Study Completion Date :
Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants who had sex without a condom [immediately post-intervention, 6-months and 12-months-post intervention]

    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.

  2. Number of participants who ever had sex [immediately post-intervention, 6-months and 12-months-post intervention]

    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.

  3. Number of penile-vaginal sex acts [immediately post-intervention, 6-months and 12-months-post intervention]

    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.

  4. Number of participants who used other birth control methods [immediately post-intervention, 6-months and 12-months-post intervention]

    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.

  5. Number of participants who had an STI [immediately post-intervention, 6-months and 12-months-post intervention]

    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.

  6. Number of participants who increased knowledge concerning risks associated with unprotected sex [immediately post intervention]

    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.

Secondary Outcome Measures

  1. Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy [12-months-post intervention]

    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.

  2. Number of participants who had had a teenage pregnancy [12-months-post intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bee Busy Inc. Houston Texas United States 77036

Sponsors and Collaborators

  • Winter Rose Services, LLC
  • Department of Health and Human Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dawn Marie Baletka, CEO, Winter Rose Services, LLC
ClinicalTrials.gov Identifier:
NCT03311061
Other Study ID Numbers:
  • 00004955
First Posted:
Oct 16, 2017
Last Update Posted:
Oct 16, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dawn Marie Baletka, CEO, Winter Rose Services, LLC

Study Results

No Results Posted as of Oct 16, 2017