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

Teen Pregnancy Clinical Trial

— DREAMS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03311061
• Other study ID #: 00004955
• Status: Active, not recruiting
• Phase: N/A
• First received: October 10, 2017
• Last updated: October 10, 2017
• Start date: October 10, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2017
• Source: Winter Rose Services, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Teen Pregnancy

Intervention

Other:
• DREAMS Curriculum
Teen Pregnancy Prevention Curriculum as described in arm/group description.

Locations

Country	Name	City	State
United States	Bee Busy Inc.	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Winter Rose Services, LLC	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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