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- Klinische proef NCT03311061
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
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Texas
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Houston, Texas, Verenigde Staten, 77036
- Bee Busy Inc.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Teen Pregnancy Prevention Curriculum as described in arm/group description.
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Actieve vergelijker: 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.
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Teen Pregnancy Prevention Curriculum as described in arm/group description.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of participants who had sex without a condom
Tijdsspanne: immediately post-intervention, 6-months and 12-months-post intervention
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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.
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immediately post-intervention, 6-months and 12-months-post intervention
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Number of participants who ever had sex
Tijdsspanne: immediately post-intervention, 6-months and 12-months-post intervention
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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.
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immediately post-intervention, 6-months and 12-months-post intervention
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Number of penile-vaginal sex acts
Tijdsspanne: immediately post-intervention, 6-months and 12-months-post intervention
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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.
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immediately post-intervention, 6-months and 12-months-post intervention
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Number of participants who used other birth control methods
Tijdsspanne: immediately post-intervention, 6-months and 12-months-post intervention
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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.
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immediately post-intervention, 6-months and 12-months-post intervention
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Number of participants who had an STI
Tijdsspanne: immediately post-intervention, 6-months and 12-months-post intervention
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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.
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immediately post-intervention, 6-months and 12-months-post intervention
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Number of participants who increased knowledge concerning risks associated with unprotected sex
Tijdsspanne: immediately post intervention
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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.
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immediately post intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Tijdsspanne: 12-months-post intervention
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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.
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12-months-post intervention
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Number of participants who had had a teenage pregnancy
Tijdsspanne: 12-months-post intervention
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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.
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12-months-post intervention
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 00004955
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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