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

10 oktober 2017 bijgewerkt door: Dawn Marie Baletka, Winter Rose Services, LLC

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.

Studie Overzicht

Toestand

Onbekend

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

2000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

13 jaar tot 19 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

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

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
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.
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.
Teen Pregnancy Prevention Curriculum as described in arm/group description.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants who had sex without a condom
Tijdsspanne: 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.
immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who ever had sex
Tijdsspanne: 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.
immediately post-intervention, 6-months and 12-months-post intervention
Number of penile-vaginal sex acts
Tijdsspanne: 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.
immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who used other birth control methods
Tijdsspanne: 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.
immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who had an STI
Tijdsspanne: 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.
immediately post-intervention, 6-months and 12-months-post intervention
Number of participants who increased knowledge concerning risks associated with unprotected sex
Tijdsspanne: 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.
immediately post intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Tijdsspanne: 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.
12-months-post intervention
Number of participants who had had a teenage pregnancy
Tijdsspanne: 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.
12-months-post intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 oktober 2017

Primaire voltooiing (Verwacht)

30 september 2020

Studie voltooiing (Verwacht)

30 september 2020

Studieregistratiedata

Eerst ingediend

10 oktober 2017

Eerst ingediend dat voldeed aan de QC-criteria

10 oktober 2017

Eerst geplaatst (Werkelijk)

16 oktober 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 oktober 2017

Laatste update ingediend die voldeed aan QC-criteria

10 oktober 2017

Laatst geverifieerd

1 oktober 2017

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

Undecided

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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