Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS)
10. oktober 2017 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Forventet)
2000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Texas
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Houston, Texas, Forente stater, 77036
- Bee Busy Inc.
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
13 år til 19 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants who had sex without a condom
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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immediately post-intervention, 6-months and 12-months-post intervention
|
|
Number of participants who increased knowledge concerning risks associated with unprotected sex
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. oktober 2017
Primær fullføring (Forventet)
30. september 2020
Studiet fullført (Forventet)
30. september 2020
Datoer for studieregistrering
Først innsendt
10. oktober 2017
Først innsendt som oppfylte QC-kriteriene
10. oktober 2017
Først lagt ut (Faktiske)
16. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. oktober 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 00004955
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
Undecided
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Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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