- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77036
- Bee Busy Inc.
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants who had sex without a condom
Tidsram: 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
Tidsram: 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
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|
Number of penile-vaginal sex acts
Tidsram: 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.
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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
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 00004955
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