Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS)
10. oktober 2017 opdateret af: 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.
Studieoversigt
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
2000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77036
- Bee Busy Inc.
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
13 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. oktober 2017
Primær færdiggørelse (Forventet)
30. september 2020
Studieafslutning (Forventet)
30. september 2020
Datoer for studieregistrering
Først indsendt
10. oktober 2017
Først indsendt, der opfyldte QC-kriterier
10. oktober 2017
Først opslået (Faktiske)
16. oktober 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 00004955
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
Undecided
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Teen graviditet
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaAfsluttet
-
Eunice Kennedy Shriver National Institute of Child...AfsluttetTeen graviditetForenede Stater
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHS; Planned Parenthood of the Great Northwest...AfsluttetTeen graviditet | STD forebyggelseForenede Stater
-
Children's Hospital Los AngelesETR AssociatesRekruttering
-
Philliber Research & EvaluationThe Office of Adolescent Health, HHSUkendt
-
The University of Texas Health Science Center at...The Office of Adolescent Health, HHSAfsluttet
-
Children's Hospital of PhiladelphiaUniversity of PennsylvaniaAfsluttetTeen-chauffører | MotorkøretøjsulykkerForenede Stater
-
Abt AssociatesDepartment of Health and Human Services; Decision Information Resources...AfsluttetTeen graviditet | Seksuel risikotagningsadfærd
-
Centers for Disease Control and PreventionBaltimore City Health Department; NORC at the University of Chicago; Ogilvy... og andre samarbejdspartnereAfsluttetTeen Dating Vold | Sund datingforholdForenede Stater
-
MetroHealth Medical CenterRekrutteringDepression | Familieforskning | Teen depressionForenede Stater
Kliniske forsøg med DREAMS Curriculum
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RekrutteringKost, sundForenede Stater
-
Mayo ClinicAfsluttetMedicinske praktikanter i onkologiske programmerForenede Stater
-
University of ChicagoAfsluttet
-
South Dakota State UniversityUnited States Department of Agriculture (USDA)AfsluttetFysisk aktivitet | Pædiatrisk fedme | Kostændring | Viden, holdninger, praksis
-
Washington University School of MedicineAfsluttet
-
Providence Health & ServicesAfsluttetUdbrændthed, professionel
-
University Hospital Schleswig-HolsteinUkendtMinimalt invasiv kirurgi grundlæggende færdighederTyskland
-
BeamCitruslabsAfsluttetSøvn | Søvnforstyrrelser | SøvnhygiejneForenede Stater
-
Public Health Institute, CaliforniaUniversity of Southern California; Ford Foundation; Planned Parenthood Los...AfsluttetSeksuelt overførte sygdomme | GraviditetForenede Stater
-
Hawaii Pacific UniversityArizona State University; University of HawaiiUkendtStof-relaterede lidelser