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- Klinische proef NCT00151151
The S.A.F.E. Study : Computer-Aided Counseling to Prevent Teen Pregnancy/Sexually Transmitted Diseases (STDs)
12 september 2011 bijgewerkt door: University of Pittsburgh
The S.A.F.E. Study: Computer-Aided Counseling to Prevent Teen Pregnancy/STDs - Validity and Reliability Testing of Computer Measures, Pilot-testing of Timeline Followback Calendar Protocol, and Randomized Efficacy Study
This is a randomized clinical trial assessing the efficacy of two types of counseling (Computer-Assisted Motivational Intervention [CAMI] versus Didactic Educational Counseling [DEC]) to see which can better reduce female adolescents' risk taking behaviors that put them at risk for unintended pregnancy and sexually transmitted diseases (STDs).
The intervention phase consists of three 30-minute counseling sessions over the first 6 months followed by a visit every three months during the 12 month follow up phase.
We, the researchers, hypothesize that the CAMI will decrease the proportion of subjects who engage in any intercourse that is poorly protected against pregnancy and against STDs.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
Adolescent unintended pregnancy and STDs remain at epidemic levels in the United States.
Healthy People 2010 Objectives set a goal to increase to 90% the proportion of sexually active adolescents who use contraception that both effectively prevents pregnancy and provides barrier protection against disease.
How to effectively counsel adolescents to reach this goal is unclear.
Counseling and feedback based on the Transtheoretical Model (TTM) have demonstrated greater success than standard, action-oriented advice in several domains of behavior change.
The effectiveness of this type of counseling to alter female adolescents' sexual and contraceptive behaviors has not been rigorously evaluated.
We propose recruiting 660 female adolescents, ages 13 to 21 years, from an inner-city, hospital-based clinic and randomizing them to either an innovative Computer-Assisted Motivational Intervention (CAMI) or a Didactic Educational Control (DEC).
The CAMI group will receive three, 30-minute sessions of one-on-one counseling with a counselor that is guided by computer-generated personalized feedback.
The CAMI is based on the principles of the TTM and on Motivational Interviewing.
The DEC provides three 30-minute sessions of one-on-one didactic information on contraception, STD prevention, and abstinence.
The two interventions are identical in length and timing but vary in educational content, counseling style, and the provision of personalized feedback.
We will track the two groups of female adolescents in this study through a 6-month intervention phase and a 12-month follow-up phase to assess differences in sexual and contraceptive behaviors by group.
The primary specific aim for the study is to evaluate the efficacy of the CAMI as compared to the DEC in reducing sexual behaviors that increase the risks of both unintended pregnancy and STDs.
We will examine protective sexual behaviors in three ways: 1) behaviors that protect against pregnancy; 2) behaviors that protect against STDs; and 3) behaviors that protect against both pregnancy and STDs.
Our primary hypothesis is that the CAMI will decrease the proportion of subjects who engage in any intercourse that is poorly protected against pregnancy and against STDs.
We also predict that among sexually active subjects, the CAMI will increase the percentage of episodes of intercourse that are well protected by the use of both condoms plus another contraceptive.
Finally, we also predict that the CAMI will increase the prevalence of abstinence among the entire sample.
If proven effective, computer-assisted personalized motivational counseling could be broadly implemented as a method to decrease the incidence of unintended pregnancy and STDs among female adolescents.
Studietype
Ingrijpend
Inschrijving (Verwacht)
660
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
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15213
- Children's Hospital of Pittsburgh
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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 21 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Female adolescents,
- Ages 13 to 21 years of age,
- Not currently pregnant or planning pregnancy in next 18 months,
- English speaking,
- Able to return every 3 months to study office for 18 months
Exclusion Criteria:
- Medically or surgically sterile,
- Has intrauterine device (IUD) or subdermal contraceptive implant,
- Hearing or visual impairments that might interfere with using the computerized assessment or participating in counseling session,
- In foster care or on house arrest,
- Has sex exclusively with female partners
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: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Self-reported sexual and contraceptive behaviors recorded by a 90-day timeline follow back interview at 9 and 18 months compared to baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
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Stage of readiness to be abstinent, use condoms, spermicide, and hormonal contraception based on a computerized assessment
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Reported drug and alcohol use recorded by a 90-day timeline follow back interview
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Melanie A. Gold, DO, University of Pittsburgh
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
1 februari 2003
Primaire voltooiing (Werkelijk)
1 december 2007
Studie voltooiing (Werkelijk)
1 december 2007
Studieregistratiedata
Eerst ingediend
6 september 2005
Eerst ingediend dat voldeed aan de QC-criteria
7 september 2005
Eerst geplaatst (Schatting)
8 september 2005
Updates van studierecords
Laatste update geplaatst (Schatting)
13 september 2011
Laatste update ingediend die voldeed aan QC-criteria
12 september 2011
Laatst geverifieerd
1 januari 2008
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0405473
- HD41058
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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