- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00151151
The S.A.F.E. Study : Computer-Aided Counseling to Prevent Teen Pregnancy/Sexually Transmitted Diseases (STDs)
12 september 2011 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
660
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Children's Hospital of Pittsburgh
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
13 år till 21 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Self-reported sexual and contraceptive behaviors recorded by a 90-day timeline follow back interview at 9 and 18 months compared to baseline
|
Sekundära resultatmått
Resultatmått |
---|
Stage of readiness to be abstinent, use condoms, spermicide, and hormonal contraception based on a computerized assessment
|
Reported drug and alcohol use recorded by a 90-day timeline follow back interview
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Melanie A. Gold, DO, University of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2003
Primärt slutförande (Faktisk)
1 december 2007
Avslutad studie (Faktisk)
1 december 2007
Studieregistreringsdatum
Först inskickad
6 september 2005
Först inskickad som uppfyllde QC-kriterierna
7 september 2005
Första postat (Uppskatta)
8 september 2005
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 september 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 september 2011
Senast verifierad
1 januari 2008
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0405473
- HD41058
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Computer-Assisted Motivational Intervention
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute on Alcohol... och andra samarbetspartnersAvslutadHIV-infektionFörenta staterna
-
University Hospitals Cleveland Medical CenterEmory UniversityRekryteringAkut smärta | Distal pankreatektomi | Whipple-förfarandeFörenta staterna
-
University of MichiganNational Institute on Drug Abuse (NIDA)AvslutadDrogmissbrukFörenta staterna
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Johns Hopkins University; Thai Nguyen...AvslutadAlkohol dricka | HIVVietnam
-
University of MiamiAB InBev FoundationAvslutad
-
LuciLabCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal och andra samarbetspartnersAvslutadRiskbeteende | Kognitiv försämringKanada
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AvslutadAlkoholmissbrukFörenta staterna
-
Cambridge Health AllianceUniversity of South Florida; Centers for Disease Control and PreventionAvslutadBeteendesymtom | Opioidanvändningsstörning | Psykiatriska eller humörsjukdomar eller tillståndFörenta staterna