An interventional study of Computer-Assisted Motivational Intervention and Didactic Educational Counseling in Pregnancy and Sexually Transmitted Diseases, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to female participants aged 13 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-13.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Prevention
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.
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.
435 studies on the registry are indexed under Sexually Transmitted Diseases; 73 are open to participants now.
This study's planned enrollment of 660 is above the median of 460 across 356 interventional studies indexed under Sexually Transmitted Diseases.
Browse Sexually Transmitted Diseases studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Self-reported sexual and contraceptive behaviors recorded by a 90-day timeline follow back interview at 9 and 18 months compared to baseline
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
The record gives a start of Feb 2003, a primary completion of Dec 2007 and a completion of Dec 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.
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Sexually Transmitted Diseases →