- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00151151
The S.A.F.E. Study : Computer-Aided Counseling to Prevent Teen Pregnancy/Sexually Transmitted Diseases (STDs)
September 12, 2011 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
660
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Melanie A. Gold, DO, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2003
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (Estimate)
September 8, 2005
Study Record Updates
Last Update Posted (Estimate)
September 13, 2011
Last Update Submitted That Met QC Criteria
September 12, 2011
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0405473
- HD41058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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