The S.A.F.E. Study : Computer-Aided Counseling to Prevent Teen Pregnancy/Sexually Transmitted Diseases (STDs)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00151151
First received: September 6, 2005
Last updated: September 12, 2011
Last verified: January 2008
  Purpose

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.


Condition Intervention
Pregnancy
Sexually Transmitted Diseases
Behavioral: Computer-Assisted Motivational Intervention
Behavioral: Didactic Educational Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Self-reported sexual and contraceptive behaviors recorded by a 90-day timeline follow back interview at 9 and 18 months compared to baseline

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 660
Study Start Date: February 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151151

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Melanie A. Gold, DO University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00151151     History of Changes
Other Study ID Numbers: 0405473, HD41058
Study First Received: September 6, 2005
Last Updated: September 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
pregnancy prevention
STD prevention
adolescents
motivational interviewing
abstinence
contraception
transtheoretical model
sexual behavior

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014