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

NCT00151151 | Completed

• 2 other identifiers: 0405473HD41058
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Sexually Transmitted Diseases

Keywords

pregnancy prevention; STD prevention; adolescents; motivational interviewing; abstinence; contraception; transtheoretical model; sexual behavior

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

Computer-Assisted Motivational Intervention BEHAVIORAL

Didactic Educational Counseling BEHAVIORAL

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Sexual Behavior

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Melanie A. Gold, DO

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: February 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: September 13, 2011

Record last verified: 2008-01

Locations

US (1)