The S.A.F.E. Study : Computer-Aided Counseling to Prevent Teen Pregnancy/Sexually Transmitted Diseases (STDs)
Condition: Pregnancy; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Computer-Assisted Motivational Intervention; Didactic Educational Counseling
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy prevention; STD prevention; adolescents; motivational interviewing; abstinence; contraception; transtheoretical model; sexual behavior