Project Prepared: Risks, Roles and Relationships

Overview

Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.

Full Title of Study: “Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: March 2014

Interventions

  • Behavioral: Project Prepared
    • Behavioral intervention to reduce sexual risk and promote healthy relationships
  • Behavioral: TEEN
    • Control condition the promote communication, decision-making skills etc.

Arms, Groups and Cohorts

  • Experimental: Project Prepared
  • Active Comparator: TEEN-Teen Education & Employment Network

Clinical Trial Outcome Measures

Primary Measures

  • Change in Intentions to engage in safer sex behavior at 6 months
    • Time Frame: 6 months post baseline
    • measuring change from baseline to 6 months (as compared to control group)
  • Change in Intentions to engage in safer sex behavior at 1 year
    • Time Frame: 1 year post baseline
    • measuring change from baseline to 1 year (as compared to control group)

Secondary Measures

  • Change in Cognitive Factors at 6 months
    • Time Frame: 6 months post baseline
    • measuring change in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 6 months (compared to control group)
  • Change in Cognitive Factors at 1 year
    • Time Frame: 1 year post baseline
    • measuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)

Participating in This Clinical Trial

Inclusion Criteria

  • 12-14 yrs old – lives in the Bronx, NY at Baseline – Has been seen at some point in one of the Montefiore Medical Center community health clinics. Exclusion Criteria:

  • Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities. – Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 14 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Albert Einstein College of Medicine
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laurie Bauman, Professor; Director, Preventive Intervention Research Center – Albert Einstein College of Medicine
  • Overall Official(s)
    • Laurie J Bauman, PhD, Principal Investigator, Albert Einstein College of Medicine, Pediatrics Division

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