Project Prepared: Risks, Roles and Relationships (Prepared)

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laurie Bauman, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01880450
First received: July 12, 2011
Last updated: January 12, 2015
Last verified: January 2015
  Purpose
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.

Condition Intervention
F01.145.802.845
F01.145.802.987
Behavioral: Project Prepared
Behavioral: TEEN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Change in Intentions to engage in safer sex behavior at 6 months [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measuring change from baseline to 1 year (as compared to control group)


Secondary Outcome Measures:
  • Change in Cognitive Factors at 6 months [ Time Frame: 6 months post baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)


Enrollment: 397
Study Start Date: May 2009
Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Project Prepared Behavioral: Project Prepared
Behavioral intervention to reduce sexual risk and promote healthy relationships
Active Comparator: TEEN-Teen Education & Employment Network Behavioral: TEEN
Control condition the promote communication, decision-making skills etc.

  Eligibility

Ages Eligible for Study:   12 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01880450

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Laurie J Bauman, PhD Albert Einstein College of Medicine, Pediatrics Division
  More Information

Responsible Party: Laurie Bauman, Professor; Director, Preventive Intervention Research Center, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01880450     History of Changes
Other Study ID Numbers: 2008-551  5R01HD062079 
Study First Received: July 12, 2011
Last Updated: January 12, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 24, 2016