Project Prepared: Risks, Roles and Relationships (Prepared)

January 12, 2015 updated by: Laurie Bauman, Albert Einstein College of Medicine

Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

397

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months post baseline
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)
1 year post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months post baseline
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)
1 year post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

June 15, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-551
  • 5R01HD062079 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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