Project Prepared: Risks, Roles and Relationships

Not Applicable

Completed

• Conditions: F01.145.802.845; F01.145.802.987
• Interventions: Behavioral: TEEN; Behavioral: Project Prepared

• Registration Number: NCT01880450
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2013-06-15
• Study First Posted: 2013-06-19
• Primary Completion: 2014-03
• Study Completion: 2014-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-12
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEEN-Teen Education & Employment Network	TEEN	-
Project Prepared	Project Prepared	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive Factors at 1 year	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)
Change in Cognitive Factors at 6 months	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)

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States