Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Completed
NCT Number: NCT01880450
Project Prepared: Risks, Roles and Relationships
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.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
12 year–14 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Project Prepared
BehavioralBehavioral intervention to reduce sexual risk and promote healthy relationships
TEEN
BehavioralControl condition the promote communication, decision-making skills etc.
Primary outcomes
-
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 outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Albert Einstein College of Medicine
Other
Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Registry information
Official study title
Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes
Acronym: Prepared
Important dates
- Study start
- 2009
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jun 19, 2013
- Registry last updated
- Jan 14, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.