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.
Brief Title
Project Prepared: Risks, Roles and Relationships
Categories
Completion Date
Completion Date Type
Actual
Conditions
F01.145.802.845
F01.145.802.987
Eligibility 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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
14 Years
Minimum Age
12 Years
NCT Id
NCT01880450
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2008-551
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes
Primary Outcomes
Outcome Description
measuring change from baseline to 6 months (as compared to control group)
Outcome Measure
Change in Intentions to engage in safer sex behavior at 6 months
Outcome Time Frame
6 months post baseline
Outcome Description
measuring change from baseline to 1 year (as compared to control group)
Outcome Measure
Change in Intentions to engage in safer sex behavior at 1 year
Outcome Time Frame
1 year post baseline
Secondary Ids
Secondary Id
5R01HD062079
Secondary Outcomes
Outcome Description
measuring change in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 6 months (compared to control group)
Outcome Time Frame
6 months post baseline
Outcome Measure
Change in Cognitive Factors at 6 months
Outcome Description
measuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)
Outcome Time Frame
1 year post baseline
Outcome Measure
Change in Cognitive Factors at 1 year
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
14
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Laurie Bauman
Investigator Email
laurie.bauman@einsteinmed.org
Investigator Phone
bauman