Project Prepared: Risks, Roles and Relationships

Study Overview
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Brief Summary
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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.

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

Conditions
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F01.145.802.845, F01.145.802.987

Intervention / Treatment
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* Behavioral: Project Prepared
* Behavioral: TEEN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Prepared<br> | Behavioral: Project Prepared<br>* Behavioral intervention to reduce sexual risk and promote healthy relationships<br>|
| Active Comparator: TEEN-Teen Education & Employment Network<br> | Behavioral: TEEN<br>* Control condition the promote communication, decision-making skills etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intentions to engage in safer sex behavior at 6 months | 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 | 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 | 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 | 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 |