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Project Prepared: Risks, Roles and Relationships

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01880450
Acronym
Prepared
Enrollment
397
Registered
2013-06-19
Start date
2009-05-31
Completion date
2014-12-31
Last updated
2015-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F01.145.802.845, F01.145.802.987

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.

Interventions

BEHAVIORALProject Prepared

Behavioral intervention to reduce sexual risk and promote healthy relationships

BEHAVIORALTEEN

Control condition the promote communication, decision-making skills etc.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Albert Einstein College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Intentions to engage in safer sex behavior at 6 months6 months post baselinemeasuring change from baseline to 6 months (as compared to control group)
Change in Intentions to engage in safer sex behavior at 1 year1 year post baselinemeasuring change from baseline to 1 year (as compared to control group)

Secondary

MeasureTime frameDescription
Change in Cognitive Factors at 6 months6 months post baselinemeasuring 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 year1 year post baselinemeasuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026