Project Prepared: Risks, Roles and Relationships

NCT ID: NCT01880450

Last Updated: 2015-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-12-31

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.

Detailed Description

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Conditions

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F01.145.802.845 F01.145.802.987

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Project Prepared

Group Type EXPERIMENTAL

Project Prepared

Intervention Type BEHAVIORAL

Behavioral intervention to reduce sexual risk and promote healthy relationships

TEEN-Teen Education & Employment Network

Group Type ACTIVE_COMPARATOR

TEEN

Intervention Type BEHAVIORAL

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

Interventions

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Project Prepared

Behavioral intervention to reduce sexual risk and promote healthy relationships

Intervention Type BEHAVIORAL

TEEN

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

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Laurie Bauman

Professor; Director, Preventive Intervention Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laurie J Bauman, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine, Pediatrics Division

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Bauman LJ, Watnick D, Silver EJ, Rivera A, Sclafane JH, Rodgers CRR, Leu CS. Reducing HIV/STI Risk Among Adolescents Aged 12 to 14 Years: a Randomized Controlled Trial of Project Prepared. Prev Sci. 2021 Nov;22(8):1023-1035. doi: 10.1007/s11121-021-01203-0. Epub 2021 Feb 19.

Reference Type DERIVED
PMID: 33606173 (View on PubMed)

Other Identifiers

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5R01HD062079

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008-551

Identifier Type: -

Identifier Source: org_study_id

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