NCT01326195

Brief Summary

This project is designed to develop and test a group-based preventive intervention to reduce dating violence and sexual risk behavior among adolescent females with prior dating violence exposure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 30, 2011

Status Verified

March 1, 2011

Enrollment Period

4.8 years

First QC Date

March 28, 2011

Last Update Submit

March 29, 2011

Conditions

Keywords

HIV PreventionDating ViolenceFemalesRomantic relationshipsAdolescentsSexualityUnderserved youth

Outcome Measures

Primary Outcomes (1)

  • Change in number (#) of unprotected sex acts

    Baseline, 3 months, 6 months, 9 months

Secondary Outcomes (1)

  • Change in number of acts of dating violence perpetration and victimization

    Baseline, 3 months, 6 months, 9 months

Study Arms (2)

Skills

EXPERIMENTAL

Cognitive-Behavioral Dating Violence and HIV Prevention Group

Behavioral: Cognitive-Behavioral Dating Violence and HIV Prevention Group

Health Promotion

ACTIVE COMPARATOR

Psycho-educational Dating Violence and HIV Prevention group

Behavioral: Psycho-educational Dating Violence and HIV prevention group

Interventions

Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females

Also known as: Date SMART
Skills

Knowledge based intervention matched for time and attention to skills arm

Health Promotion

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent must be English-speaking
  • Adolescent must have a lifetime history of physical dating violence perpetration or victimization

You may not qualify if:

  • Current enrollment in an intervention for dating violence or HIV prevention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

  • Rizzo CJ, Joppa M, Barker D, Collibee C, Zlotnick C, Brown LK. Project Date SMART: a Dating Violence (DV) and Sexual Risk Prevention Program for Adolescent Girls with Prior DV Exposure. Prev Sci. 2018 May;19(4):416-426. doi: 10.1007/s11121-018-0871-z.

MeSH Terms

Conditions

HIV InfectionsSexuality

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSexual BehaviorBehavior

Study Officials

  • Christie J. Rizzo, Ph.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christie J. Rizzo, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

May 1, 2009

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 30, 2011

Record last verified: 2011-03

Locations