NCT01084421

Brief Summary

The purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 31, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

March 9, 2010

Last Update Submit

August 29, 2016

Conditions

Keywords

AdolescentsParentsComputer BasedLatinoSexual Communication

Outcome Measures

Primary Outcomes (1)

  • general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication

    pretest, 1 week, 3 months

Study Arms (2)

Computer based intervention

EXPERIMENTAL

Participants receive content about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general.

Behavioral: Computer-based parent-adolescent HIV communication

Wait list control group

NO INTERVENTION

Participants will receive the computer based intervention at 3 months follow-up

Interventions

The parental intervention consists of a 60 minute computer-based program delivered in two sessions (one per week). The DVD ROM provides information about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. The computer based education program is provided in Spanish.

Also known as: Cuidalos
Computer based intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Latino parents who have adolescents 14 to 17 years of age
  • Spanish dominant or bilingual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Hispanic Development Corporation (DHDC)

Detroit, Michigan, 48216, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Antonia M Villarruel, PhD,RN,FAAN

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

June 1, 2010

Last Updated

August 31, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations