NCT01631721

Brief Summary

The purpose of this study is to understand the factors that lead to adolescent sexual risk behavior by investigating both the family contexts and romantic relationships that influence adolescent couples' decision-making.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,960

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 28, 2022

Status Verified

March 1, 2016

Enrollment Period

5.2 years

First QC Date

June 26, 2012

Last Update Submit

October 25, 2022

Conditions

Behavior and Behavior Mechanisms

Keywords

adolescent couple decision-makingparenting practicessexual risk behavior

Outcome Measures

Primary Outcomes (1)

  • Incidence of vaginal intercourse with romantic partner

    Number of times ever had vaginal intercourse with current romantic partner

    Baseline

Secondary Outcomes (11)

  • Frequency of condom use during vaginal intercourse with romantic partner

    Baseline

  • Incidence of oral sex with romantic partner

    Baseline

  • Frequency of condom use for oral sex with romantic partner

    Baseline

  • Incidence of anal intercourse with current romantic partner

    Baseline

  • Frequency of condom use for anal intercourse with romantic partner

    Baseline

  • +6 more secondary outcomes

Study Arms (3)

Cohort 1

Cohort of adolescents recruited in 2012-2013 of study

Cohort 2

Cohort of adolescents recruited in year 2013-2014 of study

Cohort 3

Cohort of adolescents recruited in year 2014-15 of study

Eligibility Criteria

Age17 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Latino and African American adolescents currently involved in romantic relationships who reside in the Bronx, New York.

You may qualify if:

  • Adolescents must be between the ages of 17-19
  • Adolescents must currently reside in the Bronx, New York
  • Adolescents must be of Latino or African American descent
  • Adolescents must identify as being currently involved in romantic relationship
  • Adolescent and parent must both agree to being a participant
  • Adolescent and parent must be able to participate in questionnaire activities

You may not qualify if:

  • Any cognitive or psychiatric disability that would prevent successful participation of adolescent or parent in questionnaire activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silver School of Social Work, New York University

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

June 29, 2012

Study Start

November 1, 2010

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

October 28, 2022

Record last verified: 2016-03

Locations

US(1)