Behavior and Behavior MechanismsCFCNCT01631721
Couple & Family Contexts
An observational study of Behavior and Behavior Mechanisms, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior and Behavior Mechanisms
- How many people
- 2,960 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Latino and African American adolescents currently involved in romantic relationships who reside in the Bronx, New York.
Who may be able to join
- 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
Who cannot join
- Any cognitive or psychiatric disability that would prevent successful participation of adolescent or parent in questionnaire activities
Trial locations and contacts
1 site in 1 country.
United States1 site
Silver School of Social Work, New York University
New York, New York, 10003
About this study
Official title: Affective Influences on Adolescent Sexual Risk Behavior: Couple & Family Contexts
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.
Read the detailed description
In the United States, inner-city African American and Latino youth are vulnerable to the negative consequences of sexual risk behavior. Despite the fact that sexual risk behavior is a dyadic behavior, almost all of the social-cognitive theories emphasize individual-based variables to explain behavior. Little research has studied both members of an adolescent couple or has used measures from each member to predict future sexual activity of that dyad. The overall aim of the present study is to identify explanatory models of couple sexual risk behavior among a sample of unmarried, non co-habiting Latino and African American high school-aged dyads that are romantically linked. In addition, the present research also will study the parents of adolescent couples. In doing so, the present research will apply theories of cognition, emotion and emotion regulation, and a new theory of parental monitoring to the study of adolescent sexual risk behavior among couples.
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- adolescent couple decision-making, parenting practices, sexual risk behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vaginal intercourse with romantic partner
Number of times ever had vaginal intercourse with current romantic partner
Measured: Baseline
Secondary outcomes (11)
Frequency of condom use during vaginal intercourse with romantic partner
Of the number of times participant has ever had vaginal sex with romantic partner, number of times used a condom
Measured: Baseline
Incidence of oral sex with romantic partner
Number of times has ever given/received oral sex with current romantic partner
Measured: Baseline
Frequency of condom use for oral sex with romantic partner
Of number of times has ever had oral sex with current romantic partner, number of times used a condom
Measured: Baseline
Incidence of anal intercourse with current romantic partner
Number of times has ever had anal intercourse with current romantic partner
Measured: Baseline
Frequency of condom use for anal intercourse with romantic partner
Of times has ever had anal intercourse with current romantic partner, number of times used a condom
Measured: Baseline
Frequency of condom use during vaginal intercourse with romantic partner
Of the number of times participant has ever had vaginal sex with romantic partner, number of times used a condom
Measured: 6 Months Follow-up
Incidence of oral sex with romantic partner
Number of times has ever given/received oral sex with current romantic partner
Measured: 6 Months Follow-up
Frequency of condom use for oral sex with romantic partner
Of number of times has ever had oral sex with current romantic partner, number of times used a condom
Measured: 6 Months Follow-up
Incidence of anal intercourse with current romantic partner
Number of times has ever had anal intercourse with current romantic partner
Measured: 6 Months Follow-up
Frequency of condom use for anal intercourse with romantic partner
Of times has ever had anal intercourse with current romantic partner, number of times used a condom
Measured: 6 Months Follow-up
Incidence of vaginal intercourse romantic partner
Number of times ever had vaginal intercourse with current romantic partner
Measured: 6 Months Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior and Behavior MechanismsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,960 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631721
- Sponsor's protocol ID
- NICHD_064734
- Other IDs
- R01HD064734
- Acronym
- CFC
- Status last verified
- Mar 2016
- First submitted
- 26 Jun 2012
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affective Influences on Adolescent Sexual Risk Behavior: Couple & Family Contexts
- ClinicalTrials.gov ID
- NCT01631721
- Acronym / sponsor ID
- CFC / NICHD_064734
- Conditions
- Behavior and Behavior Mechanisms
- Keywords
- adolescent couple decision-making, parenting practices, sexual risk behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,960 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the United States, inner-city African American and Latino youth are vulnerable to the negative consequences of sexual risk behavior. Despite the fact that sexual risk behavior is a dyadic behavior, almost all of the social-cognitive theories emphasize individual-based variables to explain behavior. Little research has studied both members of an adolescent couple or has used measures from each member to predict future sexual activity of that dyad. The overall aim of the present study is to identify explanatory models of couple sexual risk behavior among a sample of unmarried, non co-habiting Latino and African American high school-aged dyads that are romantically linked. In addition, the present research also will study the parents of adolescent couples. In doing so, the present research will apply theories of cognition, emotion and emotion regulation, and a new theory of parental monitoring to the study of adolescent sexual risk behavior among couples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 17 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Latino and African American adolescents currently involved in romantic relationships who reside in the Bronx, New York.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Any cognitive or psychiatric disability that would prevent successful participation of adolescent or parent in questionnaire activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of vaginal intercourse with romantic partner
Time frame: Baseline
Number of times ever had vaginal intercourse with current romantic partner
11 secondary outcomes
Frequency of condom use during vaginal intercourse with romantic partner
Time frame: Baseline
Incidence of oral sex with romantic partner
Time frame: Baseline
Frequency of condom use for oral sex with romantic partner
Time frame: Baseline
Incidence of anal intercourse with current romantic partner
Time frame: Baseline
Frequency of condom use for anal intercourse with romantic partner
Time frame: Baseline
Frequency of condom use during vaginal intercourse with romantic partner
Time frame: 6 Months Follow-up
Incidence of oral sex with romantic partner
Time frame: 6 Months Follow-up
Frequency of condom use for oral sex with romantic partner
Time frame: 6 Months Follow-up
Incidence of anal intercourse with current romantic partner
Time frame: 6 Months Follow-up
Frequency of condom use for anal intercourse with romantic partner
Time frame: 6 Months Follow-up
Incidence of vaginal intercourse romantic partner
Time frame: 6 Months Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavior and Behavior Mechanisms, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vaginal intercourse with romantic partner (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.