A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

This study is not yet open for participant recruitment.

Verified July 2012 by Yale University

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01643005

First received: July 12, 2012

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 12, 2012

Last Updated Date

July 16, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

High risk sexual behavior [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
High risk sexual behavior [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
High risk sexual behavior [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01643005 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Relationship Functioning at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Relationship Dissolution at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Change from Baseline in relationship based determinants at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Attachment, Intimacy, Communication, Equity, Relationship Conflict
Relationship Functioning at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Relationship Dissolution at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Change from Baseline in relationship based determinants at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Attachment, Intimacy, Communication, Equity, Relationship Conflict

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

Official Title ^ICMJE

Pilot Phase of Couples-Based Intervention to Reduce HIV/STD Risk (Concurrency, Number of Partners, Unprotected Sex), Strengthen Relationships, and Improve Parenting Among Young Parenting Heterosexual Couples

Brief Summary

This study seeks to develop, implement, and assess an innovative 15-session couple-based intervention to be delivered in a group format to young parents that aims to strengthen relationships and reduce HIV risk. The ultimate goal of our intervention is to reduce HIV/STD risk (concurrency, number of partners, unprotected sex), strengthen relationships, and improve parenting among young parenting heterosexual couples.

Detailed Description

This study develops a couple-based HIV prevention intervention that is innovative and important because it integrates an intervention that improves sexual health, relationship functioning, and parenting skills. Our intervention will be integrated with an existing community based parenting program. By targeting high risk heterosexual couples experiencing an important life transition that increases their stress, conflict, and sexual risk, the investigators can provide maximum benefit to the men, women, and children in our communities. Using the guiding framework of Attachment Theory and the principles of Emotion Focused Therapy, the investigators will directly address issues of emotion, intimacy,and relationship functioning to create an intervention that strengthens romantic relationships and reduces HIV risk behavior. The investigators will conduct a small pilot randomized controlled trial of 50 parenting couples randomized to either the relationship strengthening HIV prevention intervention or an active control. The intervention will last 15 weeks and each session will be approximately 1.5 hours long. The investigators will assess couples at baseline, 4-months, and 8-months.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

HIV

Intervention ^ICMJE

Behavioral: Relationship Strengthening HIV Prevention Intervention
The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.

Other Name: Partners in Life
Behavioral: Parenting Program Intervention
Nurturing Parenting curriculum delivered in a group format.

Other Name: Nurturing Parenting

Study Arm (s)

Active Comparator: Active Control Group
For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.

Intervention: Behavioral: Parenting Program Intervention
Experimental: Relationship Strengthening HIV Prevent.
The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.

Intervention: Behavioral: Relationship Strengthening HIV Prevention Intervention

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

July 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women's age between 14 and 25
Men's age 14 or older
Have a child that is 0-1 year old
In a romantic relationship with the mother/father of the baby
Not known to be HIV positive
English speaking

Exclusion Criteria:

Child older than 1 year
HIV positive

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Valen Diaz, B.A.

203-785-5293

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01643005

Other Study ID Numbers ^ICMJE

1105008508, R34MH094354

Has Data Monitoring Committee

Yes

Responsible Party

Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute of Mental Health (NIMH)

Investigators ^ICMJE

Principal Investigator:

Trace S Kershaw, PhD

Yale School of Public Health

Information Provided By

Yale University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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