A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2012 by Yale University.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01643005

First Posted: July 17, 2012

Last Update Posted: July 17, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Yale University

Purpose

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.

Condition	Intervention
HIV	Behavioral: Relationship Strengthening HIV Prevention Intervention Behavioral: Parenting Program Intervention


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Parenting

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

High risk sexual behavior [ Time Frame: Baseline ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
High risk sexual behavior [ Time Frame: 4 months ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy
High risk sexual behavior [ Time Frame: 8 months ]
Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy

Secondary Outcome Measures:

Relationship Functioning at 4 months [ Time Frame: 4 months ]
Relationship Dissolution at 4 months [ Time Frame: 4 months ]
Change from Baseline in relationship based determinants at 4 months [ Time Frame: 4 months ]
Attachment, Intimacy, Communication, Equity, Relationship Conflict
Relationship Functioning at 8 months [ Time Frame: 8 months ]
Relationship Dissolution at 8 months [ Time Frame: 8 months ]
Change from Baseline in relationship based determinants at 8 months [ Time Frame: 8 months ]
Attachment, Intimacy, Communication, Equity, Relationship Conflict


Estimated Enrollment:	100
Study Start Date:	August 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active Control Group For the active control group we will use Nurturing Parenting Groups currently being run by the community collaborator.	Behavioral: Parenting Program Intervention Nurturing Parenting curriculum delivered in a group format. Other Name: Nurturing Parenting
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.	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

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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	14 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643005

Contacts


Contact: Valen Diaz, B.A.	203-785-5293

Locations


United States, Connecticut
Children's Community Programs of Connecticut	Not yet recruiting
New Haven, Connecticut, United States, 06515
Contact: Victoria Dancy vdancy@childrenscommunityprograms.org
Principal Investigator: Hans Sherrod

Sponsors and Collaborators

Yale University

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Trace S Kershaw, PhD	Yale School of Public Health

More Information


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01643005 History of Changes
Other Study ID Numbers:	1105008508 R34MH094354 ( U.S. NIH Grant/Contract )
First Submitted:	July 12, 2012
First Posted:	July 17, 2012
Last Update Posted:	July 17, 2012
Last Verified:	July 2012

Keywords provided by Yale University:


HIV

To Top