A Couple-Based Relationship Strengthening HIV Intervention for Young Parents

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

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Parenting Program Intervention; Behavioral: Relationship Strengthening HIV Prevention Intervention

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06515
      • Children's Community Programs of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Partners in Life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	Baseline
High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	4 months
High risk sexual behavior	Number of sexual partners, Concurrent sexual partners, Unprotected sex, Repeat pregnancy	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship Functioning at 4 months		4 months
Relationship Dissolution at 4 months		4 months
Change from Baseline in relationship based determinants at 4 months	Attachment, Intimacy, Communication, Equity, Relationship Conflict	4 months
Relationship Functioning at 8 months		8 months
Relationship Dissolution at 8 months		8 months
Change from Baseline in relationship based determinants at 8 months	Attachment, Intimacy, Communication, Equity, Relationship Conflict	8 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Trace S Kershaw, PhD, Yale School of Public Health

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 13, 2020
• Study Completion (Actual): May 13, 2020

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: HIV
• Other Study ID Numbers: 1105008508; R34MH094354 (U.S. NIH Grant/Contract)