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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
Recruitment status was: Not yet recruiting
Sponsor:
Yale University
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
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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:
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| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643005
Please refer to this study by its ClinicalTrials.gov identifier: 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 ) |
| Study First Received: | July 12, 2012 |
| Last Updated: | July 16, 2012 |
Keywords provided by Yale University:
|
HIV |
ClinicalTrials.gov processed this record on August 17, 2017