NCT05367102

Brief Summary

The overarching objective for the Supporting Health Relationships (SHR) program is to create and sustain families in the Bronx by improving relationship skills, improving parenting skills, and improving parental financial support for children. The investigator's local evaluation addresses a research question about the effectiveness of delivering the SHR curriculum virtually: To what extent do couples show improvements in engagement, skills learning, and relationship quality outcomes when receiving the curriculum over Zoom?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,022

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

March 28, 2022

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Relationship Satisfaction at 6 months

    Relationship satisfaction is assessed using the Couples Satisfaction Index-32 (Funk \& Rogge, 2007): Considered the gold standard, this measure detects differences in relationship satisfaction with great precision. This outcome measure is a scale (value 0 to 5 and 6 for one item, ranging from never; extremely bad; extremely unhappy; not at all true; always disagree, to more often; extremely good; perfect; completely true; always agree), calculated by summing the responses across all of the items. Scores can range from 0 to 161. Higher scores indicate higher levels of relationship satisfaction and scores falling below 104.5 suggest notable relationship dissatisfaction. This measure has demonstrated excellent internal consistency, convergent validity, and construct validity.

    Baseline and 6 month follow up

Secondary Outcomes (8)

  • Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics

    Baseline

  • Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey

    At start of intervention (Week 1 of 12)

  • Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey

    Immediately post intervention (Week 12 of 12 weeks)

  • Assessing Emotions Scale (Emotion Intelligence)

    Changes from Baseline Emotion Intelligence at 6 month follow up

  • Parenting Alliance Inventory (Quality of Co-Parenting Relationship)

    Changes from Baseline Quality of Co-Parenting Relationship at 6 month follow up

  • +3 more secondary outcomes

Study Arms (2)

In Person

EXPERIMENTAL

Participants will receive all services in person, including participating in the initial intake process, and attending all workshops.

Behavioral: Supporting Healthy Relationships program

Virtual (Zoom)

EXPERIMENTAL

Participants will complete their intake process in person, but will complete all workshops virtually through Zoom.

Behavioral: Supporting Healthy Relationships program

Interventions

The investigator will provide the following 4 activities: 1) marriage and relationship education \[using a modified version of the empirically supported Loving Couples, Loving Children (LCLC); 2) pre-marital education and marriage skills; 3) marriage enhancement and marriage skills for married couples; and 4) divorce reduction and relationship skills. All couples will be expected to participate in 24 hours of core relationship education workshops (including parenting education). Since parental financial support represents a core element of family stability, relationship education workshops will address motivation for providing financial support through employment for all couples (employed and unemployed) as well as how to manage conflicts over money. All couples will be invited to supplemental workshops (with couples from other cohorts) on topics of specialized interest, including employment services and financial literacy (i.e. budgeting, debt, etc.)

In PersonVirtual (Zoom)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Married or unmarried couples who are 18 years or older
  • Must have custodial children (biological, foster, adopted) under the age of 18 (or expectant parents)
  • Income below 200% of poverty level

You may not qualify if:

  • Active intimate partner violence and increased risk of intimate partner violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10451, United States

Location

Study Officials

  • Scott Wetzler, PhD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The investigator will run workshops virtually, through Zoom, and in person. Participants will be randomized either to the virtual condition, or to the in person condition. Note that effective 1/1/2025, participants will no longer be randomized to one of the two study arms. See 'Detailed Description.'
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 10, 2022

Study Start

April 1, 2021

Primary Completion

June 10, 2025

Study Completion

June 10, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations