- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03697421
Montefiore Medical Center Healthy Marriage and Relationship Education Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of the proposed evaluation is to delineate those factors and sub-groups that account for the observed impact of HMRE services on the quality of relationships. Specifically, we are interested in investigating the following factors:
- Commitment: Are couples that are more committed to each other (measured in terms of marital status, duration of relationship, or relationship commitment scale scores) more motivated to attend a greater number of HMRE workshops? Do they actually learn more relationship skills, and report improvements in their relationship quality?
- Hopefulness: How does hopefulness about the relationship impact outcomes?
- Dosage: Is attendance at a greater number of workshops related to improvements in relationship satisfaction and relationship quality?
- Couple characteristics: How are various demographic factors related to observed outcomes?
- Skill acquisition: How much did couples actually learn during the course of the relationship workshop?
In order to explore these research questions, we will be conducting an evaluation that utilizes pre-and post-survey data and qualitative interview information from participants. This will be a descriptive study and not a random assignment design. Data collection will begin when couples who expressed interest in the program attend a preliminary interview with one of Montefiore's clinical staff on site. The program and study will be explained to the couple and they will be asked to consent to participate. Once consent is gathered, on-site staff will administer measures required by our funders through an online system called nForm, or Information, Family Outcomes, Reporting, and Management. This online system was developed by Mathematica Policy Research, an agency contracted by the Department of Health and Human Services to conduct a Cross-Site evaluation of all grantees who received funding to provide relationship education services. Preliminary demographic information will be collected through surveys completed by participants online through secure web browsing at a Montefiore facility.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10451
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- In a committed relationship
- 18 years or older
- expecting a child or are caring for a child in the home at least 50% of the time (biological, foster, adopted, kinship care, etc.)
Exclusion Criteria:
- Active intimate partner violence and increased risk of intimate partner violence
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Local Evaluation
The SHR program intends to serves couples who are over 18 years of age, are in a romantic relationship, and have at least one child (biological or adopted) under the age of 18 residing in the home or are expecting.
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We 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.).
For couples in need of job search, job retention, and career advancement services, we will provide employment services.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Couples Satisfaction Index (CSI-32)
Time Frame: Change from Baseline CSI at 6 months
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Considered the gold standard, this measure detects differences in relationship satisfaction with great precision.
It is a 32-item scale, total score range from 0 to 161.
Higher scores indicate higher levels of relationship satisfaction.
CSI-32 scores falling below 104.5 suggest notable relationship dissatisfaction.
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Change from Baseline CSI at 6 months
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Change in Relationship Hope Scale
Time Frame: Change from Baseline Relationship Hope at 6 months
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This is a newly developed 5-item scale by a major relationship researcher (Alan Hawkins), which has reportedly good psychometric properties.
It will allow us to hone in on the level of hopefulness and cynicism among our couples.
This is a 5-item scale, scores determined by mean, ranging 1-7.
Mean scores less than or equal to 5 suggest low hope.
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Change from Baseline Relationship Hope at 6 months
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Change in Maybe I Do? Scale (Commitment)
Time Frame: Change from Baseline Commitment at 6 months
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A 4-item measure of commitment developed by another major relationship research group (Scott Stanley and Howard Markman).
This is a 4-item scale, with a total score range 1-20.
Low commitment is indicated at a total score of 12 or below.
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Change from Baseline Commitment at 6 months
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Change in Assessing Emotions Scale (Emotional Intelligence)
Time Frame: Change from Baseline Emotional Intelligence at 6 months
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Assesses the extent individuals perceive, understand, regulate, and harness emotions adaptively.
This is a 33-item self-report inventory focusing on typical emotional intelligence.
Scores can range from 33 to 165.
Low EI is less than or equal to 115 for females and 108 for males; average EI is 116-145 for females and 109-131 for males; high EI is greater than or equal to 146 for females and 132 for male.
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Change from Baseline Emotional Intelligence at 6 months
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Change Skills Assessment Measure (Skill Acquisition)
Time Frame: Change from Baseline Skills at immediately post intervention and at 6 months
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Assesses whether the individual has/has learned the skills and knowledge taught through the program curriculum.
There are two forms of this measure, A and B, each 14 items.
Scores are percentages ranging from 0-100%.
Higher scores represent a higher outcome.
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Change from Baseline Skills at immediately post intervention and at 6 months
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Adverse Childhood Experiences (ACE) Survey
Time Frame: Halfway through intervention (Week 6 of 12 weeks, or Week 5 of 9 weeks)
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The Adverse Childhood Experience (ACE) Questionnaire is a 10-item self-report measure developed for the ACE study to identify childhood experiences of abuse and neglect.
Scores range 0-10.
Higher scores suggest worse outcomes.
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Halfway through intervention (Week 6 of 12 weeks, or Week 5 of 9 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics
Time Frame: Baseline
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This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study, that gathers demographic information regarding participants.
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Baseline
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Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey
Time Frame: At start of intervention (Week 1 of 12 or 9 weeks)
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This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.
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At start of intervention (Week 1 of 12 or 9 weeks)
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nformation, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey
Time Frame: Immediately post intervention (Week 12 of 12 weeks or Week 9 of 9 weeks)
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This is a survey developed by the Office of Family Assistance utilized by all grantees participating in the national study that includes questions regarding relationship satisfaction, financial stability, and parenting.
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Immediately post intervention (Week 12 of 12 weeks or Week 9 of 9 weeks)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Wetzler, PhD, Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2015-5900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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