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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697421
Other study ID # 2015-5900
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2016
Est. completion date September 30, 2020

Study information

Verified date December 2021
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The proposed program will flexibly provide an array of relationship promotion activities incorporating case management and job placement/career advancement activities: marriage and relationship education; pre-marital education and marriage skills; marriage enhancement and marriage skills for married couples; and divorce reduction and relationship skills. In addition, our proposed local evaluation will examine factors that might account for the observed impacts of attending relationship education programs (i.e., higher levels of relationship satisfaction), including dosage of workshops, relationship commitment and longevity, and skill learning.


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: 1. 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? 2. Hopefulness: How does hopefulness about the relationship impact outcomes? 3. Dosage: Is attendance at a greater number of workshops related to improvements in relationship satisfaction and relationship quality? 4. Couple characteristics: How are various demographic factors related to observed outcomes? 5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1029
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Relationship Education
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.).
Employment Services
For couples in need of job search, job retention, and career advancement services, we will provide employment services.

Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (3)

Lead Sponsor Collaborator
Montefiore Medical Center Children's Bureau - Administration for Children and Families, Metis Associates

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Couples Satisfaction Index (CSI-32) 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. Change from Baseline CSI at 6 months
Primary Change in Relationship Hope Scale 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. Change from Baseline Relationship Hope at 6 months
Primary Change in Maybe I Do? Scale (Commitment) 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. Change from Baseline Commitment at 6 months
Primary Change in Assessing Emotions Scale (Emotional Intelligence) 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. Change from Baseline Emotional Intelligence at 6 months
Primary Change Skills Assessment Measure (Skill Acquisition) 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. Change from Baseline Skills at immediately post intervention and at 6 months
Primary Adverse Childhood Experiences (ACE) Survey 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. Halfway through intervention (Week 6 of 12 weeks, or Week 5 of 9 weeks)
Secondary Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics 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. Baseline
Secondary Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey 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. At start of intervention (Week 1 of 12 or 9 weeks)
Secondary nformation, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey 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. Immediately post intervention (Week 12 of 12 weeks or Week 9 of 9 weeks)
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