ParentingNCT03697421
Montefiore Medical Center Healthy Marriage and Relationship Education Program
An observational study of Parenting and Family Relationships, run by Montefiore Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parenting, Family Relationships
- What is being tested?
- Relationship Education and Employment Services
- How many people
- 1,029 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population is 47% Hispanic and 44% African-American. The income level of the majority of the couples enrolled was at or below 200% of poverty level, and 36% received income from public assistance. The majority of couples we served (72%) had a high school degree or less, and nearly half (49%) of participants were unemployed at program enrollment with many more under-employed. Their average age was 36 years old, including 10% between the ages of 17 and 24. The average duration of marriage for couples in our program was 7 years; however, the range of relationship longevity was quite wide, spanning from newlywed couples married for a few months to couples married for over 30 years. All couples had at least one child under 18 years old living in the home (or were expecting a child), and we estimate that approximately two thirds of families in our program were comprised of at least one partner with a child from a previous relationship.
Who may be able to join
- 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.)
Who cannot join
- Active intimate partner violence and increased risk of intimate partner violence
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10451
About this study
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.
Read the 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.
- Conditions
- Parenting, Family Relationships
- Being tested
- Relationship Education, Employment Services
- Keywords
- parenting, relationships, relationship education, couples, marriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relationship EducationOther
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 ServicesOther
For couples in need of job search, job retention, and career advancement services, we will provide employment services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Relationship Education; Other: Employment Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline CSI at 6 months
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.
Measured: Change from Baseline Relationship Hope at 6 months
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.
Measured: Change from Baseline Commitment at 6 months
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.
Measured: Change from Baseline Emotional Intelligence at 6 months
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.
Measured: Change from Baseline Skills at immediately post intervention and at 6 months
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.
Measured: Halfway through intervention (Week 6 of 12 weeks, or Week 5 of 9 weeks)
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: At start of intervention (Week 1 of 12 or 9 weeks)
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.
Measured: Immediately post intervention (Week 12 of 12 weeks or Week 9 of 9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start1 Jul 2016
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, Metis Associates
- Responsible party
- Principal investigator, Traci Maynigo, Montefiore Medical Center
- Investigators
- Scott Wetzler, PhD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697421
- Sponsor's protocol ID
- 2015-5900
- Status last verified
- Dec 2021
- First submitted
- 2 Oct 2018
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montefiore Medical Center Healthy Marriage and Relationship Education Program
- ClinicalTrials.gov ID
- NCT03697421
- Acronym / sponsor ID
- 2015-5900
- Conditions
- Parenting, Family Relationships
- Keywords
- parenting, relationships, relationship education, couples, marriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Children's Bureau - Administration for Children and Families, Metis Associates
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Local Evaluation | – | Other: Relationship Education, Other: Employment ServicesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population is 47% Hispanic and 44% African-American. The income level of the majority of the couples enrolled was at or below 200% of poverty level, and 36% received income from public assistance. The majority of couples we served (72%) had a high school degree or less, and nearly half (49%) of participants were unemployed at program enrollment with many more under-employed. Their average age was 36 years old, including 10% between the ages of 17 and 24. The average duration of marriage for couples in our program was 7 years; however, the range of relationship longevity was quite wide, spanning from newlywed couples married for a few months to couples married for over 30 years. All couples had at least one child under 18 years old living in the home (or were expecting a child), and we estimate that approximately two thirds of families in our program were comprised of at least one partner with a child from a previous relationship.
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (1 listed)
- Active intimate partner violence and increased risk of intimate partner violence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relationship EducationWe 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.). | Other | Local Evaluation |
| Employment ServicesFor couples in need of job search, job retention, and career advancement services, we will provide employment services. | Other | Local Evaluation |
Primary outcome
Change in Couples Satisfaction Index (CSI-32)
Time frame: Change from Baseline CSI at 6 months
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 in Relationship Hope Scale
Time frame: Change from Baseline Relationship Hope at 6 months
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 in Maybe I Do? Scale (Commitment)
Time frame: Change from Baseline Commitment at 6 months
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 in Assessing Emotions Scale (Emotional Intelligence)
Time frame: Change from Baseline Emotional Intelligence at 6 months
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 Skills Assessment Measure (Skill Acquisition)
Time frame: Change from Baseline Skills at immediately post intervention and at 6 months
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.
Adverse Childhood Experiences (ACE) Survey
Time frame: Halfway through intervention (Week 6 of 12 weeks, or Week 5 of 9 weeks)
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.
3 secondary outcomes
Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics
Time frame: Baseline
Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey
Time frame: At start of intervention (Week 1 of 12 or 9 weeks)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Wetzler, PhD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting and Family Relationships, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Couples Satisfaction Index (CSI-32) (time frame: Change from Baseline CSI at 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.