Clinical trial NCT05367102: Supporting Healthy Relationships Program for FRAMEWorks (SHR FRAMEWorks)
Official title: Montefiore Medical Center Supporting Healthy Relationships Program for FRAMEWorks
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Family Relations
Relationship, Family
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Bureau - Administration for Children and Families
First posted: 2022-05-10
Enrollment: 2944
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

Detailed description: More specifically, the investigator is interested in answering the following research questions:

Primary Study Question:

1. To what extent do clients show increased relationship satisfaction (Primary Endpoint: Couples Satisfaction Index-CSI) after receiving the virtual Zoom relationship education intervention? a) To what extent do partner effects impact this outcome?

   Secondary Study Questions:
2. To what extent do clients learn and retain the knowledge and skills that are taught in the relationship education intervention? a) To what extent do partner effects impact this outcome?
3. To what extent do clients become more emotionally intelligent after the relationship education intervention? a) To what extent do partner effects impact this outcome?
4. To what extent do clients show improved co-parenting relationships after the relationship education intervention? a) To what extent do partner effects impact this outcome?
5. To what extent do clients become more securely attached to their partners after receiving the relationship education intervention?

   a) To what extent do partner effects impact this outcome?
6. To what extent do clients attend workshops when they are delivered virtually via Zoom?

   a) To what extent do partner effects impact this outcome?
7. To what extent are clients engaged in workshops when they are delivered virtually via Zoom? a) To what extent do partner effects impact this outcome?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Relationship Satisfaction at 6 months
timeFrame: Baseline and 6 month follow up
Secondary outcomes:
measure: Information, Family Outcomes, Reporting, and Management (nFORM) Applicant Characteristics
timeFrame: Baseline
measure: Information, Family Outcomes, Reporting, and Management (nFORM) Pre-Program Survey
timeFrame: At start of intervention (Week 1 of 12)
measure: Information, Family Outcomes, Reporting, and Management (nFORM) Post-Program Survey
timeFrame: Immediately post intervention (Week 12 of 12 weeks)
measure: Assessing Emotions Scale (Emotion Intelligence)
timeFrame: Changes from Baseline Emotion Intelligence at 6 month follow up
measure: Parenting Alliance Inventory (Quality of Co-Parenting Relationship)
timeFrame: Changes from Baseline Quality of Co-Parenting Relationship at 6 month follow up
measure: The Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) (Adult Attachment Patterns)
timeFrame: Changes from Baseline Adult Attachment Patterns at 6 month follow up
measure: Skills Assessment (Skills Acquisition)
timeFrame: Change from Baseline Skills at immediately post intervention and at 6 months
measure: Childhood Trauma Questionnaire-Short Form (CTQ-SF) (Childhood Trauma)
timeFrame: Baseline
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Scott Wetzler, PhD
role: PRINCIPAL_INVESTIGATOR
References: