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临床试验/NCT05367102
NCT05367102已完成不适用

Montefiore Medical Center Supporting Healthy Relationships Program for FRAMEWorks

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 1,022 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,022
试验地点
1
主要终点
Change in Relationship Satisfaction at 6 months

研究概览

简要总结

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?

详细描述

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?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

In Person

Experimental

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

干预措施: Supporting Healthy Relationships program (Behavioral)

Virtual (Zoom)

Experimental

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

干预措施: Supporting Healthy Relationships program (Behavioral)

结局指标

主要结局

Change in Relationship Satisfaction at 6 months

时间窗: Baseline and 6 month follow up

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.

次要结局

  • The Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) (Adult Attachment Patterns)(Changes from Baseline Adult Attachment Patterns at 6 month follow up)
  • Assessing Emotions Scale (Emotion Intelligence)(Changes from Baseline Emotion Intelligence at 6 month follow up)
  • 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))
  • Parenting Alliance Inventory (Quality of Co-Parenting Relationship)(Changes from Baseline Quality of Co-Parenting Relationship at 6 month follow up)
  • Skills Assessment (Skills Acquisition)(Change from Baseline Skills at immediately post intervention and at 6 months)
  • Childhood Trauma Questionnaire-Short Form (CTQ-SF) (Childhood Trauma)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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