Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05367102
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supporting Healthy Relationships Program for FRAMEWorks (SHR FRAMEWorks)
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
Montefiore Medical Center Supporting Healthy Relationships Program for FRAMEWorks
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRAMEWorks
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?
1. 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?
NOTE: The Post-Randomization Phase of the study begins on 01/01/2025. Participants will no longer be randomized to one of the two study arms during this phase. Additionally, data collection at the 6-month follow-up point will not occur during this phase. Participants will now have the autonomy to choose their preferred mode of participation, either in virtual or in-person workshops. This choice aims to provide greater flexibility and accommodate participants' preferences while continuing to deliver the same curriculum. Both arms will maintain identical workshop content, facilitation quality, and support services to ensure consistency across delivery modes. The shift to a non-randomized structure in this phase reflects the conclusion of the initial randomized trial while enabling ongoing access to the program for participants under a more participant-centered delivery model. This approach will allow researchers to observe participation trends and engagement levels under conditions of self-selection, complementing the insights gained from the randomized control trial.
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?
1. 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?
NOTE: The Post-Randomization Phase of the study begins on 01/01/2025. Participants will no longer be randomized to one of the two study arms during this phase. Additionally, data collection at the 6-month follow-up point will not occur during this phase. Participants will now have the autonomy to choose their preferred mode of participation, either in virtual or in-person workshops. This choice aims to provide greater flexibility and accommodate participants' preferences while continuing to deliver the same curriculum. Both arms will maintain identical workshop content, facilitation quality, and support services to ensure consistency across delivery modes. The shift to a non-randomized structure in this phase reflects the conclusion of the initial randomized trial while enabling ongoing access to the program for participants under a more participant-centered delivery model. This approach will allow researchers to observe participation trends and engagement levels under conditions of self-selection, complementing the insights gained from the randomized control trial.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 90ZB0022 | OTHER_GRANT | Children's Bureau - Administration for Children and Families | View |