Connected Through Coaching for Flourishing Families (CCFF)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06145451 |
Recruitment Status :
Not yet recruiting
First Posted : November 24, 2023
Last Update Posted : April 11, 2024
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Condition or disease | Intervention/treatment | Phase |
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Maltreatment by Parent | Behavioral: Family Success Network | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 612 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Masking Description: | Researchers have no direct contact with research participants as all data collection activities are carried out by care providers. |
Primary Purpose: | Prevention |
Official Title: | Caregiver Relational Responsiveness (RR): An Understudied Fidelity Construct as a Mechanism to Increase Protective Factors Against Maltreatment |
Estimated Study Start Date : | May 2024 |
Estimated Primary Completion Date : | August 31, 2024 |
Estimated Study Completion Date : | September 29, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment group
The Family Success Network is a multi-tier, multi-component community-based maltreatment prevention program that offers tailored preventive services for caregivers of children aged 0-18. Average lengths of service completion is approximately 3 months.
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Behavioral: Family Success Network
The Family Success Network (FSN) is a community-based maltreatment prevention program that is being piloted to serve caregivers of children aged between 0-18 in the Trumbull, Mahoning, and Columbiana Counties in Ohio. FSN is a comprehensive multi-tier program providing information and referrals to community resources at Tier I (i.e., the initial contact stage), caregiver education, and financial literacy program along with concrete support at Tier II (i.e., enrollment in family coaching services in FSN), and a life skills program and monthly home visits for families with more intensive needs at tier III (most intensive level of FSN services).
Other Name: FSN |
No Intervention: Waitlist Control Group
Families in the Control Group will not receive any FSN services except concrete support of upto $500.
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- Protective factors [ Time Frame: baseline vs. 3 month (at the time of service completion) ]The family protective factors will be assessed using the Protective Factors Survey - Second Edition (PFS-2). It is a 19-item, 5-point Likert scale assessing 1) Family Functioning/Resilience [family's adaptive skills and strategies to persevere in times of crisis, 3 items, subscale score of 0-3], 2) Nurturing/Attachment [emotional bond and positive parent-child interactions, 4 items, subscale score of 0-4]; 3) Concrete Supports [perceived access to tangible goods and services, 2 items, subscale score of 0-8]; 4) Social Supports [4 items, subscale score of 0-16 plus the number of items checked in the social support checklist, which ranges between 0-4]. Except for the concrete support subscale in which higher scores indicate lower level of concrete support, higher scores indicate higher level of assessed qualities in all the other subscales.
- Relational Responsiveness [ Time Frame: baseline vs. 3 month (at the time of service completion) ]Participant relational responsiveness (RR) will be assessed using the Working Alliance Inventory Short-Revised (WAI-SR), which is a 12-item, 5-point Likert scale with the response categories ranging from "Seldom" to "Always". WAI consists of three domains including agreement on goals, agreement on tasks, and bond between clients and providers. Instead of aggregating multiple items into a continuous variable, RR will be treated as a single order continuous latent construct with 3 distinct domains.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Being an adult primary caregiver living in the tri-county area
- Having at least one child aged between 0-17
- Reporting at least one maltreatment risk factor at the time of intake
- Receiving family coaching services at Tier II and above in FSN.
Exclusion Criteria:
- Having a substantiated history of child maltreatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06145451
Contact: Deborah J Moon, PhD | 412-383-5156 | djm207@pitt.edu |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
Contact: Nancy Rolock, PhD 708-408-1815 nancy.rolock@case.edu | |
Principal Investigator: Nancy Rolock, PhD | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
Contact: Michelle Johnson-Motoyama, PhD 614-688-2491 johnson-motoyama.1@osu.edu | |
Principal Investigator: Michelle Johnson-Motoyama, PhD | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15260 | |
Contact: Deborah Moon, Phd 412-383-5156 djm207@pitt.edu | |
Principal Investigator: Deborah J Moon, PhD |
Principal Investigator: | Deborah Moon, PhD | University of Pittsburgh |
Responsible Party: | Deborah Moon, Assistant Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT06145451 |
Other Study ID Numbers: |
STUDY23110074 1 K01CE003543-01-00 ( Other Grant/Funding Number: Centers for Disease Control and Prevention ) |
First Posted: | November 24, 2023 Key Record Dates |
Last Update Posted: | April 11, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | De-identified qualitative data may be shared upon request. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
maltreatment prevention, relational responsiveness |