Child Abuse Clinical Trial
— CCIROfficial title:
Collaborative Care for Infants at Risk
NCT number | NCT03199326 |
Other study ID # | 00098047 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2017 |
Est. completion date | July 31, 2020 |
Verified date | November 2020 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the feasibility, acceptability, and impact of a collaborative care practice for infants investigated by state Child Protective Services (CPS) for suspected maltreatment. Recognizing the vulnerability of infants referred into CPS in the first year of life, as well as the frequent contact of infants with health care providers in the first year of life, the investigators will conduct a RCT to measure the impact of a collaborative practice model linking CPS caseworkers with primary health care providers during an investigation for suspected infant maltreatment. With this trial, the investigators will ask (3a) Can a collaborative practice model improve parent-reported infant health-related quality of life 6 months following child welfare involvement for suspected infant maltreatment? and (3b) Does a collaborative practice model impact repeat child welfare involvement for suspected child maltreatment over 6 months?
Status | Completed |
Enrollment | 468 |
Est. completion date | July 31, 2020 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 364 Days |
Eligibility | Inclusion Criteria: - Less than 12 months of age at referral - Involved in a child welfare investigation for suspected maltreatment - Investigation occurring in Utah DCFS Salt Lake Valley or Western regions Exclusion Criteria: For the primary and selected secondary outcomes, - Caregiver with primary spoken language other than English or Spanish, - CPS caseworkers not yet randomized to a practice arm - Infants in out-of-home placement at the time of referral or case closure, - Infants suffering fatal maltreatment - Prior investigation of an infant in a household during study timeframe (e.g., twins, infant siblings, and repeat referrals will be excluded). For other secondary outcomes related to CPS outcomes, language exclusion will not be considered. |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Safe and Healthy Families, Primary Children's Hospital Eccles Outpatient Building, 81 North Mario Capecchi Dr 4E-200 | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Robert Wood Johnson Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Engagement of child welfare caseworkers | Proportion of eligible cases investigated that were offered collaborative practice | baseline | |
Other | Acceptance of parents | Proportion of cases offered collaborative practice in which parents allowed practice | baseline | |
Other | Recruiting and retention of high-risk longitudinal cohort | Proportion of eligible cases willing to enroll in and follow-up with researchers | baseline and 6 months | |
Primary | Infant Health Related Quality of Life | Difference in Change in Infant Health Related Quality of Life based on practice arm | Change from baseline to 6 months following CPS case closure | |
Secondary | Parent Perception of Child Welfare and Child Health Care | Difference in parent perceptions of child welfare and child health care based on practice arm | at baseline (child welfare) and at 6 months (child health care) | |
Secondary | Repeat Child Welfare Involvement | Repeat Child Welfare Involvement | 6 months after CPS case closure |
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