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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2020
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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?


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Collaborative Care
CPS caseworkers will explain collaborative care to parents, ask parents to allow communication with an infant's primary care provider, and have willing parents sign a release allowing communication with the infant's provider during the investigation. Caseworkers will make at least two attempts to contact identified providers with parental consent. In the first week, caseworkers will contact the provider, identify the infant, and summarize the child maltreatment concerns. The caseworker will ask whether the provider recognizes any additional strengths or vulnerabilities for the infant. Prior to case closure, caseworkers will provide a summary of investigation findings, disposition, and service referrals including placement changes, safety planning, family preservation, and community resources, with a summary letter delivered to the provider after case closure.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of Utah Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

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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