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Clinical Trials/NCT03199326
NCT03199326CompletedNot Applicable

Collaborative Care for Infants at Risk

University of Utah1 site in 1 country468 target enrollmentStarted: August 15, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
468
Locations
1
Primary Endpoint
Infant Health Related Quality of Life

Study Overview

Brief 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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

Surveys will be collected without knowledge of intervention assignment

Eligibility Criteria

Ages
0 Days to 364 Days (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Collaborative Care

Experimental

CPS caseworkers will be randomized to collaborative or comparison practice. For any infant investigated by a caseworker in the collaborative practice, the caseworkers will conduct a standard CPS investigation. Additionally, caseworkers will seek parental permission to contact an identified primary health care provider at two points in the CPS investigation for information sharing related to health needs, social risks, and recommended interventions.

Intervention: Collaborative Care (Other)

Comparison Care

No Intervention

CPS caseworkers will be randomized to collaborative or comparison practice. For any infant investigated by a caseworker in the comparison practice, the caseworkers will conduct a standard CPS investigation.

Outcomes

Primary Outcomes

Infant Health Related Quality of Life

Time Frame: Change from baseline to 6 months following CPS case closure

Difference in Change in Infant Health Related Quality of Life based on practice arm

Secondary Outcomes

  • Parent Perception of Child Welfare and Child Health Care(at baseline (child welfare) and at 6 months (child health care))
  • Repeat Child Welfare Involvement(6 months after CPS case closure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kristine Campbell

Associate Professor, Pediatrics

University of Utah

Study Sites (1)

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