Collaborative Care for Infants at Risk (CCIR)

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 Overview

• Status: Completed
• Conditions: Child Abuse; Primary Health Care; Child Welfare
• Intervention / Treatment: Other: Collaborative Care

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • The Center for Safe and Healthy Families, Primary Children's Hospital Eccles Outpatient Building, 81 North Mario Capecchi Dr 4E-200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 11 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collaborative Care; 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.	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.
No Intervention: Comparison Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Repeat Child Welfare Involvement	Repeat Child Welfare Involvement	6 months after CPS case closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement of child welfare caseworkers	Proportion of eligible cases investigated that were offered collaborative practice	baseline
Acceptance of parents	Proportion of cases offered collaborative practice in which parents allowed practice	baseline
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Kristine A Campbell, MD, MSc, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 00098047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No