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CompletedNCT03199326CCIRUpdated Nov 10, 2020

Collaborative Care for Infants at Risk

An interventional study of Collaborative Care in Child Abuse, Primary Health Care and Child Welfare, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 0 Days to 364 Days. Per ClinicalTrials.gov, last updated 2020-11-10.

Sponsored by University of Utah · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
468
Allocation
Randomized
Ages
0 Days to 364 Days
Sex
All
01

Study 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?

02

Conditions studied

  • Child Abuse
  • Primary Health Care
  • Child Welfare
03

In context

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Days to 364 Days
Sexes eligible
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

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.

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
468 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherCollaborative 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.

06

What researchers measure

Primary outcomes

  1. Infant Health Related Quality of Life

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

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

Secondary outcomes

  1. Parent Perception of Child Welfare and Child Health Care

    Difference in parent perceptions of child welfare and child health care based on practice arm

    Time frame: at baseline (child welfare) and at 6 months (child health care)

  2. Repeat Child Welfare Involvement

    Repeat Child Welfare Involvement

    Time frame: 6 months after CPS case closure

Other outcomes

  1. Engagement of child welfare caseworkers

    Proportion of eligible cases investigated that were offered collaborative practice

    Time frame: baseline

  2. Acceptance of parents

    Proportion of cases offered collaborative practice in which parents allowed practice

    Time frame: baseline

  3. Recruiting and retention of high-risk longitudinal cohort

    Proportion of eligible cases willing to enroll in and follow-up with researchers

    Time frame: baseline and 6 months

07

Study locations

1 site
  • 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 84113, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03199326
Lead sponsor
University of Utah
Collaborators
Robert Wood Johnson Foundation
Responsible party
Kristine Campbell (Associate Professor, Pediatrics, University of Utah) — Principal investigator
First posted
Jun 26, 2017
Start date
Aug 15, 2017
Primary completion
Apr 30, 2019
Completion
Jul 31, 2020
Last update
Nov 10, 2020

Study contacts

Kristine A Campbell, MD, MSc
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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