NCT03199326

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
468

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

June 21, 2017

Last Update Submit

November 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Other Outcomes (3)

  • Engagement of child welfare caseworkers

    baseline

  • Acceptance of parents

    baseline

  • Recruiting and retention of high-risk longitudinal cohort

    baseline and 6 months

Study Arms (2)

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.

Other: Collaborative Care

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.

Interventions

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.

Collaborative Care

Eligibility Criteria

Age0 Days - 364 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Study Officials

  • Kristine A Campbell, MD, MSc

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Surveys will be collected without knowledge of intervention assignment
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatrics

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 26, 2017

Study Start

August 15, 2017

Primary Completion

April 30, 2019

Study Completion

July 31, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations