Collaborative Care for Infants at Risk (CCIR)

November 8, 2020 updated by: Kristine Campbell, University of Utah
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 6 months following CPS case closure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Perception of Child Welfare and Child Health Care
Time Frame: at baseline (child welfare) and at 6 months (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
Time Frame: 6 months after CPS case closure
Repeat Child Welfare Involvement
6 months after CPS case closure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Engagement of child welfare caseworkers
Time Frame: baseline
Proportion of eligible cases investigated that were offered collaborative practice
baseline
Acceptance of parents
Time Frame: baseline
Proportion of cases offered collaborative practice in which parents allowed practice
baseline
Recruiting and retention of high-risk longitudinal cohort
Time Frame: baseline and 6 months
Proportion of eligible cases willing to enroll in and follow-up with researchers
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Robert Wood Johnson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristine A Campbell, MD, MSc, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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