Child AbuseCCIRNCT03199326
Collaborative Care for Infants at Risk
A study testing Collaborative Care in people with Child Abuse and Primary Health Care, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 364 days
- Conditions the study is for
- Child Abuse, Primary Health Care, Child Welfare
- What is being tested?
- Collaborative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 364 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 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
About this study
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?
- Conditions
- Child Abuse, Primary Health Care, Child Welfare
- Being tested
- Collaborative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Health Related Quality of Life
Difference in Change in Infant Health Related Quality of Life based on practice arm
Measured: Change from baseline to 6 months following CPS case closure
Secondary outcomes (2)
Parent Perception of Child Welfare and Child Health Care
Difference in parent perceptions of child welfare and child health care based on practice arm
Measured: at baseline (child welfare) and at 6 months (child health care)
Repeat Child Welfare Involvement
Repeat Child Welfare Involvement
Measured: 6 months after CPS case closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start15 Aug 2017
- Primary completion30 Apr 2019
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 468 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Kristine Campbell, University of Utah
- Investigators
- Kristine A Campbell, MD, MSc, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199326
- Sponsor's protocol ID
- 00098047
- Acronym
- CCIR
- Status last verified
- Nov 2020
- First submitted
- 21 Jun 2017
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Infants at Risk
- ClinicalTrials.gov ID
- NCT03199326
- Acronym / sponsor ID
- CCIR / 00098047
- Conditions
- Child Abuse, Primary Health Care, Child Welfare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care | Experimental | Other: Collaborative CareCPS 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. |
| 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. |
Who may qualify
- Ages
- 0 to 364 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative CareCPS 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. | Other | Collaborative Care |
Primary outcome
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
2 secondary outcomes
Parent Perception of Child Welfare and Child Health Care
Time frame: at baseline (child welfare) and at 6 months (child health care)
Repeat Child Welfare Involvement
Time frame: 6 months after CPS case closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine A Campbell, MD, MSc principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care in people with Child Abuse and Primary Health Care, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Health Related Quality of Life (time frame: Change from baseline to 6 months following CPS case closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020; AzTrials last refreshed its copy on 28 Oct 2026.