- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01391754
Effectiveness Trial for Project SafeCare for Child Neglect
July 8, 2011 updated by: University of Oklahoma
The study is a field trial comparing the SafeCare family preservation model to a comparable usual care model for parents in child welfare.
The study also compares two levels of service quality control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study is a cluster-randomized field trial of the SafeCare(SC) home-based family preservation model for families in the child welfare system.
The trial is conducted in collaboration with the state child welfare agency and their contracted in-home service system.
The service system is regionalized and provides in home services to families referred by child welfare.
Regions of the state are assigned by the study to either the SC model or to services as usual.
Provider teams, nested within regions, are assigned to either a monitored or unmonitored model implementation quality control condition.
The aims of the project are to test client level child welfare reentry outcomes between SC and standard conditions, across the two implementation and quality control conditions.
Study Type
Interventional
Enrollment (Actual)
2175
Phase
- 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
-
-
Oklahoma
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McAlester, Oklahoma, United States, 74501
- Eastern Oklahoma Youth Services
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Oklahoma City, Oklahoma, United States, 73112
- NorthCare
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Tulsa, Oklahoma, United States, 74120
- Family and Children's Services
-
-
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
Ages Eligible for Study
14 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Parents in the child welfare system for neglect with or without physical abuse
Exclusion Criteria:
- Parents in the child welfare system for sexual abuse
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SafeCare with Coached Implementation
Home-based services with the SafeCare model, implemented with in vivo provider coaching as quality control
|
Behavioral home based family preservation.
Weekly visits X six months.
Live observation of practice with expert coaching, feedback and fidelity monitoring
|
Experimental: SafeCare without Coaching
Home-based services using the SafeCare model, implemented without in vivo coached implementation quality control
|
Behavioral home based family preservation.
Weekly visits X six months.
No in vivo coached quality control or fidelity monitoring
|
Experimental: Services As Usual with Coaching
Usual home based services, with in vivo coached implementation quality control
|
Live observation of practice with expert coaching, feedback and fidelity monitoring
Home based services not using the SafeCare model
|
Active Comparator: Services As Usual Without Coaching
Usual home based services without in vivo coached quality control
|
No in vivo coached quality control or fidelity monitoring
Home based services not using the SafeCare model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child welfare system recidivism
Time Frame: Up to 2766 days
|
Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system
|
Up to 2766 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Abuse Potential Inventory
Time Frame: Approximately 180 days and 365 days
|
This is a questionnaire survey measuring parenting distress, parenting attitudes, and risk for committing child abuse
|
Approximately 180 days and 365 days
|
Family Resources Scale
Time Frame: Approximately 180 and 365 days
|
This is a questionnaire survey measuring sufficiency of basic concrete resources in a family, such as adequate food, shelter, utilities, clothing, access to health care, etc.
|
Approximately 180 and 365 days
|
Beck Depression Inventory
Time Frame: Approximately 180 and 365 days
|
This is a questionnaire measuring symptoms of depression
|
Approximately 180 and 365 days
|
Social Provisions Scale
Time Frame: Approximately 180 and 356 days
|
This is a questionnaire measuring the degree of social support and quality of social relationships
|
Approximately 180 and 356 days
|
Diagnostic Interview Schedule--Drug and Alcohol Disorders Module
Time Frame: Approximately 180 and 365 days
|
This is a structured diagnostic psychiatric interview, adapted to questionnaire format, measuring symptoms of alcohol disorders and drug disorders, with associated DSM based diagnostic algorithms.
|
Approximately 180 and 365 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Chaffin, PhD, University of Oklahoma
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Aarons GA, Sommerfeld DH, Hecht DB, Silovsky JF, Chaffin MJ. The impact of evidence-based practice implementation and fidelity monitoring on staff turnover: evidence for a protective effect. J Consult Clin Psychol. 2009 Apr;77(2):270-80. doi: 10.1037/a0013223.
- Chaffin M, Bard D. Changes in parental depression symptoms during family preservation services. Child Abuse Negl. 2011 Jun;35(6):448-58. doi: 10.1016/j.chiabu.2011.02.005. Epub 2011 Jun 1.
- Chaffin M, Bard D, Hecht D, Silovsky J. Change trajectories during home-based services with chronic child welfare cases. Child Maltreat. 2011 May;16(2):114-25. doi: 10.1177/1077559511402048. Epub 2011 Apr 13.
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
October 1, 2003
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
June 29, 2011
First Submitted That Met QC Criteria
July 8, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Estimate)
July 12, 2011
Last Update Submitted That Met QC Criteria
July 8, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5R01MH065667 (U.S. NIH Grant/Contract)
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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