Effectiveness Trial for Project SafeCare for Child Neglect

This study has been completed.
Sponsor:
Collaborators:
Oklahoma Department of Health and Human Services
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01391754
First received: June 29, 2011
Last updated: July 8, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Child Neglect
Behavioral: SafeCare
Other: In vivo coached quality control
Behavioral: Services As Usual
Other: Uncoached

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness Trial for Project SafeCare for Child Neglect

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Child welfare system recidivism [ Time Frame: Up to 2766 days ] [ Designated as safety issue: No ]
    Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system


Secondary Outcome Measures:
  • Child Abuse Potential Inventory [ Time Frame: Approximately 180 days and 365 days ] [ Designated as safety issue: No ]
    This is a questionnaire survey measuring parenting distress, parenting attitudes, and risk for committing child abuse

  • Family Resources Scale [ Time Frame: Approximately 180 and 365 days ] [ Designated as safety issue: No ]
    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.

  • Beck Depression Inventory [ Time Frame: Approximately 180 and 365 days ] [ Designated as safety issue: No ]
    This is a questionnaire measuring symptoms of depression

  • Social Provisions Scale [ Time Frame: Approximately 180 and 356 days ] [ Designated as safety issue: No ]
    This is a questionnaire measuring the degree of social support and quality of social relationships

  • Diagnostic Interview Schedule--Drug and Alcohol Disorders Module [ Time Frame: Approximately 180 and 365 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 2175
Study Start Date: October 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SafeCare with Coached Implementation
Home-based services with the SafeCare model, implemented with in vivo provider coaching as quality control
Behavioral: SafeCare
Behavioral home based family preservation. Weekly visits X six months.
Other: In vivo coached quality control
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: SafeCare
Behavioral home based family preservation. Weekly visits X six months.
Other: Uncoached
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
Other: In vivo coached quality control
Live observation of practice with expert coaching, feedback and fidelity monitoring
Behavioral: Services As Usual
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
Behavioral: Services As Usual
Home based services not using the SafeCare model
Other: Uncoached
No in vivo coached quality control or fidelity monitoring

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.

  Eligibility

Ages Eligible for Study:   14 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391754

Locations
United States, Oklahoma
Eastern Oklahoma Youth Services
McAlester, Oklahoma, United States, 74501
NorthCare
Oklahoma City, Oklahoma, United States, 73112
Family and Children's Services
Tulsa, Oklahoma, United States, 74120
Sponsors and Collaborators
University of Oklahoma
Oklahoma Department of Health and Human Services
Investigators
Principal Investigator: Mark Chaffin, PhD University of Oklahoma
  More Information

Publications:
Responsible Party: Mark Chaffin, PhD - Principal Investigator, University of Oklahoma Health Sciences Center
ClinicalTrials.gov Identifier: NCT01391754     History of Changes
Other Study ID Numbers: 5R01MH065667
Study First Received: June 29, 2011
Last Updated: July 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
child abuse

ClinicalTrials.gov processed this record on October 20, 2014