Effectiveness Trial for Project SafeCare for Child Neglect

Child Neglect Clinical Trial

Official title:

Effectiveness Trial for Project SafeCare for Child Neglect

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391754
• Other study ID #: 5R01MH065667
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: July 8, 2011
• Start date: October 2003
• Est. completion date: September 2007

Study information

• Verified date: July 2011
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2175
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Neglect

Intervention

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

Behavioral:
• Services As Usual
Home based services not using the SafeCare model

Other:
• Uncoached
No in vivo coached quality control or fidelity monitoring

Locations

Country	Name	City	State
United States	Eastern Oklahoma Youth Services	McAlester	Oklahoma
United States	NorthCare	Oklahoma City	Oklahoma
United States	Family and Children's Services	Tulsa	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
University of Oklahoma	Centers for Disease Control and Prevention, National Institute of Mental Health (NIMH), Oklahoma Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (3)

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/a001 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child welfare system recidivism	Follow-up for recidivism reports to child welfare, captured from administrative data maintained by the state child welfare system	Up to 2766 days	No
Secondary	Child Abuse Potential Inventory	This is a questionnaire survey measuring parenting distress, parenting attitudes, and risk for committing child abuse	Approximately 180 days and 365 days	No
Secondary	Family Resources Scale	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	No
Secondary	Beck Depression Inventory	This is a questionnaire measuring symptoms of depression	Approximately 180 and 365 days	No
Secondary	Social Provisions Scale	This is a questionnaire measuring the degree of social support and quality of social relationships	Approximately 180 and 356 days	No
Secondary	Diagnostic Interview Schedule--Drug and Alcohol Disorders Module	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	No