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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595010
Other study ID # R34MH076972
Secondary ID R34MH076972
Status Completed
Phase Phase 1
First received January 4, 2008
Last updated June 8, 2016
Start date September 2007
Est. completion date November 2012

Study information

Verified date June 2016
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine the effectiveness of a complex parent training program, based on the SafeCare model, in reducing the occurrence of child maltreatment.


Description:

Child maltreatment is the general term used to characterize all forms of child abuse, including neglect and physical, sexual, and emotional abuse. These forms of maltreatment can lead to a large number of child developmental, emotional, and behavioral difficulties. As adults, children who are maltreated are more prone to unhealthy behaviors and conditions, such as drug and alcohol abuse, smoking, eating disorders, and depression. A previous study found that Project SafeCare, a treatment program that provides parent training to families with children who were at risk for or victims of maltreatment, resulted in fewer child welfare reports. Participants in Project SafeCare reported improvements in child healthcare, home safety, and parent-child relations. However, the study suggested that the SafeCare program may not be equally effective in decreasing the occurrence of all forms of child maltreatment, particularly child physical abuse. This study will determine the effectiveness of a complex evidence-based practice program, extending upon the SafeCare program, in reducing the occurrence of physical abuse and other forms of child maltreatment.

Participants in this study will receive services from Oklahoma Comprehensive Home-Based Services (CHBS), a program provided to families with issues of child abuse and neglect. Upon entry into the CHBS program, participants will undergo a computerized interview, lasting between 1 and 2 hours. The interview will include questions about family strengths and weaknesses, personal beliefs, substance abuse history, and opinion on CHBS. This computerized interview will be repeated at the end of treatment, approximately 6 to 12 months later. During the first few weeks of CHBS, an agent will make five visits to the homes of participants to observe pretreatment family life. Treatment services will concentrate on improving healthcare skills, parent-child interactions, and safety in homes and will specifically address ways to reduce physical abuse and other identified family issues. Study participation will continue for 12 months after completion of CHBS. Study researchers will obtain child welfare reports from the Department of Human Services (DHS) for up to 10 years after completion of CHBS.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Enrolled in Oklahoma Comprehensive Home-Based Services (CHBS)

- Child referred by Office of Community Services

Exclusion Criteria:

- Primary referral of sexual abuse

- Primary referral goal to maintain permanent placement

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
SafeCare
Treatment will be based on an updated version of the SafeCare program, which specifically addresses parenting and discipline associated with child physical abuse. Participants will receive services from Comprehensive Home-Based Services.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Oklahoma National Institute of Mental Health (NIMH)

Outcome

Type Measure Description Time frame Safety issue
Primary Fidelity of service provider Measured throughout study No
Secondary Parent behavior Measured at baseline and at some point between Months 6 and 12 No
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