- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00595010
Effectiveness of a Multi-Component Evidence-Based Parent Training Program in Reducing Child Maltreatment
Developing Multi-Component Evidence Based Practice in Child Abuse Service Systems
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Managing Child Behavior
Families with a high risk for or a history of child abuse and are enrolled in Comprehensive Home-Based Services and receive services as usual, which includes SafeCare, plus Managing Child Behavior module if they report significant behavior problems with their child between the ages of 2-12.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fidelity of service provider
Time Frame: Measured throughout study
|
Measured throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Parent behavior
Time Frame: Measured at baseline and at some point between Months 6 and 12
|
Measured at baseline and at some point between Months 6 and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Debra B. Hecht, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R34MH076972 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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