- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586677
Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment
September 19, 2014 updated by: Duke University
Evaluation of Parenting Interventions to Decrease Family Risk for Child
The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure.
We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship.
We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27701
- Center for Child and Family Health
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- resident of Durham, NC
- a child between the ages of 0-7 was the focus of the Department of Social Services report
- child's caregiver was the focus of the report
- Child Protective Services report occurred on or after June 1, 2004
- family is English speaking
- Sexual abuse was not "confirmed" or "highly suspicious" during an evaluation
Exclusion Criteria:
- Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: RF
Relationship focused where the primary goals are to strengthen the relationship between the parent and the child and to give the parent additional skills that can be used to manage the behavior of the child.
|
Sixteen one hour sessions done in-home for children ages 2-7.
Proceed through protocol based on mastery of predefined skills.
Other Names:
Sixteen one-hour sessions for children age 0-2 provided in-home.
|
Active Comparator: HS
The physical health and safety are the primary components of this parenting program where the parent is taught about basic healthcare and safety in the home.
|
Sixteen one hour sessions for children age 0-7 conducted in the home.
Participants are quizzed on material to determine mastery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Durham County, North Carolina Department of Social Services accepted reports of child maltreatment
Time Frame: 2011
|
2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenneth Dodge, Ph.D., Duke University
- Principal Investigator: Karen O'Donnell, Ph.D., Duke University
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
May 1, 2005
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 4, 2008
Study Record Updates
Last Update Posted (Estimate)
September 22, 2014
Last Update Submitted That Met QC Criteria
September 19, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00016431
- 7194 (Other Identifier: Duke legacy protocol number)
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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