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Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 4, 2008
Last Update Posted: September 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
The Duke Endowment
Information provided by (Responsible Party):
Duke University
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.

Condition Intervention
Child Abuse Behavioral: Parent-Child Interaction Therapy Behavioral: Health and Safety Behavioral: Early Relationships

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Parenting Interventions to Decrease Family Risk for Child

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Durham County, North Carolina Department of Social Services accepted reports of child maltreatment [ Time Frame: 2011 ]

Enrollment: 123
Study Start Date: May 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Parent-Child Interaction Therapy
Sixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills.
Other Name: PCIT
Behavioral: Early Relationships
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.
Behavioral: Health and Safety
Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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"
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586677

United States, North Carolina
Center for Child and Family Health
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
The Duke Endowment
Principal Investigator: Kenneth Dodge, Ph.D. Duke University
Principal Investigator: Karen O'Donnell, Ph.D. Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00586677     History of Changes
Other Study ID Numbers: Pro00016431
7194 ( Other Identifier: Duke legacy protocol number )
First Submitted: December 21, 2007
First Posted: January 4, 2008
Last Update Posted: September 22, 2014
Last Verified: September 2014

Keywords provided by Duke University:
child abuse
child neglect