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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00586677
Other study ID # Pro00016431
Secondary ID 7194
Status Completed
Phase N/A
First received December 21, 2007
Last updated September 19, 2014
Start date May 2005
Est. completion date December 2011

Study information

Verified date September 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
Health and Safety
Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.
Early Relationships
Sixteen one-hour sessions for children age 0-2 provided in-home.

Locations

Country Name City State
United States Center for Child and Family Health Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University The Duke Endowment

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Durham County, North Carolina Department of Social Services accepted reports of child maltreatment 2011 No
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