NCT00586677

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 22, 2014

Status Verified

September 1, 2014

Enrollment Period

6.6 years

First QC Date

December 21, 2007

Last Update Submit

September 19, 2014

Conditions

Keywords

child abusechild neglectPCITLutzkerattachmentparenting

Outcome Measures

Primary Outcomes (1)

  • Durham County, North Carolina Department of Social Services accepted reports of child maltreatment

    2011

Study Arms (2)

RF

ACTIVE COMPARATOR

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 TherapyBehavioral: Early Relationships

HS

ACTIVE COMPARATOR

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

Interventions

Sixteen one hour sessions done in-home for children ages 2-7. Proceed through protocol based on mastery of predefined skills.

Also known as: PCIT
RF

Sixteen one hour sessions for children age 0-7 conducted in the home. Participants are quizzed on material to determine mastery.

HS

Sixteen one-hour sessions for children age 0-2 provided in-home.

RF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Child and Family Health

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Interventions

HealthSafety

Intervention Hierarchy (Ancestors)

Population CharacteristicsAccident PreventionAccidentsPublic HealthEnvironment and Public Health

Study Officials

  • Kenneth Dodge, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR
  • Karen O'Donnell, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

May 1, 2005

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 22, 2014

Record last verified: 2014-09

Locations