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Trial record 1 of 1 for:    Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program
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Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program

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.
 
ClinicalTrials.gov Identifier: NCT00187772
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date September 19, 2013
Study Start Date  ICMJE December 1996
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Child symptomatology (CBCL)
  • Traumatic stress symptomatology (DC 0-3 Traumatic Stress Disorder)
  • Parent-Child Relationship at posttreatment and 6 month follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Maternal symptomatology (Symptom Checklist Revised and Clinician Administered PTSD Scale)
  • Child cognitive functioning (WPPSI-R)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Child-Parent Psychotherapy for Preschooler Witnesses of Domestic Violence Program
Official Title  ICMJE Preschooler Witnesses of Domestic Violence: A Preventive Intervention Program
Brief Summary This study will examine the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence.
Detailed Description

This study examines the efficacy of Child-Parent Psychotherapy (CPP) for the treatment of preschoolers exposed to marital violence. Multi-ethnic preschool-mother dyads from diverse socioeconomic backgrounds were randomly assigned to CPP or to a case management plus community referral for individual treatment comparison group. It was hypothesized the children who received CPP treatment would show significantly greater improvement in general symptomatology and in traumatic stress symptoms than those in the comparison group.

There is growing recognition that, contrary to the long-standing assumption that young children are impervious to environmental stresses, preschoolers exposed to violence show increased rates of disturbances in self-regulation and in emotional, social and cognitive functioning (Osofsky, 2004; Pynoos et al., 1999; van der Kolk, 2003). The present study examines the efficacy of a relationship-based treatment approach involving the child and the mother. Dyads were randomly assigned to either the Child-Parent Psychotherapy (CPP) treatment group or to a comparison group that consisted of monthly case management by an experienced Ph.D.-level clinician plus referrals for individual treatment in the community for mothers and child. We hypothesized that Child-Parent Psychotherapy would be more effective in alleviating children's traumatic stress symptoms and behavior problems because it focuses on improving the quality of the child-mother relationship and engages the mother as the child's ally in coping with the trauma. Treatment was offered for 50 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Domestic Violence Exposure
Intervention  ICMJE Behavioral: Child-Parent Psychotherapy (CPP)
Study Arms  ICMJE Not Provided
Publications * Lieberman AF, Van Horn P, Ippen CG. Toward evidence-based treatment: child-parent psychotherapy with preschoolers exposed to marital violence. J Am Acad Child Adolesc Psychiatry. 2005 Dec;44(12):1241-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 14, 2005)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Actual Primary Completion Date September 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • child 3-5 years old
  • child exposed to marital violence as confirmed by mother's report on the Conflict Tactics Scale 2 (Straus et al., 1996)
  • perpetrator was not living in the home.

Exclusion Criteria:

  • mother's documented abuse of the target child
  • current maternal substance abuse
  • homelessness
  • maternal mental retardation
  • maternal psychosis
  • child mental retardation or autistic-spectrum disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00187772
Other Study ID Numbers  ICMJE R21MH059661( U.S. NIH Grant/Contract )
R21MH059661 ( U.S. NIH Grant/Contract )
IRB #HR 793-12912-06
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Alicia F. Lieberman, Ph.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP