Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of Parent-Child Interaction Therapy (PCIT)

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: NCT01085305
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE March 10, 2010
First Posted Date  ICMJE March 11, 2010
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE September 2006
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Pre intervention, 6 months, 18 months ]
ECBI is taken at study entry, after 6 months and after 18 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2010)
  • Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: Pre intervention, 6 months, 18 months ]
    Parent-child interaction coded from standardized situations
  • Parenting Stress Index [ Time Frame: Pre intervention, 6 months, 18 months ]
    Number and degree of perceived stresses by parents
  • Working Model of the Child Interview (WMCI) [ Time Frame: Pre intervention, 6 months, 18 months ]
    Parents' attachment to the child
  • Child Behavior Check List (CBCL)/Teacher Report Form (TRF) [ Time Frame: Pre intervention, 6 months, 18 months ]
    Psychiatric symptoms as rated by parents and teachers, respectively
  • Beck Depression Inventory (BDI) [ Time Frame: Pre intervention, 6 months, 18 months ]
    Depressive symptoms in parents
  • Parental Locus of Control - Short Form (PLOC-SF) [ Time Frame: Pre intervention, 6 months, 18 months ]
    Parents' perceptions of internal versus external locus of control
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 The Effectiveness of Parent-Child Interaction Therapy (PCIT)
Official Title  ICMJE The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
Brief Summary The purpose of this study was to investigate whether a type of parent-based intervention, Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children more than treatment as usual.
Detailed Description Behaviour problems, i.e. symptoms of oppositional defiant disorder (ODD) and conduct disorder (CD) are among the prevalent psychiatric disorders in children and one of the leading causes of help-seeking for mental health problems in children. There are several efficacious treatments for such problems in young children. However, most of these require that parents meet in groups. This is not always feasible. It is therefore a need to develop treatments that can deal with parents and families individually. Parent-Child Interaction Therapy (PCIT) is such an individually based treatment. Efficacy studies indicate symptom reduction greater that in treatment as usual (TAU). However, there is a need to study its effectiveness in ordinary clinical practise. This trial will study its effect in ordinary psychiatric clinics in the middle of Norway and compare it to the regular treatment (TAU) provided to young children with behavior problems in these clinics.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Behavior Problems
  • Oppositional Defiant Disorder
  • Conduct Disorder
Intervention  ICMJE
  • Behavioral: Parent-Child Interaction Therapy
    Parents will be trained in interaction with their children in ways which foster non-hostility and cooperation in their children. By means of an ear-plug they will receive instruction on how to play and set limits for their child from their therapist who watches the interaction through a one-way mirror. Treatment is given until the parent masters these skill, which commonly takes 15-20 session of 1 hour.
  • Behavioral: TAU
    Usual treatment for behavioral disorders
Study Arms  ICMJE
  • Experimental: PCIT
    Provision of Parent-Child Interaction Therapy
    Intervention: Behavioral: Parent-Child Interaction Therapy
  • Active Comparator: TAU
    Treatment as usual from other therapists in the same clinics
    Intervention: Behavioral: TAU
Publications * Bjørseth Å, Wichstrøm L. Effectiveness of Parent-Child Interaction Therapy (PCIT) in the Treatment of Young Children's Behavior Problems. A Randomized Controlled Study. PLoS One. 2016 Sep 13;11(9):e0159845. doi: 10.1371/journal.pone.0159845. eCollection 2016.

*   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
Actual Enrollment  ICMJE
 (submitted: August 19, 2013)
63
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2010)
70
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Referred to Child mental health specialty clinic for behavioral or attentional/hyperactive problems
  • ECBI score of > 120
  • 2 to 7 years of age
  • Parental consent to the study

Exclusion Criteria:

  • Psychosis or serious drug abuse in parents
  • Lack of sufficient proficiency in Norwegian to fill in the questionnaires
  • Mental retardation or pervasive developmental disorder in the child
  • Suspicion of parental neglect or abuse of the child warranting a report to the child protection services
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085305
Other Study ID Numbers  ICMJE 4.2006.789
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Lars Wichstrøm, prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date September 2016

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