The Effectiveness of Parent-Child Interaction Therapy (PCIT)

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01085305
First received: March 10, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Behavior Problems
Oppositional Defiant Disorder
Conduct Disorder
Behavioral: Parent-Child Interaction Therapy
Behavioral: TAU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Eyberg Child Behavior Inventory (ECBI) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    ECBI is taken at study entry, after 6 months and after 18 months


Secondary Outcome Measures:
  • Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Parent-child interaction coded from standardized situations

  • Parenting Stress Index [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Number and degree of perceived stresses by parents

  • Working Model of the Child Interview (WMCI) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Parents' attachment to the child

  • Child Behavior Check List (CBCL)/Teacher Report Form (TRF) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Psychiatric symptoms as rated by parents and teachers, respectively

  • Beck Depression Inventory (BDI) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Depressive symptoms in parents

  • Parental Locus of Control - Short Form (PLOC-SF) [ Time Frame: Pre intervention, 6 months, 18 months ] [ Designated as safety issue: No ]
    Parents' perceptions of internal versus external locus of control


Enrollment: 63
Study Start Date: September 2006
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCIT
Provision of Parent-Child Interaction Therapy
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.
Active Comparator: TAU
Treatment as usual from other therapists in the same clinics
Behavioral: TAU
Usual treatment for behavioral disorders

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.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085305

Locations
Norway
barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge
Trondheim, Sør-trøndelag, Norway
Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag
Trondheim, Norway, 7057
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Lars Wichstrøm, prof Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01085305     History of Changes
Other Study ID Numbers: 4.2006.789
Study First Received: March 10, 2010
Last Updated: August 19, 2013
Health Authority: Norway: Data Protection Authority

Keywords provided by Norwegian University of Science and Technology:
Behavior problems
Parent-Child Interaction
Locus of control
Psychiatric symptoms
Depressive symptoms
Attachment

Additional relevant MeSH terms:
Attention Deficit and Disruptive Behavior Disorders
Conduct Disorder
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014