The Effectiveness of Parent-Child Interaction Therapy (PCIT)
Primary Purpose
Behavior Problems, Oppositional Defiant Disorder, Conduct Disorder
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Parent-Child Interaction Therapy
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problems focused on measuring Behavior problems, Parent-Child Interaction, Locus of control, Psychiatric symptoms, Depressive symptoms, Attachment
Eligibility 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
Sites / Locations
- barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge
- Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCIT
TAU
Arm Description
Provision of Parent-Child Interaction Therapy
Treatment as usual from other therapists in the same clinics
Outcomes
Primary Outcome Measures
Eyberg Child Behavior Inventory (ECBI)
ECBI is taken at study entry, after 6 months and after 18 months
Secondary Outcome Measures
Dyadic Parent-Child Interaction Coding System (DPICS)
Parent-child interaction coded from standardized situations
Parenting Stress Index
Number and degree of perceived stresses by parents
Working Model of the Child Interview (WMCI)
Parents' attachment to the child
Child Behavior Check List (CBCL)/Teacher Report Form (TRF)
Psychiatric symptoms as rated by parents and teachers, respectively
Beck Depression Inventory (BDI)
Depressive symptoms in parents
Parental Locus of Control - Short Form (PLOC-SF)
Parents' perceptions of internal versus external locus of control
Full Information
NCT ID
NCT01085305
First Posted
March 10, 2010
Last Updated
September 14, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01085305
Brief Title
The Effectiveness of Parent-Child Interaction Therapy (PCIT)
Official Title
The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems, Oppositional Defiant Disorder, Conduct Disorder
Keywords
Behavior problems, Parent-Child Interaction, Locus of control, Psychiatric symptoms, Depressive symptoms, Attachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCIT
Arm Type
Experimental
Arm Description
Provision of Parent-Child Interaction Therapy
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual from other therapists in the same clinics
Intervention Type
Behavioral
Intervention Name(s)
Parent-Child Interaction Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
Usual treatment for behavioral disorders
Primary Outcome Measure Information:
Title
Eyberg Child Behavior Inventory (ECBI)
Description
ECBI is taken at study entry, after 6 months and after 18 months
Time Frame
Pre intervention, 6 months, 18 months
Secondary Outcome Measure Information:
Title
Dyadic Parent-Child Interaction Coding System (DPICS)
Description
Parent-child interaction coded from standardized situations
Time Frame
Pre intervention, 6 months, 18 months
Title
Parenting Stress Index
Description
Number and degree of perceived stresses by parents
Time Frame
Pre intervention, 6 months, 18 months
Title
Working Model of the Child Interview (WMCI)
Description
Parents' attachment to the child
Time Frame
Pre intervention, 6 months, 18 months
Title
Child Behavior Check List (CBCL)/Teacher Report Form (TRF)
Description
Psychiatric symptoms as rated by parents and teachers, respectively
Time Frame
Pre intervention, 6 months, 18 months
Title
Beck Depression Inventory (BDI)
Description
Depressive symptoms in parents
Time Frame
Pre intervention, 6 months, 18 months
Title
Parental Locus of Control - Short Form (PLOC-SF)
Description
Parents' perceptions of internal versus external locus of control
Time Frame
Pre intervention, 6 months, 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Wichstrøm, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge
City
Trondheim
State/Province
Sør-trøndelag
Country
Norway
Facility Name
Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag
City
Trondheim
ZIP/Postal Code
7057
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27622458
Citation
Bjorseth A, Wichstrom 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.
Results Reference
result
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The Effectiveness of Parent-Child Interaction Therapy (PCIT)
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