- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085305
The Effectiveness of Parent-Child Interaction Therapy (PCIT)
September 14, 2016 updated by: Norwegian University of Science and Technology
The Effectiveness of Parent-Child Interaction Therapy (PCIT) in Treating Behavior Problems in Young Children
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
63
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Trondheim, Norway, 7057
- Barne- og ungdomspsykiatrisk klinikk, Sør-Trøndelag
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Sør-trøndelag
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Trondheim, Sør-trøndelag, Norway
- barne- og ungdomspsykiatrisk klinikk, Helse Midt-Norge
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 7 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCIT
Provision of 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
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Usual treatment for behavioral disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Pre intervention, 6 months, 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyadic Parent-Child Interaction Coding System (DPICS)
Time Frame: Pre intervention, 6 months, 18 months
|
Parent-child interaction coded from standardized situations
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Pre intervention, 6 months, 18 months
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Parenting Stress Index
Time Frame: Pre intervention, 6 months, 18 months
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Number and degree of perceived stresses by parents
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Pre intervention, 6 months, 18 months
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Working Model of the Child Interview (WMCI)
Time Frame: Pre intervention, 6 months, 18 months
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Parents' attachment to the child
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Pre intervention, 6 months, 18 months
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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
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Pre intervention, 6 months, 18 months
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Beck Depression Inventory (BDI)
Time Frame: Pre intervention, 6 months, 18 months
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Depressive symptoms in parents
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Pre intervention, 6 months, 18 months
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Parental Locus of Control - Short Form (PLOC-SF)
Time Frame: Pre intervention, 6 months, 18 months
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Parents' perceptions of internal versus external locus of control
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Pre intervention, 6 months, 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Lars Wichstrøm, prof, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
March 10, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 14, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4.2006.789
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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