Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Willy-Tore Morch
ORCID ID
Contact details
University of Tromso Faculty of Medicine
Centre of Child and Adolescent Mental Health
Tromsoe
N-9037
Norway
+47 77 64 58 54
willy@fagmed.uit.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Treatment of oppositional defiant and conduct problems in young Norwegian children: results of a randomised controlled replication trial
Acronym
Study hypothesis
The aims of the present study were to compare the effects of the Incredible Years (IY) basic parent training (PT) program, or PT combined with child therapy (PT+CT) to a waiting list control (WLC) condition in a randomised controlled trial including a one-year follow-up.
Ethics approval
Informed consent was obtained from all parents. The study was approved by The Regional Committee for Ethics in Medical Research, University of Tromsø, and by the Norwegian Data Inspectorate in January 2001.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oppositional defiant disorder and/or conduct disorder
Intervention
The treatment program, IY, was developed by Professor Carolyn Webster-Stratton at the parenting clinic at the University of Washington. IY is a manualised and video-based training program for young children with conduct problems.
In child training (CT), groups of six children met with two therapists in the clinic for 18 - 20 weekly two-hour sessions, in all 36 - 40 hours of treatment in the Incredible Years Dinosaur School Program. The parents to children in CT participated in PT parallel to the CT intervention.
The parents assigned to the PT condition were divided into groups of 10 - 12 parents (i.e. the parents of about six children in each group), who met weekly for 12 - 14 weeks for two hours with two accredited therapists. During the sessions, parents watched 250 video vignettes showing parent-child interactions. The therapists led discussions of central aspects of parenting on the basis of the video vignettes. The aims of the parent program are to promote parent competences and strengthen families by increasing parents' positive parenting, self-confidence in parenting, reduce negative parenting, improve parents' problem-solving skills and anger management, and improve school involvement. Parents receive home tasks and each session started with the parents describing their experience of these exercises.
Children/families in the waiting list condition (WLC) were offered treatment after six months of waiting, for ethical reasons and these children were unavailable at the one-year follow-up. The children/families underwent a three-hour assessment before and after the waiting period.
One year after ended treatment, a one-year follow-up assessment (12 months after terminated treatment) was conducted.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Eyberg Child Behaviour Inventory (ECBI)
2. Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS)
Assessments in the active treatment were conducted before treatment and at the end of the treatment interventions (approximately 21 - 24 weeks after the initiation of the intervention), and 12 months after the post-assessments the one-year follow-up was conducted. The WLC was not available at the one-year follow-up.
Secondary outcome measures
1. Child Behaviour Checklist (CBCL)
2. Teacher Report Form (TFR)
3. Parental Stress Index (PSI)
Assessments in the active treatment were conducted before treatment and at the end of the treatment interventions (approximately 21 - 24 weeks after the initiation of the intervention), and 12 months after the post-assessments the one-year follow-up was conducted. The WLC was not available at the one-year follow-up.
Overall trial start date
01/09/2001
Overall trial end date
01/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
The child characteristics for inclusion in the study were:
1. The child was 4 - 8 years old, either sex
2. The primary referral reason was misconduct (e.g., noncompliance, aggressive or oppositional behaviours)
3. The childs behaviour was within the clinical range and above the 90th percentile (a score above 119 for girls and 126 for boys) on Eyberg Child Behaviour Inventory (ECBI) using Norwegian norms
4. The child met diagnostic criteria for oppositional defiant disorder (ODD) and/or conduct disorder (CD) according to standards set by the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV) or sub-clinical diagnostic criteria for ODD or CD
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
127
Participant exclusion criteria
The child had no debilitating physical impairment.
Recruitment start date
01/09/2001
Recruitment end date
01/07/2004
Locations
Countries of recruitment
Norway
Trial participating centre
University of Tromso Faculty of Medicine
Tromsoe
N-9037
Norway
Sponsor information
Organisation
Ministry of Health and Social Affairs (Norway)
Sponsor details
P.O. Box 7000
St Olavs Plass
Oslo
N-0130
Norway
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Health and Social Affairs (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Norwegian Research Council (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary