The Incredible Years in Norway: treatment of oppositional defiant and conduct problems in young Norwegian children

ISRCTN	ISRCTN10430476
DOI	https://doi.org/10.1186/ISRCTN10430476
Protocol serial number	N/A
Sponsor	Ministry of Health and Social Affairs (Norway)
Funders	Ministry of Health and Social Affairs (Norway), Norwegian Research Council (Norway)

Submission date: 22/02/2008
Registration date: 10/03/2008
Last edited: 04/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Willy-Tore Morch
Scientific

University of Tromso Faculty of Medicine
Centre of Child and Adolescent Mental Health
Tromsoe
N-9037
Norway

Phone	+47 77 64 58 54
Email	willy@fagmed.uit.no

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Treatment of oppositional defiant and conduct problems in young Norwegian children: results of a randomised controlled replication trial
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/07/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	8 Years
Sex	All
Target sample size at registration	127
Total final enrolment	127
Key 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
Key exclusion criteria	The child had no debilitating physical impairment.
Date of first enrolment	01/09/2001
Date of final enrolment	01/07/2004

Locations

Countries of recruitment

Norway

Study participating centre

University of Tromso Faculty of Medicine

Tromsoe
N-9037
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/2018	04/06/2019	Yes	No
Results article	results	01/01/2009	04/06/2019	Yes	No
Results article	results	01/07/2010	04/06/2019	Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/06/2019: Total final enrolment and publication reference were added.