Condition category
Mental and Behavioural Disorders
Date applied
22/02/2008
Date assigned
10/03/2008
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.deutroligearene.no/

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 child’s 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

http://www.shdir.no/

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

Publication citations

Additional files

Editorial Notes