Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Barbara J. van den Hoofdakker

ORCID ID

Contact details

University Medical Centre Groningen
University Center for Child and Adolescent Psychiatry
Department of Psychiatry
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 3681100
b.van.den.hoofdakker@accare.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR297

Study information

Scientific title

Acronym

Study hypothesis

1. Parent training will lead to a significant reduction of behaviour problems in comparison with routine medical care
2. Parent training will be as effective as routine medical care with respect to the reduction of ADHD symptoms
3. Parent training will lead to a significant reduction of parenting stress in comparison with routine medical care

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Attention deficit hyperactivity disorder (ADHD), psychological problems

Intervention

1. Parent training in group format, 12 sessions in a period of 4 months, delivered by trained and supervised psychologists
2. Routine medical care for 4 months, delivered by 4 experienced child psychiatrists, including medication treatment and check-ups, crisis-interventions, parent counselling and support, further psycho-education

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Target behaviour problems. Measures: a Dutch adaptation of the PDR and CBCL Externalising.
2. Adhd-symptoms. Measures: all subscales of the CPRS-R:S.
3. Parenting stress. Measures: Parent Domain and Child Domain of the NOSI (Dutch version of the PSI).

Assessments on all measures pre-treatment and post-treatment. A follow-up assessment on all measures after 5 months was done for the parents in the PT group.

Secondary outcome measures

1. Internalising problems. Measure: CBCL Internalising. Assessment pre-treatment and post-treatment. A follow-up assessment after 5 months was done for the parents in the PT group.
2. Medication status. Monitoring during the study by the child psychiatrist.
3. Consumption of routine medical care. Monitoring during the study by the child-psychiatrist.

Overall trial start date

01/06/2002

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 4 and 12 years
2. Average intelligence quotient (IQ) greater than 80
3. Meeting Diagnostic Interview Schedule for Children (DISC) criteria for ADHD
4. Children under the age of 6 need an additional AVL-score greater than 32
5. Parents can identify at least three target behaviour problems on the PDR
6. Child is living with at least one of his/her biological parents
7. Child medication status is stable
8. Both parents are able to participate in parent training

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Diagnosis of autism or psychosis
2. Crisis in family
3. Intensive psychosocial treatment in past year, including in-patient treatment, intensive parent training, home-based treatments
4. Child having additional problems requiring other treatment

Recruitment start date

01/06/2002

Recruitment end date

01/05/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9713 GZ
Netherlands

Sponsor information

Organisation

National Expertise Centre for Child and Adolescent Psychiatry (Accare) (The Netherlands)

Sponsor details

P.O. Box 660
Groningen
9700 AR
Netherlands
+31 (0)50 3610973
info@accare.nl

Sponsor type

University/education

Website

http://www.accare.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Groningen (UMCG) (The Netherlands) - Stimuleringsgelden

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