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
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