The effects of parent training on behaviour problems, attention deficit hyperactivity disorder (ADHD) symptoms and parenting stress in children with ADHD in routine child psychiatric out-patient care

ISRCTN	ISRCTN00662276
DOI	https://doi.org/10.1186/ISRCTN00662276
Secondary identifying numbers	NTR297

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 13/11/2008

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Barbara J. van den Hoofdakker
Scientific

University Medical Centre Groningen
University Center for Child and Adolescent Psychiatry
Department of Psychiatry
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone	+31 (0)50 3681100
Email	b.van.den.hoofdakker@accare.nl

Study information

Study design	Randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2002
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	96
Key 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
Key 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
Date of first enrolment	01/06/2002
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Centre Groningen

Groningen
9713 GZ
Netherlands

Sponsor information

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

P.O. Box 660
Groningen
9700 AR
Netherlands

Phone	+31 (0)50 3610973
Email	info@accare.nl
Website	http://www.accare.nl/
"ROR"	https://ror.org/02h4pw461

Funders

Funder type

Hospital/treatment centre

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan