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
Protocol serial number NTR297
Sponsor National Expertise Centre for Child and Adolescent Psychiatry (Accare) (The Netherlands)
Funder University Medical Centre Groningen (UMCG) (The Netherlands) - Stimuleringsgelden
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

Primary study designInterventional
Study designRandomised, active controlled, parallel group trial
Secondary study designRandomised controlled trial
Scientific title
Study objectives1. 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) studiedAttention deficit hyperactivity disorder (ADHD), psychological problems
Intervention1. 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

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.

Completion date01/05/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit12 Years
SexAll
Target sample size at registration96
Key inclusion criteria1. 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 criteria1. 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 enrolment01/06/2002
Date of final enrolment01/05/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Groningen
Groningen
9713 GZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan