|- candidate number||1495|
|- NTR Number||NTR297|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The effects of parent training on behavior problems, ADHD-symptoms and parenting stress in children with ADHD in routine child psychiatric out-patient care.|
|- Scientific Title||The effects of parent training on behavior problems, ADHD-symptoms and parenting stress in children with ADHD in routine child psychiatric out-patient care.|
|- hypothesis||1. Parent training will lead to a significant reduction of behavior 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 siginificant reduction of parenting stress in comparison with routine medical care.
|- Healt Condition(s) or Problem(s) studied||Attention Deficit Hyperactivity Disorder (ADHD), Psychological problems|
|- Inclusion criteria||1. Age between 4 and 12 years;|
2. Average IQ > 80;
3. Meeting DISC-criteria for ADHD;
4. Children under the age of 6 need an additional AVL-score > 32;
5. Parents can identify at least 3 target behavior 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.
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2002|
|- planned closingdate||1-mei-2005|
|- Target number of participants||96|
|- Interventions||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 counseling and support, further psycho-education.
|- Primary outcome||1. Target behavior 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||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.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Barbara J. Hoofdakker, van den|
|- CONTACT for SCIENTIFIC QUERIES|| Barbara J. Hoofdakker, van den|
|- Sponsor/Initiator ||Accare, Division University Center for Child and Adolescent Psychiatry|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG), Stimuleringsgelden|
|- Publications||J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1263-71.|
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 9-jul-2008|