|- candidate number||15538|
|- NTR Number||NTR4206|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-okt-2013|
|- Secondary IDs||C.2524.0493.01 University of Amsterdam|
|- Public Title||My child has ADHD: Medication or Meditation?|
|- Scientific Title||Medication or Meditation? Mindfulness training versus medication in the treatment of childhood ADHD|
|- hypothesis||Mindfulness training as well as medication will reduce symptoms of attention, hyperactivity and impulsivity, not only directly after training but also at follow-up. |
|- Healt Condition(s) or Problem(s) studied||ADHD|
|- Inclusion criteria||- Child aged 9-18 years.|
- DSM classification of ADHD.
- ADIS-C is administered to verify ADHD diagnosis.
- (Estimated) IQ > 80.
- At least one parent is willing to participate in the Mindful Parenting training.
|- Exclusion criteria||- (Estimated) IQ < 80.|
- Suffering from suicidal ideation, psychosis or schizophrenia.
- Co-morbid autism or Conduct Disorder.
- Current or past use of methylphenidate (Ritalin).
- Participation in current active other psychological intervention.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||31-dec-2016|
|- Target number of participants||120|
|- Interventions||Medication (methylphenidate; Ritalin): 8 weeks of optimal daily dose of Ritalin, followed by a second period of 8 weeks of optimally dosed Ritalin. Parents receive 2-3 standardized parental guidance/psycho education sessions.
Mindfulness training: children follow an 8-weeks mindfulness training of 1.5 hours per week plus daily homework (around 15-20 minutes per day). Parents participate in a parallel 8-weeks Mindful Parenting training of 1.5 hours a week plus daily homework (around 20-30 minutes a day). The second block of 8 weeks participants in the mindfulness group don't receive treatment. AFter follow-up measurement participants are not require to maintain treatment or can choose a different type of treatment. |
|- Primary outcome||Attention, hyperactivity, and impulsivity in the child (i.e., DBDRS, CBCL, TRF, YSR, BRIEF, TEA-Ch, D2, TOF etc.), percentage of children free of of a DSM classification (i.e., ADIS). |
|- Secondary outcome||Symptoms of anxiety, depression, sleeping problems, social functioning, child and parental quality of life, parental symptomatology, parental mindfulness and stress (i.e., ASR, PS, NOSIK, CSBQ, PSS, CSRQ, PSQI, SVK, WHO-5, FFMQ, IM-P etc.). In addition cost-effectiveness of both treatments is assessed. |
|- Timepoints||Pre intervention, post intervention (after 8 weeks), follow-up (after 16 weeks) and long term follow-up (after 9 months). |
|- Trial web site||www.ADHD-medicatieofmeditatie.nl|
|- CONTACT FOR PUBLIC QUERIES|| Esther Bruin, de|
|- CONTACT for SCIENTIFIC QUERIES|| Esther Bruin, de|
|- Sponsor/Initiator ||University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|NWO, University of Amsterdam|
|- Brief summary||The Netherlands|
|- Main changes (audit trail)|
|- RECORD||11-okt-2013 - 29-okt-2013|