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My child has ADHD: Medication or Meditation?


- candidate number15538
- NTR NumberNTR4206
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-okt-2013
- Secondary IDsC.2524.0493.01 University of Amsterdam
- Public TitleMy child has ADHD: Medication or Meditation?
- Scientific TitleMedication or Meditation? Mindfulness training versus medication in the treatment of childhood ADHD
- ACRONYMN/A
- hypothesisMindfulness 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) studiedADHD
- 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate31-dec-2016
- Target number of participants120
- InterventionsMedication (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 outcomeAttention, 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 outcomeSymptoms 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.
- TimepointsPre intervention, post intervention (after 8 weeks), follow-up (after 16 weeks) and long term follow-up (after 9 months).
- Trial web sitewww.ADHD-medicatieofmeditatie.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Esther Bruin, de
- CONTACT for SCIENTIFIC QUERIES Esther Bruin, de
- Sponsor/Initiator University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
NWO, University of Amsterdam
- PublicationsN/A
- Brief summaryThe Netherlands
- Main changes (audit trail)
- RECORD11-okt-2013 - 29-okt-2013


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