The comparison of the effects (and cost effectiveness) of mindfulness training for the child + Mindful Parenting for the parents versus medication (Methylphenidate) in a randomized controlled trial (RCT) in children with ADHD, aged 9-18.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Attention problems (also hyperactivity and impulsivity) as reported by the
parents, child, teacher, and test observer.
Secondary outcome
Symptoms of anxiety, depression, social functioning, stress, tiredness and
quality of life.
Background summary
Medication is the first choice intervention in the treatment of children and
youngsters with ADHD. Methylphenidate works for around 70% of the children.
However, for around 30% it does not work, many parents prefer their child not
to take medication, the effects are often only short-acting and compliance is
often low. It is therefore undesirable that medication is prescribed for
(young) children when other effective alternatives are available. Pilot studies
show that the effects of mindfulness training for children and youngsters with
ADHD (and their parents) are very promising. However, it is unclear how these
effects are compared to the effects of medication.
Study objective
The comparison of the effects (and cost effectiveness) of mindfulness training
for the child + Mindful Parenting for the parents versus medication
(Methylphenidate) in a randomized controlled trial (RCT) in children with ADHD,
aged 9-18.
Study design
A RCT with a pre-test, a post-test and two follow-up measurements. After the
pre-test participants are randomized. Treatment in both study arms will take
8-9 weeks followed by a post-test. Subsequently, treatment in the medication
group continues another block of 8-9 weeks while participants in the
mindfulness group will not receive treatment (this is conform regular
mindfulness training). Mindfulness training follows the MYmind protocol and in
the treatment with methylphenidate guidelines of the Trimbos institute are
followed. Subsequently the first follow-up measurement takes place. After this,
participants are free to choose which treatment they want to receive, if any.
Thus, at this point in the study -after 16-18 weeks- they have the choice to
swap treatment allocation if they wish so. After nine months the last follow-up
measurement takes place in order to get an idea about the long term effects of
both interventions. In this study four informants are included (parents,
children, teachers and test observers) as well as self-reports but also
independent neuropsychological and computer tasks (mostly targeting the
measurement of attention).
Intervention
The mindfulness training for children consists of 8-9 weekly group meetings of
1.5 hours. Parallel to this parents participate in the weekly Mindful Parenting
training which also takes 1.5 hours each time. Children and adolescents are
split into different groups (roughly 9-12 year olds and 13-18 year olds are
placed together). Children in the medication group are first titrated to their
optimal dosage under supervision of a child psychiatrist. After this they take
methylphenidate daily for a period of 8-9 weeks (see medication guidelines
"Multidisciplinaire richtlijn ADHD" Trimbos instituut) combined with 2 parent
guidance sessions focusing on psycho education about ADHD. Parents in both
groups receive the same psycho education about ADHD. In the second block of 8-9
weeks children and parents in the mindfulness group don't receive treatment
(they are however encouraged to practice at home) apart from the booster
session after 8-9 weeks, and the children in the medication group continue to
receive daily methylphenidate, this time not combined with parent guidance
sessions.
Study burden and risks
Children in the mindfulness group participate in 8-9 weekly group sessions,
lasting 1.5 hours in a group of 6-8 children. In addition children are asked to
practice 15-20 minutes daily at home. After the first block of 8-9 weeks a
period of 8-9 weeks follows with no training for these children apart from the
booster session after 8-9 weeks. Parents participate in the parallel Mindful
Parenting training which is 1.5 hours a week. In adittion parents are requested
to practice 20-30 minutes daily at home. Our clinical impression as well as
scores on evaluation forms and questionnaires in the current mindfulness
studies show that the burden is minimal. Participants report a decline in
complaints, more peace of mind, like the yoga exercises, and they are well
informed before the training starts of what the training will involve. In
general this is considered as reasonable. Compliance in the mindfulness
training for children as well in the Mindful Parenting training for their
parents is high so far. Questionnaires can be filled in online at home. For the
computer tasks children need to visit the treatment center. They receive a
small reward/incentive for this. Participation in the mindfulness training does
not carry any risks. The mindfulness intervention in this project is carried
out the same way as in the project "Mindfulness in child and adolescent
psychiatry" for which the METC has previously granted permission.
Participants in the medication group experience the same extent of burden with
respect to filling out questionnaires and computer tasks as the participants in
the mindfulness group. We presume that, for reasons mentioned above, that this
is a reasonable burden. Before the start of treatment they need to visit the
child psychiatrist a few times to titrate to the optimal dosage of
methylphenidate. In this titration period parents and children also keep a
record of the side effects (as well as teachers). After this parents will
receive 2 parent guidance sessions of a maximum of 1 hour each time, in the
first block of 8-9 weeks treatment with methylphenidate. Children take
methylphenidate daily. In the second block of 8-9 weeks children keep taking
the medication but parents receive no further parent guidance sessions apart
from a booster session after 8-9 weeks comparable to the one in the mindfulness
group. The burden or risks in this group consist of the possible side effects
of methylphenidate on the sleeping, the appetite, and the growth. However,
extended literature shows that these side effects are limited in severity and
Ritalin is prescribed world wide in the treatment of ADHD. Since
methylphenidate is so widely used we assume that the side effects are not
harmful and when parents don't want their child to take medication, they always
have the right to refuse participation in this project and still receive
treatment for their child.
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Listed location countries
Age
Inclusion criteria
- The child is between 9 and 18 years of age (also turning 9 during time of study)
- The child has a primary DSM classification of ADHD
- ADHD is verified by standardized structured DSM interview
- (Estimated) IQ is over 80
- At least one parent is willing to participate in the Mindful Parenting training
Exclusion criteria
- (Estimated) IQ is below 80
- Suicidal risk
- Suffering from psychosis, schizophrenia, or untreated PTSD
- Co morbid conduct problems that are so severe, already during intake, that interaction/talking between parent and child is not possible.
- Current or previous use of methylphenidate in the past month
- Current or previous participation in mindfulness training in the past month
- Participation in a currently active other psychological intervention
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2013-003888-59-NL |
CCMO | NL46168.018.13 |
Other | nog onbekend |