Our primary objective is to evaluate the effectiveness of mindfulness training in improving self-control of youth with ADHD. As secondary objectives, we aim to quantify the effectiveness in reducing ADHD symptoms, reducing comorbid (e.g. ASD)…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome measure consists of parent ratings of child self-control on
the Behaviour Rating Inventory of Executive Function (BRIEF), which involves
standardised ecologically-valid ratings of everyday self-control.
Secondary outcome
Other measures of child self-control, child behaviour, parental self-control,
parental behaviour, and other measures (e.g. quality of life).
Background summary
Deficits in self-control (e.g. planning, delay of gratification, inhibition of
responses) are a key problem in attention deficit hyperactivity disorder
(ADHD). However, although existing interventions for ADHD are effective in
reducing the core symptoms of ADHD, they all have limited effects on improving
self-control in ADHD. Further, residual symptoms and impairment remain. Hence,
there is need for new interventions that target shortcomings in existing
interventions for ADHD. Effective strategies to improve children*s self-control
come with the potential to substantially benefit the child*s further
development, and to significantly lower negative academic, health, wealth,
social and public safety outcomes linked to poor self-control. A promising
approach is the use of mindfulness, an innovative non-pharmacological
therapeutic intervention.
Study objective
Our primary objective is to evaluate the effectiveness of mindfulness training
in improving self-control of youth with ADHD. As secondary objectives, we aim
to quantify the effectiveness in reducing ADHD symptoms, reducing comorbid
(e.g. ASD) symptoms, reducing impairment of functioning, and improving outcomes
in the parents of youth with ADHD.
Study design
We will provide mindfulness training as an add-on to care-as-usual (CAU). This
will optimise CAU for ADHD. We will randomly assign 100 children with ADHD and
their parents to mindfulness training (N=50) (plus CAU), and to control
condition (CAU-only) (N=50). Data from children and parents will be collected
at baseline, endpoint and at 6-month follow-up, and will include assessments of
self-control, ADHD symptoms, comorbid symptoms, impairment, and parental
outcomes (e.g. parental self-control, parenting). We will also collect saliva
samples from children at baseline and at endpoint.
Intervention
We will use the MYmind mindfulness training, which uses a standardised protocol
based on mindfulness-based cognitive therapy. It consists of 8 weekly group
sessions of 90 minutes for youth with ADHD, and parallel mindful parenting
training for the parents. For eight weeks after the last session the families
undergo home self-practice, followed by a single 90 minutes joint parent-child
booster session. This booster session signifies study endpoint. CAU usually
consists of behavioural interventions and/or medication.
Study burden and risks
The risks and discomforts are estimated as low. Burden for all participants are
the recurrent non-invasive assessments. For children these include diagnostic
assessment (baseline only), questionnaires, behaviour observation, and
cognitive tests (baseline, endpoint, follow-up); for parents these include
diagnostic assessment (baseline only), questionnaires and cognitive tests
(baseline, endpoint, follow-up).
Benefits for the participants are good monitoring of treatment effect and the
possibility to receive mindfulness training free of charge, which is currently
not covered by health insurance. If the mindfulness training proves effective,
they will receive additional treatment for their disorder targeting deficits
that are not covered by CAU. A further benefit is that this study will allow
optimisation of CAU.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
(1) Child has a clinical diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders; DSM-IV or DSM-5 system, and confirmed by a structured interview (K-SADS).
(2) 8-16 years old.
(3) At least one parent willing to participate.
(4) ADHD medication dose is stable, or there is an informed decision on not taking ADHD medication.
(5) Child and parent have an estimated IQ >= 80.
(6) Child and parent have adequate mastery of Dutch language.
(7) We allow for psychiatric comorbidities except psychosis, bipolar illness, active suicidality, untreated posttraumatic stress disorder or substance use, provided ADHD is the primary diagnosis in the child; similarly, we allow for psychopathology in the parents, except psychosis, bipolar disorder, active suicidality, untreated posttraumatic stress disorder or substance use.
(8) Not participating in another intervention study.
Exclusion criteria
none
Design
Recruitment
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 |
---|---|
CCMO | NL53815.091.15 |