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Attention Deficit Hyperactivity DisorderMindChampNCT03220308

Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Mindful Parenting

A study testing MYmind mindfulness training and Care-as-usual for children (8-16 years old) with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Karakter Kinder- en Jeugdpsychiatrie at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effectiveness of an 8-week mindfulness group training for children (8-16 years old) with ADHD in combination with a parallel mindful parenting training for their parents. Read more about this study

Who is it for?
Ages 8 to 16 years
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
MYmind mindfulness training and Care-as-usual for children (8-16 years old) with ADHD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
3 sitesNetherlands
Study dates
18 Feb 2016to 22 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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 (The Schedule for Affective Disorders and Schizophrenia for school-Age Children (K-SADS)).
  • Child receives CAU and has remaining ADHD-symptoms (average score > 1.0 on the investigator-rated DSM-5 items from the Conners' ADHD rating scale).
  • Child is between 8 and 16 years old.
  • At least one parent is willing to participate.
  • ADHD medication dose is stable, or there is an informed decision on not taking ADHD medication.
  • Psychiatric comorbidities are allowed except psychosis, bipolar illness, active suicidality, untreated posttraumatic stress disorder or substance use, provided ADHD is the primary diagnosis in the child; similarly, psychopathology in the parents is allowed except psychosis, bipolar disorder, active suicidality, untreated posttraumatic stress disorder or substance use.
  • Child and parent have an estimated intelligence quotient (IQ) ≥ 80.
  • Child and parent have adequate mastery of Dutch language.

Who cannot join

  • Child or the participating parent(s) have participated in a mindfulness programme in the past year or ever in a Mindful Parenting training.
  • Child or parent is participating in another intervention study.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

    Arnhem, Gelderland, 6812DE

  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

    Ede, Gelderland, 6717LX

  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

    Nijmegen, Gelderland, 6525GC

Other trials in Netherlands

About this study

Official title: Mindfulness Training for Children With ADHD and Mindful Parenting

This study evaluates the effectiveness of an 8-week mindfulness group training for children (8-16 years old) with ADHD in combination with a parallel mindful parenting training for their parents. Half of the participants will be randomly assigned to the mindfulness training in addition to care-as-usual (CAU); the other half to CAU-only.

The hypothesis is that compared to care-as-usual only, the addition of the mindfulness training will improve self-control of youth with ADHD.

Being tested
MYmind mindfulness training, Care-as-usual for children (8-16 years old) with ADHD
Keywords
Self-control, Well-being
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYmind mindfulness trainingOther

    Also called Mindfulness for children with ADHD and mindful parenting

    The MYmind mindfulness training 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. Eight weeks after the last session there is a single 90 minutes booster session.

  • Care-as-usual for children (8-16 years old) with ADHDOther

    According to the Dutch Multidisciplinary guidelines for the diagnosis and treatment of ADHD, care-as-usual for children aged 8-16 years with ADHD consists of psycho-education and the prescription of medication approved for ADHD and/or evidence-based parent and/or teacher-administered behaviour therapy, preferably both medication and behaviour therapy. First-line option for medication is a psychostimulant, second-line option is atomoxetine, and third-line options are alpha-2 presynaptic agonists or tricyclic antidepressants (imipramine).

Study groups in NCT03220308
Study groupRoleWhat they receive
Care-as-usual (CAU) onlyOtherCare-as-usual for children (8-16 years old) with ADHD
Receives: Other: Care-as-usual for children (8-16 years old) with ADHD
Mindfulness for child and parent + CAUExperimentalMYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD
Receives: Other: MYmind mindfulness training; Other: Care-as-usual for children (8-16 years old) with ADHD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in parent-rated self-control of the child

    Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)

    Measured: Baseline, 3, 5 and 9 months

Secondary outcomes (22)

  1. Change from Baseline in parent-rated behaviour problems of the child

    Conners' Parent Rating Scales-Revised: Long (CPRS-R), subscales: inattentive and hyperactive-impulsive symptoms according to the 4th version of the Diagnostic and Statistical Manual (DSM-IV), oppositional, anxious/shy, social problems and the Emotional Lability index

    Measured: Baseline, 3, 5 and 9 months

  2. Change from Baseline in parent-rated autistic social impairment of the child

    Social Responsiveness Scale, parent-report (SRS-P)

    Measured: Baseline, 3 and 9 months

  3. Change from Baseline in parent-rated quality of life of the child

    KIDSCREEN-10, parent-report

    Measured: Baseline, 3 and 9 months

  4. Change from Baseline in teacher-rated self-control of the child

    Behaviour Rating Inventory of Executive Function, teacher-report (BRIEF-T)

    Measured: Baseline, 3 and 5 months

  5. Change from Baseline in teacher-rated behaviour problems of the child

    Conners' Teacher Rating Scales-Revised: Long (CTRS-R), subscales: inattentive and hyperactive-impulsive symptoms according to the 4th version of the Diagnostic and Statistical Manual (DSM-IV), oppositional, anxious/shy, social problems and the Emotional Lability index

    Measured: Baseline, 3 and 5 months

  6. Change from Baseline in teacher-rated autistic social impairment of the child

    Social Responsiveness Scale, teacher-report (SRS-T)

    Measured: Baseline and 3 months

  7. Change from Baseline in self-rated dispositional mindfulness of the child

    Child and Adolescent Mindfulness Measure (CAMM), self-report

    Measured: Baseline, 3, 5 and 9 months

  8. Change from Baseline in self-rated brooding of the child

    Ruminative Response Scale (RRS), subscale: brooding, self-report

    Measured: Baseline, 3 and 9 months

  9. Change from Baseline on the Stop task in the child

    Computer based neurocognitive assessments of self-control in the child

    Measured: Baseline, 3 and 9 months

  10. Change from Baseline on the Probabilistic reversal learning task in the child

    Computer based neurocognitive assessments of self-control in the child

    Measured: Baseline, 3 and 9 months

  11. Change from Baseline on the Temporal discounting task in the child

    Computer based neurocognitive assessments of self-control in the child

    Measured: Baseline, 3 and 9 months

  12. Change from Baseline in self-rated self-control of the parent

    Behaviour Rating Inventory of Executive Function, self-report (BRIEF-A)

    Measured: Baseline, 3, 5 and 9 months

  13. Change from Baseline in self-rated ADHD traits of the parent

    DSM-5 based ADHD traits, self-report

    Measured: Baseline, 3, 5 and 9 months

  14. Change from Baseline in self-rated mindfulness in parenting of the parent

    Interpersonal Mindfulness in Parenting Scale (IM-P), self-report

    Measured: Baseline, 3, 5 and 9 months

  15. Change from Baseline in self-rated autistic traits of the parent

    Short Autism Quotient Questionnaire-Adult Version (AQ-10), self-report

    Measured: Baseline, 3 and 9 months

  16. Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent

    Depression Anxiety Stress Scale-21 (DASS-21), self-report

    Measured: Baseline, 3 and 9 months

  17. Change from Baseline in self-rated emotional well-being, psychological well-being and social well-being of the parent

    Mental Health Continuum-Short Form (MHC-SF), self-report

    Measured: Baseline, 3 and 9 months

  18. Change from Baseline in self-rated quality of life of the parent

    World Health Organization-Five Well-Being Index (WHO-5), self-report

    Measured: Baseline, 3 and 9 months

  19. Change from Baseline in self-rated brooding of the parent

    Ruminative Response Scale (RRS), subscale: brooding, self-report

    Measured: Baseline, 3 and 9 months

  20. Change from Baseline on the Stop task in the parent

    Computer based neurocognitive assessments of self-control in the parent

    Measured: Baseline, 3 and 9 months

  21. Change from Baseline on the Probabilistic reversal learning task in the parent

    Computer based neurocognitive assessments of self-control in the parent

    Measured: Baseline, 3 and 9 months

  22. Change from Baseline on the Temporal discounting task in the parent

    Computer based neurocognitive assessments of self-control in the parent

    Measured: Baseline, 3 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start18 Feb 2016
  3. Primary completion26 Jul 2018
  4. Study completion22 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03220308
Sponsor's protocol ID
20016 MIND
Acronym
MindChamp
Status last verified
Mar 2019
First submitted
20 Jun 2017
Last updated
7 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be available 18 months after finishing the study. The investigators will give limited access to the data, that is, data can be obtained provided that the applicant will submit a research plan and the investigator of the current study will be involved in the research on the shared data. Data will be anonymised and accompanied by the present study protocol and data list description. Other researchers can contact Karakter (sponsor of the study) to obtain data: Address: Reinier Postlaan 12 6525 GC Nijmegen Phone: 024 351 22 22 Email: info.nijmegen@karakter.com

Publications

  • Siebelink NM, Bogels SM, Boerboom LM, de Waal N, Buitelaar JK, Speckens AE, Greven CU. Mindfulness for children with ADHD and Mindful Parenting (MindChamp): Protocol of a randomised controlled trial comparing a family Mindfulness-Based Intervention as an add-on to care-as-usual with care-as-usual only. BMC Psychiatry. 2018 Jul 25;18(1):237. doi: 10.1186/s12888-018-1811-y.

    PubMed 30045714

Questions about this trial

What is this clinical trial studying?

A study testing MYmind mindfulness training and Care-as-usual for children (8-16 years old) with ADHD in people with Attention Deficit Hyperactivity Disorder, run by Karakter Kinder- en Jeugdpsychiatrie at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in parent-rated self-control of the child (time frame: Baseline, 3, 5 and 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220308, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2019.

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