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

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ClinicalTrials.gov Identifier: NCT03220308
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborators:
Fonds Psychische Gezondheid
European Commission
UvA minds
Radboud University
University of Amsterdam
Information provided by (Responsible Party):
Karakter Kinder- en Jeugdpsychiatrie

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: MYmind mindfulness training Other: Care-as-usual for children (8-16 years old) with ADHD Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Training for Children With ADHD and Mindful Parenting
Actual Study Start Date : February 18, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Care-as-usual (CAU) only
Care-as-usual for children (8-16 years old) with ADHD
Other: Care-as-usual for children (8-16 years old) with ADHD
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).

Experimental: Mindfulness for child and parent + CAU
MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD
Other: MYmind mindfulness training
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.
Other Name: Mindfulness for children with ADHD and mindful parenting

Other: Care-as-usual for children (8-16 years old) with ADHD
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).




Primary Outcome Measures :
  1. Change from Baseline in parent-rated self-control of the child [ Time Frame: Baseline, 3, 5 and 9 months ]
    Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)


Secondary Outcome Measures :
  1. Change from Baseline in parent-rated behaviour problems of the child [ Time Frame: Baseline, 3, 5 and 9 months ]
    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

  2. Change from Baseline in parent-rated autistic social impairment of the child [ Time Frame: Baseline, 3 and 9 months ]
    Social Responsiveness Scale, parent-report (SRS-P)

  3. Change from Baseline in parent-rated quality of life of the child [ Time Frame: Baseline, 3 and 9 months ]
    KIDSCREEN-10, parent-report

  4. Change from Baseline in teacher-rated self-control of the child [ Time Frame: Baseline, 3 and 5 months ]
    Behaviour Rating Inventory of Executive Function, teacher-report (BRIEF-T)

  5. Change from Baseline in teacher-rated behaviour problems of the child [ Time Frame: Baseline, 3 and 5 months ]
    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

  6. Change from Baseline in teacher-rated autistic social impairment of the child [ Time Frame: Baseline and 3 months ]
    Social Responsiveness Scale, teacher-report (SRS-T)

  7. Change from Baseline in self-rated dispositional mindfulness of the child [ Time Frame: Baseline, 3, 5 and 9 months ]
    Child and Adolescent Mindfulness Measure (CAMM), self-report

  8. Change from Baseline in self-rated brooding of the child [ Time Frame: Baseline, 3 and 9 months ]
    Ruminative Response Scale (RRS), subscale: brooding, self-report

  9. Change from Baseline on the Stop task in the child [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the child

  10. Change from Baseline on the Probabilistic reversal learning task in the child [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the child

  11. Change from Baseline on the Temporal discounting task in the child [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the child

  12. Change from Baseline in self-rated self-control of the parent [ Time Frame: Baseline, 3, 5 and 9 months ]
    Behaviour Rating Inventory of Executive Function, self-report (BRIEF-A)

  13. Change from Baseline in self-rated ADHD traits of the parent [ Time Frame: Baseline, 3, 5 and 9 months ]
    DSM-5 based ADHD traits, self-report

  14. Change from Baseline in self-rated mindfulness in parenting of the parent [ Time Frame: Baseline, 3, 5 and 9 months ]
    Interpersonal Mindfulness in Parenting Scale (IM-P), self-report

  15. Change from Baseline in self-rated autistic traits of the parent [ Time Frame: Baseline, 3 and 9 months ]
    Short Autism Quotient Questionnaire-Adult Version (AQ-10), self-report

  16. Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent [ Time Frame: Baseline, 3 and 9 months ]
    Depression Anxiety Stress Scale-21 (DASS-21), self-report

  17. Change from Baseline in self-rated emotional well-being, psychological well-being and social well-being of the parent [ Time Frame: Baseline, 3 and 9 months ]
    Mental Health Continuum-Short Form (MHC-SF), self-report

  18. Change from Baseline in self-rated quality of life of the parent [ Time Frame: Baseline, 3 and 9 months ]
    World Health Organization-Five Well-Being Index (WHO-5), self-report

  19. Change from Baseline in self-rated brooding of the parent [ Time Frame: Baseline, 3 and 9 months ]
    Ruminative Response Scale (RRS), subscale: brooding, self-report

  20. Change from Baseline on the Stop task in the parent [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the parent

  21. Change from Baseline on the Probabilistic reversal learning task in the parent [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the parent

  22. Change from Baseline on the Temporal discounting task in the parent [ Time Frame: Baseline, 3 and 9 months ]
    Computer based neurocognitive assessments of self-control in the parent



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220308


Contacts
Contact: Corina U Greven 0031646616038 c.greven@donders.ru.nl
Contact: Nienke M Siebelink 0031646622594 n.siebelink@karakter.com

Locations
Netherlands
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie Recruiting
Arnhem, Gelderland, Netherlands, 6812DE
Contact: Corina U Greven    0031646616038    c.greven@donders.ru.nl   
Contact: Nienke M Siebelink    0031646622594    n.siebelink@karakter.com   
Principal Investigator: Jan K Buitelaar         
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie Recruiting
Ede, Gelderland, Netherlands, 6717LX
Contact: Corina U Greven    0031646616038    c.greven@donders.ru.nl   
Contact: Nienke M Siebelink    0031646622594    n.siebelink@karakter.com   
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie Recruiting
Nijmegen, Gelderland, Netherlands, 6525GC
Contact: Corina U Greven    0031646616038    c.greven@donders.ru.nl   
Contact: Nienke M Siebelink    0031646622594    n.siebelink@karakter.com   
Principal Investigator: Jan K Buitelaar         
Sponsors and Collaborators
Karakter Kinder- en Jeugdpsychiatrie
Fonds Psychische Gezondheid
European Commission
UvA minds
Radboud University
University of Amsterdam
Investigators
Principal Investigator: Jan K Buitelaar Karakter Kinder- en Jeugdpsychiatrie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karakter Kinder- en Jeugdpsychiatrie
ClinicalTrials.gov Identifier: NCT03220308     History of Changes
Other Study ID Numbers: 20016 MIND
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karakter Kinder- en Jeugdpsychiatrie:
Self-control
Well-being

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms