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Completed

NCT Number: NCT03220308

Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Mental Disorders Neurodevelopmental Disorders Self-Control Social Behavior

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie, Arnhem, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MYmind mindfulness training

Other

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 names: Mindfulness for children with ADHD and mindful parenting

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karakter Kinder- en Jeugdpsychiatrie

Other

Collaborators

  • European Commission
  • Fonds Psychische Gezondheid
  • Radboud University Medical Center
  • University of Amsterdam
  • UvA minds

Registry information

Official study title

Mindfulness Training for Children With ADHD and Mindful Parenting

Acronym: MindChamp

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jul 18, 2017
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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