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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: Care-as-usual for children (8-16 years old) with ADHD; Other: MYmind mindfulness training

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6812DE
      • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
    • Ede, Gelderland, Netherlands, 6717LX
      • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
    • Nijmegen, Gelderland, Netherlands, 6525GC
      • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: 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).; 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 Names: Mindfulness for children with ADHD and mindful parenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in parent-rated self-control of the child	Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)	Baseline, 3, 5 and 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 3, 5 and 9 months
Change from Baseline in parent-rated autistic social impairment of the child	Social Responsiveness Scale, parent-report (SRS-P)	Baseline, 3 and 9 months
Change from Baseline in parent-rated quality of life of the child	KIDSCREEN-10, parent-report	Baseline, 3 and 9 months
Change from Baseline in teacher-rated self-control of the child	Behaviour Rating Inventory of Executive Function, teacher-report (BRIEF-T)	Baseline, 3 and 5 months
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	Baseline, 3 and 5 months
Change from Baseline in teacher-rated autistic social impairment of the child	Social Responsiveness Scale, teacher-report (SRS-T)	Baseline and 3 months
Change from Baseline in self-rated dispositional mindfulness of the child	Child and Adolescent Mindfulness Measure (CAMM), self-report	Baseline, 3, 5 and 9 months
Change from Baseline in self-rated brooding of the child	Ruminative Response Scale (RRS), subscale: brooding, self-report	Baseline, 3 and 9 months
Change from Baseline on the Stop task in the child	Computer based neurocognitive assessments of self-control in the child	Baseline, 3 and 9 months
Change from Baseline on the Probabilistic reversal learning task in the child	Computer based neurocognitive assessments of self-control in the child	Baseline, 3 and 9 months
Change from Baseline on the Temporal discounting task in the child	Computer based neurocognitive assessments of self-control in the child	Baseline, 3 and 9 months
Change from Baseline in self-rated self-control of the parent	Behaviour Rating Inventory of Executive Function, self-report (BRIEF-A)	Baseline, 3, 5 and 9 months
Change from Baseline in self-rated ADHD traits of the parent	DSM-5 based ADHD traits, self-report	Baseline, 3, 5 and 9 months
Change from Baseline in self-rated mindfulness in parenting of the parent	Interpersonal Mindfulness in Parenting Scale (IM-P), self-report	Baseline, 3, 5 and 9 months
Change from Baseline in self-rated autistic traits of the parent	Short Autism Quotient Questionnaire-Adult Version (AQ-10), self-report	Baseline, 3 and 9 months
Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent	Depression Anxiety Stress Scale-21 (DASS-21), self-report	Baseline, 3 and 9 months
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	Baseline, 3 and 9 months
Change from Baseline in self-rated quality of life of the parent	World Health Organization-Five Well-Being Index (WHO-5), self-report	Baseline, 3 and 9 months
Change from Baseline in self-rated brooding of the parent	Ruminative Response Scale (RRS), subscale: brooding, self-report	Baseline, 3 and 9 months
Change from Baseline on the Stop task in the parent	Computer based neurocognitive assessments of self-control in the parent	Baseline, 3 and 9 months
Change from Baseline on the Probabilistic reversal learning task in the parent	Computer based neurocognitive assessments of self-control in the parent	Baseline, 3 and 9 months
Change from Baseline on the Temporal discounting task in the parent	Computer based neurocognitive assessments of self-control in the parent	Baseline, 3 and 9 months

Collaborators and Investigators

• Sponsor: Karakter Kinder- en Jeugdpsychiatrie
• Collaborators: Radboud University Medical Center; University of Amsterdam; European Commission; Fonds Psychische Gezondheid; UvA minds
• Investigators: Principal Investigator: Jan K Buitelaar, Karakter kinder- en jeugdpsychiatrie

Publications and helpful links

General 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.

Helpful Links

• recruitment text (Dutch)
• recruitment text (Dutch)
• abstract for symposium (English)
• blog post on the feasibility of the study (English)

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2016
• Primary Completion (Actual): July 26, 2018
• Study Completion (Actual): February 22, 2019

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Well-being; Self-control
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 20016 MIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No