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

March 4, 2019 updated by: Karakter Kinder- en Jeugdpsychiatrie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, 3, 5 and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline, 3, 5 and 9 months
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)
Baseline, 3 and 9 months
Change from Baseline in parent-rated quality of life of the child
Time Frame: Baseline, 3 and 9 months
KIDSCREEN-10, parent-report
Baseline, 3 and 9 months
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)
Baseline, 3 and 5 months
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
Baseline, 3 and 5 months
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)
Baseline and 3 months
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
Baseline, 3, 5 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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)
Baseline, 3, 5 and 9 months
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
Baseline, 3, 5 and 9 months
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
Baseline, 3, 5 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months
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
Baseline, 3 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karakter Kinder- en Jeugdpsychiatrie

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radboud University Medical Center
University of Amsterdam
European Commission
Fonds Psychische Gezondheid
UvA minds

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan K Buitelaar, Karakter kinder- en jeugdpsychiatrie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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