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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MYmind mindfulness training
Care-as-usual for children (8-16 years old) with ADHD
Sponsored by
Karakter Kinder- en Jeugdpsychiatrie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Self-control, Well-being

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
  • Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Care-as-usual (CAU) only

Mindfulness for child and parent + CAU

Arm Description

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

MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD

Outcomes

Primary Outcome Measures

Change from Baseline in parent-rated self-control of the child
Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2017
Last Updated
March 4, 2019
Sponsor
Karakter Kinder- en Jeugdpsychiatrie
Collaborators
Fonds Psychische Gezondheid, European Commission, UvA minds, Radboud University Medical Center, University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT03220308
Brief Title
Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Mindful Parenting
Acronym
MindChamp
Official Title
Mindfulness Training for Children With ADHD and Mindful Parenting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 18, 2016 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
February 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karakter Kinder- en Jeugdpsychiatrie
Collaborators
Fonds Psychische Gezondheid, European Commission, UvA minds, Radboud University Medical Center, University of Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Self-control, Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care-as-usual (CAU) only
Arm Type
Other
Arm Description
Care-as-usual for children (8-16 years old) with ADHD
Arm Title
Mindfulness for child and parent + CAU
Arm Type
Experimental
Arm Description
MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD
Intervention Type
Other
Intervention Name(s)
MYmind mindfulness training
Other Intervention Name(s)
Mindfulness for children with ADHD and mindful parenting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Care-as-usual for children (8-16 years old) with ADHD
Intervention Description
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 Measure Information:
Title
Change from Baseline in parent-rated self-control of the child
Description
Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)
Time Frame
Baseline, 3, 5 and 9 months
Secondary Outcome Measure Information:
Title
Change from Baseline in parent-rated behaviour problems of the child
Description
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
Time Frame
Baseline, 3, 5 and 9 months
Title
Change from Baseline in parent-rated autistic social impairment of the child
Description
Social Responsiveness Scale, parent-report (SRS-P)
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in parent-rated quality of life of the child
Description
KIDSCREEN-10, parent-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in teacher-rated self-control of the child
Description
Behaviour Rating Inventory of Executive Function, teacher-report (BRIEF-T)
Time Frame
Baseline, 3 and 5 months
Title
Change from Baseline in teacher-rated behaviour problems of the child
Description
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
Time Frame
Baseline, 3 and 5 months
Title
Change from Baseline in teacher-rated autistic social impairment of the child
Description
Social Responsiveness Scale, teacher-report (SRS-T)
Time Frame
Baseline and 3 months
Title
Change from Baseline in self-rated dispositional mindfulness of the child
Description
Child and Adolescent Mindfulness Measure (CAMM), self-report
Time Frame
Baseline, 3, 5 and 9 months
Title
Change from Baseline in self-rated brooding of the child
Description
Ruminative Response Scale (RRS), subscale: brooding, self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Stop task in the child
Description
Computer based neurocognitive assessments of self-control in the child
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Probabilistic reversal learning task in the child
Description
Computer based neurocognitive assessments of self-control in the child
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Temporal discounting task in the child
Description
Computer based neurocognitive assessments of self-control in the child
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in self-rated self-control of the parent
Description
Behaviour Rating Inventory of Executive Function, self-report (BRIEF-A)
Time Frame
Baseline, 3, 5 and 9 months
Title
Change from Baseline in self-rated ADHD traits of the parent
Description
DSM-5 based ADHD traits, self-report
Time Frame
Baseline, 3, 5 and 9 months
Title
Change from Baseline in self-rated mindfulness in parenting of the parent
Description
Interpersonal Mindfulness in Parenting Scale (IM-P), self-report
Time Frame
Baseline, 3, 5 and 9 months
Title
Change from Baseline in self-rated autistic traits of the parent
Description
Short Autism Quotient Questionnaire-Adult Version (AQ-10), self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent
Description
Depression Anxiety Stress Scale-21 (DASS-21), self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in self-rated emotional well-being, psychological well-being and social well-being of the parent
Description
Mental Health Continuum-Short Form (MHC-SF), self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in self-rated quality of life of the parent
Description
World Health Organization-Five Well-Being Index (WHO-5), self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline in self-rated brooding of the parent
Description
Ruminative Response Scale (RRS), subscale: brooding, self-report
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Stop task in the parent
Description
Computer based neurocognitive assessments of self-control in the parent
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Probabilistic reversal learning task in the parent
Description
Computer based neurocognitive assessments of self-control in the parent
Time Frame
Baseline, 3 and 9 months
Title
Change from Baseline on the Temporal discounting task in the parent
Description
Computer based neurocognitive assessments of self-control in the parent
Time Frame
Baseline, 3 and 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan K Buitelaar
Organizational Affiliation
Karakter Kinder- en Jeugdpsychiatrie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
City
Arnhem
State/Province
Gelderland
ZIP/Postal Code
6812DE
Country
Netherlands
Facility Name
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6717LX
Country
Netherlands
Facility Name
Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GC
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30045714
Citation
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.
Results Reference
background
Links:
URL
http://www.google.nl/url?sa=t&rct=j&q=&esrc=s&source=web&cd=25&cad=rja&uact=8&ved=0ahUKEwjJzP3slp_UAhXRZFAKHQ0zB3s4FBAWCEgwBA&url=http%3A%2F%2Fwww.ru.nl%2Fpublish%2Fpages%2F829896%2Fmindchamp.pdf&usg=AFQjCNErU__IASzNyGwRKHOeb2c-Qk5r8g
Description
recruitment text (Dutch)
URL
http://www.adhdnetwerk.nl/ADHD.aspx?id=481&idn=450
Description
recruitment text (Dutch)
URL
https://www.radboudcentrumvoormindfulness.nl/wp-content/uploads/2016/02/Mindfulness-with-children-with-ADHD-potential-working-mechanisms-Corina-Greven-Nienke-Siebelink.pdf
Description
abstract for symposium (English)

Learn more about this trial

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

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