NCT03220308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.4 years

First QC Date

June 20, 2017

Last Update Submit

March 4, 2019

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Self-controlWell-being

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (22)

  • Change from Baseline in parent-rated behaviour problems of the child

    Baseline, 3, 5 and 9 months

  • Change from Baseline in parent-rated autistic social impairment of the child

    Baseline, 3 and 9 months

  • Change from Baseline in parent-rated quality of life of the child

    Baseline, 3 and 9 months

  • Change from Baseline in teacher-rated self-control of the child

    Baseline, 3 and 5 months

  • Change from Baseline in teacher-rated behaviour problems of the child

    Baseline, 3 and 5 months

  • +17 more secondary outcomes

Study Arms (2)

Care-as-usual (CAU) only

OTHER

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

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

Mindfulness for child and parent + CAU

EXPERIMENTAL

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

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

Interventions

MYmind mindfulness trainingOTHER

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.

Also known as: Mindfulness for children with ADHD and mindful parenting
Mindfulness for child and parent + CAU
Care-as-usual for children (8-16 years old) with ADHDOTHER

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).

Care-as-usual (CAU) onlyMindfulness for child and parent + CAU

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

Arnhem, Gelderland, 6812DE, Netherlands

Location

Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

Ede, Gelderland, 6717LX, Netherlands

Location

Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie

Nijmegen, Gelderland, 6525GC, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 30045714BACKGROUND

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySelf-Control

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jan K Buitelaar

    Karakter Kinder- en Jeugdpsychiatrie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2017

First Posted

July 18, 2017

Study Start

February 18, 2016

Primary Completion

July 26, 2018

Study Completion

February 22, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

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

Locations

NL(3)