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

Attention Deficit Hyperactivity Disorder Clinical Trial

— MindChamp  

Official title:

Mindfulness Training for Children With ADHD and Mindful Parenting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03220308
• Other study ID #: 20016 MIND
• Status: Completed
• Phase: N/A
• Start date: February 18, 2016
• Est. completion date: February 22, 2019

Study information

• Verified date: March 2019
• Source: Karakter Kinder- en Jeugdpsychiatrie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: February 22, 2019
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.
• 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).

Locations

Country	Name	City	State
Netherlands	Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie	Arnhem	Gelderland
Netherlands	Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie	Ede	Gelderland
Netherlands	Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie	Nijmegen	Gelderland

Sponsors (6)

Lead Sponsor	Collaborator
Karakter Kinder- en Jeugdpsychiatrie	European Commission, Fonds Psychische Gezondheid, Radboud University, University of Amsterdam, UvA minds

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Siebelink NM, Bögels 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from Baseline in parent-rated autistic social impairment of the child	Social Responsiveness Scale, parent-report (SRS-P)	Baseline, 3 and 9 months
Secondary	Change from Baseline in parent-rated quality of life of the child	KIDSCREEN-10, parent-report	Baseline, 3 and 9 months
Secondary	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
Secondary	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
Secondary	Change from Baseline in teacher-rated autistic social impairment of the child	Social Responsiveness Scale, teacher-report (SRS-T)	Baseline and 3 months
Secondary	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
Secondary	Change from Baseline in self-rated brooding of the child	Ruminative Response Scale (RRS), subscale: brooding, self-report	Baseline, 3 and 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in self-rated ADHD traits of the parent	DSM-5 based ADHD traits, self-report	Baseline, 3, 5 and 9 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in self-rated brooding of the parent	Ruminative Response Scale (RRS), subscale: brooding, self-report	Baseline, 3 and 9 months
Secondary	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
Secondary	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
Secondary	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

External Links

•   abstract for symposium (English)
•   article on the feasibility of the study (Dutch)
•   blog post on the feasibility of the study (English)
•   recruitment information for parents and clinicians (Dutch)
•   recruitment text (Dutch)
•   recruitment text (Dutch)
•   recruitment text (Dutch)
•   webpage of the project