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

N/ACompletedNCT03220308

Karakter Kinder- en Jeugdpsychiatrie103 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Attention Deficit Hyperactivity Disorder

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.

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).

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (3)

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, Netherlands

Outcomes

Primary Outcomes

Change from Baseline in parent-rated self-control of the child

Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P)

Time frame: Baseline, 3, 5 and 9 months

Secondary Outcomes

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

Time frame: 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)

Time frame: Baseline, 3 and 9 months

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

KIDSCREEN-10, parent-report

Time frame: 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)

Time frame: 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

Time frame: Baseline, 3 and 5 months

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

Data from ClinicalTrials.gov

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