Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Self-control, Well-being
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.
Interventions
OTHERMYmind 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.
OTHERCare-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).
Sponsors
Radboud University Medical Center
Fonds Psychische Gezondheid
European Commission
UvA minds
University of Amsterdam
Karakter Kinder- en Jeugdpsychiatrie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in parent-rated self-control of the child | Baseline, 3, 5 and 9 months | Behaviour Rating Inventory of Executive Function, parent-report (BRIEF-P) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in parent-rated autistic social impairment of the child | Baseline, 3 and 9 months | Social Responsiveness Scale, parent-report (SRS-P) |
| Change from Baseline in parent-rated quality of life of the child | Baseline, 3 and 9 months | KIDSCREEN-10, parent-report |
| Change from Baseline in teacher-rated self-control of the child | Baseline, 3 and 5 months | Behaviour Rating Inventory of Executive Function, teacher-report (BRIEF-T) |
| Change from Baseline in teacher-rated behaviour problems of the child | 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 |
| Change from Baseline in teacher-rated autistic social impairment of the child | Baseline and 3 months | Social Responsiveness Scale, teacher-report (SRS-T) |
| Change from Baseline in self-rated dispositional mindfulness of the child | Baseline, 3, 5 and 9 months | Child and Adolescent Mindfulness Measure (CAMM), self-report |
| Change from Baseline in self-rated brooding of the child | Baseline, 3 and 9 months | Ruminative Response Scale (RRS), subscale: brooding, self-report |
| Change from Baseline on the Stop task in the child | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the child |
| Change from Baseline on the Probabilistic reversal learning task in the child | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the child |
| Change from Baseline on the Temporal discounting task in the child | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the child |
| Change from Baseline in parent-rated behaviour problems of the child | 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 |
| Change from Baseline in self-rated ADHD traits of the parent | Baseline, 3, 5 and 9 months | DSM-5 based ADHD traits, self-report |
| Change from Baseline in self-rated mindfulness in parenting of the parent | Baseline, 3, 5 and 9 months | Interpersonal Mindfulness in Parenting Scale (IM-P), self-report |
| Change from Baseline in self-rated autistic traits of the parent | Baseline, 3 and 9 months | 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 | Baseline, 3 and 9 months | 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 | Baseline, 3 and 9 months | Mental Health Continuum-Short Form (MHC-SF), self-report |
| Change from Baseline in self-rated quality of life of the parent | Baseline, 3 and 9 months | World Health Organization-Five Well-Being Index (WHO-5), self-report |
| Change from Baseline in self-rated brooding of the parent | Baseline, 3 and 9 months | Ruminative Response Scale (RRS), subscale: brooding, self-report |
| Change from Baseline on the Stop task in the parent | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the parent |
| Change from Baseline on the Probabilistic reversal learning task in the parent | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the parent |
| Change from Baseline on the Temporal discounting task in the parent | Baseline, 3 and 9 months | Computer based neurocognitive assessments of self-control in the parent |
| Change from Baseline in self-rated self-control of the parent | Baseline, 3, 5 and 9 months | Behaviour Rating Inventory of Executive Function, self-report (BRIEF-A) |
Countries
Netherlands
Outcome results
None listed