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

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness Training for Children With ADHD and Mindful Parenting

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: MYmind mindfulness training
* Other: Care-as-usual for children (8-16 years old) with ADHD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Care-as-usual (CAU) only<br>Care-as-usual for children (8-16 years old) with ADHD | Other: Care-as-usual for children (8-16 years old) with ADHD<br>* 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).<br>|
| Experimental: Mindfulness for child and parent + CAU<br>MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD | Other: MYmind mindfulness training<br>* 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.<br>* Other names: Mindfulness for children with ADHD and mindful parenting;Other: Care-as-usual for children (8-16 years old) with ADHD<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-control, Well-being