Clinical trial NCT03220308: Mindfulness Training for Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and Mindful Parenting
Official title: Mindfulness Training for Children With ADHD and Mindful Parenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Self-control
Well-being
Lead sponsor: Karakter Kinder- en Jeugdpsychiatrie
Sponsor class: OTHER
Collaborators: name: Fonds Psychische Gezondheid
name: European Commission
name: UvA minds
name: Radboud University Medical Center
name: University of Amsterdam
First posted: 2017-07-18
Enrollment: 103
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in parent-rated self-control of the child
timeFrame: Baseline, 3, 5 and 9 months
Secondary outcomes:
measure: Change from Baseline in parent-rated behaviour problems of the child
timeFrame: Baseline, 3, 5 and 9 months
measure: Change from Baseline in parent-rated autistic social impairment of the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in parent-rated quality of life of the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in teacher-rated self-control of the child
timeFrame: Baseline, 3 and 5 months
measure: Change from Baseline in teacher-rated behaviour problems of the child
timeFrame: Baseline, 3 and 5 months
measure: Change from Baseline in teacher-rated autistic social impairment of the child
timeFrame: Baseline and 3 months
measure: Change from Baseline in self-rated dispositional mindfulness of the child
timeFrame: Baseline, 3, 5 and 9 months
measure: Change from Baseline in self-rated brooding of the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Stop task in the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Probabilistic reversal learning task in the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Temporal discounting task in the child
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in self-rated self-control of the parent
timeFrame: Baseline, 3, 5 and 9 months
measure: Change from Baseline in self-rated ADHD traits of the parent
timeFrame: Baseline, 3, 5 and 9 months
measure: Change from Baseline in self-rated mindfulness in parenting of the parent
timeFrame: Baseline, 3, 5 and 9 months
measure: Change from Baseline in self-rated autistic traits of the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in self-rated emotional well-being, psychological well-being and social well-being of the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in self-rated quality of life of the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline in self-rated brooding of the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Stop task in the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Probabilistic reversal learning task in the parent
timeFrame: Baseline, 3 and 9 months
measure: Change from Baseline on the Temporal discounting task in the parent
timeFrame: Baseline, 3 and 9 months
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
state: Gelderland
city: Ede
country: Netherlands
facility: Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Karakter, Expertisecentrum voor kinder- en jeugdpsychiatrie
state: Gelderland
Study officials:
affiliation: Karakter Kinder- en Jeugdpsychiatrie
name: Jan K Buitelaar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.