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Clinical Trials/NCT03220308
NCT03220308CompletedNot Applicable

Mindfulness Training for Children With ADHD and Mindful Parenting

Karakter Kinder- en Jeugdpsychiatrie4 sites in 1 country103 target enrollmentStarted: February 18, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
103
Locations
4
Primary Endpoint
Change from Baseline in parent-rated self-control of the child
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 16 Years (Child)
Sex
All
Accepts 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) ≥
  • •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.

Arms & Interventions

Care-as-usual (CAU) only

Other

Care-as-usual for children (8-16 years old) with ADHD

Intervention: Care-as-usual for children (8-16 years old) with ADHD (Other)

Mindfulness for child and parent + CAU

Experimental

MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD

Intervention: MYmind mindfulness training (Other)

Mindfulness for child and parent + CAU

Experimental

MYmind mindfulness training in addition to care-as-usual for children aged 8-16 years with ADHD

Intervention: Care-as-usual for children (8-16 years old) with ADHD (Other)

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 3, 5 and 9 months

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

Secondary Outcomes

  • Change from Baseline in parent-rated quality of life of the child(Baseline, 3 and 9 months)
  • Change from Baseline in teacher-rated self-control of the child(Baseline, 3 and 5 months)
  • Change from Baseline in teacher-rated behaviour problems of the child(Baseline, 3 and 5 months)
  • Change from Baseline in teacher-rated autistic social impairment of the child(Baseline and 3 months)
  • Change from Baseline in self-rated dispositional mindfulness of the child(Baseline, 3, 5 and 9 months)
  • Change from Baseline in self-rated brooding of the child(Baseline, 3 and 9 months)
  • Change from Baseline on the Stop task in the child(Baseline, 3 and 9 months)
  • Change from Baseline on the Probabilistic reversal learning task in the child(Baseline, 3 and 9 months)
  • Change from Baseline on the Temporal discounting task in the child(Baseline, 3 and 9 months)
  • Change from Baseline in self-rated self-control of the parent(Baseline, 3, 5 and 9 months)
  • Change from Baseline in self-rated ADHD traits of the parent(Baseline, 3, 5 and 9 months)
  • Change from Baseline in self-rated mindfulness in parenting of the parent(Baseline, 3, 5 and 9 months)
  • Change from Baseline in self-rated autistic traits of the parent(Baseline, 3 and 9 months)
  • Change from Baseline in self-rated symptoms of depression, anxiety and stress in the parent(Baseline, 3 and 9 months)
  • Change from Baseline in self-rated brooding of the parent(Baseline, 3 and 9 months)
  • Change from Baseline on the Stop task in the parent(Baseline, 3 and 9 months)
  • Change from Baseline on the Probabilistic reversal learning task in the parent(Baseline, 3 and 9 months)
  • Change from Baseline in self-rated emotional well-being, psychological well-being and social well-being of the parent(Baseline, 3 and 9 months)
  • Change from Baseline in self-rated quality of life of the parent(Baseline, 3 and 9 months)
  • Change from Baseline on the Temporal discounting task in the parent(Baseline, 3 and 9 months)
  • Change from Baseline in parent-rated behaviour problems of the child(Baseline, 3, 5 and 9 months)
  • Change from Baseline in parent-rated autistic social impairment of the child(Baseline, 3 and 9 months)

Investigators

Sponsor
Karakter Kinder- en Jeugdpsychiatrie
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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