Mindfulness Training for Children With ADHD and Mindful Parenting

Karakter Kinder- en Jeugdpsychiatrie1 site in 1 country103 target enrollmentFebruary 18, 2016

ConditionsAttention Deficit Hyperactivity Disorder

Overview

Phase: N/A
Intervention: Not specified
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Karakter Kinder- en Jeugdpsychiatrie
Enrollment: 103
Locations: 1
Primary Endpoint: Change from Baseline in parent-rated self-control of the child
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 18, 2016

End Date

February 22, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karakter Kinder- en Jeugdpsychiatrie

Responsible Party

Sponsor

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) ≥
•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.

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)