Clinical trial NCT04316832: Mindfulness Based Cognitive Training in Children and Adolescents With ADHD
Official title: A Randomized-Controlled Trial: the Effectiveness of a Single-session of Mindfulness Based Cognitive Training on CVC and Core Symptoms in Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
mindfulness based cognitive training
cardiac vagal control
children and adolescents
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a two-arm, randomized controlled trial exploring whether a single-session of MBIs could improve task-related scores of attention, mood and CVC in children and adolescents with ADHD/ADD referred to a Romanian Child and Adolescent Psychiatric Unit. Outcomes assessment will be conducted at baseline, immediately after the session of training (T1) and 4 weeks after the intervention (T2)
Primary purpose: TREATMENT

Brief summary: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders, with a pooled worldwide prevalence of 7.2% among children. Although medication and behavioral therapy, have been shown to be effective for reducing core symptoms, about 30% of patients with ADHD would not achieve the treatment response and symptomatic remission. Additionally, some children can experience sides effects related to medication. Therefore, other psychological approaches such as Mindfulness based interventions (MBIs) have been designed for the management of ADHD.

Recent research showed that ADHD is associated with autonomic nervous system dysregulation, characterized by reduced vagally mediated-HRV, in response to a task demand. HRV is an accurate, non-invasive, cost-effective quantitative biomarker of autonomic nervous system (ANS) activity. There is evidence that MBIs could significantly reduce ADHD core symptoms and may enhance HRV through increased parasympathetic modulation. No studies have jointly examined the differential effect of MBIs on ADHD core symptoms, task related-HRV and mood.

The aim of this study is to assess the effectiveness of a single-session of mindfulness based cognitive training on CVC, core symptoms and mood in children and adolescents with ADHD, aged 6 y-17y, referred to an outpatient Romanian Child and Adolescent Psychiatric Unit by mental health professionals, teachers and/or parents.

Detailed description: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders, with a pooled worldwide prevalence of 7.2% among children. Children/adolescents with ADHD face significant disease burden; they experience poorer academic achievement and attainment, higher rates of risky sexual practices and early unwanted pregnancies, increase risk of substance use and relationship difficulties. Although medication and behavioral therapy, particularly given by parents and with active child and teacher involvement, have been shown to be effective for reducing core symptoms, about 30% of patients with ADHD would not achieve the treatment response and symptomatic remission. Additionally, some children can experience sides effects related to medication such as sleep problem or weight loss. Therefore, other psychological approaches such as Mindfulness based interventions (MBIs), have been designed for the management of ADHD.

Heart rate variability (HRV) represents the oscillation in time between successive heartbeats, and it can be evaluated by time- and frequency-domain measures. Recent research showed that ADHD is associated with autonomic nervous system dysregulation, characterized by reduced vagally mediated-HRV, in response to a task demand. HRV is an accurate, non-invasive, cost-effective quantitative biomarker of autonomic nervous system (ANS) activity.

Over the years, research has cumulated for supporting the use of mindfulness for various clinical health conditions. There is evidence that MBIs could significantly reduce ADHD core symptoms and may enhance HRV through increased parasympathetic modulation.

Although emerging research has shown that mindfulness has led to improvements in the core symptoms of ADHD, most of the research in this area involves extensive multi week trainings; there is limited research evaluating brief mindfulness programs in the context. Therefore, the aim of this study is to assess the effectiveness of a single-session of mindfulness based cognitive training on CVC, core symptoms and mood in children and adolescents with ADHD, aged 6 y-17y.

Eligibility criteria: Inclusion Criteria:

* Confirmed clinical diagnosis of ADHD
* Able to verbally communicate and write in Romanian.
* Normal intellectual ability.
* Not taking any medication/No change in ADHD specific medication(dose/type) or psychological intervention within 3 months of trial onset.

Exclusion Criteria:

* Comorbidities of Conduct Disorder, ODD, OCD
* Other chronic diseases
* Previous participation in mindfulness-based training

Primary outcomes:
measure: Reaction time (RT) to correct responses during a computerized Continuous performance tests (CPTs)
timeFrame: Change from baseline RT (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
measure: % Omission errors (OR) during a computerized Continuous performance tests (CPTs)
timeFrame: Change from baseline OR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
measure: % Commission errors (CR) during a computerized Continuous performance tests (CPTs)
timeFrame: Change from baseline CR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
Secondary outcomes:
measure: Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)
timeFrame: Change from baseline CVC (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)
measure: Mood
timeFrame: Change from baseline mood (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)
Other outcomes:
measure: The empirically based syndromes scales of the Child Behavioral Checklist (CBCL): Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems,Thought Problems, Attention Problems, Rule Breaking Behavior, Aggressive Behavior
timeFrame: Changes in time from baseline (time 0) at 4 weeks after the intervention '(time 2).
measure: Inattention (IA) subscale raw score and Hyperactivity- Impulsivity (HI) subscale raw score
timeFrame: Changes in time IA and HI subscale from baseline (time 0) at 4 weeks after the intervention (time 2)
Locations:
city: Cluj Napoca
country: Romania
facility: S.C. Rega Med SRL
Study officials:
affiliation: UBB
name: Andreea Robe
role: PRINCIPAL_INVESTIGATOR
affiliation: UBB
name: Anca Dobrean
role: STUDY_DIRECTOR
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