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NCT Number: NCT04316832

Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

S.C. Rega Med SRL

Cluj-Napoca, 400380, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness based cognitive training

Behavioral

The mindfulness based cognitive training will include three short mindfulness exercises: a) a breathing exercise, b) a body scan exercise, and c) a mindfulness attention exercise.

Control Exercise

Other

Participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.

Primary outcomes

  1. Reaction time (RT) to correct responses during a computerized Continuous performance tests (CPTs)

    Time frame: Change from baseline RT (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .

    A non-x CPT task in wich the subjects must press the space bar for any letter but X. The RT measures the amount of time between the presentation of the stimulus and the client's response.

  2. % Omission errors (OR) during a computerized Continuous performance tests (CPTs)

    Time frame: Change from baseline OR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .

    A non-x CPT task in wich the subjects must press the space bar for any letter but X. The OR indicates the number of times the target was presented, but the client did not respond/click the mouse.

  3. % Commission errors (CR) during a computerized Continuous performance tests (CPTs)

    Time frame: Change from baseline CR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .

    A non-x CPT task in wich the subjects must press the space bar for any letter but X. The score of CR indicates the number of times the client responded but no target was presented.

Secondary outcomes

  1. Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)

    Time frame: Change from baseline CVC (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)

    The oscillation in time between successive heartbeats.

  2. Mood

    Time frame: Change from baseline mood (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)

    Mood will be evaluated through a 4 basic emotions, using a Visual Analogue Scale (VAS) (e.g., To what extent are you experiencing anxiety, sadness, anger or worry at this moment?'). A 10 cm (100 mm) horizontal line with verbal descriptors at each side of the line to express the extremes of the feeling (e.g., 'not at all' versus 'very much') will be used.

Other outcomes

  1. 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

    Time frame: Changes in time from baseline (time 0) at 4 weeks after the intervention '(time 2).

    Child Behavioral Checklist for Ages 6-18, (Achenbach & Rescorla, 2004) is The Child Behavior Checklist (CBCL) is a checklist parents complete to detect emotional and behavioural problems in children and adolescents. It consists of 113 questions, scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often).

  2. Inattention (IA) subscale raw score and Hyperactivity- Impulsivity (HI) subscale raw score

    Time frame: Changes in time IA and HI subscale from baseline (time 0) at 4 weeks after the intervention (time 2)

    ADHD Rating Scale-IV: Parent Version; is a 18-questions questionnaire in which the parents rate the the frequency of a specific behavior related to innatention or hyperactivity-impulsivity using one of the following "always or very often", "often", "somewhat", or "rarely or never".

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 20, 2020
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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