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Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04316832
Enrollment
70
Registered
2020-03-20
Start date
2020-10-30
Completion date
2021-07-30
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD

Keywords

ADHD, mindfulness based cognitive training, cardiac vagal control, children and adolescents

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.

Interventions

BEHAVIORALMindfulness based cognitive training

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.

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

Sponsors

Babes-Bolyai University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomisation will be implemented using a random numbers generator, https://www.random.org/lists/. The allocation ratio will be 1:1.

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)

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
% Omission errors (OR) during a computerized Continuous performance tests (CPTs)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.
Reaction time (RT) to correct responses during a computerized Continuous performance tests (CPTs)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.
% Commission errors (CR) during a computerized Continuous performance tests (CPTs)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

MeasureTime frameDescription
MoodChange 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.
Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)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.

Other

MeasureTime frameDescription
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 BehaviorChanges 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).
Inattention (IA) subscale raw score and Hyperactivity- Impulsivity (HI) subscale raw scoreChanges 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.

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026