Mindfulness Based Cognitive Training in Children and Adolescents With ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Mindfulness based cognitive training
Control exercise
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, mindfulness based cognitive training, cardiac vagal control, children and adolescents
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
Sites / Locations
- S.C. Rega Med SRL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention/treatment
No intervention
Arm Description
The mindfulness based cognitive training will be delivered in one session and will include short mindfulness exercises.
Control exercise, participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.
Outcomes
Primary Outcome Measures
Reaction time (RT) to correct responses during a computerized Continuous performance tests (CPTs)
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.
% Omission errors (OR) during a computerized Continuous performance tests (CPTs)
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.
% Commission errors (CR) during a computerized Continuous performance tests (CPTs)
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 Outcome Measures
Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)
The oscillation in time between successive heartbeats.
Mood
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04316832
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Babes-Bolyai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, mindfulness based cognitive training, cardiac vagal control, children and adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomisation will be implemented using a random numbers generator, https://www.random.org/lists/. The allocation ratio will be 1:1.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention/treatment
Arm Type
Experimental
Arm Description
The mindfulness based cognitive training will be delivered in one session and will include short mindfulness exercises.
Arm Title
No intervention
Arm Type
Placebo Comparator
Arm Description
Control exercise, participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based cognitive training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control exercise
Intervention Description
Participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.
Primary Outcome Measure Information:
Title
Reaction time (RT) to correct responses during a computerized Continuous performance tests (CPTs)
Description
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.
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) .
Title
% Omission errors (OR) during a computerized Continuous performance tests (CPTs)
Description
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.
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) .
Title
% Commission errors (CR) during a computerized Continuous performance tests (CPTs)
Description
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.
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) .
Secondary Outcome Measure Information:
Title
Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)
Description
The oscillation in time between successive heartbeats.
Time Frame
Change from baseline CVC (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)
Title
Mood
Description
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.
Time Frame
Change from baseline mood (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)
Other Pre-specified Outcome Measures:
Title
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
Description
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).
Time Frame
Changes in time from baseline (time 0) at 4 weeks after the intervention '(time 2).
Title
Inattention (IA) subscale raw score and Hyperactivity- Impulsivity (HI) subscale raw score
Description
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".
Time Frame
Changes in time IA and HI subscale from baseline (time 0) at 4 weeks after the intervention (time 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea Robe
Organizational Affiliation
UBB
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anca Dobrean
Organizational Affiliation
UBB
Official's Role
Study Director
Facility Information:
Facility Name
S.C. Rega Med SRL
City
Cluj Napoca
ZIP/Postal Code
400380
Country
Romania
12. IPD Sharing Statement
Plan to Share IPD
No
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Mindfulness Based Cognitive Training in Children and Adolescents With ADHD
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