search
Back to results

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
Babes-Bolyai University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
March 11, 2020
Last Updated
March 1, 2022
Sponsor
Babes-Bolyai University
search

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
Citations:
PubMed Identifier
26272488
Citation
Beauchaine TP, Thayer JF. Heart rate variability as a transdiagnostic biomarker of psychopathology. Int J Psychophysiol. 2015 Nov;98(2 Pt 2):338-350. doi: 10.1016/j.ijpsycho.2015.08.004. Epub 2015 Aug 11.
Results Reference
background
PubMed Identifier
28700715
Citation
Catala-Lopez F, Hutton B, Nunez-Beltran A, Page MJ, Ridao M, Macias Saint-Gerons D, Catala MA, Tabares-Seisdedos R, Moher D. The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: A systematic review with network meta-analyses of randomised trials. PLoS One. 2017 Jul 12;12(7):e0180355. doi: 10.1371/journal.pone.0180355. eCollection 2017.
Results Reference
background
Citation
DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale-IV: Checklists, norms, and clinical interpretation. Guilford Press.
Results Reference
background
PubMed Identifier
19897823
Citation
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
Results Reference
background
PubMed Identifier
18278977
Citation
Graham J, Coghill D. Adverse effects of pharmacotherapies for attention-deficit hyperactivity disorder: epidemiology, prevention and management. CNS Drugs. 2008;22(3):213-37. doi: 10.2165/00023210-200822030-00003.
Results Reference
background
PubMed Identifier
26620873
Citation
Hall CL, Valentine AZ, Groom MJ, Walker GM, Sayal K, Daley D, Hollis C. The clinical utility of the continuous performance test and objective measures of activity for diagnosing and monitoring ADHD in children: a systematic review. Eur Child Adolesc Psychiatry. 2016 Jul;25(7):677-99. doi: 10.1007/s00787-015-0798-x. Epub 2015 Nov 30.
Results Reference
background
Citation
Howarth, A., Smith, J. G., Perkins-Porras, L., & Ussher, M. (2019). Effects of Brief Mindfulness-Based Interventions on Health-Related Outcomes: A Systematic Review. 10, 1957-1958. https://doi.org/10.1007/s12671-019-01163-1
Results Reference
background
PubMed Identifier
23778017
Citation
Kramer RS, Weger UW, Sharma D. The effect of mindfulness meditation on time perception. Conscious Cogn. 2013 Sep;22(3):846-52. doi: 10.1016/j.concog.2013.05.008. Epub 2013 Jun 15.
Results Reference
background
PubMed Identifier
30685483
Citation
Robe A, Dobrean A, Cristea IA, Pasarelu CR, Predescu E. Attention-deficit/hyperactivity disorder and task-related heart rate variability: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2019 Apr;99:11-22. doi: 10.1016/j.neubiorev.2019.01.022. Epub 2019 Jan 24.
Results Reference
background
PubMed Identifier
30384420
Citation
Zou L, Sasaki JE, Wei GX, Huang T, Yeung AS, Neto OB, Chen KW, Hui SS. Effects of Mind(-)Body Exercises (Tai Chi/Yoga) on Heart Rate Variability Parameters and Perceived Stress: A Systematic Review with Meta-Analysis of Randomized Controlled Trials. J Clin Med. 2018 Oct 31;7(11):404. doi: 10.3390/jcm7110404.
Results Reference
background
PubMed Identifier
31169722
Citation
Xue J, Zhang Y, Huang Y. A meta-analytic investigation of the impact of mindfulness-based interventions on ADHD symptoms. Medicine (Baltimore). 2019 Jun;98(23):e15957. doi: 10.1097/MD.0000000000015957.
Results Reference
background
PubMed Identifier
25733754
Citation
Thomas R, Sanders S, Doust J, Beller E, Glasziou P. Prevalence of attention-deficit/hyperactivity disorder: a systematic review and meta-analysis. Pediatrics. 2015 Apr;135(4):e994-1001. doi: 10.1542/peds.2014-3482. Epub 2015 Mar 2.
Results Reference
background
PubMed Identifier
27103462
Citation
Shim SH, Yoon HJ, Bak J, Hahn SW, Kim YK. Clinical and neurobiological factors in the management of treatment refractory attention-deficit hyperactivity disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Oct 3;70:237-44. doi: 10.1016/j.pnpbp.2016.04.007. Epub 2016 Apr 19.
Results Reference
background
Citation
Achenbach, T. M., & Rescorla, L. A. (2004). The Achenbach System of Empirically Based Assessment (ASEBA) for Ages 1.5 to 18 Years. In The use of psychological testing for treatment planning and outcomes assessment: Instruments for children and adolescents, Volume 2, 3rd ed. (pp. 179-213). Lawrence Erlbaum Associates Publishers.
Results Reference
result
PubMed Identifier
35608666
Citation
Robe A, Dobrean A. The effectiveness of a single session of mindfulness-based cognitive training on cardiac vagal control and core symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD): a preliminary randomized controlled trial. Eur Child Adolesc Psychiatry. 2023 Oct;32(10):1863-1872. doi: 10.1007/s00787-022-02005-7. Epub 2022 May 24.
Results Reference
derived

Learn more about this trial

Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

We'll reach out to this number within 24 hrs