Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316832
• Other study ID #: Phd study ARobe
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2022
• Source: Babes-Bolyai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Mindfulness 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.

Other:
• Control exercise
Participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.

Locations

Country	Name	City	State
Romania	S.C. Rega Med SRL	Cluj Napoca

Sponsors (1)

Lead Sponsor	Collaborator
Babes-Bolyai University

Country where clinical trial is conducted

Romania, 

References & Publications (14)

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

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. Review. — View Citation

Catalá-López F, Hutton B, Núñez-Beltrán A, Page MJ, Ridao M, Macías Saint-Gerons D, Catalá MA, Tabarés-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. — View Citation

DuPaul, G. J., Power, T. J., Anastopoulos, A. D., & Reid, R. (1998). ADHD Rating Scale-IV: Checklists, norms, and clinical interpretation. Guilford Press.

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. — View 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. Review. — View 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. Review. — View 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

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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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). pii: E404. doi: 10.3390/jcm7110404. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	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).	Changes in time from baseline (time 0) at 4 weeks after the intervention '(time 2).
Other	Inattention (IA) subscale raw score and Hyperactivity- Impulsivity (HI) subscale raw score	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".	Changes in time IA and HI subscale from baseline (time 0) at 4 weeks after the intervention (time 2)
Primary	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.	Change from baseline RT (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
Primary	% 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.	Change from baseline OR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
Primary	% 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.	Change from baseline CR (time 0) at immediately after the intervention (time 1) and after additional 4 weeks after the intervention (time 2) .
Secondary	Vagally mediated heart rate variability (HRV)= Cardiac Vagal Control (CVC)	The oscillation in time between successive heartbeats.	Change from baseline CVC (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)
Secondary	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.	Change from baseline mood (time 0) at immediately after the intervention (time 1) and after additional 4 weeks (time 2)