Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

NCT04316832 | Completed

• 1 other identifier: Phd study ARobe
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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) .

• % 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) .

• % 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 Outcomes (2)

• 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)

• Mood

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

Other Outcomes (2)

• 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

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

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

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

Study Arms (2)

Intervention/treatment

EXPERIMENTAL

The mindfulness based cognitive training will be delivered in one session and will include short mindfulness exercises.

Behavioral: Mindfulness based cognitive training

No intervention

PLACEBO COMPARATOR

Control exercise, participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.

Other: Control exercise

Interventions

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.

Intervention/treatment

Control exercise OTHER

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

No intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Comorbidities of Conduct Disorder, ODD, OCD
• Other chronic diseases
• Previous participation in mindfulness-based training

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

S.C. Rega Med SRL

Cluj-Napoca, 400380, Romania

Location

Related Publications (15)

• 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.

  PMID: 26272488 BACKGROUND

• 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.

  PMID: 28700715 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 19897823 BACKGROUND

• 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.

  PMID: 18278977 BACKGROUND

• 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.

  PMID: 26620873 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23778017 BACKGROUND

• 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.

  PMID: 30685483 BACKGROUND

• 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.

  PMID: 30384420 BACKGROUND

• 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.

  PMID: 31169722 BACKGROUND

• 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.

  PMID: 25733754 BACKGROUND

• 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.

  PMID: 27103462 BACKGROUND

• 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.

  RESULT

• 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.

  PMID: 35608666 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andreea Robe

  UBB

  PRINCIPAL INVESTIGATOR

• Anca Dobrean

  UBB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation will be implemented using a random numbers generator, https://www.random.org/lists/. The allocation ratio will be 1:1.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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)

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 20, 2020
• Study Start: October 30, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)