Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

NCT ID: NCT04316832

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-07-30

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention/treatment

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

Group Type: EXPERIMENTAL

Mindfulness based cognitive training

Intervention Type: 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.

No intervention

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

Group Type: PLACEBO_COMPARATOR

Control exercise

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

Control exercise

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Babes-Bolyai University

OTHER

Sponsor Role: lead

Responsible Party

Andeea Robe

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreea Robe

Role: PRINCIPAL_INVESTIGATOR

UBB

Anca Dobrean

Role: STUDY_DIRECTOR

UBB

Locations

S.C. Rega Med SRL

Cluj-Napoca, , Romania

Countries

Romania

References

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Reference Type: 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.

Reference Type: DERIVED

PMID: 35608666 (View on PubMed)

Other Identifiers

Phd study ARobe

Identifier Type: -

Identifier Source: org_study_id