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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• ADHD

• NCT number: NCT04316832
• Study type: Interventional
• Source: Babes-Bolyai University
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Completion date: July 30, 2021