Mindfulness Based Cognitive Training in Children and Adolescents With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    

Intervention name(s): Mindfulness based cognitive training; Control exercise
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; Participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; mindfulness based cognitive training; cardiac vagal control; children and adolescents