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Mindfulness Based Cognitive Training in Children and Adolescents With ADHD

NCT04316832 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-03-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Babes-Bolyai University

    lead OTHER

Principal Investigators

  • Andreea Robe · UBB

  • Anca Dobrean · UBB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2021-05-30
Completion
2021-07-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316832 on ClinicalTrials.gov