Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study).
Tania Badia-Aguarón, Estíbaliz Royuela-Colomer, Vanessa Pera-Guardiola, Pere Vergés-balasch, Ausiàs Cebolla, Juan V Luciano, Joaquim Soler, Albert Feliu-Soler, Anna Huguet Miguel
Frontiers in Psychology 2024 DOI: 10.3389/fpsyg.2024.1291198 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 120 |
| Population | Children aged 7 to 12 years with ADHD recruited at a Child and Adolescent Mental Health Service in Spain |
| Interventions | Mindfulness for Health Mindfulness Cognitive Training |
| Duration | 5-month intervention and follow-up |
| Topics | Meditation |
| Keywords | ADHD Children Cognitive training Effectiveness Executive functions Feasibility Randomized controlled trial |
| Citations | 1 |
| Registration | NCT05937347 |
| Key findings | The study will evaluate whether adding Mindfulness for Health, cognitive training, or their combination to treatment-as-usual is effective and feasible for children with ADHD. |
Abstract
Attention Deficit Hyperactivity Disorder (ADHD) has a global mean prevalence of 5%. Cognitive Training (CT) and Mindfulness-Based Interventions (MBIs) have shown promising results in managing ADHD symptoms, but they are not its Treatment-As-Usual (TAU). The NeuroMind Study aims to evaluate the preliminary effectiveness and feasibility of three interventions: Mindfulness for Health (M4H), CT using the NeuronUP® platform (CT), and a combination of both, Mindfulness Cognitive Training (MCT). There is empirical evidence supporting the effectiveness of the M4H and NeuronUP® platform; however, this study explores for the first time the effectiveness of MCT and CT, as well as the integration of M4H into TAU. The objectives of this 5-month Randomized Controlled Trial (RCT) are: (1) To analyze the preliminary effectiveness and feasibility of M4H, CT or a combination of both (MCT) added to TAU for children with ADHD; (2) To evaluate the role of psychological process variables (mindfulness and emotional regulation) as mediators of 5-month follow-up clinical outcomes; (3) To preliminarily explore whether specific sociodemographic and clinical characteristics can predict the short-and medium-term clinical response to the specific treatments. Participants will be 120 children (7 to 12 years) with ADHD recruited at Child and Adolescent Mental Health Service (CAMHS) Sant Joan de Déu Terres de Lleida (Spain) randomly allocated to one of the four study arms: TAU vs. TAU + CT vs. TAU + M4H vs. TAU + MCT. An assessment to collect ADHD symptoms, Executive Functions (EF), comorbid symptoms and global functioning will be conducted pre-intervention, post-intervention (2 months after baseline) and at the 5-month follow-up. Linear mixed models and mediational models will be computed. If the preliminary effectiveness and feasibility of the MCT are demonstrated, this study could be a preliminary basis to do a full RCT with a larger sample to definitively validate the intervention. The MCT could be applied in clinical practice if it is definitively validated.Clinical trial registration:ClinicalTrials.gov, identifier, NCT05937347. https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 18
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
- Research Review: The effects of mindfulness‐based interventions on cognition and mental health in children and adolescents – a meta‐analysis of randomized controlled trials Journal of Child Psychology and Psychiatry October 22, 2018
- Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry January 1, 2023
- The Reliability of Rating via Audio-Recording Using the Mindfulness-Based Interventions: Teaching Assessment Criteria. Global Advances in Integrative Medicine and Health 2023
- Effects of Mindfulness-Based Interventions in Children and Adolescents with ADHD: A Systematic Review and Meta-Analysis of Randomized Controlled Trials International Journal of Environmental Research and Public Health November 1, 2022
and 13 more in the library