Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study)
IntroductionAttention 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 evalua...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-02-01
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| Series: | Frontiers in Psychology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyg.2024.1291198/full |
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| author | Tania Badia-Aguarón Estíbaliz Royuela-Colomer Estíbaliz Royuela-Colomer Vanessa Pera-Guardiola Vanessa Pera-Guardiola Vanessa Pera-Guardiola Pere Vergés-Balasch Ausiàs Cebolla Ausiàs Cebolla Juan V. Luciano Juan V. Luciano Juan V. Luciano Joaquim Soler Joaquim Soler Joaquim Soler Albert Feliu-Soler Albert Feliu-Soler Albert Feliu-Soler Anna Huguet Miguel Anna Huguet Miguel Anna Huguet Miguel |
| author_facet | Tania Badia-Aguarón Estíbaliz Royuela-Colomer Estíbaliz Royuela-Colomer Vanessa Pera-Guardiola Vanessa Pera-Guardiola Vanessa Pera-Guardiola Pere Vergés-Balasch Ausiàs Cebolla Ausiàs Cebolla Juan V. Luciano Juan V. Luciano Juan V. Luciano Joaquim Soler Joaquim Soler Joaquim Soler Albert Feliu-Soler Albert Feliu-Soler Albert Feliu-Soler Anna Huguet Miguel Anna Huguet Miguel Anna Huguet Miguel |
| author_sort | Tania Badia-Aguarón |
| collection | DOAJ |
| description | IntroductionAttention 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.Methods and analysisParticipants 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.DiscussionIf 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. |
| first_indexed | 2024-03-08T05:12:17Z |
| format | Article |
| id | doaj.art-92a9913de957448a8d818f0a35bc4926 |
| institution | Directory Open Access Journal |
| issn | 1664-1078 |
| language | English |
| last_indexed | 2024-03-08T05:12:17Z |
| publishDate | 2024-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychology |
| spelling | doaj.art-92a9913de957448a8d818f0a35bc49262024-02-07T05:34:27ZengFrontiers Media S.A.Frontiers in Psychology1664-10782024-02-011510.3389/fpsyg.2024.12911981291198Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study)Tania Badia-Aguarón0Estíbaliz Royuela-Colomer1Estíbaliz Royuela-Colomer2Vanessa Pera-Guardiola3Vanessa Pera-Guardiola4Vanessa Pera-Guardiola5Pere Vergés-Balasch6Ausiàs Cebolla7Ausiàs Cebolla8Juan V. Luciano9Juan V. Luciano10Juan V. Luciano11Joaquim Soler12Joaquim Soler13Joaquim Soler14Albert Feliu-Soler15Albert Feliu-Soler16Albert Feliu-Soler17Anna Huguet Miguel18Anna Huguet Miguel19Anna Huguet Miguel20Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, SpainPsychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, SpainCIBER of Epidemiology and Public Health (CIBERESP), Madrid, SpainChild and Adolescent Mental Health Service Sant Joan de Déu Terres de Lleida, Lleida, SpainDepartment of Psychology, University of Lleida, Lleida, SpainInstitut de Recerca Biomèdica de Lleida, Lleida, SpainChild and Adolescent Mental Health Service Sant Joan de Déu Terres de Lleida, Lleida, SpainDepartment of Personality, Assessment and Psychological Treatments, University of Valencia, Valencia, SpainCIBER of Obesity and Nutrition (CIBEROBN), Madrid, SpainPsychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, SpainCIBER of Epidemiology and Public Health (CIBERESP), Madrid, SpainDepartment of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain0Servei de Psiquiatria, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain1Department of Psychiatry and Forensic Medicine, Autonomous University of Barcelona, Barcelona, Spain2CIBER of Mental Health (CIBERSAM), Madrid, SpainPsychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, SpainCIBER of Epidemiology and Public Health (CIBERESP), Madrid, SpainDepartment of Clinical and Health Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, SpainChild and Adolescent Mental Health Service Sant Joan de Déu Terres de Lleida, Lleida, Spain3Department of Medicine, University of Lleida, Lleida, Spain4Sant Joan de Déu Research Institute (IRSJD), Esplugues de Llobregat, SpainIntroductionAttention 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.Methods and analysisParticipants 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.DiscussionIf 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.https://www.frontiersin.org/articles/10.3389/fpsyg.2024.1291198/fullADHDchildrenexecutive functionsmindfulnesscognitive trainingrandomized controlled trial |
| spellingShingle | Tania Badia-Aguarón Estíbaliz Royuela-Colomer Estíbaliz Royuela-Colomer Vanessa Pera-Guardiola Vanessa Pera-Guardiola Vanessa Pera-Guardiola Pere Vergés-Balasch Ausiàs Cebolla Ausiàs Cebolla Juan V. Luciano Juan V. Luciano Juan V. Luciano Joaquim Soler Joaquim Soler Joaquim Soler Albert Feliu-Soler Albert Feliu-Soler Albert Feliu-Soler Anna Huguet Miguel Anna Huguet Miguel Anna Huguet Miguel Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) Frontiers in Psychology ADHD children executive functions mindfulness cognitive training randomized controlled trial |
| title | Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) |
| title_full | Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) |
| title_fullStr | Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) |
| title_full_unstemmed | Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) |
| title_short | Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study) |
| title_sort | combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder study protocol of a pilot randomized controlled trial the neuromind study |
| topic | ADHD children executive functions mindfulness cognitive training randomized controlled trial |
| url | https://www.frontiersin.org/articles/10.3389/fpsyg.2024.1291198/full |
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