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Introduction: 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. Methods and analysis: 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. Discussion: 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.
RESUMO
Outcome measurement in outpatient and day-care mental health facilities for children and adolescents in Spain remains limited, in part due to a lack of validated scales. To address this issue, we translated HoNOSCA (glossary, score sheet, self-rated questionnaire, and parent/legal guardian questionnaire) into Spanish and Catalan using a reverse translation approach. We ascertained the validity and psychometric quality of the HoNOSCA in Spanish by assessing correlation with the Children's Global Assessment Scale (C-GAS). We recruited 64 participants 7-17 years of age in five day-care Psychiatry hospitals in Catalonia (Spain). Two evaluators administered both instruments twice, two weeks apart. Patients and parents/legal guardians completed the corresponding HoNOSCA versions. We calculated Cronbach's alpha for assessing internal consistency, intra-class correlation coefficients (ICC) for inter-rater and test-retest reliability, and Pearson's correlation coefficients for validity. We found that all HoNOSCA versions in Spanish presented satisfactory internal consistency, inter-rater and test-retest reliability. Concurrent validity for HoNOSCA-Glossary was also acceptable, with Pearson's coefficients of -0.543 and -0.519 for evaluators in the first administration, and of -0.675 and -0.685 in the second administration. HoNOSCA was also successfully translated into Catalan; acceptability was determined using cognitive interviews.
