NCT05937347

Mindfulness and Cognitive Training Programs for Children with ADHD (the NeuroMind Study)

Mindfulness and Cognitive Training Programs for Children with Attention Deficit Hyperactivity Disorder (ADHD): a Randomized, Controlled Trial (the NeuroMind Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The present project will evaluate through a Randomized Controlled Trial (RCT) with 5-month follow-up, the efficacy (5-month time horizon), adjunctive to TAU, of three 8-week interventions: a) the Mindfulness for Health program (i. e., M4H), b) a Cognitive Training (CT) program through NeuronUp platform and a program combining both (Mindfulness and Cognitive Training program, i. e., UP4H), a, as compared to TAU, in children (7-12 years old) with ADHD. In order to evaluate stability of clinical changes and to determine the mechanisms of action of the interventions studied, pre-post changes and at 5-months followup after the start of treatment will be evaluated in ADHD symptoms (inattention, hyperactivity, impulsivity), general functioning, clinical global impression, executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), and comorbid symptoms (disruptive behavior, anxiety and depression) along with mindfulness skills. In the field of personalized treatment in ADHD, the design of the present study will also make it possible to establish whether certain baseline psychosocial and clinical characteristics may be associated with short- and medium-term clinical response to each of the treatments studied.

Detailed description

Introduction: The NeuroMind study is aimed at assessing the efficacy of 3 interventions based on Mindfulness and/or Cognitive Training programs: a Mindfulness and Cognitive Training program (i. e., UP4H), a Mindfulness program (i. e., M4H) and a Cognitive Training program (i. e. CT). This study will evaluate the short- and mid-time efficacy of these 3 interventions for the first time in children with ADHD. The objectives of this 5-month RCT, are (i) to examine the efficacy of adding UP4H, M4H or CT to treatment-as-usual (TAU) for children (7-12 years old) with ADHD; (ii) to identify pre-post differences in ADHD symptoms (inattention, hyperactivity, impulsivity), in executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), and in comorbid symptoms (disruptive behavior, anxiety and depression) in the four study arms and (iii) to analyze the role of the mindful attention awareness as a psychological process variable mediator of 5-month clinical outcomes. Methods and analysis: Participants will be 120 children with ADHD (7-12 years old) recruited at CSMIJ Sant Joan de Déu Terres de Lleida (Lleida, Spain), randomly allocated to one of the four study arms: TAU vs TAU+CT vs TAU+M4H vs TAU+UP4H. A comprehensive assessment to collect ADHD symptoms (inattention, hyperactivity, impulsivity), executive functions (verbal fluency, working memory, cognitive flexibility, inhibition), comorbid symptoms (disruptive behavior, anxiety and depression), mindful attention awareness, general functioning and clinical global impression will be conducted pre-intervention, post-intervention (8 weeks), and at 5-month follow-up. Linear mixed-effects model analyses, mediation analysis and sensitivity analyses will be conducted on the basis of intention-to-treat approach and according to whether the patients are completers, or whether they completed the majority of the sessions (75% attendance).

Conditions

• ADHD

Interventions

Type	Name	Description
BEHAVIORAL	TAU + UP4H	Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).
BEHAVIORAL	TAU + M4H	Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).
BEHAVIORAL	TAU + CT	Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).
OTHER	Treatment as Usual (TAU)	Standard pharmacological treatment usually provided to children with ADHD.

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-03-22
• Completion: 2024-07-26
• First posted: 2023-07-10
• Last updated: 2024-12-13

Locations

1 site across 1 country: Spain