An interventional study of TAU + UP4H and TAU + M4H in ADHD, sponsored by Fundació Sant Joan de Déu. Completed at 1 site in Spain. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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.
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).
1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's enrollment of 122 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Fundació Sant Joan de Déu is the lead sponsor of 70 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training.
Behavioral: TAU + UP4H
M4H is a face-to-face non-pharmacological program based on Mindfulness Training.
Behavioral: TAU + M4H
CT is a virtual non-pharmacological program based on Cognitive Training.
Behavioral: TAU + CT
Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child.
Other: Treatment as Usual (TAU)
Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).
Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).
Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).
Standard pharmacological treatment usually provided to children with ADHD.
ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners' Parent Rating Scale-Revised (CPRS-R) Short form
Time frame: Change from baseline values at 5 months
ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners Continuous Performance Test 3rd Edition (CPT-3)
Time frame: Change from baseline values at 5 months
Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)
Neuropsychological Assessment of Executive Functions in Children (ENFEN)
Time frame: Change from baseline values at 5 months
Disruptive behavior, anxiety and depression
Child Behavior Checklist (CBCL)
Time frame: Change from baseline values at 5 months
Mindful attention awareness
Mindful Attention Awareness Scale Adapted for Children (MAAS-C). Total scores of the MAAS-C range from 15 to 90, where higher scores mean a better mindful attention awareness.
Time frame: Change from baseline values at 5 months
General functioning
Children's Global Assessment Scale (CGAS). Total scores of the CGAS range from 1 to 100, where higher scores means a better general functioning.
Time frame: Change from baseline values at 5 months
Clinical Global Impression
Clinical Global Impression Scale (CGI). Total scores of the CGI range from 0 to 7, where higher scores means a worse clinical global impression.
Time frame: Change from baseline values at 5 months
Anxiety
Screen for Child Anxiety Related Disorders (SCARED)
Time frame: Change from baseline values at 5 months
Plan to share: No
Ran from Jul 2023 to primary completion in Mar 2024, 8 months.
Of 393 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity →
Fundació Sant Joan de Déu