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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Mindfulness and Cognitive Training Programs for Children With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized, Controlled Trial (the NeuroMind Study)

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: TAU + UP4H
* Behavioral: TAU + M4H
* Behavioral: TAU + CT
* Other: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children of both sexes, between 7 and 12 years of age. Diagnosis of ADHD according to the DSM-5 criteria by a specialist and confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia, Present and Lifetime Version (K-SADS-PL). ADHD medication dose is stable in the last 2 months or there is an informed decision on not taking ADHD medication. Children and parents have an adequate mastery of the Spanish language. Children and parents are available to meet all visits. Children's representatives (either parents or legal guardians) must understand the conditions of the study and sign the informed consent. Psychiatric comorbidities are allowed except psychosis, bipolar illness, active suicidality, untreated posttraumatic stress disorder or substance use (checked by the structured interview K-SADS-PL) , provided ADHD is the primary diagnosis in the child. Children have an IQ ≥ 80 checked by the Kaufman Brief Intelligence Test (K-BIT). Exclusion Criteria: Diagnosis of Autism Spectrum Disorder (ASD) according to the DSM-5 criteria by a specialist or confirmed by the Social Communication Questionnaire (SCQ). Children who received psychological or psycho-educational treatment in the last 2 months or whose parents don't agree not to seek it during the study. Children have participated in a mindfulness programme in the past or the current year Children are participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU + UP4H<br>UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training. | Behavioral: TAU + UP4H<br>* Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).<br>|
| Active Comparator: TAU + M4H<br>M4H is a face-to-face non-pharmacological program based on Mindfulness Training. | Behavioral: TAU + M4H<br>* Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).<br>|
| Active Comparator: TAU + CT<br>CT is a virtual non-pharmacological program based on Cognitive Training. | Behavioral: TAU + CT<br>* Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).<br>|
| Active Comparator: Treatment as Usual (TAU)<br>Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child. | Other: Treatment as Usual (TAU)<br>* Standard pharmacological treatment usually provided to children with ADHD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD symptoms (inattention, hyperactivity, impulsivity) | Conners' Parent Rating Scale-Revised (CPRS-R) Short form | Change from baseline values at 5 months | 
| ADHD symptoms (inattention, hyperactivity, impulsivity) | Conners Continuous Performance Test 3rd Edition (CPT-3) | Change from baseline values at 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition) | Neuropsychological Assessment of Executive Functions in Children (ENFEN) | Change from baseline values at 5 months | 
| Disruptive behavior, anxiety and depression | Child Behavior Checklist (CBCL) | 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. | 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. | 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. | Change from baseline values at 5 months | 
| Anxiety | Screen for Child Anxiety Related Disorders (SCARED) | Change from baseline values at 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Children, Mindfulness, Cognitive Training, Randomized Controlled Trial