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

NCT ID: NCT05937347

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-07-26

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).

Conditions

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ADHD

Keywords

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ADHD Children Mindfulness Cognitive Training Randomized Controlled Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TAU + UP4H

UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training.

Group Type EXPERIMENTAL

TAU + UP4H

Intervention Type BEHAVIORAL

Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).

TAU + M4H

M4H is a face-to-face non-pharmacological program based on Mindfulness Training.

Group Type ACTIVE_COMPARATOR

TAU + M4H

Intervention Type BEHAVIORAL

Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).

TAU + CT

CT is a virtual non-pharmacological program based on Cognitive Training.

Group Type ACTIVE_COMPARATOR

TAU + CT

Intervention Type BEHAVIORAL

Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).

Treatment as Usual (TAU)

Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child.

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type OTHER

Standard pharmacological treatment usually provided to children with ADHD.

Interventions

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TAU + UP4H

Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).

Intervention Type BEHAVIORAL

TAU + M4H

Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).

Intervention Type BEHAVIORAL

TAU + CT

Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).

Intervention Type BEHAVIORAL

Treatment as Usual (TAU)

Standard pharmacological treatment usually provided to children with ADHD.

Intervention Type OTHER

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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitat Autonoma de Barcelona

OTHER

Sponsor Role collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anna Huguet, PhD

Role: PRINCIPAL_INVESTIGATOR

CSMIJ Sant Joan de Déu Terres de Lleida

Albert Feliu, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Autonoma de Barcelona

Locations

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Fundació Privada per a la Recerca i la Docència Sant Joan de Déu (FSJD)

Esplugues de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

References

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Badia-Aguaron T, Royuela-Colomer E, Pera-Guardiola V, Verges-Balasch P, Cebolla A, Luciano JV, Soler J, Feliu-Soler A, Huguet Miguel A. Combining mindfulness and cognitive training in children with attention deficit hyperactivity disorder: study protocol of a pilot randomized controlled trial (the NeuroMind study). Front Psychol. 2024 Feb 7;15:1291198. doi: 10.3389/fpsyg.2024.1291198. eCollection 2024.

Reference Type DERIVED
PMID: 38384348 (View on PubMed)

Other Identifiers

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NeuroMind

Identifier Type: -

Identifier Source: org_study_id