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

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.

Conditions

• ADHD

Interventions

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.

Sponsors & Collaborators

• Universitat Autonoma de Barcelona

  collaborator OTHER

• Fundació Sant Joan de Déu

  lead OTHER

Principal Investigators

• Anna Huguet, PhD · CSMIJ Sant Joan de Déu Terres de Lleida

• Albert Feliu, PhD · Universitat Autonoma de Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-20

Primary Completion

2024-03-22

Completion

2024-07-26

Countries

• Spain

Study Locations