NCT05937347

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2024

Completed
Last Updated

December 13, 2024

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 29, 2023

Last Update Submit

December 9, 2024

Conditions

ADHD

Keywords

ADHDChildrenMindfulnessCognitive TrainingRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)

    Change from baseline values at 5 months

  • Disruptive behavior, anxiety and depression

    Change from baseline values at 5 months

  • Mindful attention awareness

    Change from baseline values at 5 months

  • General functioning

    Change from baseline values at 5 months

  • Clinical Global Impression

    Change from baseline values at 5 months

  • +1 more secondary outcomes

Study Arms (4)

TAU + UP4H

EXPERIMENTAL

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

Behavioral: TAU + UP4H

TAU + M4H

ACTIVE COMPARATOR

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

Behavioral: TAU + M4H

TAU + CT

ACTIVE COMPARATOR

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

Behavioral: TAU + CT

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Other: Treatment as Usual (TAU)

Interventions

TAU + UP4HBEHAVIORAL

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

TAU + UP4H
TAU + M4HBEHAVIORAL

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

TAU + M4H
TAU + CTBEHAVIORAL

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

TAU + CT
Treatment as Usual (TAU)OTHER

Standard pharmacological treatment usually provided to children with ADHD.

Treatment as Usual (TAU)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

  • 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.

    PMID: 38384348DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Anna Huguet, PhD

    CSMIJ Sant Joan de Déu Terres de Lleida

    PRINCIPAL INVESTIGATOR

  • Albert Feliu, PhD

    Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2023

First Posted

July 10, 2023

Study Start

July 20, 2023

Primary Completion

March 22, 2024

Study Completion

July 26, 2024

Last Updated

December 13, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)