search
Back to results

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

Primary Purpose

ADHD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
TAU + UP4H
TAU + M4H
TAU + CT
Treatment as Usual (TAU)
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Children, Mindfulness, Cognitive Training, Randomized Controlled Trial

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

TAU + UP4H

TAU + M4H

TAU + CT

Treatment as Usual (TAU)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners' Parent Rating Scale-Revised (CPRS-R) Short form
ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners Continuous Performance Test 3rd Edition (CPT-3)

Secondary Outcome Measures

Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)
Neuropsychological Assessment of Executive Functions in Children (ENFEN)
Disruptive behavior, anxiety and depression
Child Behavior Checklist (CBCL)
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.
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.
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.
Anxiety
Screen for Child Anxiety Related Disorders (SCARED)

Full Information

First Posted
May 29, 2023
Last Updated
July 5, 2023
Sponsor
Fundació Sant Joan de Déu
Collaborators
Universitat Autonoma de Barcelona
search

1. Study Identification

Unique Protocol Identification Number
NCT05937347
Brief Title
Mindfulness and Cognitive Training Programs for Children With ADHD (the NeuroMind Study)
Acronym
NeuroMind
Official Title
Mindfulness and Cognitive Training Programs for Children With Attention Deficit Hyperactivity Disorder (ADHD): A Randomized, Controlled Trial (the NeuroMind Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 20, 2023 (Anticipated)
Primary Completion Date
March 22, 2024 (Anticipated)
Study Completion Date
July 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Universitat Autonoma de Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Children, Mindfulness, Cognitive Training, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + UP4H
Arm Type
Experimental
Arm Description
UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training.
Arm Title
TAU + M4H
Arm Type
Active Comparator
Arm Description
M4H is a face-to-face non-pharmacological program based on Mindfulness Training.
Arm Title
TAU + CT
Arm Type
Active Comparator
Arm Description
CT is a virtual non-pharmacological program based on Cognitive Training.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child.
Intervention Type
Behavioral
Intervention Name(s)
TAU + UP4H
Intervention Description
Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).
Intervention Type
Behavioral
Intervention Name(s)
TAU + M4H
Intervention Description
Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).
Intervention Type
Behavioral
Intervention Name(s)
TAU + CT
Intervention Description
Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).
Intervention Type
Other
Intervention Name(s)
Treatment as Usual (TAU)
Intervention Description
Standard pharmacological treatment usually provided to children with ADHD.
Primary Outcome Measure Information:
Title
ADHD symptoms (inattention, hyperactivity, impulsivity)
Description
Conners' Parent Rating Scale-Revised (CPRS-R) Short form
Time Frame
Change from baseline values at 5 months
Title
ADHD symptoms (inattention, hyperactivity, impulsivity)
Description
Conners Continuous Performance Test 3rd Edition (CPT-3)
Time Frame
Change from baseline values at 5 months
Secondary Outcome Measure Information:
Title
Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)
Description
Neuropsychological Assessment of Executive Functions in Children (ENFEN)
Time Frame
Change from baseline values at 5 months
Title
Disruptive behavior, anxiety and depression
Description
Child Behavior Checklist (CBCL)
Time Frame
Change from baseline values at 5 months
Title
Mindful attention awareness
Description
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
Title
General functioning
Description
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
Title
Clinical Global Impression
Description
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
Title
Anxiety
Description
Screen for Child Anxiety Related Disorders (SCARED)
Time Frame
Change from baseline values at 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Huguet, PhD
Phone
+34 973 26 72 22
Email
anna.huguet@sjd.es
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Badia
Email
tania.badia@autonoma.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Huguet, PhD
Organizational Affiliation
CSMIJ Sant Joan de Déu Terres de Lleida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Albert Feliu, PhD
Organizational Affiliation
Universitat Autonoma de Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundació Privada per a la Recerca i la Docència Sant Joan de Déu (FSJD)
City
Esplugues De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Huguet, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs