ADHDNeuroMindNCT05937347
Mindfulness and Cognitive Training Programs for Children with ADHD (the NeuroMind Study)
A study testing TAU + UP4H, TAU + M4H and TAU + CT in people with ADHD, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- ADHD
- What is being tested?
- TAU + UP4H, TAU + M4H and TAU + CT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jul 2023to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundació Privada per a la Recerca i la Docència Sant Joan de Déu (FSJD)
Esplugues de Llobregat, Barcelona, 08950
About this study
Official title: Mindfulness and Cognitive Training Programs for Children with Attention Deficit Hyperactivity Disorder (ADHD): a Randomized, Controlled Trial (the NeuroMind Study)
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.
Read the 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).
- Conditions
- ADHD
- Being tested
- TAU + UP4H, TAU + M4H, TAU + CT, Treatment as Usual (TAU)
- Keywords
- ADHD, Children, Mindfulness, Cognitive Training, Randomized Controlled Trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU + UP4HBehavioural
Group treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention).
TAU + M4HBehavioural
Group treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention).
TAU + CTBehavioural
Group treatment protocol of 8 weekly 60 minutes sessions (virtual intervention).
Treatment as Usual (TAU)Other
Standard pharmacological treatment usually provided to children with ADHD.
| Study group | Role | What they receive |
|---|---|---|
| TAU + UP4H | Experimental | UP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training. Receives: Behavioral: TAU + UP4H |
| TAU + M4H | Active comparator | M4H is a face-to-face non-pharmacological program based on Mindfulness Training. Receives: Behavioral: TAU + M4H |
| TAU + CT | Active comparator | CT is a virtual non-pharmacological program based on Cognitive Training. Receives: 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners' Parent Rating Scale-Revised (CPRS-R) Short form
Measured: Change from baseline values at 5 months
ADHD symptoms (inattention, hyperactivity, impulsivity)
Conners Continuous Performance Test 3rd Edition (CPT-3)
Measured: Change from baseline values at 5 months
Secondary outcomes (6)
Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)
Neuropsychological Assessment of Executive Functions in Children (ENFEN)
Measured: Change from baseline values at 5 months
Disruptive behavior, anxiety and depression
Child Behavior Checklist (CBCL)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline values at 5 months
Anxiety
Screen for Child Anxiety Related Disorders (SCARED)
Measured: Change from baseline values at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start20 Jul 2023
- Primary completion22 Mar 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Responsible party
- Sponsor
- Investigators
- Anna Huguet, PhD, Principal investigator, CSMIJ Sant Joan de Déu Terres de LleidaAlbert Feliu, PhD, Principal investigator, Universitat Autonoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937347
- Sponsor's protocol ID
- NeuroMind
- Acronym
- NeuroMind
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38384348
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Cognitive Training Programs for Children with Attention Deficit Hyperactivity Disorder (ADHD): a Randomized, Controlled Trial (the NeuroMind Study)
- ClinicalTrials.gov ID
- NCT05937347
- Acronym / sponsor ID
- NeuroMind / NeuroMind
- Conditions
- ADHD
- Keywords
- ADHD, Children, Mindfulness, Cognitive Training, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Universitat Autonoma de Barcelona
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAU + UP4H | Experimental | Behavioral: TAU + UP4HUP4H is a face-to-face and virtual non-pharmacological program based on Mindfulness Training and Cognitive Training. |
| TAU + M4H | Active comparator | Behavioral: TAU + M4HM4H is a face-to-face non-pharmacological program based on Mindfulness Training. |
| TAU + CT | Active comparator | Behavioral: TAU + CTCT is a virtual non-pharmacological program based on Cognitive Training. |
| Treatment as Usual (TAU) | Active comparator | Other: Treatment as Usual (TAU)Treatment as Usual (TAU) consisted of the prescribed drugs adapted to the ADHD symptomatic profile of each child. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU + UP4HGroup treatment protocol of 8 weeks (approximately 105 minutes per week, 75 of face-to-face and 30 of virtual intervention). | Behavioural | TAU + UP4H |
| TAU + M4HGroup treatment protocol of 8 weekly 75 minute sessions (face-to-face intervention). | Behavioural | TAU + M4H |
| TAU + CTGroup treatment protocol of 8 weekly 60 minutes sessions (virtual intervention). | Behavioural | TAU + CT |
| Treatment as Usual (TAU)Standard pharmacological treatment usually provided to children with ADHD. | Other | Treatment as Usual (TAU) |
Primary outcome
ADHD symptoms (inattention, hyperactivity, impulsivity)
Time frame: Change from baseline values at 5 months
Conners' Parent Rating Scale-Revised (CPRS-R) Short form
ADHD symptoms (inattention, hyperactivity, impulsivity)
Time frame: Change from baseline values at 5 months
Conners Continuous Performance Test 3rd Edition (CPT-3)
6 secondary outcomes
Executive functions (verbal fluency, working memory, cognitive flexibility, inhibition)
Time frame: Change from baseline values at 5 months
Disruptive behavior, anxiety and depression
Time frame: Change from baseline values at 5 months
Mindful attention awareness
Time frame: Change from baseline values at 5 months
General functioning
Time frame: Change from baseline values at 5 months
Clinical Global Impression
Time frame: Change from baseline values at 5 months
Anxiety
Time frame: Change from baseline values at 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 38384348Badia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Huguet, PhD principal investigator
CSMIJ Sant Joan de Déu Terres de Lleida
Albert Feliu, PhD principal investigator
Universitat Autonoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU + UP4H, TAU + M4H and TAU + CT in people with ADHD, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptoms (inattention, hyperactivity, impulsivity) (time frame: Change from baseline values at 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.