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ADHDE-FARNCT06881719

Experimental Research on the Training of Executive Functions Through the APP "The Apollo & Rosetta Adventures" (E-FAR) in Children with ADHD (8-13 Yrs)

A study testing The Adventures of Apollo & Rosetta in people with ADHD, run by University of Milano Bicocca at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

ADHD is one of the most prevalent neurodevelopmental disorders, with a strong impact on general functioning and in daily life. Executive Functions play an important role on this disorder, and numerous treatments have been developed over the years to try to contain its symptoms. Read more about this study

Who is it for?
Ages 8 to 13 years
Conditions the study is for
ADHD
What is being tested?
The Adventures of Apollo & Rosetta
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesItaly
Study dates
9 Jan 2024to 31 Jan 2025
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 8 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • IRCCS E. Medea

    Bosisio Parini, Lecco, 23842

  • University of Milan Bicocca

    Milan, Michigan, 20126

Other trials in Italy

About this study

Official title: Training of Executive Functions Through the APP "The Apollo & Rosetta Adventures"

ADHD is one of the most prevalent neurodevelopmental disorders, with a strong impact on general functioning and in daily life. Executive Functions play an important role on this disorder, and numerous treatments have been developed over the years to try to contain its symptoms. The present study aimed to investigate whether the use of a video game, "The incredible adventures of Apollo and Rosetta", could enhance Fxecutive Functions and improve the impact of symptoms in children with ADHD. A longitudinal study was carried out with 35 subjects aged 8 to 11 years. They were assessed twice, at the beginning and after three months. 17 subjects were assigned to the experimental group, which downloaded and used the application systematically. 18 participants, on the other hand, were assigned to the wait-and-see condition, as a control group. Participants were administered four tests, while in contemporary, parents filled out two self-report questionnaires. A mixed between and within ANOVA was used to analyze the data. The results, although not showing significantly impactful effects, are promising and move in the direction of the research hypothesis. In fact, systematic use of this application appears to play a role in increasing executive functions and seems to act as a protective factor against any worsening.

Read the detailed description

Introduction Executive Functions represent a series of coordinated and higher-order processes to allow the child to develop adequate self-regulation of behavior in order to implement adaptive behaviors. Executive deficits represent the most critical area in the 5-10 age group precisely because the development deficit of the prefrontal regions prevents the acquisition of skills which are then fundamental throughout the development to young adulthood.

The enhancement of Executive Functions for many children with atypical development is necessary to reduce subsequent developmental risks. Among the various training proposals, those that involve cognitive and motor processes are those that have shown the greatest benefits; it is also important that the child is motivated and experiences pleasure in carrying out these activities.

The use of APPs on tablets and computer games allows children to increase their motivation to play, eliciting the pleasure of doing fun exercises. The motivation to carry out the task allows the child to spend more time carrying out training to enhance Executive Functions and determines an improvement in cognitive skills.

The research group of the University of Feevale (Brazil) coordinated by Prof. Debora Nice Ferrari Barbosa has also created a new APP that stimulates Executive Functions in children, as demonstrated by their recent study on typical development. The video game is called "The adventures of Apollo and Rosetta" in which two characters face various missions in space in which they must avoid dangers or hit threatening objects according to the rules that are made explicit. The child must learn to remember rules, targets (working memory), stop automatic responses and manage distractions (inhibition) or change behavior patterns (flexibility).

The aim of the study is to verify whether the application of training via APP allows children with ADHD to improve performance in their Executive Functions and whether these improvements are generalized by reducing the symptoms of inattention and impulsivity.

Participants Participants in the study are 15 children with ADHD (in the absence of comorbidities) according to the ICD-10 criteria aged between 6 and 10 years who are not receiving any therapy (psychological and pharmacological) for the entire duration of the training (3 months). Diagnostic confirmation will occur through the administration of Conners-3 questionnaires (cut-off T> 65 of inattention and / or hyperactivity-impulsivity symptoms).

In addition to the experimental group, a control group of children with ADHD with similar characteristics in terms of gender, age, IQ and severity of symptoms will be identified. The children in the control group will not undergo any therapy and will be tested before and after a 3-month interval. Participants with ADHD from the experimental and control groups will be recruited at the IRCCS E. Medea in Bosisio Parini (LC).

Training The new APP "The adventures of Apollo and Rosetta" consists of 7 exercises (1. Explorer; 2. Deciphering codes; 3. Particle accelerator tunnel; and 4. Leaping asteroids, - 5. Galactic art; 6. Stellar Laboratory; 7. Challenge of opposites).

The training program provides for the application of 36 mini-game sessions lasting 15-20 minutes each (alternating the first 4 and the last 3 games) over 12 weeks (the child must practice 3 times a week).

The training via APP can be administered in the first sessions on an outpatient basis, then it can be delegated to parents who take care of the exercises 3 times a week (20-15-20 minutes). A work diary will be kept monitoring the progress of the activities.

Measures To verify the effectiveness of the intervention, behavioral measures are collected, before and after the training.

Primary outcome - Neuropsychological Tests:

  1. Raven colored matrices to monitor Fluid Reasoning
  2. the Ranette test of the BIA-R (Marzocchi et al, 2021) to evaluate the response inhibition capacity (administration in paper format);
  3. the Horn Test (Marzocchi et al, 2013) to evaluate response inhibition and flexibility (using the "Self-regulate attention" software installed on a PC provided by the Milano-Bicocca University);
  4. the Nepsy-II inhibition test (Korkman et al, 2007) to evaluate flexibility (administration in paper format);
  5. the CO-TT test by Marsura et al (2020) to evaluate the updating component of working memory (the presentation of the items of this test will take place via power point, while the answers will be recorded on a paper protocol).

Secondary measures - Questionnaires:

  1. Questionnaire for the assessment of executive functions (QUFE) - teachers and parents' version
  2. Conners-3 Questionnaire to Assess ADHD Symptoms - Teachers and Parents Version.

Expected results It is hypothesized that ADHD children of the experimental group will improve their skills related to Executive Functions (near transfer) by finding a greater number of correct answers to the computerized tests. The improvement can be estimated in the measure of an effect size between 0.4 and 0.8 (average effect). Furthermore, a generalization of the improvements detected by the QUFE and Conners-3 questionnaires of about 0.3-0.4 (medium-low, but significant effect) is expected.

Conditions
ADHD
Being tested
The Adventures of Apollo & Rosetta
Keywords
EXECUTIVE FUNCTION, TRAINING, APP MOBILE
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.

  • The Adventures of Apollo & RosettaDevice

    The new APP "The Adventures of Apollo and Rosetta" consists of 7 exercises (1. Explorer; 2. Deciphering codes; 3. Particle accelerator tunnel; and 4. Leaping asteroids, - 5. Galactic art; 6. Stellar Laboratory; 7. Challenge of opposites).

    The training program provides for the application of 36 mini-game sessions lasting 15-20 minutes each (alternating the first 4 and the last 3 games) over 12 weeks (the child must practice 3 times a week).

    The training via APP can be administered in the first sessions on an outpatient basis, then it can be delegated to parents who take care of the exercises 3 times a week (20-15-20 minutes). A work diary will be kept monitoring the progress of the activities.

Study groups in NCT06881719
Study groupRoleWhat they receive
Training Executive Function through Apollo and Rosetta appExperimentalThe new APP "The Adventures of Apollo and Rosetta" consists of 7 exercises The training program provides for the application of 36 mini-game sessions lasting 15-20 minutes each (alternating the first 4 and the last 3 games) over 12 weeks (the child must practice 3 times a week).
Receives: Device: The Adventures of Apollo & Rosetta
Control groupNo interventionA control group of children with ADHD with similar characteristics in terms of gender, age, IQ and severity of symptoms will be identified. The children in the control group will not undergo any therapy and will be tested before and after a 3-month interval.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Executive Function and Attention tasks

    To verify the effectiveness of the intervention, neuropsychological measures are collected, before and after the training.

    1. the number of correct responses at Ranette test of the BIA-R (Marzocchi et al, 2021) to evaluate the response inhibition capacity (administration in paper format);
    2. the decreased number of commission errors and the Reaction Time of correct responses at Horn Test (Marzocchi et al, 2013) to evaluate response inhibition and flexibility ;
    3. the number of correct responses at Nepsy-II inhibition test (Korkman et al, 2007) to evaluate flexibility (administration in paper format);
    4. the number of correct responses at CO-TT test by Marsura et al (2020) to evaluate the updating component of Working Memory.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2025
  2. Study start9 Jan 2024
  3. Primary completion20 Dec 2024
  4. Study completion31 Jan 2025

Resources

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
Model description
Comparison of the effects of the App Apollo \& Rosetta on Executive Function (EF) in a group of children with ADHD, compared to the typical development of EF in a group of children with ADHD not treated.
Masking
Single blind
Who is masked
Investigator
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06881719
Sponsor's protocol ID
PsicoMilanoBicocca
Acronym
E-FAR
Status last verified
Mar 2025
First submitted
3 Feb 2025
Last updated
21 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Tramoni M, Giudici L, Mancini S, Scheffler EL, Benites de Cerqueira B, Mossmann JB, Ferrari Barbosa DN, Trabattoni S, Mauri V, Nobile M, Crippa A, Marzocchi GM. "The incredible adventures of Apollo and Rosetta in space": Training executive functions in children with attention-deficit/hyperactivity disorder. Appl Neuropsychol Child. 2026 May 23:1-12. doi: 10.1080/21622965.2026.2672445. Online ahead of print.

    PubMed 42175852

Questions about this trial

What is this clinical trial studying?

A study testing The Adventures of Apollo & Rosetta in people with ADHD, run by University of Milano Bicocca at 2 sites in Italy.

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 0 inclusion and 1 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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?

Executive Function and Attention tasks (time frame: 12 months). 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 NCT06881719, 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 21 Mar 2025.

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