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.
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
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:
- Raven colored matrices to monitor Fluid Reasoning
- the Ranette test of the BIA-R (Marzocchi et al, 2021) to evaluate the response inhibition capacity (administration in paper format);
- 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);
- the Nepsy-II inhibition test (Korkman et al, 2007) to evaluate flexibility (administration in paper format);
- 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:
- Questionnaire for the assessment of executive functions (QUFE) - teachers and parents' version
- 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 group | Role | What they receive |
|---|---|---|
| Training Executive Function through Apollo and Rosetta app | Experimental | The 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 group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function and Attention tasks
To verify the effectiveness of the intervention, neuropsychological measures are collected, before and after the training.
- 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);
- 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 ;
- the number of correct responses at Nepsy-II inhibition test (Korkman et al, 2007) to evaluate flexibility (administration in paper format);
- 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.
- First posted18 Mar 2025
- Study start9 Jan 2024
- Primary completion20 Dec 2024
- Study completion31 Jan 2025
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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Eugenio Medea
- Responsible party
- Principal investigator, Gian Marco Marzocchi, University of Milano Bicocca
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training of Executive Functions Through the APP "The Apollo & Rosetta Adventures"
- ClinicalTrials.gov ID
- NCT06881719
- Acronym / sponsor ID
- E-FAR / PsicoMilanoBicocca
- Conditions
- ADHD
- Keywords
- EXECUTIVE FUNCTION, TRAINING, APP MOBILE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- IRCCS Eugenio Medea
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Mar 2025 (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.
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.
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:
- Raven colored matrices to monitor Fluid Reasoning
- the Ranette test of the BIA-R (Marzocchi et al, 2021) to evaluate the response inhibition capacity (administration in paper format);
- 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);
- the Nepsy-II inhibition test (Korkman et al, 2007) to evaluate flexibility (administration in paper format);
- 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:
- Questionnaire for the assessment of executive functions (QUFE) - teachers and parents' version
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Training Executive Function through Apollo and Rosetta app | Experimental | Device: The Adventures of Apollo & RosettaThe 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). |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| The Adventures of Apollo & RosettaThe 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. | Device | Training Executive Function through Apollo and Rosetta app |
Primary outcome
Executive Function and Attention tasks
Time frame: 12 months
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.
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 21 Mar 2025.
- Derived from this study: PubMed 42175852Tramoni 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.