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

NCT06881719 | Completed

• 1 other identifier: PsicoMilanoBicocca
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

ADHD

Keywords

EXECUTIVE FUNCTION; TRAINING; APP MOBILE

Outcome Measures

Primary Outcomes (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.

  12 months

Study Arms (2)

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).

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.

Interventions

The Adventures of Apollo & Rosetta DEVICE

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.

Training Executive Function through Apollo and Rosetta app

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of Milano Bicocca: lead
• IRCCS Eugenio Medea: collaborator

Study Sites (2)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

University of Milan Bicocca

Milan, Michigan, 20126, Italy

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Collaborators of the investigator are blind about the two groups (trained vs not-trained) when administering the tasks before and after the training
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: March 18, 2025
• Study Start: January 9, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

IT (2)