AutismNCT06310317
Applied Behavior Analysis With Technologies
A study testing Applied Behavior Analysis protocol and Traditional intervention in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Applied Behavior Analysis protocol and Traditional intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with diagnosis of autism
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Maria Valeria Maiorana, +393285856656, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Evaluating the Effect of Use of Technologies to Increase the Cognitive Abilities in Children With Autism Spectrum Disorders
Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.
In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Applied Behavior Analysis protocol, Traditional intervention
- Keywords
- Autism, autism spectrum disorder, children, Applied Behavior Analysis, ABA
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Behavior Analysis protocolBehavioural
The main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. The use of Applied Behavior Analysis procedures, with the help of technological tools such as a tablet or robot can facilitate the increase of new knowledge and skills.
The criterion is acquired if the subject emits 8 out of 10 independent correct responses (90%) for 3 consecutive sessions.
The objective is to test whether the technological tool used (tablet or robot) can make the proposed learning procedure more effective. The experimental group carries out the procedure by means of stimuli presented on tablets or robots.
Traditional interventionBehavioural
The main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. In this group the materials are traditional, such as image printed. The criterion is acquired if the subject emits 9 out of 10 independent correct responses (90%) for 3 consecutive sessions. The control group performs the procedure with images printed on A4 laminated sheets.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | 15 children belonging to the experimental group will undergo the treatment carries out the procedure by means of stimuli presented with technologies supports Receives: Behavioral: Applied Behavior Analysis protocol |
| control group | Other | 15 children belonging to the control group will undergo the treatment by performing the procedure with images printed on laminated A4 sheets. Receives: Behavioral: Traditional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
Is an assessment tool that attends to all those skills that are fundamental to the development and enhancement of verbal communication skills and the proper use of language in social interactions. It focuses especially on the assessment of language prerequisites fundamental to the development of verbal behavior in accordance with the classification of verbal operants proposed by Skinner: mand, tact, echoic, intraverbal. It consists of a manual, a protocol and a set of materials (pictures and standardized items for assessment). The protocol is divided into:
- Tables
- Early Echoic Skills Assessment (EESA) - Assessment of barriers: behaviors that might hinder the child's learning
- Assessment of transitions: the child's ability to make the transition to teaching modes based on the natural context
- Task Analysis and Skills Monitoring: describes the individual milestones required to reach the main milestone
- Scoring grids
Measured: the test need approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310317
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-003
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi KR, Bhakta B, Knight EA, Becerra-Culqui TA, Gahre TL, Zima B, Coleman KJ. Patient Outcomes After Applied Behavior Analysis for Autism Spectrum Disorder. J Dev Behav Pediatr. 2022 Jan 1;43(1):9-16. doi: 10.1097/DBP.0000000000000995.
PubMed 34342287Yu Q, Li E, Li L, Liang W. Efficacy of Interventions Based on Applied Behavior Analysis for Autism Spectrum Disorder: A Meta-Analysis. Psychiatry Investig. 2020 May;17(5):432-443. doi: 10.30773/pi.2019.0229. Epub 2020 May 8.
PubMed 32375461Valencia K, Rusu C, Quinones D, Jamet E. The Impact of Technology on People with Autism Spectrum Disorder: A Systematic Literature Review. Sensors (Basel). 2019 Oct 16;19(20):4485. doi: 10.3390/s19204485.
PubMed 31623200
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Use of Technologies to Increase the Cognitive Abilities in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06310317
- Acronym / sponsor ID
- CNR-IRIB-PRO-2024-003
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- Autism, autism spectrum disorder, children, Applied Behavior Analysis, ABA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 15 Mar 2024 (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.
Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.
In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Applied Behavior Analysis protocol15 children belonging to the experimental group will undergo the treatment carries out the procedure by means of stimuli presented with technologies supports |
| control group | Other | Behavioral: Traditional intervention15 children belonging to the control group will undergo the treatment by performing the procedure with images printed on laminated A4 sheets. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with diagnosis of autism
Key exclusion criteria (1 listed)
- presence of other medical disorders
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 |
|---|---|---|
| Applied Behavior Analysis protocolThe main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. The use of Applied Behavior Analysis procedures, with the help of technological tools such as a tablet or robot can facilitate the increase of new knowledge and skills. The criterion is acquired if the subject emits 8 out of 10 independent correct responses (90%) for 3 consecutive sessions. The objective is to test whether the technological tool used (tablet or robot) can make the proposed learning procedure more effective. The experimental group carries out the procedure by means of stimuli presented on tablets or robots. | Behavioural | experimental group |
| Traditional interventionThe main objective of the experimental protocol is to promote the development of cognitive skills, facilitate the acquisition of new skills and promote the adoption of functional and adaptive behaviors. In this group the materials are traditional, such as image printed. The criterion is acquired if the subject emits 9 out of 10 independent correct responses (90%) for 3 consecutive sessions. The control group performs the procedure with images printed on A4 laminated sheets. | Behavioural | control group |
Primary outcome
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
Time frame: the test need approximately 1 hour
Is an assessment tool that attends to all those skills that are fundamental to the development and enhancement of verbal communication skills and the proper use of language in social interactions. It focuses especially on the assessment of language prerequisites fundamental to the development of verbal behavior in accordance with the classification of verbal operants proposed by Skinner: mand, tact, echoic, intraverbal. It consists of a manual, a protocol and a set of materials (pictures and standardized items for assessment). The protocol is divided into: * Tables * Early Echoic Skills Assessment (EESA) - Assessment of barriers: behaviors that might hinder the child's learning * Assessment of transitions: the child's ability to make the transition to teaching modes based on the natural context * Task Analysis and Skills Monitoring: describes the individual milestones required to reach the main milestone * Scoring grids
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 34342287Choi KR, Bhakta B, Knight EA, Becerra-Culqui TA, Gahre TL, Zima B, Coleman KJ. Patient Outcomes After Applied Behavior Analysis for Autism Spectrum Disorder. J Dev Behav Pediatr. 2022 Jan 1;43(1):9-16. doi: 10.1097/DBP.0000000000000995.
- Background: PubMed 32375461Yu Q, Li E, Li L, Liang W. Efficacy of Interventions Based on Applied Behavior Analysis for Autism Spectrum Disorder: A Meta-Analysis. Psychiatry Investig. 2020 May;17(5):432-443. doi: 10.30773/pi.2019.0229. Epub 2020 May 8.
- Background: PubMed 31623200Valencia K, Rusu C, Quinones D, Jamet E. The Impact of Technology on People with Autism Spectrum Disorder: A Systematic Literature Review. Sensors (Basel). 2019 Oct 16;19(20):4485. doi: 10.3390/s19204485.
- 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.
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Behavior Analysis protocol and Traditional intervention in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavia Marino (+393395798263, flavia.marino@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP) (time frame: the test need approximately 1 hour). 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 NCT06310317, which also lists 3 linked publications.
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 15 Mar 2024.