Group Intervention on Executive Function in Children With Autism Spectrum Disorder
NCT ID: NCT05977075
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
12 participants
INTERVENTIONAL
2022-12-01
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The present protocol aims to test the first absolute and then comparative effectiveness of two executive function development programs: the "APISMELA" training and the "UNSTUCK \& ON TARGET! SECOND EDITION". Two groups will be held at the same time and will conduct the two programs in reverse order. In fact, the protocol is divided into two phases.
Participants subjected to the APISMELA group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the UNSTUCK \& ON TARGET! SECOND EDITION protocol.
Participants subjected to the UNSTUCK \& ON TARGET! SECOND EDITION group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the APISMELA protocol.
Group intervention programs were chosen for two reasons: group intervention compared with individual intervention have lower costs for patients and their families and thus higher overall social acceptability. The second is that group intervention within the social-constructivist paradigm, to which the two chosen programs belong, becomes a fundamental resource for stimulating that augmentative learning that is a source of development on the cognitive and conceptual levels for human beings.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Social Relations Training for Children With ASD
NCT06278155
Awareness Training in Children With Autism Spectrum Disorder.
NCT06278168
Emotional Skills Training with Social Robot
NCT06179953
Improving Academic and Social Functioning in Middle-Schoolers With Autism
NCT06705907
Group Intervention on Theory of Mind in Children With Autism Spectrum Disorder.
NCT06179927
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
"ApisMela/Unstuck" Group
Six children belonging to the experimental group. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Being a crossover clinical trial, the group ending with the ApisMela protocol continues with the Ustuck protocol.
ApisMela protocol
The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.
"Unstuck and on Target" protocol
The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.
"Unstuck/ApisMela" Group
Six children belonging to the experimental group. Unstuck protocol teaches people to be more flexible, skillful in planning and goal-oriented. Being a crossover clinical trial, the group ending with the Unstuck protocol continues with the ApisMela protocol.
ApisMela protocol
The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.
"Unstuck and on Target" protocol
The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ApisMela protocol
The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.
"Unstuck and on Target" protocol
The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
7 Years
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione di ComunitĂ di Messina onlus
UNKNOWN
Istituto per la Ricerca e l'Innovazione Biomedica
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Flavia Marino
Head of Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Flavia Marino
Role: PRINCIPAL_INVESTIGATOR
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Nydén, A., Gillberg, C., Hjelmquist, E., & Heiman, M. (1999). Executive function/attention deficits in boys with Asperger syndrome, attention disorder and reading/writing disorder. Autism, 3(3), 213-228.
Jolles DD, Crone EA. Training the developing brain: a neurocognitive perspective. Front Hum Neurosci. 2012 Apr 9;6:76. doi: 10.3389/fnhum.2012.00076. eCollection 2012.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
Wilson TD, Reinhard DA, Westgate EC, Gilbert DT, Ellerbeck N, Hahn C, Brown CL, Shaked A. Social psychology. Just think: the challenges of the disengaged mind. Science. 2014 Jul 4;345(6192):75-7. doi: 10.1126/science.1250830.
Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
Orsolini, Margherita & Melogno, Sergio & Santese, Angela & Toma, Chiara & Latini, Nausica & Salomone, Samantha & Andreagiovanni, Jacopo. (2019). "Pensando si Impara" STIMOLARE L'ATTENZIONE, LE FUNZIONI ESECUTIVE E LA MEMORIA DI LAVORO NEI BAMBINI CON BISOGNI EDUCATIVI SPECIALI.
Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.
Cannon J, O'Brien AM, Bungert L, Sinha P. Prediction in Autism Spectrum Disorder: A Systematic Review of Empirical Evidence. Autism Res. 2021 Apr;14(4):604-630. doi: 10.1002/aur.2482. Epub 2021 Feb 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNR-IRIB-PRO-2023-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.