Group Intervention on Executive Function in Children With Autism Spectrum Disorder

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder; Autism
• Interventions: Other: ApisMela protocol; Other: "Unstuck and on Target" protocol

• Registration Number: NCT05977075
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Brief Summary

Autism is a developmental disorder characterized by difficulties in social communication, repetitive behaviors, and social interaction. A key aspect of autism concerns executive functions, which are a set of cognitive processes that regulate attention, planning, inhibition, and impulse control. These functions are often impaired in children with autism, affecting their learning and daily functioning.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Children with diagnosis of autism and autism spectrum disorder

Exclusion Criteria

• Presence of other medical disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"ApisMela/Unstuck" Group	ApisMela protocol	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/Unstuck" Group	"Unstuck and on Target" protocol	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.
"Unstuck/ApisMela" Group	ApisMela protocol	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.
"Unstuck/ApisMela" Group	"Unstuck and on Target" protocol	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.

Primary Outcome Measures

Name	Time	Method
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)	The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.	Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.; The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.
Changes in NEuroPSYcology second edition (NEPSY-II) evaluations	The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion,about 1 year (T2).The T1 and T2 evaluations were conducted to determine whether the protocols carried out made a change.The test needs about 120-180 minutes.	NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age.; Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min \<2% - max \>75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance.

Trial Locations

Locations (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR); 🇮🇹 Messina, Italy