Group Intervention on Executive Function in Children With Autism Spectrum Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Training Unstuck and On Target! Second Edition Versus Training ApisMela

Conditions
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Autism Spectrum Disorder, Autism

Intervention / Treatment
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* Other: ApisMela protocol
* Other: Unstuck and on Target protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with diagnosis of autism and autism spectrum disorder Exclusion Criteria: Presence of other medical disorders

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ApisMela/Unstuck Group<br>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. | Other: ApisMela protocol<br>* 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.<br>Other: Unstuck and on Target protocol<br>* 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.<br>|
| Experimental: Unstuck/ApisMela Group<br>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. | Other: ApisMela protocol<br>* 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.<br>Other: Unstuck and on Target protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) | 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. | The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete. | 
| Changes in NEuroPSYcology second edition (NEPSY-II) evaluations | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, children, executive functions