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Group Intervention on Executive Function in Children With Autism Spectrum Disorder

I

Istituto per la Ricerca e l'Innovazione Biomedica

Status

Enrolling

Conditions

Autism Spectrum Disorder
Autism

Treatments

Other: ApisMela protocol
Other: "Unstuck and on Target" protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05977075
CNR-IRIB-PRO-2023-003

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

7 to 13 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children with diagnosis of autism and autism spectrum disorder

Exclusion criteria

  • Presence of other medical disorders

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 2 patient groups

"ApisMela/Unstuck" Group
Experimental group
Description:
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.
Treatment:
Other: "Unstuck and on Target" protocol
Other: ApisMela protocol
"Unstuck/ApisMela" Group
Experimental group
Description:
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.
Treatment:
Other: "Unstuck and on Target" protocol
Other: ApisMela protocol

Trial contacts and locations

1

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Central trial contact

Flavia Marino; Giovanni Pioggia

Data sourced from clinicaltrials.gov

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