Efficacy of LEGO Therapy for Adolescent With Level 1 Autism

NCT06641583 | Completed

• 1 other identifier: LEGO 126/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if LEGO therapy can enhance social skills in children aged 10-14 diagnosed with high-functioning Autism Spectrum Disorder. The main questions it aims to answer are: Does LEGO therapy improve social communication and interaction skills in children with Autism Spectrum Disorder? Do children show behavioral improvements in social skills after participating in LEGO therapy? Researchers will compare children receiving LEGO therapy to a control group (who will not receive LEGO therapy but continue their usual treatments) to see if LEGO therapy leads to greater improvements in social skills. Participants will: Complete behavioral tasks, including a LEGO construction test, at the beginning (T0) and after 3 months (T1). Attend weekly LEGO therapy sessions for 90 minutes, over the course of 3 months (12 sessions). Complete questionnaires about social behaviors, both parents and children, at T0 and T1.

Conditions

Neurodevelopmental Disorder

Keywords

Autism Spectrum Disorder; ADHD

Outcome Measures

Primary Outcomes (1)

• Social Skills

  1\. Social Skills Improvement System RatingScales (SSiS) (Gresham \& Elliott, 2008). The Social Skills Improvement System-Rating Scales (SSIS-RS; Gresham \& Elliott, 2008) is a multi-rater (teacher, parent/caregiver, and student) series of rating scales that documents the frequency of social skills and competing problem behaviors. It is a revision of the Social Skills Rating System (SSRS; Gresham \& Elliott, 1990). The SSIS-RS assess three domains of social skills, problem behaviors, and academic competence. All forms include common social skills in multiple subdomains: communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. The subscales are grouped beneath Problem Behavior and Social Skills domains. Higher scores mean a better.

  From enrollment (T0) to the end of treatment at 12 weeks

Secondary Outcomes (1)

• Autistic symtoms

  From enrollment (T0) to the end of treatment at 12 weeks

Study Arms (2)

Exprimental

EXPERIMENTAL

Experimental Group: This group will consist of children aged 10-14 diagnosed with high-functioning Autism Spectrum Disorder (ASD). These children will participate in LEGO therapy sessions once a week for 90 minutes over the course of 3 months (12 sessions total). The goal is to evaluate how LEGO therapy influences their social skills and behavior.

Behavioral: LEGO

Control

ACTIVE COMPARATOR

Control Group: This group will also consist of children aged 10-14 diagnosed with high-functioning ASD. However, these children will not receive LEGO therapy. Instead, they will continue their usual treatments in their local settings without participating in the LEGO therapy sessions. This group's outcomes will be compared with the experimental group to assess the effectiveness of LEGO therapy.

Other: Controllo

Interventions

LEGO BEHAVIORAL

The LEGO Therapy intervention in this clinical trial is designed to enhance social skills in children with high-functioning Autism Spectrum Disorder (ASD). The intervention involves the following components: Group Sessions: The therapy will be conducted in small groups of three children of the same age (10-14 years) with a diagnosis of high-functioning ASD. The sessions are designed to foster collaboration and social interaction between the participants. Duration: The intervention will last for 3 months, consisting of 12 sessions, with each session lasting 90 minutes. Sessions will take place once a week at the IRCCS Fondazione Stella Maris. Supervision: The groups will be supervised by trained professionals specializing in neurodevelopmental disorders, ensuring that the therapy is structured and supportive of each child\'s individual needs. Therapy Structure: During the sessions, children will engage in LEGO-based tasks, where they collaborate to build LEGO models.

Exprimental

Controllo OTHER

This group will also consist of children aged 10-14 diagnosed with high-functioning ASD. However, these children will not receive LEGO therapy. Instead, they will continue their usual treatments in their local settings without participating in the LEGO therapy sessions. This group\'s outcomes will be compared with the experimental group to assess the effectiveness of LEGO therapy.

Control

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 10 and 14 years;
• clinical diagnosis of Autism Spectrum Disorder according to ICD-10 (WHO, 1992);
• intellectual level in the normal range (IQ\>85);
• self-motivation to participate in the treatment both as regards the adolescent and the family;
• availability of caregiver support the participant during the programme;
• consent of the parents and the adolescent to participate in all evaluations and to be recorded during treatment sessions.

You may not qualify if:

• presence of a concomitant major psychiatric disorder (e.g., schizophrenia bipolar disorder);
• presence of oppositional/aggressive behaviour (outside the family context) family context);
• presence of genetic syndromes associated with autism spectrum disorder.

Sponsors & Collaborators

• Antonio Narzisi: lead

Study Sites (1)

Antonio Narzisi

Pisa, Italy, 56018, Italy

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders

Study Officials

• Giovanni Cioni, Neurolgy

  IRCCS Fondazione Stella Maris

  STUDY DIRECTOR

• Antonio Narzisi, Psychology

  IRCCS Fondazione Stella Maris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: September 20, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: from 01-01-2026 for 5 years
• Access Criteria: Writing a mail to principal investigator

Locations

IT (1)