Clinical trial NCT06641583: Efficacy of LEGO Therapy for Adolescent with Level 1 Autism
Official title: Efficacy of LEGO Therapy for Adolescent with Level 1 Autism
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Neurodevelopmental Disorder
Keywords: Autism Spectrum Disorder
ADHD
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Detailed description: The study aims to involve children with Autism in a social skills enhancement program called LEGO therapy. The program will consist of 12 sessions (over 3 months), held once a week for 90 minutes. These sessions will take place at the IRCCS Fondazione Stella Maris in Calambrone (Pisa). Before the program starts (T0) and after it ends (T1, 3 months later), both parents and their children will be asked to complete some questionnaires designed to investigate potential changes in certain behavioral variables before and after the LEGO Therapy intervention. Additionally, at both T0 and T1, children will also be assessed through a LEGO construction task.

LEGO Therapy Intervention The LEGO therapy sessions will be conducted in a group setting. The group will consist of three children of the same age, all diagnosed with high-functioning Autism Spectrum Disorder. The group will be supervised by staff specialized in neurodevelopmental disorders. Participation is voluntary, and partecipants may withdraw from the study at any time, for any reason, without penalty. All collected data will remain anonymous and analyzed in aggregate form. The questionnaires are not designed to collect personal information about parents or their children. The study does not intend to evaluate other aspects beyond those specified, and no incidental findings (e.g., clinical or diagnostic) are expected. The collected data will be stored on a private server and only accessible to the study supervisors (i.e., not provided to third parties) for five years. The results will be used for publications and presentations in academic and scientific settings. Participation in the study poses no specific risks, and children can pause and resume the questionnaire at any time. If partecipants have any questions or concerns about the nature of this research, please contact the lead researcher Antonio Narzisi at IRCCS Fondazione Stella Maris, 050886308, antonio.narzisi@fsm.unipi.it.

What are the characteristics of this study?

This is an interventional study involving 64 subjects with Autism Spectrum Disorder (both male and female), aged 10 to 14. The children will be consecutively recruited either from natural admissions to the IRCCS Fondazione Stella Maris - Operational Unit 2 of Child and Adolescent Psychiatry and Psychopharmacology or through outpatient services. The study will last 6 months, during which time the investigators plan to engage participants. Specifically, this is an open-label randomized study, meaning that both the experimenter and the participant will know the type of treatment being studied. The investigators recognize that open-label studies can introduce bias due to participants and caregivers being aware of the treatment. However, the investigators are implementing several strategies to mitigate these biases:

Blinding of Assessors: The outcome assessors will be unaware of the treatment group to which the participants have been assigned, reducing the risk of bias in outcome assessments.

Use of Objective Measures: The investigators will include objective and standardized measures to evaluate outcomes, in addition to subjective assessments from participants and caregivers.

Data Analysis: The investigators will perform rigorous statistical analyses to control for and identify potential confounding effects related to treatment awareness.

Even though LEGO therapy is well-structured and has demonstrated efficacy in the United States, the investigators cannot assume that the results will automatically translate to the Italian context. Cultural, social, and systemic differences may influence treatment effectiveness. Therefore, a local evaluation of effectiveness is essential to:

1. Validate the Intervention: Confirm that the therapy produces the same benefits in the new cultural context.
2. Adapt the Protocol: Identify and make any necessary adjustments to optimize the intervention for the Italian population.
3. Generate Local Evidence: Provide relevant data for healthcare professionals and policymakers in Italy, supporting the adoption of therapy based on local evidence.

In summary, assessing the effectiveness and cultural adaptability of LEGO therapy in the Italian context is crucial to ensure the treatment is not only applicable but also effective for the new target population. The investigators are aware of the challenges associated with bias in open-label studies and are implementing strategies to mitigate them while ensuring robust and reliable results.

What exams, tests, and procedures are included in the study? If parents decide to allow their child to participate in the study, please note that it involves the administration of certain questionnaires and semi-structured interviews to both parents and their children, as part of routine clinical practice. Specifically, parents will be asked to complete some questionnaires at baseline (T0) and at T1 (after 3 months), with an estimated completion time of around 60 minutes.

Additionally, all children will undergo a behavioral task at both T0 and T1, where they will be engaged in building a LEGO composition on their own and in collaboration with an examiner. The tasks will be recorded and will last no longer than 10 minutes.

After the T0 evaluation, the children will be randomized into two groups: experimental (LEGO therapy) and control (not receiving LEGO therapy). The experimental group will attend weekly LEGO therapy sessions at IRCCS Stella Maris, lasting 90 minutes, for three months (12 sessions). The control group will continue their regular therapies in their local areas and will not receive LEGO therapy. As stated earlier, at the end of the three-month intervention, both experimental and control groups will undergo an outcome assessment, which will take place at IRCCS Stella Maris.

Eligibility criteria: Inclusion Criteria:

* 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\&gt;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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Social Skills
timeFrame: From enrollment (T0) to the end of treatment at 12 weeks
Secondary outcomes:
measure: Autistic symtoms
timeFrame: From enrollment (T0) to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Antonio Narzisi
Study officials:
affiliation: IRCCS Fondazione Stella Maris
name: Giovanni Cioni, Neurolgy
role: STUDY_DIRECTOR
affiliation: IRCCS Fondazione Stella Maris
name: Antonio Narzisi, Psychology
role: PRINCIPAL_INVESTIGATOR
References: