Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641583
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Efficacy of LEGO Therapy for Adolescent with Level 1 Autism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of LEGO Therapy for Adolescent with Level 1 Autism
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEGO
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
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 eg clinical or diagnostic are expected The collected data will be stored on a private server and only accessible to the study supervisors ie 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 antonionarzisifsmunipiit
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
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 eg clinical or diagnostic are expected The collected data will be stored on a private server and only accessible to the study supervisors ie 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 antonionarzisifsmunipiit
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None