Efficacy of LEGO Therapy for Adolescent with Level 1 Autism
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Social Skills
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Social Skills
时间窗: From enrollment (T0) to the end of treatment at 12 weeks
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.
次要结局
- Autistic symtoms(From enrollment (T0) to the end of treatment at 12 weeks)
研究者
Antonio Narzisi
PhD
IRCCS Fondazione Stella Maris