Clinical Research Directory

Telehealth Exercise Boosts Sleep and Reduces Parental Stress in Autism

This study aims to test whether a physical activity program delivered through telehealth can help improve sleep quality in children with autism spectrum disorder (ASD) and reduce stress and improve well-being in their parents. Children in the study will wear a small device (an accelerometer) to measure their physical activity levels and sleep. Parents will answer questionnaires about their child's sleep habits, behavior, and social skills, as well as their own sleep, stress levels, and parenting experience. The program will be delivered remotely, allowing families to participate from their homes. It includes guided physical activities, family-based exercises, and regular telehealth support from professionals. The goal is to find out if this type of remote support can help both children with autism and their caregivers in daily life.

Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interaction, as well as repetitive and stereotyped behaviors. Home oral hygiene procedures are often resisted by children with ASD; consequently, maintaining an adequate level of oral hygiene can be challenging, leading to an increased risk of dental caries and gingivitis compared with children without ASD. Children with ASD frequently experience difficulties attending dental appointments, as the dental setting falls outside their usual routine. Furthermore, the smells, sounds, and visual stimuli present in the dental environment may be overwhelming for a child with ASD, causing anxiety that can exacerbate stereotyped behaviors and self-injurious actions, thereby making completion of the dental examination difficult. Given the sensory processing challenges commonly experienced by children with ASD, it is essential that dental professionals are aware of these difficulties and adopt specific strategies to reduce anxiety and promote cooperation during dental visits. Despite the use of traditional behavioral techniques, such as desensitization, modeling, and the tell-show-do approach, the management of these patients remains challenging. Clown therapy, which has already demonstrated effectiveness in reducing anxiety and pain in pediatric hospital settings, represents a potentially innovative intervention in this context, although evidence regarding its use in children with special healthcare needs remains limited. The primary objective of this study is to evaluate the number of completed steps of a dental visit protocol, comparing a familiarization pathway conducted through clown therapy with a conventional familiarization pathway conducted by dental staff in patients with ASD. The secondary objectives are to assess the level of cooperation during the familiarization sessions and to evaluate parent/caregiver satisfaction with the two proposed approaches.This study is designed as a pilot randomized controlled trial (RCT) with two parallel arms and a 1:1 allocation ratio. A total of 46 children (23 per group) aged 6 to 14 years with a diagnosis of moderate to severe Autism Spectrum Disorder (ASD Level II-III) who are uncooperative during the initial dental examination (Frankl Behavior Rating Scale score 1-2) will be recruited from the Dental Clinic of San Paolo Hospital . Eligible participants will be male or female children aged 6-14 years with a diagnosis of ASD Level II-III, a baseline Frankl score of 1-2 indicating non-cooperative behavior, inability to complete at least two steps of the dental examination, absence of coulrophobia (fear of clowns), absence of dental emergencies requiring immediate treatment, availability of a parent or caregiver to accompany the child to the familiarization sessions, and written informed consent provided by the parent or caregiver. Exclusion criteria include a diagnosis of ASD Level I, a baseline Frankl score of 3-4 indicating cooperative behavior, completion of more than two steps of the dental examination, presence of coulrophobia, dental emergencies requiring immediate treatment, lack of parental or caregiver availability for attendance at the familiarization sessions, or absence of written informed consent. Following acquisition of written informed consent from the parent or caregiver and assent from the child whenever appropriate, participants will be randomized into one of two study groups. The control group will undergo a conventional familiarization pathway based on standard behavioral management techniques delivered by dental staff, whereas the intervention group will undergo a familiarization pathway involving clown therapy, conducted collaboratively by dental professionals and professional clown therapists from Fondazione Dottor Sorriso. Both groups will attend three consecutive weekly sessions (T1-T3) following a gradual and non-coercive approach. For each participant, at the end of every session, a standardized data collection form will be completed to record the number of dental examination steps successfully completed and the level of cooperation. Upon completion of the three familiarization sessions, parents or caregivers in both study groups will be asked to complete a satisfaction questionnaire to evaluate their perceptions of the intervention received.

Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study

The purpose of this global multicenter confirmatory study is to evaluate the clinical efficacy and safety of Quantum-Inspired Intervention (QII), a novel non-invasive neurodevelopmental protocol, in children diagnosed with Autism Spectrum Disorder (ASD). Autism Spectrum Disorder involves complex neurodevelopmental dynamics characterized by challenges in emotional regulation and adaptive functioning. Existing clinical paradigms primarily rely on pharmaceuticals for secondary symptom control or behavioral methods aimed at external behavioral modification, while interventions targeting core functional shifts remain limited. Grounded in a quantum-inspired conceptual framework aimed at addressing foundational adaptive processing, QII integrates AI-enabled, fine-grained characterization of each child's needs with a proprietary quantum-inspired intervention protocol delivered by trained practitioners. While fully elucidating the fundamental mechanisms will require extended scientific timelines, the urgent needs of individuals and families make confirming tangible, real-world functional efficacy the paramount priority. Preliminary case reports of the QII protocol observed encouraging signals in emotional stabilization and spontaneous communication. Building on these initial findings, this study systematically evaluates the efficacy of QII at scale in an expanded, multicenter cohort. Eligible participants will be randomized to receive either the standardized QII protocol over a defined period or a waitlist control, with the waitlist control arm offered QII following completion of the primary analysis. The primary endpoint evaluates improvement in the autism-related symptom or functional difficulty identified as the primary intervention target at baseline, as measured by the Clinical Global Impression-Improvement (CGI-I) scale; changes in irritability and behavioral dysregulation, as measured by the Aberrant Behavior Checklist-Irritability Subscale (ABC-I), are evaluated as a secondary endpoint.All efficacy endpoints are assessed by independent clinicians blinded to group allocation. Caregivers may report any adverse event or safety concern at any time and may request to stop the intervention at any time; adverse events are also recorded at scheduled study assessments.

EEG As a Genetic Selection Lever in Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is a growing public health concern, with genetic causes identified in about 20% of cases. While exome/genome sequencing is powerful, its cost and limited yield call for better patient selection. Electroencephalography (EEG) shows promise: early EEG patterns can predict ASD, and specific EEG features may help identify subgroups more likely to have a genetic cause. This project explores using EEG to optimize genetic testing strategies in ASD.

Monitoring Daily Mobility in Children With Autism

Children with autism spectrum disorder (ASD) often show motor abnormalities and sleep disturbances that affect behavior, learning, and family quality of life. Emerging technologies such as wearable devices and markerless systems provide accessible tools for gait and sleep assessment, with actigraphy recommended for long-term monitoring in natural settings. Evidence also suggests links between sleep problems and sensory processing differences. This project, aims to integrate these approaches in a clinical-translational framework.

French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls

The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60. The main questions it aims to answer are: * Can subgroups of patients sharing a common profile of social withdrawal and anhedonia be identified, with similar clinical, genetic, biological and brain imaging characteristics? * Do other dimensions (cognitive flexibility, neurodevelopmental, sensory and sleep disturbances, impulsivity) and specific clinical forms (e.g., autoimmune psychosis, metabolic abnormalities) define relevant subgroups, and how do these subgroups evolve over time? Researchers will compare patients with healthy volunteers to identify clinical and biological signatures specific to each subgroup. Participants will: * Attend an inclusion visit, two one-day assessment visits one year apart (clinical interviews, questionnaires, cognitive tests, fasting blood sample) and two brain MRI sessions * Optionally provide a stool sample collected at home * Complete questionnaires on a smartphone app and wear a connected watch (activity, sleep, heart rate) between visits * Take part in the study for about 18 months French Minds is conducted in about 35 centres in France and aims to include 2,500 patients and 500 healthy volunteers.

Prospective Clinical Study on Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Childhood Autism

This clinical study aims to evaluate whether a nasal spray containing exosomes derived from human umbilical cord mesenchymal stem cells (hUC-MSC-EXOs) can safely and effectively improve core symptoms in children aged 3-7 years with autism spectrum disorder (ASD). It is a 24-week, non-randomized, controlled, open-label trial. Sixty pediatric patients with ASD will be non-randomly assigned at a 1:2 ratio to two groups: a no-intervention control group and an active exosome nasal spray treatment group. The treatment group will receive the nasal spray every other day, totaling 10 administrations throughout the study. The no-intervention control group will receive no experimental treatment but will undergo the same assessments and safety checks with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.

Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children

The present study will be performed to evaluate the effectiveness of peer modeling and audiovisual peer modeling video on toothbrushing skills in comparison to the visual pedagogical method at home. To monitor the improvement of teeth brushing skills in children with ASD using plaque and gingival indices.

Experiences of Healthcare for Autistic TGD Adults

To explore the experiences of autistic gender diverse adults that have attempted or are attempting to access, have accessed or are currently accessing gender identity healthcare in the United Kingdom

Assessing Outcomes of Three Different Museum-based Social Prescription Programs in Autistic Adults

This study will examine whether visiting the National Taiwan Museum can support the social and emotional well-being of autistic adults. The research team plans to recruit 90 autistic adults aged 18 to 50 from the Department of Psychiatry at National Taiwan University Hospital. Participants must have average-range intellectual ability and be able and willing to complete the study activities and assessments. People with serious physical or mental health conditions that would prevent full participation will not be included. Participants must also agree to audio and video recording during the activities. After an outpatient doctor confirms eligibility, participants will complete questionnaires and choose one of three museum participation options: 1. Visit the museum once independently. 2. Join five guided museum visits with group discussions. 3. Invite a friend to visit the museum together. Each group will include about 30 participants. For the guided group, each session will last about 90 minutes and include a professional museum tour, a question-and-answer period, time for independent exploration, and a group discussion. Participants will be encouraged to select exhibits that interest them, record their observations, share their thoughts, listen to others, and respond to different viewpoints. The five planned museum themes include Taiwan's history and identity, relationships between people and nature, architecture and living spaces, human evolution and the future, and attitudes toward money and financial planning. The discussions will explore everyday topics such as stereotypes, personal values, preferred living environments, hopes for the future, and managing money. Participants will complete questionnaires before and after the program. These questionnaires will assess areas such as autistic characteristics, social communication, empathy, sensory experiences, comfort with social touch, emotional skills, loneliness, anxiety, depression, and anxiety during social interaction. Participants will also rate how enjoyable, comfortable, safe, interesting, and socially engaging they found the museum activities. The researchers will compare participants' results before and after the program. They will also compare the three participation options to determine whether independent visits, guided group activities, or visiting with a friend produce different outcomes. The overall goal is to understand whether museum-based activities can be used as a form of social prescribing to improve social participation, emotional well-being, confidence, and quality of life among autistic adults.

Effectiveness of DIR/Floortime™ in Children With Autism Spectrum Disorder

This randomized controlled trial evaluates the efficacy of Integrated DIR/Floortime™ in improving functional emotional development and adaptive behavior in children aged 4-12 years with Autism Spectrum Disorder (ASD). Participants are randomly assigned to either an intervention group receiving DIR/Floortime™ in addition to their ongoing standard therapies or a control group receiving standard therapies alone. Functional emotional development is assessed using the Functional Emotional Assessment Scale (FEAS), while adaptive behavior is evaluated using the Vineland Adaptive Behavior Scales (VABS). The study aims to determine whether integrating DIR/Floortime™ leads to greater improvements in emotional, social, communication, and adaptive functioning compared with standard interventions alone.

Italian Validation of the Forensic Autism Risk Assessment Scale (FARAS-IT)

The study is a multicenter observational project designed to translate, culturally adapt, and validate the Italian version of the FARAS (FARAS-IT), a structured framework for assessing risk and protective factors specific to individuals with Autism Spectrum Disorder (ASD) involved in the Italian criminal justice system. Adult participants (≥18 years) with a diagnosis or well-founded clinical suspicion of ASD are consecutively enrolled over 12 months into three groups: offenders in forensic psychiatric settings under security measures, offenders considered criminally responsible and not under psychiatric care, and psychiatric patients with ASD without any history of criminal behavior followed by community mental health services or non-forensic residential facilities. All participants undergo assessment with FARAS-IT and complementary clinical and forensic instruments (e.g., WHODAS 2.0, BPRS or equivalents, HCR-20, SAPROF, DUNDRUM), alongside collection of clinical, functional, and judicial variables, in order to evaluate the psychometric properties of FARAS-IT (factor structure, internal consistency, test-retest and inter-rater reliability, convergent and discriminant validity) and its clinical-forensic usefulness in understanding criminal responsibility and judicial decision-making trajectories in individuals with ASD.

RCT of SCERTS (Social Communication, Emotional Regulation, Transactional Support) Program for Children With Autism Spectrum Disorder

This randomized control trial aims to assess the efficacy of the SCERTS intervention in children aged 3-6 years diagnosed with mild to moderate Autism Spectrum Disorder (ASD). The study evaluates the program's impact on improving social communication skills, adaptive behavior, and reducing caregiver stress while enhancing parental quality of life. The intervention incorporates components of Social Communication, Emotional Regulation, and Transactional Support, tailored to cultural and contextual needs in Pakistan. The study will also validate translated and culturally adapted tools for program evaluation. The SCERTS model is a multidisciplinary, evidence-based intervention that focuses on enhancing social communication, emotional regulation, and providing transactional support in children with ASD. This 8-week program will be tested through a single-blind randomized trial, with participants assigned to an experimental group or a waitlist control group. Outcomes include joint attention, imitation, emotional sharing, and intentional communication. The study will also evaluate the intervention's feasibility, fidelity, and acceptability in the Pakistani context. Post-intervention assessments and follow-ups will determine long-term benefits.

Exploring the Physiological Mechanisms of Austism Through Organoids

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder affecting approximately 1% of the population, characterized by difficulties with social interaction and communication. Studies have identified more than 200 genes linked to ASD, particularly those involved in chromatin remodeling and synaptic neuronal connectivity (CHD8, SCN2A, NLGN3-4X, SHANK1-3). The goal of the project is to decipher the biological mechanisms underlying ASD in order to develop therapeutic strategies, using innovative preclinical models such as organoids.

Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders

This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities. Participants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches. The purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available. This study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.

Phase II Clinical Trial to Evaluate the Efficacy and Safety of NV01-A02 in Children With Autism Spectrum Disorder

This is a multicenter, randomized, double-blind, placebo-controlled, therapeutic exploratory Phase 2 clinical trial designed to evaluate the efficacy and safety of NV01-A02 in pediatric participants diagnosed with Autism Spectrum Disorder (ASD).

Combination of Supplements for Treating Autistic Spectrum Disorder

A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.

Effectiveness of Video-feedback for Positive Parenting with Children At Risk of ASD

Improving parent-child interactions benefits child development and parents' perception of their competencies for childrearing and support for child learning and development, which in turns positively impacts on parental emotional well-being and Family Qualiy of Life. This intervention protocol aims to improve the quality of parent-child interactions in daily-routine activities (bath time, dressing, mails…), specially during play interactions at home, increasing the frequency and consistency of the 29 positive parental behaviors included in the PICCOLO. PICCOLO is an observational tool for assessing positive parental behaviors in caregiver-child interactions that have been positively related to child cognitive, socioemotional, and linguistic development. It was developed and published in the United States, and it was validated in Spain with mothers and fathers. An Spanish handbook has been also published. Guiding principles of the intervention protocol are an emphasis on the parents' strengths; a focus on daily routines in family context; and a non-directive intervention style, based on video feedback and coaching strategies as self-appraisal and reflection. Although the protocol could be applied to different populations, this study is implemented with mothers and fathers with a young child (aged 24-36 months) at risk of Autism Spectrum Disorder (ASD). All children and their families are being cared for by professionals in Early Intervention Centers in Spain. Inclusion criteria for receiving this intervention are a) child at medium-high risk of ASD; b) primary caregiver at risk of anxiety, depression, or parental stress; c) primary caregiver with a low or medium-low level of positive parental behaviors in the PICCOLO. The protocol includes bimonthly sessions of 60 minutes duration for six months with the main caregiver who participates in the program. Sessions are conducted by videoconference. Every session focuses on three different PICCOLO behaviors that have been identified in a previously recorded caregiver-child interaction during play at home (book-reading, symbolic play, or manipulative play). A new video is auto recorded every month by parents, so that each video is analyzed together with the caregiver in two sessions. After each session, the parents receive a written reminder of the aspects that have been worked on in the video feedback session, and of the agreements regarding the situations of daily life in which these aspects could be put into practice. Family picture-books are progressively created, including selected frames from the videotapes that illustrate the positive parental behaviors that have been discussed. Six new images are included every month. Caregivers are encouraged to look at and talk about the book with their children at home and to share it with other family members. The primary aim of the proposed study is to assess the efficacy of an intervention to improve caregiver competencies through the observation of caregiver-child interaction, using video-feedback coaching strategies based on parental strengths, from a collaborative model. It is hypothesized that (1) developmentally supportive parental behaviors of mothers and fathers, measured with PICCOLO, after the intervention will be significantly higher in the intervention group (IG) than in the control group (CG); (2) levels of anxiety, or depression and/or stress of mothers and fathers after intervention will be significantly lower in the IG than in the CG; (3) Parental self-efficacy of mothers and fathers after the intervention will be significantly higher in the IG than in the CG; and (4) family quality of life after intervention will be significantly higher in the IG than in the CG. Also, it is hypothesized that individual trajectories in families within the IG will show changes in the outcome variables consistent with these expectations during the intervention period. it is hypothesized that these positive changes will not be observed in the CG, who will continue receiving the usual early intervention services. With respect to intervention assessment, it is hypothesized that there will be significant and positive associations between key outcomes of the study and the scores obtained on the HOVRS-3 measure of four evidence-based home visiting practices: relationship building with families, responsiveness to family strengths, facilitating family interaction, collaboration with caregivers. Finally, it is expected to find a secondary benefit on child's development, assessed with the DP-3 (Developmental Profile-3), particularly in the communication and social adaptation areas.