Clinical Research Directory

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.

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, randomized, controlled, open-label trial. Forty pediatric patients with ASD will be randomly assigned at a 1:1 ratio to two groups: an active exosome nasal spray treatment group and a no-intervention control 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 concurrently with the treatment group. This design aims to monitor the safety and efficacy of the hUC-MSC-EXOs nasal spray.

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.

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.

Gamified Tai Chi Intervention to Improve Executive Function in Children With Autism Spectrum Disorder

This randomized controlled trial evaluates the effectiveness of a "Gamified Tai Chi" intervention on improving executive functions (such as inhibitory control, working memory, and cognitive flexibility) in children with Autism Spectrum Disorder (ASD). The study aims to determine whether integrating game mechanics (based on the Mechanics, Dynamics, and Aesthetics framework) into Tai Chi training offers superior benefits compared to traditional Tai Chi training or routine care. Approximately 200 children aged 8-15 years will be randomly assigned to one of three groups for a 12 months period: Gamified Tai Chi Group: Participants will attend sessions combining simplified Tai Chi forms with interactive tasks, such as digital chasing games and cooperative challenges, using a point-based reward system to enhance engagement. Traditional Tai Chi Group: Participants will learn the same Tai Chi movements but via standard instruction methods without gamification elements. Control Group: Participants will continue their routine rehabilitation or physical education classes (Waitlist design). Assessors who are blinded to group allocation will evaluate outcomes at baseline and post-intervention using standardized cognitive tasks (e.g., Flanker task, 1-back task) and behavioral questionnaires regarding social functioning and daily living skills.

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.

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).

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

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.