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Autism clinical trials

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NCT ID: NCT05880225 Recruiting - Clinical trials for Autism Spectrum Disorder

Reciprocal Imitation Training and Musical Rhythm Sensitivity in Autistic Toddlers

Start date: July 3, 2023
Phase: N/A
Study type: Interventional

The primary goal of this study is to examine rhythm sensitivity as a predictor of response to naturalistic developmental behavioral intervention (NDBIs) in autistic toddlers. Toddlers receive either Reciprocal Imitation Training (RIT), an evidence-based NDBI that supports children's imitation and social communication skills, or a music-enhanced version of RIT. Throughout their participation in the intervention, toddlers will complete study procedures of viewing naturalistic videos of infant-directed singing and other social scenes while eye gaze data is collected.

NCT ID: NCT05874466 Recruiting - Clinical trials for Autism Spectrum Disorder

SenseToKnow Autism Screening Device Validation Study

Start date: July 7, 2023
Phase:
Study type: Observational

This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.

NCT ID: NCT05867940 Recruiting - Cerebral Palsy Clinical Trials

Effects of Physical Activity on Prescription (PAP) as a Health-enhancing Intervention in People With Disabilities

PAP
Start date: June 5, 2023
Phase: N/A
Study type: Interventional

Physical inactivity is an increasing problem in the general population in society. However, in people with disabilities, inactivity is even more frequently reported. Physical activity on prescription (PAP) is a well-established method to enhance physical activity. The prescribed physical activity can be activities such as walking, cycling, swimming, or gardening, and should be performed over a longer period. In children with cerebral palsy, PAP has shown to be feasible to increase participation in physical activity and to reduce sedentary behaviour, and the habilitation services in the Region of Skåne have decided to offer PAP to all children and youth with disabilities. It is of great importance to study these interventions when applied on a broader group of patients than previously studied. The aim is to study the effects of an individualised and health-enhancing intervention in physically inactive people with autism, intellectual and physical disabilities. Also, the cost-effectiveness of PAP will be studied. 60 physically inactive children, aged 8- 17 years, and 20 adults, with autism, intellectual or physical disability will be included. The participants are recruited by their clinical physiotherapists, who also will be carrying out the PAP-intervention. The self-selected physical activity/activities may either be a physical activity organized by a club and/or an everyday activity such as walking a dog or riding a bicycle to school. Each participant fills in an activity logbook. Motivational interviewing will be used to support the participants. The Canadian Occupational Performance Measure can be used to identify what activities the participants are motivated to do, and to detect changes in the participants' perception of their performance of the activity. Quality of life will be monitored. Physical activity will be measured through the International Physical Activity Questionnaire (IPAQ) and a movement monitor (accelerometer). Study specific questionnaires will be filled in regarding costs and background information. Data on health care use of the participants will retrospectively be collected and studied using the health care database in Region Skåne. Data will be collected at 3 months prior to the intervention, just before the intervention starts, when the intervention is finished, and at 6, 12 and 24 months after the intervention. The study has been approved by the Swedish Ethical Review Authority.

NCT ID: NCT05862467 Recruiting - Trauma Clinical Trials

A Pilot Participatory Program Evaluation of a Virtual Trauma Support Program for Autistic Adults

Start date: October 26, 2023
Phase: N/A
Study type: Interventional

The goal of this single-group clinical trial is to learn about the initial efficacy and feasibility of telehealth-delivered Written Exposure Therapy (WET) for autistic adults with traumatic stress symptoms. The main questions the investigators aim to answer are: - Do symptoms of posttraumatic stress disorder (PTSD) and co-occurring mental health concerns decrease after receiving WET? - Do biobehavioral health outcomes, including objective (Fitbit indicators of activity, sleep, and heart rate) and subjectively-reported health variables (e.g., sleep, pain, health-related quality of life), improve after receiving WET? - How do autistic adults experience WET, and how can this program be modified and enhance in the future in collaboration with autistic adults? Participants will complete the following as part of the study, which is completed entirely over telehealth. - Participants will first complete an initial assessment, involving brief measures of cognition and autistic traits, as well as interviews and questionnaires about PTSD, mental health, and physical health. If eligible, participants will proceed to the following steps: - Eligible participants will then start wearing a Fitbit, to be used for the duration of the study. - Participants will then participate in 5 weekly virtual visits involving the WET protocol, including weekly brief assessment of PTSD and mental and physical health. - Then, participants will complete a sixth virtual visit the following week where PTSD, mental and physical health, and treatment feedback are assessed. - Lastly, participants will complete virtual visits 1 and 6 months later involving re-assessment of PTSD and mental and physical health. Therefore, this is a pre-post single group design, where all participants will receive WET to establish initial efficacy and feasibility. Investigators will also consult with an autistic advisory board throughout the project, and make adaptations as recommended in consultation with autistic adults. The goal is to better understand the initial efficacy and feasibility of WET for supporting autistic adults who have experienced trauma.

NCT ID: NCT05829161 Recruiting - Autism Clinical Trials

Sensory Phenotypes of Autism Spectrum Disorder

Start date: January 1, 2020
Phase:
Study type: Observational

This project plans to establish sensory phenotypes of a Taiwanese ASD cohort across lifespan, including variety of sensory modalities, sensory domains, and clinical correlates. Also, we will clarify the relationship between sensory phenotypes and social impairment by two specific sensory-social paradigms targeting eye gaze avoidance and social touch anxiety, as well as the atypical neural representation of ASD during eye gaze and viewing social touch by fMRI and EEG.

NCT ID: NCT05806216 Recruiting - Clinical trials for Autism Spectrum Disorder

Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD) For Children Ages 31-84 Months

MEASURE-ASD2
Start date: August 23, 2023
Phase:
Study type: Observational

The goal of this clinical study is to learn about the utility and performance of the EarliPoint System (™): Evaluation for Autism Spectrum Disorder to diagnose and assess autism spectrum disorder (ASD) in children ages 31-84 month (2.5 - 7 years chronological age). The main questions it aims to answer are: 1. To determine the sensitivity and specificity of the EarliPoint device (test) compared to Expert Clinician Diagnosis (ECD) using gold-standard clinical reference assessments in the target age-expanded population. 2. To determine the association between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 3. To determine the association between the EarliPoint Nonverbal Ability Index score and the clinical measures of non-verbal abilities as measured by the Differential Ability Scales (DAS-II). 4. To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score. 5. To determine the association between the EarliPoint Expressive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 6. To determine the association between the EarliPoint Receptive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II). 7. To estimate the incidence of adverse device effects associated with the use of the EarliPoint device.

NCT ID: NCT05794620 Recruiting - Clinical trials for Autism Spectrum Disorder

Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

FAMILY
Start date: December 20, 2022
Phase:
Study type: Observational

This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.

NCT ID: NCT05780138 Recruiting - Depression Clinical Trials

Implementation of the Parents Taking Action in Paraguay

PTA-Paraguay
Start date: December 16, 2023
Phase: N/A
Study type: Interventional

The principal aim of this study is to conduct a single group design pilot of a psychoeducational caregiver training (i.e., culturally adapted Parents Taking Action) with a group of family caregivers of young children with autism in Paraguay. The following research questions will be addressed: Research Question #1: What is the feasibility and acceptability of the intervention? Research Question #2: Do participants improve between pre and post-test on outcome measures? Parents will receive 10 weekly remote sessions on information about autism and strategies to support their child's development. The weekly sessions will be held via telehealth by the researcher and 2 and 2 Paraguayan trained parents of autistic individuals.

NCT ID: NCT05752994 Recruiting - Clinical trials for Autism Spectrum Disorder

Multisensory Environment Room in Children With Autism Spectrum Disorder

Start date: March 9, 2023
Phase: N/A
Study type: Interventional

To investigate the effect of multisensory environment room on behavior in children with autism spectrum disorder age 3-5 years old. The children will be randomized into 2 groups: the experimental and the control group. The control group will be educated about the autistic and hoe program training. The intervention group will got the same educational program as the control group plus training in multisensory room environment once a week for 10 weeks. The outcome measurement was done as the before intervention, at the 5th and 10th week.

NCT ID: NCT05741840 Recruiting - Clinical trials for Autism Spectrum Disorder

Family, Responsibility, Education, Support, and Health for Families With a Child With Autism

FRESH-A
Start date: August 18, 2023
Phase: N/A
Study type: Interventional

The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).