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Autistic Disorder clinical trials

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NCT ID: NCT05754073 Recruiting - Clinical trials for Autism Spectrum Disorder

Oxytocin Effects on Bone Metabolism in Children With Autism Spectrum Disorder

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, placebo-controlled study of the effects of intranasal oxytocin on bone health in children with autism spectrum disorder, ages 6-18 years old. Subjects will be randomized to receive intranasal oxytocin or placebo (30 IU, 2 times daily) for 12 months in the double-blind phase, followed by a 6-month open label phase during which all study subjects will receive intranasal oxytocin (30 IU, 2 times daily). Study visits include screening to determine eligibility, followed by study visits at baseline, week 2, and months 6, 12, 18 and phone calls every two weeks for the first two months and monthly thereafter for the duration of the study. Study assessments include history and physical examinations, anthropometric measurements, electrocardiogram (EKG), adverse event monitoring, laboratory tests for chemistries, hormones and biomarkers for bone metabolism, questionnaires regarding diet and exercise, and imaging to assess body composition, bone density and structure.

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: NCT05750095 Recruiting - Clinical trials for Autism Spectrum Disorder

Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs

ENACT
Start date: January 10, 2022
Phase: N/A
Study type: Interventional

Autism spectrum disorders (ASD) are disabling and impairing conditions affecting 1% of children in Norway. ASD is hallmarked by severe social deficit and lack of independence causing reliance on supportive systems throughout life. Parents are usually the primary caretakers and support, often throughout life. Normal parenting skills are however often ineffective due to the social dysfunction of the child with ASD. This causes high stress as the demands exceed the resources and capability of the parent. The high stress is associated to increased risk for mental health problems, divorce, unemployment and reduced quality of life. High parent stress may also reduce the effect of interventions in ASD. However, although the need is great and parental follow-up is an integral part of health care for ASD children, there is a lack of evidence for such interventions. The current project aims to evaluate a specific parent program that is in clinical use - the Incredible Years for children with ASD - compared with a standardised treatment as usual (TAU) composed of clinical parent workshops ("first aid for parents"). The aim is to evaluate parenting interventions and promote evidence-based practice in a clinical setting. The investigators will perform a randomized controlled trial and qualitative interviews to compare the effectiveness of treatment as usual (TAU) versus a manualized parent program (IY-ASLD). The study aims to investigate if the parental program may reduce parent stress and improve parental competence and self-efficacy. Secondary goals are to investigate whether the parent program may improve quality of life for the parent and the child and have an impact on long-term child functioning and service use.

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).

NCT ID: NCT05726708 Recruiting - Clinical trials for Autism Spectrum Disorder

Impact of an E-Learning Coaching for Parents of Young Children With Autism

ECOACH
Start date: October 24, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the impact of a parental coaching based on E-Learning (EL), intended for parents of children with autism spectrum disorder (ASD). Population: parents of young children (2 to 4 years old) with an ASD diagnosis. The main questions that our study will answer are: - Has parental coaching via E-Learning a significant impact compared to no coaching? - If so, is that impact comparable to standard parental coaching such as PACT? The impact will be evaluated in three domains: - Child development: behavior, sleep, eating behavior - Parental competences: stress, coping, feeling of parental competencies - Parent-child interaction: communication, visual attention The investigators will compare 3 groups: 1. ASD children whose parents will follow a parental coaching via E-learning, 2. ASD children whose parents will follow a standard parental coaching (PACT) 3. ASD children whose parents will not follow any specific coaching program

NCT ID: NCT05716906 Recruiting - Clinical trials for Autism Spectrum Disorder

Melatonin and Sleep Spindles in Autism

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Sleep disturbances and sensory sensitivities are common disabling features of autism, but their underlying causes are not clear. We hypothesize that both of these difficulties reflect disrupted communication between a deep brain structure, the thalamus, and the brain's outer layer, the cortex. This communication is mediated by the thalamic reticular nucleus (TRN). Due to its small size and location deep in the brain, we cannot assess TRN function without invasive techniques. Fortunately, sleep spindles, a specific brain rhythm provide a noninvasive read-out of TRN function. In Aim 1 we will examine whether reduced sleep spindles are related to worse sleep quality, impaired selective attention during wake, and sensory sensitivities in children with autism. In Aim 2, we will determine whether melatonin, which is commonly used to improve sleep, also increases sleep spindles in autism. If successful, this study will introduce TRN as a target for treatment of sleep disruption and guide larger home-based sleep studies.

NCT ID: NCT05712512 Recruiting - Clinical trials for Autism Spectrum Disorder

Experimental Techniques for Early Identification of Autism

Start date: July 19, 2021
Phase:
Study type: Observational

This project deals with essential challenges in the context of Autism Spectrum Disorder, benefiting from a longitudinal design in infancy and a cutting-edge electroencephalogram/eye-tracking integrated approach. The investigators will focus on multisensory audiovisual integration to identify early markers of autism in infants at-risk for autism. The investigators will characterize early derailments from the typical developmental trajectories to identify critical "time windows" and better describe the heterogeneity of autism.

NCT ID: NCT05707923 Recruiting - Clinical trials for Autism Spectrum Disorder

How Simplified Language Affects Comprehension and Learning in Young Autistic Children

PALS
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with ASD. The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with ASD (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with ASD will process full, grammatical utterances faster and more accurately than single-word or telegraphic utterances. Aim 2 will test the hypothesis that full, grammatical utterances will support word learning better than telegraphic or single-word utterances. Aim 3 will test the hypothesis that language and cognitive skills significantly moderate the effects of linguistic simplification on language processing and word learning in young children with ASD.

NCT ID: NCT05702658 Recruiting - Autism Clinical Trials

The Effectiveness of an Autistic-delivered Peer-support Intervention for Autistic Adults: Community Autism Peer Specialist (CAPS) Program

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

The number of autistic adults reached 5.4 million in the United States in 2017 and is projected to continue to rise, but evidence-based practices to optimize their health and well-being are limited and poor outcomes are common. This study will leverage existing infrastructure to finalize the development of a novel support service provided by peers with lived experience, incorporating input from autistic peer specialists, autism researchers, peer support researchers, and experts in peer support training. Investigators will then conduct a pilot randomized controlled trial to examine the effectiveness of the service while also examining the feasibility, acceptability, and implementation procedures in preparation for future large-scale testing and dissemination.

NCT ID: NCT05699928 Recruiting - Clinical trials for Autism Spectrum Disorder

Accuracy of Community General Pediatrician Diagnosis of Autism Compared to a Multidisciplinary Team Assessment

Start date: November 24, 2022
Phase:
Study type: Observational

The goals of this diagnostic study are to determine how accurate general pediatricians are in autism spectrum disorder (ASD) diagnostic assessment and which children might be best suited for this type of assessment. The investigators will also evaluate the use of a new virtual diagnostic tool, the Autism Assessment for Preschoolers with Language Element Sequence (AAPLES). The investigators will recruit twenty general pediatricians from across Ontario, Canada, as well as 200 of their patients (maximum 10 per pediatrician) who have been referred with possible ASD. The general pediatrician will complete their assessment and decide on a diagnosis, but will not tell the family. The ASD expert team, consisting of a developmental paediatrician and a psychologist, will also perform a diagnostic assessment without knowing the general pediatrician's opinion. The team will inform the family of their diagnostic opinion. Investigators will determine the diagnostic agreement between the two assessments. They will then determine which of the child's characteristics (age, sex, racial/ethnic background, ASD features, developmental delays, having a sibling with ASD) predict agreement in diagnosis. Some children in the study will have the option of undergoing an additional virtual autism diagnostic assessment using the AAPLES. The clinician administering the AAPLES will not know the results of the other assessments. The investigators will measure diagnostic agreement between the clinician administering the AAPLES and the expert team.