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Autistic Disorder clinical trials

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NCT ID: NCT05846932 Recruiting - Clinical trials for Autism Spectrum Disorder

Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are: - Does occupational therapy integrating horses improve self-regulation in autistic youth - Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week. Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.

NCT ID: NCT05838352 Recruiting - Clinical trials for Autism Spectrum Disorder

Multidisciplinary Telerehabilitation Practices in Autism

Start date: November 22, 2023
Phase: N/A
Study type: Interventional

The study, titled The Effect of Physiotherapy and Nutrition Services Provided by Telerehabilitation Methods on the Physical, Nutritional and Psychological Conditions of Children with Autism and Their Families, aimed to evaluate the effects of physiotherapy and nutrition education to be given to the participants. Participants were children with autism spectrum disorder and parents of children with autism spectrum disorder. There will be surveys that researchers will ask participants to answer. Parent telerehabilitation group participants via smartphone video conferencing; Researchers involved in this project; A physiotherapist and a physiotherapist senior physiotherapy intern will send 1 session of online simultaneous exercise training to the parent telerehabilitation group participants, then an exercise video containing the exercises and brochures will be sent and the parent telerehabilitation group participants will be asked to do the exercises 3 days a week. Participants will be asked to keep an exercise diary and the status of the diaries will be monitored once a week. Additionally, the concepts of physical activity and recreational activity in autism will be explained to the participants. Again, via smartphone video conferencing, the researchers participating in this project; 3 different nutrition trainings will be given by 1 dietitian and 1 senior dietitian trainee within the scope of basic nutrition and nutrition-health information at 15-day intervals. Waist, hip and height measurements of autistic child participants will be measured with a tape measure, and their body weight will be measured with a scale. The study will last 2 months.

NCT ID: NCT05830591 Recruiting - Clinical trials for Autism Spectrum Disorder

Gut-oral Axis Microbiome in Autism Spectrum Disorders

Start date: May 20, 2021
Phase:
Study type: Observational

Autism Spectrum Disorder (ASD) is a neurodevelopment disorder characterized by impairment in social interaction, communication, and behavior, as well as sensory challenges. In addition, secondary symptoms can appear, such as gastrointestinal disorders. Gut microbiota has an important role in the harvest of nutrients and energy from our diet. It influences a wide range of metabolic, developmental, and physiological processes such as the maintenance of the gut epithelial layer, immune system development, protection against pathogens, detoxification and xenobiotics degradation. The ecosystem of a healthy human gastrointestinal (GI) tract is mainly populated by Firmicutes and Bacteroidetes phyla, to a lesser extent by Actinobacteria and Proteobacteria, in this case the microbiota is in an eubiosis condition. Whether a disturbance of the microbial ecosystem occurs, gut microbiota is in a dysbiosis condition and it could lead different metabolic disorders. The two-way communication between gut microbiota and central nervous system (CNS) affects stress response, pain perception, neurochemistry and several disorders. The gut microbiota in ASD patients revealed some peculiarities such as the high percentage of Propionibacter and Clostridium, well known for their production of pro inflammatory metabolites, or an increment of Sutterella spp. and Ruminococcus torques, which are negatively associated with the health of the gut. Recent studies suggest that also the oral microbiota may be involved in ASD symptoms assuming the existence of a "microbiota-oral-brain axis". ASD patients are often suffering of several oral cavity disorders like caries, gingivitis and periodontitis, probably due to the poor oral hygiene. These disorders are linked to a dysbiosis of the oral microbiota: the characterization of the ASD subjects oral microbiota showed a lower biodiversity of bacteria species and different levels of specific bacteria, comparing to the controls. Several studies suggest that some bacteria species invade the blood-brain barriers as well as their metabolites, triggering inflammatory response and an alteration of the metabolic activity in the CNS. It has been demonstrated that ASD patients have a high level of pro-inflammatory cytokines and chemokines in the cerebrospinal fluid and an upregulation of the microglia. The oral microbiota could also affect the lower GI tract and have a significant role within the ASD-associated GI disorders and CNS inflammation

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: NCT05822921 Completed - Clinical trials for Autism Spectrum Disorder

Providing Accessible Diagnostic Evaluations and Psychoeducation for Autism Spectrum Disorder in Rural Southwest Virginia

Start date: July 17, 2019
Phase: N/A
Study type: Interventional

This study will be the pilot/feasibility phase of a future clinical trial. The proposed feasibility and pilot study aims to bridge the barriers to diagnosis by providing easy-to-access assessment for free, through a mobile unit that travels to rural locations and telehealth assessments. The diagnostic evaluation will confirm or rule out a diagnosis of ASD, followed by purposeful ASD psychoeducation for parents whose children are diagnosed. Parents of children who meet criteria for a diagnosis of autism spectrum disorder (ASD) or are suspected to have ASD will be randomized into one of three groups (i.e., in-person psychoeducation, telehealth psychoeducation, or "psychoeducation as usual" with paper psychoeducation materials). Parents will complete outcome measures related to their satisfaction, empowerment, and autism spectrum disorder knowledge. Changes in empowerment and ASD knowledge from pre- to post- psychoeducation will be measured using t-tests. The investigators will also track if participants sought and/or received additional ASD-related services throughout the study up to 6-months post-psychoeducation. Results from this study will help to guide a future, fully powered efficacy trial with a larger sample. Added April 2020: In light of the Virginia governor's stay-at-home order in response to the COVID-19 outbreak, the investigators are altering the protocol in line with the university's request to move to remote conduct of research where possible as well as to continue to provide services to families in this time, in line with Executive Order 53 from the VA Governor. Parents in the latter half of the study conducted entirely remotely, will be randomized into the two psychoeducation conditions, telehealth or paper materials psychoeducation groups, as in-person visits are not permitted. Statistical analyses will be added to compare results between and within those who received in-person versus telehealth assessments. The investigators and participants may return to in-person assessments if and when it is possible to do so, but reserve the right to continue tele-assessment even once stay-at-home orders are lifted, in order to fully answer the research aim of the feasibility and validity or tele-assessment procedures in ASD.

NCT ID: NCT05815095 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services

Start date: September 1, 2024
Phase:
Study type: Observational

This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome

NCT ID: NCT05813756 Recruiting - Clinical trials for Autism Spectrum Disorder

Validation Study of the Coping, Motivation and Post-diagnosis Psychoeducation Program for Adults With Autism

CoMPPAA
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability

NCT ID: NCT05811507 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of Serum Adrenal Androgens Among Prepubertal and Pubertal Boys With Autism Spectrum Disorder

Start date: April 2023
Phase:
Study type: Observational

Autism spectrum disorder (ASD) is a neurodevelopmental disorder of unclear etiology. There are theories depicting the importance of sex steroid hormones in autism, since the prevalence of the disorder is male-biased. What makes boys more vulnerable to achieve the diagnosis of autism remains unclear. One of the theories strengthens the importance of fetal organizational effect of testosterone on brain development. Baron Cohen with coworkers showed that elevated fetal levels of several androgens including testosterone were high in male-fetuses who later in postnatal life achieved the diagnosis of autism and fetal testosterone levels were positively correlated with autistic traits in general population. Females with conditions of abnormal prenatal exposure to testosterone and its sex steroid precursors, such as congenital adrenal hyperplasia and polycystic ovary syndrome, were found to have higher rate of autistic traits as well as their children were of higher risk of developing autism. However, the exact mechanism by which these hormones influence the manifestation of autistic traits remains undiscovered. Another model explaining higher prevalence of ASD in males is a female protective model which suggests that multiple genetic factors contribute to the development of ASD and that higher threshold of genetic liability is required in females compared to males. Zhang et al. demonstrated genetic evidence of sex differences in ASD confirming female protective model, employing investigation of de novo mutations, common variants of ASD candidate genes and their co-expression in male and female brain. During infancy: The Gonadotropin releasing hormone (GnRH) pulse generator is reactivated by 6 to 10 days after birth. This period, termed the mini puberty of infancy, was first described in the 1970s. During mini puberty, luteinizing hormone (LH) levels approximate pubertal concentrations, reaching a peak between 16 and 20 days of life. Serum testosterone levels rise in response to rising concentrations of LH, paralleling an increase in Leydig cell number and testicular testosterone concentrations. Serum testosterone levels peak from 1 to 3 months (210 ± 130 ng/dL or 7.28 ± 4.51 nmol/L on day of life 30) and decline by roughly 50% per month reaching prepubertal levels by 7 to 12 months of age. Dihydrotestosterone (DHT) concentrations parallel the rise in testosterone, reaching pubertal values during the early postnatal period. During puberty: Testosterone is produced primarily by the testes, though a small amount is also made in the adrenal gland. Gonadarche refers to the onset of sex steroid production from the gonads and occurs in response to pulsatile production of GnRH from the hypothalamus, which in turn stimulates production of LH and Follicle stimulating hormone (FSH) from the pituitary gland. LH stimulates the Leydig cells to produce testosterone, whereas FSH stimulates the Sertoli cells to proliferate and initiate spermatogenesis. Active androgens are synthesized via two alternative pathways. The first of them is known as the classic "frontdoor" pathway with pregnenolone serving as androgen precursor, which underwent a conversion to DHEA and subsequently to androstenediol. These metabolic steps are catalyzed by CYP17A1 (in the C17,20-lyase step) and (mostly adrenal) AKR1C3 enzyme, respectively. Dehydroepiandrosterone (DHEA) and androstenediol are readily sulfated by SULT2A1 in adrenal cortex and their sulfates serve as the stock pool for the production of active androgens of the adrenal origin as the production of androgens in early childhood of boys is limited to extra-gonadal tissues, such as adrenal, skin, etc. These sulfated primary androgens may be subsequently deconjugated and metabolized by HSD3B1 and HSD3B2 isoforms to androstenedione and Total testosterone (TST) and then to 5α/β-reduced 17-oxo- and 17β-androgens, respectively. In addition, the androstenedione may be readily converted to testosterone by adrenal AKR1C3. From the aforementioned substances, TST, 5α-dihydrotestosterone, and 11-oxo-testosterone are known as the most potent bioactive androgens. Besides the "frontdoor" pathway the dihydrotestosterone may be also formed by so called "backdoor" pathway. This pathway is based on a direct conversion of 5α/β-reduced pregnane steroids (C21) to their 5α/β-reduced androgen (C19) metabolites which is catalyzed by the same enzyme converting pregnenolone to DHEA (CYP17A1 in the C17,20-lyase step). These 5α/β-reduced androgen (C19) metabolites include also the most active androgen 5α-dihydrotestosterone. The "backdoor" pathway is crucial for androgen synthesis in marsupials but may also be active in various human steroid-related disorders.

NCT ID: NCT05810675 Recruiting - Clinical trials for Autism Spectrum Disorder

Parent-mediated and Telehealth Intervention for Children With Autism Spectrum Disorder

Start date: August 19, 2022
Phase: N/A
Study type: Interventional

This study has two purposes: Aim 1: To develop a Telehealth Early Intervention Program (TEIP) for children with ASD that will be carried out by parents at home when interact with their children; and to train parents in delivering developmental and behavioral techniques to their children. The participating families will be randomized in parallel to treatment and comparison groups for teaching the knowledge and techniques: (1) Treatment group: providing the training of TEIP for parents via telehealth modalities as they learn critical skills with their child with the goal of increasing multidimensional child developments. Intervention provider will provide the training for parent-child dyad interaction to work with parents to implement these strategies at home environment; and (2) Comparison group: provide general care consultation of child development for parents. Aim 2: To evaluate this program's effectiveness by measuring changes in a child's developments and behaviors. Investigator will evaluate child outcomes on the symptoms of ASD and multidimensional developmental functioning. Furthermore, investigator will measure the changes in the parent's knowledge and behaviors of parent-child interaction. Moreover, investigator will determine if parental participation in the intervention is associated with an improvement in parenting competences and decreased levels of stress.

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.