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Autistic Disorder clinical trials

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NCT ID: NCT05999240 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Pimavanserin for Rigid-compulsive Symptoms in Autism Spectrum Disorder

Start date: July 25, 2024
Phase: Phase 2
Study type: Interventional

This Phase 2 study examines the safety, tolerability, and preliminary efficacy of pimavanserin in individuals with Autism Spectrum Disorder. Male or female participants aged 16 to 40 years of age will be randomized to receive single doses of either placebo or pimavanserin in this randomized, placebo-controlled, cross-over designed study, followed by open label extension.

NCT ID: NCT05998382 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

The Effect of Parent Mediated Intervention Program on Children With ASD Exposed to Earthquake in Turkey in February 2023

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

After devastating natural events such as earthquakes, individuals with special needs experience much more difficulties. There is a limited number of studies investigating the impact of disasters on individuals with autism. Studies show that resilience and recovery of pre-disaster functioning in young people with autism largely depends on their immediate inclusion in routine, intensive rehabilitation programs and the stabilization of daily life routines as much as possible. Children with autism had to interrupt their education due to many reasons such as the destruction of special education centers due to the earthquake and the temporary or permanent relocation of families to different cities. The fact that individuals with autism stayed away from education after the earthquake caused parents' stress and anxiety levels to increase. Parent involvement, a standard intervention practice in ASD, shows that teaching intervention strategies to parents can improve children's outcomes and increase parental effectiveness. Researchers aim in this study is to investigate the effect of the online group-based parent-mediated intervention program on autism symptoms, the effect on behavioral problems and the effect on parental mental health of children with autism spectrum disorder whose education life was interrupted 8 months after the earthquake, who had major changes in their lives (such as loss of relatives, loss of health, work, home, anxiety, having to change cities ...). Online group-based intervention program ist designed to improve the interaction, play, speech and learning skills of children with autism symptoms, taking into account the earthquake conditions.

NCT ID: NCT05965648 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum

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

The goal of this clinical study is to develop a community-based program to support family members of transition-aged youth on the autism spectrum to help them plan for the future. The main aims of the study are: 1. To develop the Families FORWARD program 2. To conduct proof-of-concept testing of the Families FORWARD program Participants will complete surveys before and after participating in the program and will participate in exit interviews at the end of the program.

NCT ID: NCT05958394 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Evaluation of Skillflix for Parents of Youth With ASD

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for training parents of adolescents with ASD in talking with their teens about relationships and sexual health topics. The main questions it aims to answer are: - Does using SkillTalk increase parents' skills in communicating with their teens about relationships and sexual health? - Does using SkillTalk increase the frequency of conversations about relationships and sexual health? - Does using SkillTalk increase parents' confidence in their ability to communicate with their teens about relationships and sexual health? - Does using SkillTalk improve teen knowledge, attitudes, and behavior around sexual health and relationships? Participants will be asked to: - Take a survey at the beginning of the study, the end of the study, and at 3-month follow up - Record a short conversation between the parent and teen dyad about a sexual health topic at the beginning of the study, at the end of the study, and at 3-month follow up. - Watch a minimum of 85% of the 60 minutes of video assigned - Complete a conversation log at the end of each week during the study period, and once a month during the 3-month follow-up period.

NCT ID: NCT05953389 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

Start date: October 2023
Phase: Phase 2
Study type: Interventional

Proof of concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study to investigate the effect, safety, tolerability and pharmacokinetics of pitolisant in male children and adolescents with Autism Spectrum Disorders.

NCT ID: NCT05934812 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Intranasal Oxytocin in Youth With Autism

Start date: September 18, 2023
Phase: Phase 2
Study type: Interventional

Growing evidence demonstrates the critical contribution of the neuropeptide oxytocin in the development and maintenance of autism, due to its role in social behaviour and learning processes. While some preliminary findings in oxytocin administration trials have been promising, a complete understanding of the effects of long-term oxytocin administration in autism remains elusive, as participant numbers in oxytocin administration studies in autism have been small, most studies exclusively recruit males, and reproducibility has been inconsistent. To address this critical knowledge gap, this project will include a double-blind, placebo-controlled, randomized controlled crossover trial of a four-week intranasal oxytocin treatment (24 international units, twice-daily) in 128 male and female youth with ASD aged 12-20, with social and repetitive behaviors as primary outcome measures. The investigators predict that intranasal oxytocin treatments will increase performance on social behavior measures and reduce repetitive behaviors using caregiver-reported measures. Along with the investigation of oxytocin's long-term effects, the investigators will also assess the impact of oxytocin administration on computer-based laboratory tasks that can precisely measure how participants process social cues and disengage with repetitive behaviours. In addition, an electrocardiogram will be collected to evaluate the impact of oxytocin administration on parasympathetic nervous system activity.

NCT ID: NCT05910424 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)

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

The goals of this pilot study are to assess the presence of harmful germs for gums and to assess oral health in adults with autism spectrum disorder.

NCT ID: NCT05864508 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Interest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study.

OT-DEFI
Start date: July 2023
Phase: Phase 2
Study type: Interventional

The investigation team propose in this study to specifically evaluate the feasibility of using oxytocin in the form of an intranasal spray in a specific population of children with autism spectrum disorder and intellectual disability. The lack of studies centered on this population on the one hand, and on the other hand the severity of challenging behaviors presented by these children, make questionable the direct transfer of methods of care used in patients who do not present these challenging behavior. In this sense, the establishment of oxytocin treatment in these children requires a preliminary phase of feasibility assessment before being able to consider a comparative trial of the randomized clinical trial type.

NCT ID: NCT05860829 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Effect of Nutrition and Oral Hygiene Education Using Telehealth on Diet Diversity, Nutrition Literacy and Oral Hygiene Practices in Children With Autism: A Mixed-method Study

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

The goal of this interventional study is to assess the knowledge of caregivers of children with Autism Spectrum Disorder (ASD) regarding oral and nutritional health and the burdens they encounter in dealing and caring for these children. The main aims to answer are: Educating caregivers on - Diet diversities - Improving oral health habits Participants will have to - Fill questionnaires - Undergo educational sessions - Fill post education questionnaires Researchers will compare pre and post educational questionnaires to see if the intervention makes a difference.

NCT ID: NCT05849233 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling

Start date: May 1, 2023
Phase:
Study type: Observational

The role of gut microbiome was recently raised in the pathogenesis of neurodevelopmental disorders including autism spectrum disorder (ASD). In view of these evidences, together with poor conductance of researches on gut microbiota in ASD patients in Egypt, in addition to the absence of definite medical test or biological marker for diagnosis of ASD, the present study is designed to study clinical risk factor of autism and the predominant gut microbiome in autistic children in an attempt to identify gut bacteria which are likely related to ASD and to correlate these bacteria and clinical variables with the severity of autism. Interestingly, the totality of the studies focusing on the fecal metabolome features in ASD has investigated the differences between subjects with and without this disorder, while ignoring potential correlations between microbiome, metabolome and ASD severity