Photobiomodulation in Autism Spectrum Disorder (ASD)
AutismAutism Spectrum DisorderThe purpose of this 8-week open-label study is to assess the tolerability, safety, and efficacy of Transcranial LED Therapy in patients with Autism Spectrum Disorder (ASD). The investigators propose to enroll up to 30 subjects of both genders ages 9-59 years with intact intellectual functions who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Autism Spectrum Disorder (ASD).
Arbaclofen in Children and Adolescents With ASD
Autism Spectrum DisorderAIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and...
Autism Spectrum DisorderThe purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics...
Autism Spectrum DisorderThis study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality
Autism Spectrum DisorderThe general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD.
Evaluation of a Novel Intervention for Infants At Risk for Neurodevelopmental Disorders
Autism Spectrum DisorderNeurodevelopmental DisordersThis study entails a "proof of concept" evaluation of a novel intervention, Parents and Infants Engaged (PIE), for prodromal infants at-risk for neurodevelopmental disorders (NDs). The objectives of the current study are to examine whether the PIE intervention (a) transforms parent-infant transactions over time as intended, thereby facilitating increases in the time infants spend in joint engagement with their parents, and (b) is associated with improved social-communication functioning and positive changes in indices of autonomic self-regulation in infants at-risk for NDs.
Mobile Health (mHealth) Nutrition Intervention for Children With Autism Spectrum Disorder
Diet ModificationThe high prevalence of mealtime difficulties and obesity among children with autism spectrum disorder (ASD) calls for new and innovative ways to promote healthy eating and weight development in this population. This project aims to develop and test an interactive mobile health (mHealth) nutrition intervention, which incorporates core behavior change strategies that have been empirically tested in family-based nutrition research and behavioral interventions with children with ASD. The feasibility and efficacy of this mHealth intervention to improve dietary outcomes in children with ASD will be tested in a proof-of-concept randomized controlled trial.
Efficacy of IMPACT in Infant Siblings of Children With ASD
Autism Spectrum DisorderOver a 5 year period infant and baby siblings of children with autism spectrum disorders (ASD) will be recruited to this study and will be randomized into 2 groups. Parents of the intervention group will receive 12 weeks of coaching in how to implement this intervention. Parents randomized to the control group will not receive intervention coaching. Both groups will attend a series of clinic appointments for data collection that occur at 3 month intervals over a 9 month period.
Effectiveness of Music Therapy in Social Skill Intervention for Children With ASD/ID
Autism Spectrum DisorderIntellectual DisabilityAutism spectrum disorder (ASD) is a developmental impairment characterized by persistent deficits in social communication and interactions. The prevalence figures have increased rapidly in recent years due to the expansion of diagnostic criteria and increased public awareness. The clinical presentations of ASD vary to a large extent, and approximately 56% of children with ASD possess below average intellectual ability (IQ < 85). The intellectual, verbal, and social ability in this population may greatly influence intervention outcomes. The social development of children with ASD and comorbid intellectual disability (ID) is not well understood, and how children with ASD/ID respond to social skill interventions remains to be investigated. Musical elements are a part of various behavioral interventions for ASD, however, the effects of music as interventions for ASD individuals have not been comprehensively examined in Hong Kong. The proposed study will address limited research evidence on music therapy as an intervention for social functioning in children with ASD with mild to borderline ID. Music therapy is a systematic process of intervention, wherein a therapist helps clients promote their health by using musical experience and relationships that develop through them. In particular, the investigators will examine whether using music therapy in social skill intervention provides additional benefits relative to non-musical intervention in a 12-week randomized controlled trial. Pre-treatment neural response of electroencephalograms (EEG) to social scenes will be used to predict the outcomes of social skill interventions, whereas EEG responses to music will be used to predict the effectiveness of musical social skill intervention. If correlation is found, then the long-term goal is to develop individualized intervention based on pre-treatment markers to maximize treatment efficacy. Aims and hypotheses: Is social skill intervention using music therapy more effective in enhancing social interaction than non-musical social skill training for children with ASD and co-occurring mild/borderline ID? Participants with enhanced neural response to social scenes relative to baseline would be more responsive to social skill interventions. Participants with enhanced neural response to preferred music relative to baseline would be more responsive to music therapy targeting social skill intervention.
A Peer-mediated Vocational Social Skills Program for Young Adults With Autism
Autism Spectrum Disorder High-FunctioningThe Assistive Social Skills and Employment Training program (ASSET) is an occupationally-based, work-related social skills intervention, designed to address the pre-employment and mental health needs of young adults with high-functioning autism in school-to-work transition. Knowing that occupational therapy (OT) services designed to address the post-secondary transition needs of this population have been largely unexplored, and recognizing the need for OT students to gain practical experience facilitating psychosocial groups, this study seeks to: (1) evaluate program impacts on participants' psychosocial functioning and work readiness, and (2) pilot the use of OT students as group facilitators. The study will follow a mixed-methods, single group design, using questionnaires and interviews to assess skills, confidence, and psychological wellness before intervention, immediately after, and at follow-up. OT students will also be interviewed and complete pre- and post-intervention assessments of clinical self-efficacy and stress. This project supports the AOTF's objectives by: (1) building OT academic program capacity to partner with university services and the autism community to improve transition outcomes in an underserved group, (2) laying the groundwork for larger, more rigorous studies of ASSET's effectiveness, and (3) gathering pilot data to support future grant applications at the federal level.