999 Clinical Trials for Various Conditions
Naturalistic developmental behavioral interventions (NDBIs) are a newer class of evidence-based interventions for young autistic children to promote their positive developmental or behavioral outcomes. These are often delivered by family members or other natural change agents given the emphasis on naturalistic transactions between an adult and a child. Despite the emerging evidence, there are practical difficulties that hinder wider dissemination and implementation of NDBIs, including low level of access to some of these branded, packaged NDBIs. To mitigate these difficulties related to access, we have created a series of video modules that demonstrate nine commonly used core components in NDBI strategies. In this study, caregivers will receive training and coaching using these modules and both synchronous and asynchronous coaching from a clinician. In this type 1 hybrid implementation trial, there are two groups of participants: (1) caregivers of young autistic children or children with other developmental disabilities/delays, (2) children, and (3) clinicians. Caregivers will meet with clinicians virtually weekly to (a) watch the newly developed NDBI videos that demonstrate the strategy use, (b) discuss how this might be applied to their own child, (c) receive individualized homework planning, (d) record and upload videos of their practice of strategy use with their own child, and (e) review the videos with clinicians to receive individualized feedback on their strategy use. This will occur for 10 weeks. Each session will be video recorded to assess the clinicians' intervention fidelity. After 10 weeks, pre-post tests will be conducted to assess parents' confidence on implementing these strategies, their child's social communication, and satisfaction of providers and caregivers. Qualitative data will also be collected via interviews with some selected participants to gain a deeper understanding of their perceptions.
Implementation Research
This study investigated the human-animal interaction (HAI) and bond (HAB) between a canine trained in therapy techniques or a canine plush toy and youth with autism spectrum disorder (ASD) during animal-assisted therapy (AAT) sessions. The purpose of this study is to explore identified gaps in knowledge pertaining to AAT in pediatric ASD care management by documenting human interaction between either a live canine or the plush toy canine during AAT sessions and evaluating prosocial behaviors observed during and after AAT sessions. This study addressed the following research questions: 1. How do children with autism ages 2 to 18 years interact with a live canine during AAT sessions? 2. How do children with autism ages 2 to 18 years interact with a toy plush dog during AAT sessions? 3. Is there a difference in HAI in the live canine group and the toy plush dog group? 4. Is there a difference in prosocial behavior observed during AAT sessions between the live canine group and the toy plush dog group? 5. Is there a difference in behavior after AAT sessions between the live canine group and the toy plush dog group? Participants were randomly assigned to either the live canine or toy plush dog group. Adaptive functioning and social responsiveness evaluations were obtained to compare baseline behavior between the two groups. Participants attended an AAT session once weekly for 6 to 8 weeks. Each group received the same therapy provided by the therapist; the only difference being the incorporation of a live canine during the therapy session. Caregivers completed a weekly assessment depicting participants' positive and negative affect at the beginning of each session. Caregivers also completed a monthly assessment noting strengths and difficulties in social functioning and behavior at the start of the first, middle, and final session. AAT sessions were recorded and behavior occurring during the sessions was coded to note HAI and HAB that occurred during the sessions.
Prosocial Behavior, Emotional Regulation, Human Animal Bonding, Human Animal Interaction, Autism
The purpose of this study is to test a novel, cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. The treatment, named TUNE In (Training to Understand and Navigate Emotions and Interactions), includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings. The Investigators will test the efficacy of TUNE In to improve social functioning in adults with autism spectrum disorder (ASD), using a randomized controlled trial using the SRS-2 as the primary outcome measure.
Autism Spectrum Disorder, Autism, Autistic Disorder, Asperger Syndrome
The investigators are conducting a 10-week brain imaging and medication study. They are doing the research to study the response of Attention-Deficit/ Hyperactivity Disorder (ADHD) in youth with Autism Spectrum Disorder (ASD) on extended-release formulation of mixed amphetamine salts (MAS) (also know as Adderall XR). The investigators also want to find out if taking MAS has any effect on the brains of children and adolescents with ADHD and ASD. This study will help researchers better understand how the use of MAS to treat ADHD effects children and adolescents with ASD. The investigators will compare MAS to a placebo. The placebo will look exactly like the MAS capsules but will contain no MAS. During this study, participants may get a placebo instead of MAS. Placebos are used in research studies to see if the study results are due to the study drug or due to other reasons. Participants with ASD and ADHD will complete 4-weeks of treatment with the study medication or placebo. They will complete bi-weekly study visits virtually via a telemedicine platform with the study doctor and complete questionnaires. On alternating weeks, they will meet with a Massachusetts General Hospital (MGH) study team member to discuss medication adherence and potential side effects. Participants will have the option to attend all study visits in-person if participants prefer. They will also complete baseline and endpoint Magnetic Resonance (MR) scan visits at Massachusetts Institute of Technology (MIT). During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory. Participants without ADHD or ASD will complete eligibility screening with MGH. If eligible, they will be invited to baseline and endpoint MR scan visits at MIT. During the MR Scan visits, they will complete a series of tasks to measure inattention, impulsivity, reward sensitivity, decision-making, and working memory.
Attention Deficit Hyperactivity Disorder (ADHD), Autism, Autism Spectrum Disorder
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure" used in a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income. What Will Happen: Researchers will compare two versions of CLR-Pathways. * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours. * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Autism
The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.
Autism, Autism Spectrum Disorder
Evaluate the efficacy of accelerated theta burst stimulation (aTBS) in reducing depressive symptoms in autism spectrum disorder (ASD)
ASD, Autism Spectrum Disorder, Autism, Depression - Major Depressive Disorder, MDD
The overall objective of this research is to determine whether parentese delivered in the video format (Aim 1) and in live interaction (Aim 2) facilitates novel word learning in autistic children and to investigate if there are factors that influence the effect of parentese on word learning (Aim 3).
Autism, Autism Spectrum Disorder, Neurodevelopmental Disorders
The purpose of this open label trial is to examine the acceptability, tolerability, and feasibility and preliminary effectiveness of sleep restriction therapy for sleep problems in children with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of parent-training in delivering the intervention.
Autism Spectrum Disorder (ASD), Autism
Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds. What Will Happen: Researchers will compare two versions of the Pathways Intervention: * Version 1: Includes mutual gaze strategies. * Version 2: Does not include mutual gaze strategies. What to Expect: Participants will: * Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations). * Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.
Autism
Adolescents with ASD often have co-occurring mental health symptoms like stress, anxiety, and depression. The investigators are conducting this research study to develop interventions for adolescents with ASD that will improve co-occurring mental health symptoms.
Autism Spectrum Disorder, Autism
The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are: * Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people? * What feedback do participants have to help improve the intervention? Participants will: * engage in a four-part virtual educational intervention * answer questions via online survey before, after, and 3-months after the intervention * participate in an optional interview to provide feedback
Autism, Suicide Prevention
Anxiety is very common in autistic youth. Cognitive behavioral therapy (CBT) is the recommended treatment for both autistic and typically-developing (TD) youth with anxiety, yet most families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. The goal of this project is to increase access to care for families of autistic adolescents with anxiety through an internet-based treatment model.
Autism Spectrum Disorder, Autism, Anxiety, Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder
The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are: Will a marijuana-based drug help anxiety in autistic adults? Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better. Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.
Autism Spectrum Disorder, Anxiety
This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.
Autism Spectrum Disorder, Autism
This study will examine the potential effectiveness of a virtually delivered parent-mediated intervention for insistence on sameness behaviors in autism and investigate 1) whether caregivers can learn to deliver the adapted Supportive Parenting for Anxious Childhood emotions (SPACE) intervention for IS via telehealth and 2) whether children will show greater improvement in IS behaviors.
Autism Spectrum Disorder, Autism
The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.
Autism
Children on the autism spectrum sometimes have difficulty learning new words and using the newly taught information in different situations. In this study, the investigators are testing whether strategies that have been found to improve word learning in non-autistic children will also help autistic children. Specifically, the investigators aim to test whether autistic children learn words more successfully if novel words are taught by repeating the words to the child (re-study) or if the novel words are taught first with labeling each word and then quizzing the child (repeated quizzing). The main questions it aims to answer are: * When teaching nouns (names of exotic animals), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught words? * When teaching adjectives (visible features of objects, like a bumpy chair), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught adjectives? * Does the word learning condition (re-study vs. repeated quizzing) impact whether autistic children are more successful in demonstrating their knowledge of the newly taught words in different contexts? * Are autistic features related to patterns of word learning? Participants will: * Learn new words with half of the words being taught in one way (re-study) and the other half of the words being taught in the other way (repeated quizzing). * Participate in 5-minute and 1-week tests of the newly taught words to measure child learning. * Complete other language, thinking, and autism clinical assessments.
Autism Spectrum Disorder
This study will be a randomized trial that will examine the impact of a recreational ballet program on children with autism spectrum disorder (ASD). The research team are primarily interested in assessing changes in motor skills with secondary objectives focused on the social, psychological, and behavioral effects. The study will aim to collect data from 24 participants with ASD. Participants must be 7-12 years old, have a confirmed diagnosis of ASD, and speak English or Spanish. All participants will be enrolled in a 12 week ballet program. The ballet program is based off the curriculum and structure of Ballet for All Kids, a non-profit organization that has been tailoring ballet classes for children with ASD for over one decade. All research team members and volunteers will be trained in the BFAK program's curriculum and structure. Ballet instruction and all research materials will be provided in both English and Spanish. The research team will randomize the sample into an intervention group and waitlist control. The research team will measure outcomes through validated self-reports that caregivers will complete. For the intervention group, questionnaires will be completed at baseline and throughout the intervention (weeks 4, 8, and 12). For those in the waitlist control group, questionnaires will be completed at baseline, throughout the intervention group's ballet classes, and throughout their own participation in the program. Results of this study will help to determine if how a recreational ballet program can impact the motor, psychological, social, and behavioral skills of a child with ASD, informing the direction of future research and interventions.
Autism Spectrum Disorder
The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
Autism Spectrum Disorder, Restricted Behavior, Autism
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.
Autism Spectrum Disorder
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
Autism Spectrum Disorder, EEG With Periodic Abnormalities, Epilepsy, Neurodevelopmental Disorders, Neurological Disorder
The goal of this clinical trial is to examine how helpful and relevant the Family Care Project workbook is for families from culturally and linguistically diverse backgrounds who have a young child at autism likelihood. The main questions this trial aims to answer are: * Is the Family Care Project workbook useful for families? * Is the Family Care Project workbook easy to use? * Can the Family Care Project be implemented by non-profit workers who do not have health backgrounds? Participants will complete surveys that elicit their feedback on their use of the workbook.
Autism, Development Delay
The goal of this clinical trial is to evaluate the effectiveness of using a Microskills video training library for young adults, aged 18-28, with autism spectrum disorder (ASD) to enhance their skills in developing and maintaining healthy relationships. The main questions it aims to answer are: * Does using SkillTalk increase autistic young adults skills in the communications skills that are demonstrated in the video curriculum (skills: resolve conflict, compromise, give feedback)? * Does using SkillTalk increase reported confidence and satisfaction in communication and relationship skills? * Does using SkillTalk increase interpersonal competence? * Does using SkillTalk increase ability to cope with rejection? * Does using SkillTalk improve mental health and wellbeing? Participants will be asked to: * Take a survey at the beginning of the study, after one month the end of the study, and at 3-month follow up * Participate in recorded video calls with projects staff, comprised of 2-3 brief roleplay scenarios of relationship skills at the beginning of the study, after one month the end of the study, and at 3-month follow up * Watch a minimum of 85% of the 60 minutes of video assigned
Autism Spectrum Disorder
The investigators are looking to evaluate how effective a training program that focuses on character strengths may be in improving job maintenance skills in young adults. The investigators are examining the effects of this intervention in young adults who feel they would like to help in improving their satisfaction with work, and in keeping their jobs.
Autism
Autism spectrum disorder (ASD) is one of the most common developmental disabilities and often people with ASD have sensory processing disorders. These sensory processing disorders are often associated with problem behaviors and, more recently, have been connected to anxiety disorders in people with ASD. While it has been suggested that sensory processing responses in ASD could be malleable, current treatment strategies for sensory processing disorders in ASD have inconsistent results or lack large-sample sized data. This investigation will explore changes in neurophysiological activity in people with ASD and neurotypical peers after they are exposed to an unpleasant visual stimulus through a virtual reality systematic desensitization protocol. 30 people with ASD and 30 neurotypical people between the ages 7 - 35 will be recruited. The study have, 1) a practice magnetic resonance imaging (MRI) visit with questionnaires, 2) a per-exposure MRI with structural and functional MRI collections, 3) a virtual reality systematic desensitization session where we will record the participant's physiological response using an Emotibit device, and 4) a post-exposure MRI session with structural and functional MRI collections. This investigation aims to quantify changes in neurophysiological responses in order to determine the effect of systematic desensitization.
Autism Spectrum Disorder, Autism, Sensory Processing Disorder, Sensory Over-Responsivity
The goal of this clinical trial is to compare the effects of a specialized swimming and water-safety program (Sensory Enhanced Aquatics) and standard swimming lessons for autistic children. The main question\[s\]it aims to answer are: * Do Sensory Enhanced Aquatics and standard swimming lessons improve swimming and water-safety skills of autistic children? * Which participant characteristics are associated with the highest post-intervention swim skills and water safety across both groups? Participants will: * Complete questionnaires, motor, and swim tests before the intervention. * participate in 16, 30-minute Sensory Enhanced Aquatics lessons. * Complete a swim test after the intervention. * Complete an interview. Researchers will compare with participation in standard swim lessons to see if which bests teaches swimming and water-safety to autistic children.
Autism
The goal of this proposed trial will modify an existing toothbrushing app for teens with autism and compare toothbrushing outcomes with a control app. We have 2 specific aims: * During the 2-year UG3 phase, we will use the Discover, Design+Build, and Test Framework to modify our existing app and pilot the intervention. * During the 4-year UH3 phase, we will recruit 270 pre-adolescents and teens with autism ages 10 to 17 years, randomize participants to one of two arms, and compare outcomes. Participants will asked to use the app, complete surveys on REDCap, participate in feedback interviews and focus groups. Behavior change in the experimental group will be compared with that in the control group.
Autism
When youth with autism spectrum disorder (ASD) transition from school to adult services, they fall off a "service cliff." To increase access to services, the investigators developed the ASSIST program, which teaches parents how to advocate for adult services on behalf of youth with ASD. In a pilot randomized controlled trial (RCT: R34 MH104428), treatment group (versus control) participants demonstrated significantly improved knowledge of adult services, advocacy, and empowerment. Sons/daughters of treatment group participants had increased access to services. For advocacy services interventions like ASSIST to be equitable, they need to reach families who are at greatest risk for service disparities. Latinx youth with ASD are one such underserved population. Relative to White youth, Latinx youth with ASD receive significantly fewer post-secondary education, health, and employment services and face worse post-school outcomes. In addition to the barriers which hinder service access for all families, Latinx families face unique barriers to service access (e.g., language, cultural differences, citizenship, discrimination) making them a marginalized population. In this project, the investigators are adapting the ASSIST curriculum and related measures for Latinx parents of transition-aged youth with ASD. Specifically, the investigators will leverage ASSIST data and data from Latinx, non-ASSIST parents to inform adaptations to the ASSIST curriculum. The investigators will also conduct pre-testing and a cross-cultural adaptation process to revise the ASSIST measures for Latinx families. The investigators will test the adapted ASSIST curriculum with a randomized controlled trial to determine its feasibility, acceptability and efficacy on intervention targets (knowledge, advocacy, and empowerment) and outcome of interest (service access). This project is aligned with NIMH priorities by examining services from adolescence to adulthood (PA-21-199) and by adapting a program to improve mental health services for underserved populations NIMH 2020 Strategic plan). It is also responsive to the Interagency Autism Coordinating Committee core value of "equity" in reducing disparities with respect to cultural backgrounds. Further, if successful, it will be the first intervention to directly address service disparities for Latinx families of youth with ASD who are transitioning to adulthood.
Autism
The purpose of this clinical trial is to investigate the effectiveness of a mobile app-based mindfulness program in improving the mental well-being of caregivers with a child diagnosed with autism spectrum disorder (ASD) who live in rural areas of Maine. The primary question the investigators aim to answer is whether this mindfulness intervention can reduce stress and anxiety in these rural caregivers of children with ASD. Participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, the investigators want to assess whether this intervention helps these caregivers feel less stressed and anxious.
Stress, Anxiety