[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611790":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":57,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioral Intervention","EXPERIMENTAL","The experimental condition is a cognitive behavioral therapy intervention that is typically geared for children with ASD without intellectual disability. The established CBT, Facing Your Fears, supports participants in the following key areas: 1) building emotional regulation, 2) developing cognitive tools such as positive self-talk and affirmations, 3) enhancing coping strategies adapted to individual sensory and regulatory profiles, and 4) engaging in gradual exposure to situations or stimuli. The experimental condition will apply the Facing Your Fears model to children with ASD and intellectual disability.",[13],"Behavioral: Facing your Fears",{"label":15,"type":6,"description":16,"interventionNames":17},"Wait-List Control","A wait-list control design is employed to ethically evaluate the impact of a CBT intervention. Participants are initially screening using a comprehensive battery of standardized assessments to establish baseline functioning. The assessments include the SCARED\u002F MASC-2 to evaluate anxiety symptoms; CBCL to evaluate emotional behavioral problems; PedsQL to measure health-related quality of life; ADOS to support diagnostic clarity for autism spectrum characteristics; and the WASI to assess cognitive function and IQ. Following this pre-intervention phase, participants enter a wait-list control period where they do not receive the CBT intervention. The waiting period serves as the control condition, providing natural comparison for later outcomes. Once their cycle is assigned, the same participants transition into the experimental phase.",[18],"Behavioral: Baseline Treatment",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Facing your Fears","The Facing Your Fears intervention is a cognitive behavioral therapy program for children with ASD that is designed to establish somatic and emotional regulation strategies and enhance the use of personalized cognitive coping mantras through a gradual exposure to feared or anxiety provoking situations. The FYF program was developed for children with ASD, but prior research did not assess the feasibility of applying this intervention in children with ASD and intellectual disability. The intervention in the experimental condition will apply this core foundation of the FYF intervention to children with ASD and intellectual disability.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Baseline Treatment","The wait-list control condition is utilized as a baseline treatment phase where participants undergo a comprehensive battery of standardized assessments to establish baseline functioning. The SCARED\u002F MASC-2, CBCL and PedsQL is used to assess anxiety symptoms, identify co-occurring issues (e.g., aggression and attention problems) and overall well-being and functioning. Assessments such as the ADOS and WASI are semi-structured, direct observations, which confirm ASD diagnosis for study eligibility and estimates general cognitive ability and IQ. The results from these assessments will confirm eligibility for the study and provide baseline results for post-intervention analysis. The purpose of this pre-intervention phase is to establish a detailed baseline of each participant's functioning across key domains, provide diagnostic clarity and control for confounding variables (e.g., IQ), and enable analysis through pre and post comparison to assess the proposed intervention's effectiveness.",[15],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Janys Lim, MD","CONTACT","5196858500","56408","janys.lim@lhsc.on.ca",{"name":38,"role":33,"phone":34,"phoneExt":39,"email":40},"Kayleigh Tam, BA","75556","kayleigh.tam@lhsc.on.ca",[42],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Children's Hospital- LHSC","London","Ontario","N6A 5W9","Canada","CA",{"type":50,"coordinates":51},"Point",[52,53],-81.23304,42.98339,{"lat":53,"lon":52},[56],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Janys Lim","MD","100611790","a-cognitive-behavioral-therapy-approach-to-addressing-anxiety-in-children-with-asd-and-intellectual-disability-100611790",false,"NCT07245160","A Cognitive Behavioral Therapy Approach to Addressing Anxiety in Children With ASD and Intellectual Disability","Feasibility Study of Addressing Anxiety in Children With ASD and Intellectual Disability Through the Facing Your Fears Program","FYF","Inclusion Criteria:\n\n1. Children between the ages of 12-18 years\n2. Confirmed diagnosis of ASD that meets DSM-V criteria\n3. ADOS scores consistent with an ASD diagnosis\n4. WASI scores equivalent to 50-70\n5. CBCL with T score \\>\u002F= 70 for the anxiety subscale\n6. MASC-2\u002FSCARED score with T-scores reflecting clinically significant anxiety\n7. Not part of another interventional study or clinical trial\n8. Stable non-pharmacological therapies for at least 12 weeks\n9. Stable pharmacological therapies for at least 8 weeks\n10. Will not start new treatment for anxiety, medication or intervention, within the study 12 week study period\n11. Consistent parent partner per child throughout the duration of the study\n\nExclusion Criteria:\n\n1. Individuals with history of significant suicidal ideations or attempts\n2. Individuals involved in a concurrent interventional study","ALL","12 Years","18 Years",{"count":73,"type":74},24,"ESTIMATED","INTERVENTIONAL",[77],"NA","Anxiety can be a debilitating and common concomitant diagnosis in autism spectrum disorders (ASD). Dependent on age and subtype of anxiety, the prevalence of anxiety in individuals with autism ranges between 1.7-84%. Meanwhile, the prevalence rate of intellectual disability (ID) in individuals with ASD ranges between 50-80% based on previous studies. There is an even greater risk of anxiety, ranging between 13.6- 43%, in individuals with ASD and ID. Despite the high prevalence of anxiety within this population, there are limited studies exploring assessments and treatments geared towards addressing anxiety in autism and intellectual disabilities. Previous studies have been limited to children who are identified as high functioning, or identified as low functioning without a concomitant diagnosis of ID. Given this, the present study focuses on the population of individuals with ASD and ID by exploring the feasibility of a CBT intervention designed for individuals with high-functioning autism\n\nThis pilot study aims at addressing and treating anxiety in children with ASD and intellectual disability through the Facing Your Fears (FYF) intervention. Facing Your Fears is a cognitive behavioral therapy (CBT) program specifically designed to address anxiety symptoms in children with autism. Research exploring the effectiveness of the FYF intervention within the population of individuals with ASD and ID is limited. This study aims at evaluating the feasibility of the Facing Your Fears program to address anxiety in children with ASD and ID, while evaluating the effectiveness of this intervention in larger group settings. The duration of the study will run over two 12-week cycles with study assessments conducted in-person, once a week. The study will involve 5-6 parent-child dyads to make up 10-12 participants per cycle. The child participants must be between the ages of 12-18 years old and have a confirmed diagnosis of ASD that meets DSM-V criteria. The study will commence with a month of recruitment, and a month allotted for collating data and assessments, before and after each 12-week intervention cycle. Evaluations will take place at screening, every study visit, and post intervention. Alongside the study evaluations, weekly sessions will involve didactic and practice sessions, with the last 30 minutes reserved for parent training. The sessions focus on the use and generalization of the taught strategies to address anxious symptoms, and exposure sessions outside of the weekly sessions. At the end of the 12-week cycle, the assessments related to the study outcomes will be administered again to allow investigators to compare and analyze pre- and post-intervention scores.",[80,81],"Autism Spectrum Disorder (ASD)","Intellectual Disability",[83,84,85,86,87],"autism spectrum disorder","ASD","anxiety","cognitive behavioral therapy","intellectual disability","NOT_YET_RECRUITING","2025-11-20",{"date":91,"type":92},"2025-11-24","ACTUAL",{"date":94,"type":74},"2025-12-01",{"date":96,"type":74},"2026-12-31",{"name":5,"class":6},1]