[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06868537":3,"trial-entities:NCT06868537":121,"trial-summary:NCT06868537":125},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":54,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":91,"locations":93,"central_contacts":113,"overall_officials":116,"references":119,"see_also_links":120},"NCT06868537","HSC-MS-25-0098","A Trial of the Launching! to Adulthood Program","A Randomized Controlled Trial of the Launching! to Adulthood Program","RECRUITING","2027-09-01","2025-08","2025-09-05","2025-07-15","The University of Texas Health Science Center, Houston","OTHER",false,"The purpose of this study is to evaluate the effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the Launching intervention leads to improvements in executive functioning, co-occurring mental health symptoms, and quality of life, as measured by caregiver and self-report assessments, to assess the maintenance of treatment gains 12 weeks post-treatment and to replicate the findings of the Launching pilot study in an independent sample of young adults with ASD.",null,[19],"Autism Spectrum Disorder (ASD)",[21],"Launching intervention","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Launching! to adulthood group therapy","Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching.",[32,35],"No intervention then Launching! to adulthood group therapy",{"type":31,"name":37,"description":38,"armGroupLabels":39},"standard of care","Participants will receive a list of resources",[35],[41,45,48,51],{"measure":42,"description":43,"timeFrame":44},"Change in adaptive functioning as assessed by the Adaptive Behavior Assessment System, Third Edition (ABAS-3)","This is a 239 item questionnaire and each is scored from 0(is not able to do this behavior) to 3 \\[(always able to do this behavior)(or almost always)\\] a higher number indicating better outcome","Baseline, week 12, week 24",{"measure":46,"description":47,"timeFrame":44},"Change in social response as assessed by the Social Responsiveness Scale, Second Edition (SRS-2)","This is a 65 item questionnaire and each is scored on a 4-point Likert scale from 1(Not True) to 4(Almost Always True) for a maximum raw score of 120, higher score indicating worse outcome.",{"measure":49,"description":50,"timeFrame":44},"Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-child version","This is a 30 item questionnaire and each is scored from 1(not true for me ) to 4(true for me) for a maximum score of 120, higher score indicating better outcome.",{"measure":52,"description":53,"timeFrame":44},"Change in transition readiness as assessed by the Transition Readiness Scale (TRS)-parent version","This is a 30 item questionnaire and each is scored from 1(not true for them) to 4(true for them) for a maximum score of 120, higher score indicating better outcome.",[55,58,61,64,67,70],{"measure":56,"description":57,"timeFrame":44},"Change in executive functioning as assessed by the Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)","This is a 75 item questionnaire and each is scored from 1(never) to 3(often) for a maximum score of 225, higher number indicating worse outcome",{"measure":59,"description":60,"timeFrame":44},"Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms","This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a maximum score of 27, higher number indicating worse outcome",{"measure":62,"description":63,"timeFrame":44},"Change in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) for anxiety symptoms","This is a 7 item questionnaire and each is scored from 0(not at all) to 4(nearly every day) for a maximum score of 21 , higher score indicating more anxiety",{"measure":65,"description":66,"timeFrame":44},"Change in quality of life as assessed by the World Health Organization Quality of Life Brief Version (WHOQOL-BREF)","This is a 26 item questionnaire ,with 4 domains. Each is scored from 1(very poor) to 5(very good) ,questions 3,4 and 26 are reverse scored for a maximum raw score of 120 and higher score indicating better quality of life",{"measure":68,"description":69,"timeFrame":44},"Change in quality of life as assessed by the Autism Spectrum Quality of Life (ASQoL) questionnaire","This is a 9 item questionnaire. Each is scored on a 4-point Likert scale from 1(not at all) to 5(totally) ,questions 6,7 and 8 are reverse scored for a maximum score range of 9-36 and higher score indicating better quality of life",{"measure":71,"description":72,"timeFrame":44},"Change in parental stress as assessed by the Parental Stress Scale (PSS)","This is a 14 item questionnaire and each item is scored from 1 (strongly disagree) to 5 (strongly agree) for a score range of 18-90, higher score indicating more stress","ALL","18 Years","25 Years",{"inclusion":77,"exclusion":84,"raw_text":90},[78,79,80,81,82,83],"confirmed case of ASD from a licensed mental health or medical professional","score of \\>14 on the Social Communication Questionnaire-Lifetime (SCQ-L) completed with the mother or father","meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ASD symptom checklist","willing and motivated to participate in the treatment","a parent willing to participate","verbal intelligence quotient (IQ) score \\>70 as assessed by the Kaufman Brief Intelligence Test 2nd edition revised (KBIT-2-R)",[85,86,87,88,89],"history of a psychotic disorder or current psychotic symptoms","suicidal ideation with intent or plan","current alcohol or other substance use disorder rated severe","concurrent enrollment in another clinical trial for autism spectrum disorder","expression of unwillingness to complete study procedures","Inclusion Criteria:\n\n* confirmed case of ASD from a licensed mental health or medical professional\n* score of \\>14 on the Social Communication Questionnaire-Lifetime (SCQ-L) completed with the mother or father\n* meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ASD symptom checklist\n* willing and motivated to participate in the treatment\n* a parent willing to participate\n* verbal intelligence quotient (IQ) score \\>70 as assessed by the Kaufman Brief Intelligence Test 2nd edition revised (KBIT-2-R)\n\nExclusion Criteria:\n\n* history of a psychotic disorder or current psychotic symptoms\n* suicidal ideation with intent or plan\n* current alcohol or other substance use disorder rated severe\n* concurrent enrollment in another clinical trial for autism spectrum disorder\n* expression of unwillingness to complete study procedures",[92],"ADULT",[94],{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":110},"The University of Texas Health Science Center at Houston","Houston","Texas","77030","United States",[101,106],{"name":102,"role":103,"phone":104,"email":105},"Antonio Pagan, PhD","CONTACT","(713) 486-2700","Antonio.Pagan@uth.tmc.edu",{"name":107,"role":103,"phone":108,"email":109},"Katherine Loveland, PhD","(713) 486-2587","Katherine.A.Loveland@uth.tmc.edu",{"lat":111,"lon":112},29.76328,-95.36327,[114,115],{"name":102,"role":103,"phone":104,"email":105},{"name":107,"role":103,"phone":108,"email":109},[117],{"name":102,"affiliation":13,"role":118},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":122,"biomarkers":124},[123],"Autism Spectrum Disorder",[],{"nct_id":4,"found":126,"summary":127,"prompt_version":137},true,{"design":128,"status":129,"heading":130,"summary":131,"follow_up":132,"word_count":133,"commitments":134,"compensation":135,"drugs_mentioned":136},"This study is an interventional trial planning to enroll 40 participants. It compares the \"Launching! to adulthood\" group therapy to a standard of care group.","completed","Launching! to Adulthood Program for Young Adults with ASD","This study is testing a 12-week group therapy program called \"Launching! to adulthood\" for young adults with Autism Spectrum Disorder (ASD). The program includes weekly group sessions and individual coaching. You might be eligible if you are 18-25 years old, have a confirmed diagnosis of ASD, and are motivated to participate. The researchers want to see if this program can improve your adaptive functioning (daily living skills), readiness for adulthood, and social skills. They will compare it to a group that receives a list of resources (standard of care). The study aims to enroll 40 participants, but its current status is unclear.","Participants will be followed for 12 weeks after the treatment ends, with assessments at week 24.",102,"Participants will be in a 12-week therapy program that includes weekly group sessions and individual coaching. Assessments will be done at the beginning, at week 12, and at week 24.","Not stated in the trial record.",[37],"v2"]