[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06705907":3,"trial-entities:NCT06705907":120,"trial-summary:NCT06705907":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":47,"secondary_outcomes":59,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":86,"locations":88,"central_contacts":107,"overall_officials":115,"references":118,"see_also_links":119},"NCT06705907","IRB#2024-0148","Improving Academic and Social Functioning in Middle-Schoolers With Autism","RECRUITING","2029-08-31","2026-03","2026-03-17","2024-12-01","Children's Hospital Medical Center, Cincinnati","OTHER",true,"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.",null,[18,19],"Autism","Autism Spectrum Disorder",[21,22,23,24],"social skills","executive functions","academic achievement","middle school","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},224,"ESTIMATED",[33,41],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"BEHAVIORAL","Achieving Independence and Mastery in School (AIMS)","Intervention targeting academic executive functioning",[38],"Achieving Independence & Mastery in School (AIMS)",[40],"AIMS",{"type":34,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Building Essential Social Skills for Teens (BESST)","Intervention targeting social skills",[42],[46],"BESST",[48,52,56],{"measure":49,"description":50,"timeFrame":51},"Behavior Rating Inventory of Executive Functioning, 2nd Edition","The BRIEF-2 assesses real-world EF behaviors in the home and school environments.\n\nThe T-scores range from 30:99 with higher scores being worse.","From enrollment to the end of treatment at 8 weeks.",{"measure":53,"description":54,"timeFrame":55},"Homework Problems Checklist","The HPC assesses Homework Completion and Homework Management. Scores for Homework Completion range from 0 to 36 and for Homework Management from 0 to 21. Lower scores are better.","From enrollment to end of treatment at 8 weeks.",{"measure":57,"description":58,"timeFrame":55},"Academic Performance Rating Scale","The teacher-completed APRS assesses how well the adolescent is performing academically with 3 subscales (Academic Success, Academic Productivity, and Impulse Control). The two scores to be used in the current study include the Academic Success score which ranges from 7 to 35, while the Academic Productivity score ranges from 12 to 60. Higher scores are better.",[60,63,66],{"measure":61,"description":62,"timeFrame":51},"Children's Organizational Skills Scale","The COSS is a psychometrically strong rating scale assessing Organized Actions, Task Planning, and Memory \\& Materials Management. The T scores for each subscale range from 20 to 83 and higher scores indicate worse functioning.",{"measure":64,"description":65,"timeFrame":51},"Weekly Calendar Planning Activity","The WCPA is an objective measure of metacognition (i.e., planning, inhibition, problem solving, keeping track of rules, and monitoring passage of time) while performing a multiple-step activity (i.e., scheduling multiple appointments while adhering to various rules). The WCPA will report total appointments entered (0 to 10) and total correct appointments entered (0 to 10) with higher values being better.",{"measure":67,"description":68,"timeFrame":51},"Social Skills Assessment (TRIAD)","The TRIAD assesses social skills (i.e., emotion understanding and perspective taking, initiating and ending interactions, responding to others, maintaining interactions and problem solving, and following social rules) rated on a 1 to 4 scale (1=not very well to 4=very well). Items rated 2 or less are considered areas of weakness. Items rated as 3 or above are considered areas of strength.","ALL","10 Years","15 Years",false,{"inclusion":74,"exclusion":81,"raw_text":85},[75,76,77,78,79,80],"Diagnosis of autism","No intellectual disability","Problems with organization, materials management, and planning and prioritization","Problems with social skills","Fully included in middle school","Stable medication and behavioral treatment regime",[82,83,84],"Home schooled","Severe co-occurring psychopathology (e.g., aggression, suicidal)","Non English-speaking","Inclusion Criteria:\n\n* Diagnosis of autism\n* No intellectual disability\n* Problems with organization, materials management, and planning and prioritization\n* Problems with social skills\n* Fully included in middle school\n* Stable medication and behavioral treatment regime\n\nExclusion Criteria:\n\n* Home schooled\n* Severe co-occurring psychopathology (e.g., aggression, suicidal)\n* Non English-speaking",[87],"CHILD",[89],{"facility":90,"status":7,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Ellie Thoma","CONTACT","513-636-5994","skillsbuilder@cchmc.org",{"name":102,"role":103},"Leanne Tamm, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},39.12711,-84.51439,[108,111],{"name":102,"role":98,"phone":109,"email":110},"513-803-3176","leanne.tamm@cchmc.org",{"name":112,"role":98,"phone":113,"email":114},"Amie Duncan, Ph.D.","513-803-2416","amie.duncan@cchmc.org",[116,117],{"name":102,"affiliation":12,"role":103},{"name":112,"affiliation":12,"role":103},[],[],{"nct_id":4,"conditions":121,"biomarkers":122},[19],[],{"nct_id":4,"found":14,"summary":124,"prompt_version":133},{"design":125,"status":126,"heading":6,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an interventional study where participants will be randomly assigned to one of two group interventions. It plans to enroll 224 participants.","completed","This study is testing two group programs for middle-schoolers (ages 10-15) with autism spectrum disorder (ASD) who do not have an intellectual disability. One program, called Achieving Independence and Mastery in School (AIMS), helps with organization, planning, and study skills. The other, Building Essential Social Skills for Teens (BESST), focuses on improving social skills. You would be randomly assigned to one of these programs. Researchers will measure changes in executive functioning (skills like planning and organizing), homework problems, and academic performance after 8 weeks of treatment to see how well the programs work. The study is currently unclear on its recruitment status and aims to enroll 224 participants.","Participants are followed from enrollment to the end of treatment at 8 weeks.",108,"Participants will attend one of two group interventions for 8 weeks. Measurements will be taken from enrollment to the end of treatment at 8 weeks.","Not stated in the trial record.",[35,42],"v2"]