[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06690255":3,"trial-entities:NCT06690255":101,"trial-summary:NCT06690255":104},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":69,"locations":71,"central_contacts":89,"overall_officials":97,"references":99,"see_also_links":100},"NCT06690255","IRB-77671","Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder","Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)","RECRUITING","2030-12-15","2026-06","2026-06-22","2026-06-17","Stanford University","OTHER",false,"The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:\n\n* Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?\n* Does this training improve children's language and social interactions?\n\nResearchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.\n\nParticipants in the study will:\n\n* Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents\n* Meet with a research team member every few weeks by phone or video to ask questions and receive feedback\n* Provide video recordings of interactions with their child to track progress\n* Complete brief surveys about their experience and child's communication abilities\n\nBy focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.",null,[19],"Autism Spectrum Disorder",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Pivotal Response Treatment","PRT will target functional communication abilities",[34],"Spanish PRT Online",[36],{"measure":37,"description":38,"timeFrame":39},"Change in Parent Fidelity of PRT Implementation from Baseline to Week 12","Based on behavioral coding of parent-child interaction videos in the home","Baseline, Week 12",[41,44,46,49],{"measure":42,"description":43,"timeFrame":39},"Change in Child Frequency of Functional Utterances from Baseline to Week 12","Based on behavioral coding of parent-child interaction videos in the home and parent report measures",{"measure":42,"description":45,"timeFrame":39},"Based on parent-report on the MacArthur-Bates Communicative Development Inventories",{"measure":47,"description":48,"timeFrame":39},"Change in Child Socialization and Communication from Baseline to Week 12","Based on clinician-rated Clinical Global Impressions Scale (CGI)",{"measure":47,"description":50,"timeFrame":39},"Based on parent-rated Vineland Adaptive Behavior Scale, Third Edition (VABS-3)","ALL","2 Years","5 Years",{"inclusion":55,"exclusion":63,"raw_text":68},[56,57,58,59,60,61,62],"Children aged 2 to 5 years, 11 months at the time of consent","Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and\u002For parent questionnaire","Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale","A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish","Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study","Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes","Limited to no more than 60 minutes of one-on-one speech therapy per week",[64,65,66,67],"Primary language of the child or parent is not Spanish","Either the child or parent has a severe psychiatric disorder or an unstable medical condition","Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline","The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week","Inclusion Criteria:\n\n* Children aged 2 to 5 years, 11 months at the time of consent\n* Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and\u002For parent questionnaire\n* Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale\n* A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish\n* Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study\n* Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes\n* Limited to no more than 60 minutes of one-on-one speech therapy per week\n\nExclusion Criteria:\n\n* Primary language of the child or parent is not Spanish\n* Either the child or parent has a severe psychiatric disorder or an unstable medical condition\n* Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline\n* The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week",[70],"CHILD",[72],{"facility":13,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"Palo Alto","California","94305","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Robin Libove","CONTACT","650-736-1235","autismdd@stanford.edu",{"name":84,"role":85},"Grace Gengoux, PhD","PRINCIPAL_INVESTIGATOR",{"lat":87,"lon":88},37.44188,-122.14302,[90,94],{"name":91,"role":80,"phone":92,"email":93},"Grace Gengoux, Ph.D.","6507235511","ggengoux@stanford.edu",{"name":95,"role":80,"email":96},"Ty Vernon, Ph.D.","tyvernon@ucsb.edu",[98],{"name":91,"affiliation":13,"role":85},[],[],{"nct_id":4,"conditions":102,"biomarkers":103},[19],[],{"nct_id":4,"found":105,"summary":106,"prompt_version":116},true,{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is an interventional study planning to enroll 40 participants. It is designed to evaluate the effectiveness of an online training program.","completed","Online Spanish Pivotal Response Treatment Training for Autism","This study is testing an online course in Spanish designed to teach parents of young children with Autism Spectrum Disorder (ASD) how to use Pivotal Response Treatment (PRT). PRT is a behavioral therapy that helps improve communication and social skills. The goal is to see if Spanish-speaking parents can learn these techniques effectively and if their children's language and social interactions improve. This trial aims to help families who might have difficulty accessing autism services due to language, location, or cost. We are looking for 40 children aged 2 to 5 years, 11 months, who have an ASD diagnosis and significant language delays. Success will be measured by how well parents learn to use PRT techniques over 12 weeks.","The primary endpoint is measured at Week 12, indicating a follow-up period of at least 12 weeks.",119,"Parents will participate in regular virtual check-ins and submit videos showing their practice with PRT. The primary endpoint is measured at baseline and Week 12.","Not stated in the trial record.",[31],"v2"]