[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06005285":3,"trial-entities:NCT06005285":125,"trial-summary:NCT06005285":129},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":46,"secondary_outcomes":54,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":86,"locations":90,"central_contacts":106,"overall_officials":114,"references":119,"see_also_links":124},"NCT06005285","2030726","Examining the Effectiveness of the Early Start Denver Model in Community Programs Serving Young Autism","Examining the Effectiveness of the Early Start Denver Model in Community Programs","RECRUITING","2028-06-01","2025-12","2025-12-05","2024-03-01","University of California, Davis","OTHER",true,"This study tests the effectiveness of the Early Start Denver Model (ESDM) in community agencies that serve young autistic children. The feasibility, usability and acceptability of the model will be explored. Understanding effectiveness of new evidence-based models will increase the quality of autism care available to more diverse children and families in more geographic locations.","The rising number of children identified as autistic has led to exponential growth in for-profit applied behavior analysis (ABA) agencies and their use of highly structured approaches that may not be developmentally appropriate for young children.1 This has led to growing public health concerns regarding limited effectiveness data combined with high cost of services. Newer research has led to development of evidence-based autism interventions (EBI) called naturalistic developmental behavior interventions (NDBIs),30 supported by multiple clinical trials.31-34 NDBIs integrate theory and strategies from ABA and developmental science,30 are considered best practice for young autistic children,35 and are supported by systematic reviews and meta-analyses.9,36 However, NDBI effectiveness has not been tested in the community and there is also a need to test the variables that moderate outcomes, and the mechanisms of treatment action.2 The lack of effectiveness data regarding NDBI use in community-based agencies (CBAs) contributes to limited funding as payors are more likely to recognize older methods. The Early Start Denver Model (ESDM) is a comprehensive NDBI shown to improve social communication and language for autistic children in multiple controlled efficacy studies.6,31 ESDM engages social motivation and caregiver use of strategies as mechanisms to increase child engagement in social learning opportunities in the environment, resulting in increased rates of learning.65 ESDM is a manualized approach that includes assessment and data collection methods that meet funder requirements and a tested community training model. The transportability of ESDM is evidenced by two recent community pilot studies.63,64 This proposal addresses a critical need to understand ESDM effectiveness and whether the same treatment mechanisms operating in efficacy trials also operate in community implementation with diverse samples. Answering these critical scientific questions will determine the potential of NDBIs to meet public health goals of improving access to quality care for young autistic children.\n\nIn addition to the challenge of determining effectiveness within communities are challenges of implementation and scale-up. CBAs have grown exponentially in number and size since changes in insurance regulations allow funding for such services. The nine largest CBAs operate over 300 centers and employ thousands of therapists generating $1.07 billion this year, outpacing prescription drugs for autism symptoms. The fast growth in CBA service delivery highlights a large research gap between efficacy and clinical effectiveness findings for current community practices. Given the number of children, families, and the costs involved in this public health challenge, using hybrid effectiveness-implementation designs can accelerate scalability of effective NDBI for community settings by ensuring fit, feasibility and acceptability for CBAs and diverse families. The investigators propose to use the Exploration, Preparation, Implementation and Sustainment (EPIS) framework to identify multi-level factors that affect implementation of ESDM in the community.95\n\nThis project will use a hybrid type 1 randomized controlled design to examine ESDM effectiveness and to gather data on implementation determinants. The specific aims and hypotheses are to:\n\n1. Test the effectiveness of ESDM for improving social communication and language outcomes in a diverse community sample of autistic children using a randomized controlled trial of Community Based Agencies. Compared to treatment as usual (TAU): a) Children in the ESDM condition will demonstrate significantly increased growth rates in social communication and language (primary); b) caregivers in the ESDM condition will have greater increases in use of ESDM strategies (secondary).\n2. Examine engagement of the treatment mechanisms of social motivation and caregiver fidelity within both treatment groups. The investigators predict that: (a) increased social motivation and better caregiver fidelity will act as mechanisms of change in social communication and language in both ESDM and TAU and (b) children in the ESDM group will demonstrate greater changes in social motivation than children in TAU.\n3. Examine moderating variables on ESDM treatment effects. The investigators predict that (a) lower caregiver education and child racial\u002Fethnic diversity will have larger negative effects on child growth rates in TAU than ESDM; and that (b) CBA provider adherence to ESDM fidelity will have positive effects on child rate of growth.\n4. Exploratory AIM: Use the EPIS framework to gather data on ESDM Implementation outcomes including acceptability, feasibility, appropriateness and cultural responsivity, CBA provider ESDM fidelity, and caregiver engagement. a) participants will find ESDM to be acceptable, feasible, appropriate and culturally responsive for young autistic children; b) CBA providers will demonstrate ESDM fidelity; c) caregivers receiving ESDM will have higher attendance, parenting competence, and satisfaction than those in TAU.\n\nImpact: As indicated by Autism Interagency Coordinating Committee goals, understanding the effectiveness of an intervention like ESDM, the variables that mediate and moderate child outcomes, and engagement of its mechanisms of action in community use, has the potential to increase access to high quality, effective intervention for all young autistic children, especially those from diverse backgrounds who depend on public services. Understanding implementation determinants will support scale-up of effective models throughout a broad range communities and service systems.",[19],"Autism",[21,22,23],"early intervention","community effectiveness","early start denver model","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},600,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Early Start Denver Model (ESDM)","The Early Start Denver Model focuses on teaching inside children's play and care activities, carried out within a joint activity structure. Adults follow children's leads into activities, embed teaching objectives inside the play, use the play as the reward, and build targeted skills following developmental science and ABA principles.",[34],[38],"naturalistic developmental behavioral intervention (NDBI)",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":44},"Early Intensive Behavioral Intervention (EIBI)","Treatment as usual provided by community-based autism agencies",[43],"Treatment as Usual (TAU)",[45],"Discrete Trial Teaching (DTT)",[47,51],{"measure":48,"description":49,"timeFrame":50},"Assessment of Phase of Preschool Language (APPL)","the APPL operationalizes research-based language development stages. Language phases are derived from spoken language or augmentative communication systems and standardized assessments. Language samples will be obtained from transcriptions of child-caregiver interactions recorded at each timepoint and coded by naive observers","Baseline, 6 months, 12 months",{"measure":52,"description":53,"timeFrame":50},"Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) Communication Domain","Standardized parent interview measuring the use of adaptive communication. The Vineland Adaptive Behavior Scales-3rd Edition communication domain provides a standardized score with a mean of 100 and a standard deviation of 15. Higher scores mean better outcomes.",[55,58,61,64,67,71,75],{"measure":56,"description":57,"timeFrame":50},"Vineland Adaptive Behavior Scales-3rd Edition (VABS-3)","The Vineland Adaptive Behavior Scales-3rd Edition consists of four domains of adaptive behavior: communication, daily living skills, socialization, and motor skills. Overall adaptive behavior composite will be used in analyses. The Vineland Adaptive Behavior Scales-3rd Edition adaptive behavior composite provides a standardized score with a mean of 100 and a standard deviation of 15. Higher scores mean better outcomes.",{"measure":59,"description":60,"timeFrame":50},"Caregiver Quality of Life Instrument (CarerQoL)","The Caregiver Quality of Life Instrument assesses perceived caregiver quality of life across seven dimensions for informal caregivers. Minimum score is 0 and maximum score is 14 where higher scores indicate increased caregiving burden (worse outcomes).",{"measure":62,"description":63,"timeFrame":50},"Pediatric Quality of Life Inventory (PedsQL)","The PedsQL assesses children's quality of life across four domains based on caregiver report and has been validated in an autism population. The PedsQL is scored on a scale of 0 to 100, with higher numbers correlating with better quality of life.",{"measure":65,"description":66,"timeFrame":50},"The Parenting Sense of Competence (PSOC)","The Parenting Sense of Competence (PSOC) is a 17-item caregiver questionnaire that measures and assesses caregiver self-efficacy in working with their child. Parents will complete this at each time point. Scores range from 17 (min) to 102 (max). A higher score indicates a higher parenting sense of competency.",{"measure":68,"description":69,"timeFrame":70},"Brief Observation of Social Change (BOSCC)","The Brief Observation of Social Change consists of 15 items that are coded on a 6-point scale and results in Social Communication (SC; i.e., eye contact, facial expressions, gestures, vocalizations, integration of vocal and non-vocal communication, frequency\u002Ffunction of social overtures, frequency\u002Fquality of social responses, engagement in activities\u002Finteraction, and play with objects) and Restricted and Repetitive Behavior (RRB) domain totals (unusual sensory interests, hand\u002Ffinger or other complex mannerisms, and unusually repetitive interests\u002Fstereotyped behaviors). The Core total combines the SC and RRB scores. I","6 months, 12 months",{"measure":72,"description":73,"timeFrame":74},"ESDM Strategy Use Fidelity Measure","The ESDM Fidelity Checklist will assess use of ESDM practices. The ESDM Fidelity Checklist consists of 13 items: (a) management of child attention; (b) ABC teaching format; (c) instructional techniques; (d) Modulating child affect\u002Farousal; (e) management of unwanted behavior; (f) use of turn-taking\u002Fdyadic engagement; (g) child motivation is optimized; (h) adult use of positive affect; (i) adult sensitivity and responsivity; (j) multiple varied communicative functions; (k) adult language; (l) joint activity and elaboration; and (m) transition between activities.","quarterly during provider participation in the study",{"measure":76,"description":77,"timeFrame":74},"Naturalistic Developmental Behavioral Intervention Fidelity (NDBI-Fi) measure","This measure was developed to capture common elements across NDBI interventions. This measure has adequate reliability, sensitivity to change, and concurrent, convergent, and discriminative validity. The investigators will use the total score as well as examine differences by strategy type, responsive and directive consistent with recent studies","ALL","12 Months",null,false,{"inclusion":83,"exclusion":84,"raw_text":85},[],[],"The investigators will collect data from leaders, providers and clients in participating autism CBAs. The investigators will collect data from 20 Regional Managers, 100 supervisors, and 200 technicians working with autistic children. Participants will include 300 children ages 1-5 years with a diagnosis of autism spectrum disorder living in the US and being served by participating treatment team.\n\nInclusion criteria for Autism CBAs include: Serve at least 10 children with autism under age 5 annually and have at least 2 regions that can be randomized. Accept Medicaid or equivalent payment (e.g., funding for low income families through public service systems).\n\nInclusion criteria for supervisors are as follows:\n\n1. employed as a program supervisor at participating region\n2. plans to be employed for at least the next 12 months\n3. serves children with autism under age 5\n4. has not has previous training in ESDM\n5. supervises at least two technicians\n\nInclusion criteria for technicians is as follows:\n\n1. supervised by a participating supervisor\n2. plans to be employed for at least the next 12 months\n3. serves children with autism under age 5\n4. has not had previous ESDM training\n\nInclusion criteria for children are as follows:\n\n1. child age 1-5 years\n2. has a current autism spectrum disorder (ASD) diagnosis on record or is being served as at-risk for ASD if under age 3\n3. family speaks English or Spanish\n4. child expected to be in therapy for at least 7 months",[87,88,89],"CHILD","ADULT","OLDER_ADULT",[91],{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"University of California, Davis MIND Institute","Sacramento","California","95817","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"Deeniece Hatten, BA","CONTACT","916-703-0468","dchatten@ucdavis.edu",{"lat":104,"lon":105},38.58157,-121.4944,[107,111],{"name":108,"role":100,"phone":109,"email":110},"Aubyn Stahmer, PhD","916-703-0254","astahmer@ucdavis.edu",{"name":112,"role":100,"email":113},"Sarah Dufek, PhD","sadufek@ucdavis.edu",[115],{"name":116,"affiliation":117,"role":118},"Aubyn C Stahmer, PhD","UC Davis","PRINCIPAL_INVESTIGATOR",[120],{"pmid":121,"type":122,"citation":123},"39342272","DERIVED","Stahmer AC, Dufek S, Rogers SJ, Iosif AM. Study Protocol for a Cluster, Randomized, Controlled Community Effectiveness Trial of the Early Start Denver Model (ESDM) Compared to Community Early Behavioral Intervention (EBI) in Community Programs serving Young Autistic Children: Partnering for Autism: Learning more to improve Services (PALMS). BMC Psychol. 2024 Sep 28;12(1):513. doi: 10.1186\u002Fs40359-024-02020-0.",[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Autism Spectrum Disorder",[],{"nct_id":4,"found":15,"summary":130,"prompt_version":140},{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an interventional study comparing two behavioral interventions. It plans to enroll 600 participants, including 300 children with autism.","completed","Early Start Denver Model for Young Autistic Children","This study is looking at how well the Early Start Denver Model (ESDM) works in community programs for young children with autism. ESDM teaches skills during play and daily activities, with adults following the child's lead. This study compares ESDM to standard care, called Early Intensive Behavioral Intervention (EIBI), which is already offered by community autism agencies. The goal is to see if ESDM is practical, easy to use, and helpful for children and families. Researchers will measure language skills using the Assessment of Phase of Preschool Language (APPL) and communication skills using the Vineland Adaptive Behavior Scales-3rd Edition (VABS-3) at the start, 6 months, and 12 months. The study plans to enroll 600 participants, including 300 children aged 1-5 years with an autism diagnosis in the US. The current recruitment status is unclear.","Participants will be assessed at the start of the study, and again at 6 months and 12 months.",134,"Not specified in the trial record.","Not stated in the trial record.",[34,40],"v2"]