Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-03-10 @ 11:33 PM
Study NCT ID:
NCT05419895
Status:
RECRUITING
Last Update Posted:
2025-05-07
First Post:
2022-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnostic Response Model (EDRM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-10', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants referred to the Early Diagnostic Response Model (EDRM)', 'timeFrame': 'Until the end of the study (approximately one year)', 'description': 'Monthly numbers of high-risk referrals to the EDRM pilot project and total number of referrals made to the EDRM at the end of the study'}, {'measure': 'Number of participants consented in the Early Diagnostic Response Model (EDRM) study', 'timeFrame': 'Monthly until until the end of the study (approximately one year)', 'description': 'Monthly number of families referred who consent to EDRM participation'}, {'measure': 'Response rate in the Early Diagnostic Response Model (EDRM) study', 'timeFrame': 'Until end of the study (approximately one year)', 'description': 'Response rate will be calculated at project end using the formula \\[# of families who consented / # of families referred to project\\] x 100 = response rate)'}, {'measure': 'Number of participants that completed the Early Diagnostic Response Model (EDRM) study', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year)', 'description': 'Quarterly numbers of participants that completed the EDRM assessment protocol and total number of participants who completed EDRM assessment protocol at study conclusion'}, {'measure': 'Time from referral to completion of the program', 'timeFrame': 'Up to 12 weeks post-intervention', 'description': 'Individual calculation of time from BCW referral to final summary report sent to family using the formula:\n\nDate of Final Report sent to family - Date of referral from BCW =Time in EDRM pilot'}], 'secondaryOutcomes': [{'measure': 'Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention', 'description': 'Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol, analyzed globally. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.'}, {'measure': 'Number of of high-risk referral by BCW district', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention', 'description': 'Number of high-risk referral assessments by specific BCW district. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.'}, {'measure': 'Number of of high-risk referral by child factors', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention', 'description': 'Number of high-risk referral assessments by child factors. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.'}, {'measure': 'Number of of high-risk referral by clinician setting', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention', 'description': 'Number of high-risk referral assessments by clinician setting. Monthly, Quarterly, and Total numbers of participants who completed EDRM pilot assessment.'}, {'measure': 'Number of participants with additional information collected to make a final DSM-5 conclusion', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention', 'description': 'Number of participants with additional information collected to make a final DSM-5 conclusion'}, {'measure': 'Parent satisfaction of EDRM assessment survey', 'timeFrame': 'At completion of EDRM assessment (4 weeks post-intervention)', 'description': 'Administered at the end of individual EDRM assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project.\n\nTotal score: 0 to 110.'}, {'measure': 'BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey', 'timeFrame': 'At completion of EDRM assessment (4 weeks post-intervention)', 'description': 'Administered at end of individual EDRM assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project.\n\nTotal score: 0 to 110.'}, {'measure': 'Parent satisfaction with access to treatment survey', 'timeFrame': '3 months after completion of EDRM assessment', 'description': 'Administered 3-months after completion of EDRM assessment. Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project.\n\nTotal score: 0 to 15.'}, {'measure': 'BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey', 'timeFrame': 'Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention', 'description': 'Completed every 3 months (Quarterly). Satisfaction surveys will use a Likert-scale of 1-5 with 1 being strongly disagree and 5 being strongly agree as well as 0 being not applicable/unknown. Higher scores indicate more satisfaction with specific aspect of EDRM project.\n\nTotal score: 0 to 55'}, {'measure': 'Number of families screened high risk for ASD and referred for an evaluation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of families screened high risk for ASD and referred for an evaluation'}, {'measure': 'Number of families who received ASD evaluation by the end of the study through the pilot versus other means', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of families who received ASD evaluation by the end of the study through the pilot versus other means'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Early Intervention', 'Telehealth', 'Assessment'], 'conditions': ['Autism Spectrum Disorder', 'Autism']}, 'descriptionModule': {'briefSummary': "Babies Can't Wait (BCW) in Georgia will be referring families with children seeking an autism spectrum disorder (autism) diagnosis at the Emory Autism Center's (EAC) Child Screening and Assessment Clinic.The objective of this study is to develop, pilot, and evaluate a diagnostic protocol for children identified at high risk for autism in the BCW early intervention program screening (part of a public health service). This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.", 'detailedDescription': "The objective of this study is to develop, pilot, and evaluate a diagnostic protocol to assess high-risk toddlers for autism spectrum disorder (ASD) diagnosis of families enrolled in the Georgia Babies Can't Wait (BCW) early intervention program. The Early Diagnostic Response Model (EDRM) project will be addressing children who are identified at high risk for ASD according to the BCW screening protocol, which is the M-CHAT-R/F. Community psychologist will be taught the protocol and receive referrals to build capacity and better address the need across the state. Currently, many children who are screening high-risk for ASD in BCW districts are unable to access follow-up evaluations due to limited community resources and long wait times. It is hypothesized that the EDRM will be successful in increasing the number of BCW families that access an ASD evaluation using telehealth tools and testing protocols and that the families and clinicians involved will be satisfied with the streamlined process. The clinicians' conclusions from the EDRM assessment will be based on the Diagnostic and Statistical Manual, 5th edition (DSM-5; American Psychiatric Association \\[APA\\], 2013) and are hypothesized to be able to provide high-risk children and their families with the same access to services as an in-person assessment.\n\nA secondary objective is to investigate how many high-risk referral assessments can be completed entirely via streamlined telehealth protocol and how many required additional information to be collected to make a final DSM-5 conclusion.\n\nA tertiary objective is to investigate the improvement of the EDRM as an early identification model to assess for ASD by comparing the numbers of families screened high risk for ASD and referred for an evaluation prior to the study to the number of families who received ASD evaluation by the end of the study through the pilot versus other means. These numbers will be analyzed globally as well as by specific BCW district and other child factors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '16 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All families of children between the ages of 16-30 months of age who scored ≥8 on the MCHAT-R and whose BCW provider refers the child to our clinic by 33 months of age will be a possible participant. Evaluations will be done by 36 months of age.\n* Referring BCW provider must be one of the participating BCW health districts in this pilot study.\n* Parent/Guardian needs to have basic English proficiency\n* Parent/Guardian needs to have internet access\n* Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).\n* Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.\n\nExclusion Criteria:\n\n* Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.\n* Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.\n* Non-English speakers will be excluded from participation due to the current protocol not being applicable to their needs as well as a high correlation between verbal language abilities and social communication and social interaction (SCI) abilities as part of the DSM-5-TR autism criteria.'}, 'identificationModule': {'nctId': 'NCT05419895', 'briefTitle': 'Early Diagnostic Response Model (EDRM)', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Early Diagnostic Response Model (EDRM): Evaluating an Early Screening to Evaluation Pilot Protocol for Children Identified as High Risk for Autism in Early Intervention Health Districts', 'orgStudyIdInfo': {'id': 'STUDY00003763'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Families with children enrolled in BCW with suspected diagnosis of autism', 'description': 'Post-consent, families with children between 16-33 months will receive a link to complete the EAC Developmental History Survey on REDCap and a link to complete parent/caregiver questionnaires about developmental and/or adaptive information. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later).', 'interventionNames': ['Behavioral: Early Diagnostic Response Model (EDRM)']}], 'interventions': [{'name': 'Early Diagnostic Response Model (EDRM)', 'type': 'BEHAVIORAL', 'description': 'Use of telehealth capabilities to implement measures and capture and code information related to an autism diagnosis. This program evaluation will be using pre- and post-data and data collected through the process to evaluate the effectiveness of the EDRM pilot.', 'armGroupLabels': ['Families with children enrolled in BCW with suspected diagnosis of autism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Allison Schwartz, PhD', 'role': 'CONTACT', 'email': 'allison.schwartz@emory.edu', 'phone': '404.727.8350'}], 'facility': 'Emory Autism Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Allison Schwartz, PhD', 'role': 'CONTACT', 'email': 'allison.schwartz@emory.edu', 'phone': '404.727.8350'}], 'overallOfficials': [{'name': 'Allison Schwartz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After completion of the EDRM pilot project; Beginning 3 months and ending within 3 years of published results through peer-review process.', 'ipdSharing': 'YES', 'description': "All individual participant data collected during the EDRM pilot will be shared, after de-identification process has been completed.\n\nProposals may be submitted to up to 3 years following article publication. After 3 years, data will be provided in Emory University's data warehouse but without investigator support other than deposited materials.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal that has been approved by an IRB. To achieve aims in proposed activity and/or for meta-analysis of telehealth assessments'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgia Department of Public Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Allison Schwartz', 'investigatorAffiliation': 'Emory University'}}}}