Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program
2026년 5월 29일 업데이트: Allison Schwartz, Emory University
Early Diagnostic Telehealth Pilot for Moderate- and High-risk Children: Evaluating Protocols for Children in Georgia's Early Intervention Program
This pilot study includes children identified as moderate- as well as high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program.
The project will evaluate the feasibility, acceptability, and implementation of a diagnostic protocol, including optional measures, through measures of recruitment, retention, adherence, provider confidence, and time from referral to report completion.
It will also examine which child diagnostic measures are essential and needed to improve psychologists' diagnostic confidence.
Caregiver, early intervention provider, and clinician experiences and satisfaction before, during, and after assessment will be assessed to evaluate protocol acceptability, knowledge, and access to services.
Outcomes will be analyzed using the RE-AIM Framework (reach, effectiveness, adoption, implementation, maintenance) and compared across BCW districts and child characteristics, including changes in autism screening, referral, and evaluation rates over time.
연구 개요
상세 설명
The objective of this study is to develop, pilot, and evaluate a telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program.
Many BCW children with moderate- or high-risk screening results face long wait times and limited access to diagnostic evaluations. This pilot will evaluate how many of these assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved. It is hypothesized that the EDRM-E will increase access to timely, evidence-based autism evaluations and yield diagnostic outcomes comparable to in-person assessments based on DSM-5-TR criteria.
Secondary aims include identifying which additional assessment measures increase clinician confidence and are most acceptable to families and providers. It is hypothesized that moderate-risk children will require more in-depth evaluation and that families receiving expanded assessments will report higher satisfaction and acceptability.
A further objective is to examine family, BCW provider, and clinician satisfaction, understanding, and access to services following participation in the EDRM-E pilot. No data will be submitted to the FDA, and no algorithm, product, or software will be commercialized or used outside Emory.
연구 유형
중재적
등록 (추정된)
100
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Allison J Schwartz, PhD
- 전화번호: 404-727-6865
- 이메일: allison.schwartz@emory.edu
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University
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연락하다:
- Allison J Schwartz, PhD
- 전화번호: 404-727-6865
- 이메일: allison.schwartz@emory.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Child is enrolled in a participating BCW district.
- Child is 16-36 months of age at the time of referral.
- Child is identified as moderate- or high-risk on the M-CHAT-R/F
- BCW provider submits a referral to the EDRM-E pilot by 33 months of age.
- Parent/guardian has basic English proficiency in order to complete intake forms and in-depth interview, and the child has exposure to English at home or in out-of-home care.
- Documentation of the M-CHAT-R/F screening results and parental consent to refer is completed and submitted.
Exclusion Criteria:
- Families making self-referrals to the EAC or referred from non-onboarded BCW districts.
- Child is older than 33 months at referral.
- Non-English speaking families due to staffing and resource limitations as the consent, parent interview and child assessment would need to be done and accessible in other languages and are not available within this study scope at this time. .
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Families with children enrolled in BCW with suspected diagnosis of autism
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.
Children will be assessed via a remote telehealth session with an EAC clinician, using age-appropriate standardized measures.
Clinicians rate confidence after four points: intake review, parent interview and child observation, child assessment, and DSM-5-TR checklist completion.
Feedback is provided via telehealth, and a final report with recommendations is issued.
Psychologists will be asked about the protocol after each assessment.
Parents/caregivers will be asked to answer questions during the assessment, immediately after the assessment, and 3 months later.
EI providers will also be asked questions about their experience after the assessment.
Total length of enrollment range 3-16 weeks.
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A telehealth diagnostic protocol for assessing toddlers identified as moderate- or high-risk for autism spectrum disorder (ASD) within Georgia's Babies Can't Wait (BCW) Early Intervention (EI) program.
This pilot will evaluate how many of the initial assessments can be completed entirely via a streamlined telehealth protocol and the level of diagnostic confidence achieved.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol
기간: Monthly until the end of the study (approximately one year)
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Number of moderate and high-risk referral assessments that can be completed entirely via streamlined telehealth protocol
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Monthly until the end of the study (approximately one year)
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Number of participants referred to the Early Diagnostic Response Model Expanded (EDRM-E)
기간: End of study (up to 16 weeks post-intervention)
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Monthly numbers of high-risk referrals to the EDRM-E pilot project and total number of referrals made to the EDRM-E at the end of the study.
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End of study (up to 16 weeks post-intervention)
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Number of participants consented in the Early Diagnostic Response Model Expanded (EDRM-E) study
기간: Monthly until the end of the study (approximately one year)
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Monthly number of families referred who consent to EDRM-E participation
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Monthly until the end of the study (approximately one year)
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Response rate in the Early Diagnostic Response Model Expanded (EDRM-E) study
기간: Monthly until the end of the study (approximately one year)
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Response rate will be calculated at project end using the formula [# of families who consented / # of families referred to project] x 100 = response rate)
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Monthly until the end of the study (approximately one year)
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Number of participants that completed the Early Diagnostic Response Model Expanded (EDRM-E) study
기간: Every 3 months (Quarterly) until end of study (approximately one year)
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Quarterly numbers of participants that completed the EDRM-E assessment protocol and total number of participants who completed EDRM-E assessment protocol at study conclusion
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Every 3 months (Quarterly) until end of study (approximately one year)
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Time from referral to completion of the program
기간: Up to 12 weeks post-intervention
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Individual calculation of time from BCW referral to final summary report sent to family using the formula: Date of Final Report sent to family - Date of referral from BCW =Time in EDRM-E pilot |
Up to 12 weeks post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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최종 DSM-5 결론을 내리기 위해 수집된 추가 정보가 있는 참가자 수
기간: 연구가 끝날 때까지(약 1년) 3개월마다(분기마다), 개입 후 최대 12주
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최종 DSM-5 결론을 내리기 위해 수집된 추가 정보가 있는 참가자 수
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연구가 끝날 때까지(약 1년) 3개월마다(분기마다), 개입 후 최대 12주
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파일럿과 다른 수단을 통해 연구가 끝날 때까지 ASD 평가를 받은 가족 수
기간: 연구 수료를 통해 평균 1년
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파일럿과 다른 수단을 통해 연구가 끝날 때까지 ASD 평가를 받은 가족 수
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연구 수료를 통해 평균 1년
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Number of moderate and high-risk referrals by BCW district
기간: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Number of moderate-high risk referral assessments by specific BCW district.
Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.
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Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Number of moderate and high-risk referral by child factors
기간: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Number of high-risk referral assessments by child factors.
Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.
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Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Number of moderate and high-risk referrals by clinician setting
기간: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Number of high-risk referral assessments by clinician setting.
Monthly, Quarterly, and Total numbers of participants who completed EDRM-E pilot assessment.
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Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention
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Parent satisfaction of EDRM-E assessment survey
기간: At completion of EDRM-E assessment (4 weeks post-intervention)
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Administered at the end of individual EDRM-E 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.
Total score: 0 to 110.
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At completion of EDRM-E assessment (4 weeks post-intervention)
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BCW provider(s) Service Coordinator satisfaction with EDRM-E assessment survey
기간: At completion of EDRM-E assessment (4 weeks post-intervention)
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Administered at end of individual EDRM-E 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-E project.
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At completion of EDRM-E assessment (4 weeks post-intervention)
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Parent satisfaction with access to treatment survey
기간: 3 months after completion of EDRM-E assessment
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Parent satisfaction with access to treatment survey Administered 3-months after completion of EDRM-E 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-E project.
Total score: 0 to 15.
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3 months after completion of EDRM-E assessment
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BCW provider(s) Early Intervention Coordinator satisfaction with EDRM-E pilot survey
기간: Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
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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.
Total score: 0 to 55
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Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention
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Number of families screened moderate and high-risk for ASD and referred for an evaluation
기간: Through study completion, an average of 1 year
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Number of families screened moderate and high-risk for ASD and referred for an evaluation
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Through study completion, an average of 1 year
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Allison J Schwartz, PhD, Emory University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data will be shared with qualified researchers with relevant expertise, researchers affiliated with academic or clinical institutions, and investigators with IRB/ethics approval for secondary analyses as needed, including basic demographic information, scores on assessments, and final diagnostic results.
IPD 공유 기간
Proposals 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.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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