Early Diagnostic Telehealth Pilot for Moderate- and High-Risk Children: Evaluating Assessment Protocols and Efficiency in Georgia's Early Intervention Program
2026年5月29日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
100
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Allison J Schwartz, PhD
- 電話番号：404-727-6865
- メール：allison.schwartz@emory.edu
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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コンタクト：
- Allison J Schwartz, PhD
- 電話番号：404-727-6865
- メール：allison.schwartz@emory.edu
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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. .
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of moderate and high-risk referral assessments that were completed entirely via a streamlined telehealth protocol
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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DSM-5 の最終結論を出すために追加情報を収集した参加者の数
時間枠：研究終了まで（約1年）3ヶ月ごと（四半期ごと）、介入後最大12週間
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DSM-5 の最終結論を出すために追加情報を収集した参加者の数
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研究終了まで（約1年）3ヶ月ごと（四半期ごと）、介入後最大12週間
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研究終了までに試験的手段と他の手段で ASD 評価を受けた家族の数
時間枠：学習完了までに平均1年
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研究終了までに試験的手段と他の手段で ASD 評価を受けた家族の数
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学習完了までに平均1年
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Number of moderate and high-risk referrals by BCW district
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Allison J Schwartz, PhD、Emory University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
自閉症スペクトラム障害の臨床試験
Early Diagnostic Response Model Expandedの臨床試験
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Bruno RhinerUniversity of Arkansas; West Virginia University終了しました