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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Number of participants referred to the Early Diagnostic Response Model (EDRM)
研究概览
简要总结
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.
详细描述
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.
A 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.
A 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Referring BCW provider must be one of the participating BCW health districts in this pilot study.
- •Parent/Guardian needs to have basic English proficiency
- •Parent/Guardian needs to have internet access
- •Child must have exposure to English either at home or in out-of-home care (e.g., childcare setting).
- •Documentation of M-CHAT-R High-Risk failed score (≥ 8) must be documented in referral.
排除标准
- •Families making self-referrals to the EAC or referrals outside of the targeted BCW districts will be excluded from recruitment for this study.
- •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.
- •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.
研究组 & 干预措施
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. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later).
干预措施: Early Diagnostic Response Model (EDRM) (Behavioral)
结局指标
主要结局
Number of participants referred to the Early Diagnostic Response Model (EDRM)
时间窗: Until the end of the study (approximately one year)
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
Number of participants consented in the Early Diagnostic Response Model (EDRM) study
时间窗: Monthly until until the end of the study (approximately one year)
Monthly number of families referred who consent to EDRM participation
Response rate in the Early Diagnostic Response Model (EDRM) study
时间窗: Until end of the study (approximately one year)
Response rate will be calculated at project end using the formula \[# of families who consented / # of families referred to project\] x 100 = response rate)
Number of participants that completed the Early Diagnostic Response Model (EDRM) study
时间窗: Every 3 months (Quarterly) until end of study (approximately one year)
Quarterly numbers of participants that completed the EDRM assessment protocol and total number of participants who completed EDRM assessment protocol at study conclusion
Time from referral to completion of the program
时间窗: Up to 12 weeks post-intervention
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 pilot
次要结局
- Number of families screened high risk for ASD and referred for an evaluation(Through study completion, an average of 1 year)
- Number of high-risk referral assessments that completed entirely via streamlined telehealth protocol(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention)
- Number of of high-risk referral by BCW district(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention)
- Number of of high-risk referral by child factors(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention)
- Number of of high-risk referral by clinician setting(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention)
- BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey(At completion of EDRM assessment (4 weeks post-intervention))
- Parent satisfaction with access to treatment survey(3 months after completion of EDRM assessment)
- Number of participants with additional information collected to make a final DSM-5 conclusion(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks post-intervention)
- Parent satisfaction of EDRM assessment survey(At completion of EDRM assessment (4 weeks post-intervention))
- BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey(Every 3 months (Quarterly) until end of study (approximately one year), Up to 12 weeks postintervention)
- Number of families who received ASD evaluation by the end of the study through the pilot versus other means(Through study completion, an average of 1 year)
研究者
Allison Schwartz
Assistant Professor
Emory University