Table 1 Pragmatic Features Employed in SRT Clinical Trial

Eligibility

• Providers: Community-based PCPs and EI providers in 4 selected counties

• Parents: Parents of children 16–36 months old receiving care from an enrolled provider; meet criteria for ASD concerns or No concerns based on study screening interview; English- or Spanish-Speaking; No significant comorbid medical conditions.

Recruitment

• Providers: Recruited from usual care settings; Compensation provided only for research-related activities (e.g., mailing recruitment flyers; completing surveys)

• Parents: Recruited by participating PCPs and EI providers via: posting flyers in waiting area, handing flyers to parents, and/or sending flyers to all families with age-eligible children (i.e., not otherwise targeted). Compensation provided for completing study surveys.

Setting

• Conducted exclusively within usual care settings

Organization

• Care delivery is consistent with that provided in PCP (i.e., screening; referral) and EI (i.e., assessment; intervention) settings.

• Study provides training and technical assistance in using evidence-based tools.

• Study provides compensation to programs for EI providers’ workshop attendance.

Additional resources provided through the study:

• PCPs & EIs: Materials about early features of ASD and communicating with parents about ASD concerns.

• PCPs only: Information about local ASD resources; Hand-held tablets parents use to complete the online M-CHAT-R/F; Access to a REDCap database for obtaining M-CHAT-R/F results; CME and/or MOC credits (at no cost) for workshop and project participation

• EIs only: Interview probes for eliciting behavioral reports from parents; Telemedicine equipment for receiving online consultation. and feedback; STAT materials and certification at no cost; (4) optional CEU credits for workshops (self-pay).

Flexibility/Delivery

• PCPs & EIs: Freedom to use additional screening, assessment, and/or intervention tools; freedom to use the M-CHAT-R/F, STAT, and/or RIT with non-enrolled families and/or children outside the study age range; freedom to develop their own workflow plans.

Study-specific expectations:

• PCPs: Use of the web-based M-CHAT-R/F universally at 18 months; Referral of positive screens to EI programs. Both are consistent with AAP practice guidelines.

• EIs: Use of the STAT for children referred from PCPs with positive M-CHAT-R/F screens; Use of RIT for children who continue to screen positive for ASD.

Flexibility/Adherence

• Adherence to the intervention protocol (i.e., use of the M-CHAT-R/F, STAT, or RIT) is not required for continued study participation.

• PCPs & EIs: Adherence is monitored through self-report surveys at predetermined intervals.

• PCPs only: Use of web-based M-CHAT-R/F is monitored at the practice level through the REDCap database. Office managers are contacted if M-CHAT-R/F use is low or declines, to identify possible technical assistance needs.

Follow-up

• PCPs & EIs: Completion of self-report surveys 3 times over an 18-month period after the training workshops.

• PCPs only: Monitoring of M-CHAT-R/F use through REDCap database records for 18 months following the training workshop.

Primary outcomes

• Providers: Feasibility, acceptability, and use of the M-CHAT-R/F, STAT, and RIT.

• Parents: Improvements in overall well-being, health care satisfaction, parenting stress, and parenting efficacy for ASD concerns group.

• Children: Improved social communication skills and earlier receipt of specialized intervention for children with ASD concerns.

Primary analysis

All data are analyzed using an intent-to-treat model.