Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design

Lisa V Ibañez, Ann Vander Stoep, Kathleen Myers, Chuan Zhou, Shannon Dorsey, Kyle J Steinman, Wendy L Stone, Lisa V Ibañez, Ann Vander Stoep, Kathleen Myers, Chuan Zhou, Shannon Dorsey, Kyle J Steinman, Wendy L Stone

Abstract

Background: Despite the known benefits of early, specialized intervention for toddlers with Autism Spectrum Disorder (ASD), access to such intervention remains limited. This pragmatic trial examines a novel healthcare delivery model (Screen-Refer-Treat [SRT]), which capitalizes upon existing health care and early intervention (EI) infrastructure to increase community capacity for ASD detection and treatment before age 3, when it is likely to have the greatest impact. This model comprises three components: (1) universal use of Stage 1 ASD screening by primary care providers (PCPs) at 18-month well-child visits (i.e., Screen); (2) immediate referral of positive screens to a community-based EI program (i.e., Refer); and (3) provision of an inexpensive, evidence-based ASD-specialized treatment by EI providers, after verifying ASD risk with a Stage 2 screen (i.e., Treat). This paper describes our research design and the initial successes, challenges, and adaptations made during the early implementation phase.

Method/design: A stepped-wedge cluster RCT was used to implement the SRT model sequentially in four diverse Washington State counties ("clusters"). Counties are randomly assigned to the time of receipt of the SRT intervention, which comprises training workshops and technical assistance focused on the use of evidence-based ASD screening and intervention tools. Separate cohorts of families with toddlers (16-35 months old) with and without ASD concerns are recruited before and after the SRT intervention from participating PCP practices and EI programs. PCPs and EI providers complete measures on their screening, referral, and intervention practices before and after the SRT intervention. Each family cohort completes surveys about their well-being, parenting efficacy, health care satisfaction, and toddler's social-communicative behaviors.

Conclusion: This trial is the first of its kind to work simultaneously with two service delivery systems with the goal of improving early detection and treatment for ASD. Our approach was successful in attaining buy-in from PCPs and EI providers, building and maintaining partnerships with providers, and achieving high levels of retention and survey completion. Fostering provider engagement and problem-solving issues together as partners were integral to overcoming the main challenges. Numerous lessons have been learned thus far, which have applicability for implementation researchers in ASD and those in other fields.

Trial registration: The registration number for this trial is NCT02409303 and it was posted on ClinicalTrials.gov on April 6, 2015.

Keywords: Autism Spectrum Disorder; Early detection; Pragmatic trial; Preventive intervention; Stage 2 screening; Stepped-wedge design; Universal screening.

Conflict of interest statement

WS is co-developer of the Screening Tool for Autism in Toddlers (STAT) and receives royalties from its sales.

Figures

Fig. 1
Fig. 1
SRT flow across systems
Fig. 2
Fig. 2
Stepped-Wedge Cluster RCT Study Design. The four counties (C1-C4) are randomized to the timing of their SRT training workshops. Lighter shading indicates the period of Pre-SRT family recruitment and data collection, darker shading indicates the Post-SRT family recruitment and data collection window, and black shading indicates the 3-month training and technical assistance (TA) period for providers

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