Social COmmunication Program supported by E-health (SCOPE) for infants and toddlers at elevated likelihood of autism spectrum disorder: study design of a cluster randomized controlled trial
BEAR is the first blended e-health NDBI trial for pre-diagnostic infants — results pending, but the design builds on a solid stack of parent-training evidence.
01Research in Context
What this study did
Snijder and colleagues are running a cluster RCT called SCOPE. They want to see if a blended e-health program helps babies and toddlers who may later be diagnosed with autism.
Parents use the BEAR app at home. It teaches them naturalistic strategies like responding to every babble and following the child’s gaze. The team will compare BEAR plus usual care against usual care alone.
The study is still running. No outcome data are out yet, so we cannot say if the app works.
What they found
Nothing yet — the paper is only a protocol. The authors plan to enroll 88 families and watch for gains in social communication, language, and parent-child play.
Final numbers are expected in 2023. Until then, the trial is a placeholder on the evidence map.
How this fits with other research
Earlier work says parent-mediated NDBIs do help. Pacia et al. (2021) reviewed eight RCTs and found steady gains in social communication and language for toddlers with ASD. Tiede et al. (2019) pooled 27 studies and showed medium benefits in play and engagement. These reviews give reason to test BEAR, but they also set the bar — the new trial must beat or match those results.
Two fully virtual programs came first. Fisher et al. (2020) taught parents ABA skills through video lessons and saw large gains. Granich et al. (2016) planned an iPad app called TOBY for home EIBI. BEAR extends both ideas by mixing online modules with real-life coaching for infants as young as 6 months.
Stahmer et al. (2019) delivered Project ImPACT for Toddlers face-to-face in community clinics and improved parent-child interaction. BEAR keeps the same NDBI core but swaps clinic visits for app prompts and tele-coaching. If BEAR works, it could let families start intervention months earlier without leaving home.
Why it matters
You may soon have a new tool that fits in a parent’s pocket and starts before diagnosis. If the upcoming results are positive, you can hand families an evidence-based app instead of a wait-list. Watch for the 2023 data — and maybe download the BEAR demo now so you are ready to pilot it in your early-intervention cases.
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02At a glance
03Original abstract
Although the importance of early detection and early intervention of autism spectrum disorders (ASD) is widely recognized, multiple barriers exist in accessing early intervention services. As an alternative to these barriers, the SCOPE project presents a new, easy accessible and blended intervention called BEAR (Blended E-health for children at eArly Risk). This paper describes this BEAR intervention and study design of an ongoing two arm cluster randomized controlled trial (RCT). BEAR (Blended E-health for children at eArly Risk) is a blended e-health intervention, based on evidence-based naturalistic developmental behavioral interventions (NDBI’s) and can be offered to parents and infants/toddlers at high likelihood for ASD. During the ongoing RCT, N = 88 high risk infants and toddlers will be cluster randomized over the BEAR intervention and care-as-usual (CAU) conditions. The finalized version of the intervention protocol and study design are presented in this paper. The primary outcome measure is joint engagement measured by the Joint Engagement Rating Inventory (JERI) during videotaped parent–child interaction. Secondary outcome measures include severity of ASD symptoms, global level of adaptive functioning, parental well-being, parental skills and satisfaction with healthcare. Also, costs will be estimated from society's perspective. Assessments take place at the start of the study (T1), after eight weeks (T2) and after six months (T3) and include behavioral home observations and parental questionnaires. The SCOPE project aims to contribute to improved early identification and timely start of suitable interventions for infants and toddlers at elevated likelihood for ASD. This ongoing RCT will offer insight in the feasibility, short-term and six months effects of the innovative BEAR intervention. It is estimated that inclusion for the trial (N = 88) is completed in spring 2023. Dutch Trial Register, NTR7695. Registered at December 17th, 2018, www.trialregister.nl. The online version contains supplementary material available at 10.1186/s12888-022-04351-x.
BMC Psychiatry, 2022 · doi:10.1186/s12888-022-04351-x