The following is a summary of the Social COmmunication Program supported by E-health (SCOPE) for infants and toddlers at the elevated likelihood of autism spectrum disorder: study design of a cluster randomized controlled trial” published in the December 2022 issue of Psychiatry by Snijder et al.
SCOPE stands for Social COmmunication Program supported by E-health. Multiple difficulties persist in gaining access to early intervention programs despite the widespread acknowledgment of the need for early detection and early management of autism spectrum disorders (ASD). The SCOPE project offers a novel, easily available, and multimodal intervention called BEAR (Blended E-health for children at eArly Risk) to overcome these obstacles. This paper aims to outline the methodology behind the ongoing 2 cluster randomized controlled trial (RCT) involving the BEAR intervention.
Evidence-based naturalistic developmental behavioral interventions (NDBIs) form the basis of BEAR (Blended E-health for children at eArly Risk), a blended e-health intervention that can be provided to parents and infants/toddlers at high risk for ASD. There is now a RCT being conducted in which (N=88) high-risk infants and toddlers will be cluster-randomized to either the BEAR intervention or care-as-usual (CAU). This report presents the definitive version of the intervention protocol and research design. Joint engagement during parent-child interactions captured on camera is the key outcome measure. The severity of ASD symptoms, overall adaptive functioning, parental health, and satisfaction with healthcare are secondary outcome indicators.
The societal price tag will be calculated as well. At baseline (T1), 8 weeks (T2), and 6 months (T3), researchers observe and survey the family to gauge the child’s development and behavior. The SCOPE project’s ultimate goal is to aid in the speedier detection of children at high risk for autism spectrum disorders and initiate appropriate interventions. The results of this current randomized controlled trial (RCT) will shed light on the effectiveness of the novel BEAR intervention in the short term and over a 6 month period. Estimates place the final enrollment period for the trial (N=88) in the spring of 2023.
Source: bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-04351-x