105 SCOPE study design 5 will be investigated. Fixed effect in the model for baseline covariates, time and interaction with treatment condition will be included. For cost effectiveness analysis, all cost data will be accumulated. Cost differences between the two conditions will be compared. Incremental cost-effectiveness ratios will be calculated by dividing the difference in total costs by the difference in the WEMWBS. Data collection started just before the COVID-19 pandemic. During a lockdown period where home visits were not possible because of COVID-19 restrictions, small changes were made in collecting the data and providing the BEAR intervention. Due to this, a sensitivity analysis will be undertaken, excluding participants included during the first lockdown. Data monitoring Adverse events (AE’s) reported by the parent/primary caregiver of the participant or observed by the research team or BEAR professional will be recorded. If a serious AE occurs, the researchers will report to the ethics committee within fifteen days of first knowledge of the AE. All AEs will be followed until they have abated, or until a stable situation has been reached. As adverse events resulting from study participation are very unlikely, review or advice of a Data Safety Monitoring Board or a safety committee is not required for the current study. In accordance with the European General Data Protection Regulation, an independent data protection officer is appointed, and monitors the privacy of the participants. The research team (MS and IO) are responsible for processing the data. Discussion The goal of the current study was to describe an innovative early intervention called BEAR and present the finalized study design and methods of the SCOPE study after pilot testing for feasibility. Via a cluster randomized controlled trial with two arms, SCOPE aims to compare the short term and relatively long term effects of BEAR. It is hypothesized that BEAR will lead to improved joint engagement in the parent-child interaction, decreased ASD symptoms, improved parental skills, improved satisfaction of parents with healthcare, a sooner start between first concerns and start of intervention and cost efficiency, both on short and long term (at six months). It is estimated that inclusion for the trial (N=88) is completed in spring 2023 and that follow-up data are completed by the end of 2023. Please note that the observations from the JERI and BOSCC(parent) are based on the parent-child interaction and that the parents are not an experimental fixed factor since they have been part of the intervention. However, this is not only a limitation but provides also opportunities. For it would allow to disentangle the respective contributions of the parent and
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