95 SCOPE study design 5 theoretical framework, but rather in the combination of an early start of intervention (prediagnosis), easy accessibility (no waiting list and at home), and strong collaboration between first line (executer) and specialized mental healthcare (supervisor). Without the need of an ASD diagnosis, BEAR is presumably more acceptable for those parents who do not yet have great concerns or an explicit question for help, and is at the same time an appropriate form of healthcare for the children who show unclear risk signals. Additionally, for some children this intervention will be the influx to more intensive and specialized healthcare. Considered this way, BEAR might function as a triage agent, whereas for other children BEAR will function as a way of (secondary) prevention. In the SCOPE project, a cluster randomized controlled trial (RCT) (two armed, 44:44 ratio) will be employed to study the immediate short time effects, effects after six months and costeffectiveness of the BEAR intervention in a highly indigent target population. The primary objective is to improve joint engagement in the parent-child interaction. Secondary objectives are improving social-communicative development of the child at elevated likelihood of ASD, improving parental skills and well-being and decreasing the gap between first concerns and start of adequate intervention. Before starting a larger cluster RCT, an important first step was to pilot test the intervention in a small sample. Based on insights gained from the pilot sample, potential research problems were identified and solved, in order to fully maximize the potential of a successful cluster RCT. The aims of the current paper are to present (1) the BEAR intervention protocol and (2) the study design of the cluster RCT. Methods BEAR intervention BEAR (Blended E-health for children at eArly Risk) is a short and easily accessible, parent adopted and blended e-health intervention. It can be offered to parents and children aged between 12-30 months when first concerns of ASD have been expressed. The intervention is to be delivered by a trained professional working in preventive care, preferably under supervision of a professional working in specialized mental healthcare and considered to be an ASD expert, in order to obtain the best of both worlds (easy access through preventive care and expert knowledge through specialized care) and promote collaboration between different healthcare settings. The BEAR intervention consists of seven home visits and five additional e-learning sessions for parents. The first session is a general introduction module, containing psycho-education for parents about child development on the areas of play, social communication, flexible behavior and sensory interest. Next, BEAR offers five possible intervention modules aimed aforementioned areas, partially based on the DIR/Floortime model (Greenspan & Wieder, 2007). Modules include (1) improving attention to the (play)
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