116 Chapter 6 included an e-learning and a workshop where WBCs were instructed to follow the ASD guideline (i.e. conducting a high risk screening approach) and recruit participants for both the experimental group (BEAR) or the care-as-usual (CAU) group as applicable (see below). Preventive care physicians and nurses who followed training were awarded with Continuing Medical Education (CME) points. Study design and procedures The effectiveness of the BEAR intervention was studied through a two-armed cluster (i.e. at the level of the WBC) randomized controlled trial (CRCT) (Hemming & Taljaard, 2023). The study is registered under Dutch trial number NL7453 and was approved by the Medical Ethics Committee on Research involving Human Subjects (CMO, ArnhemNijmegen) and the local institutional research committee of Karakter, child-and adolescent psychiatry center. Before the start of the current study, a pilot study was conducted in a small sample (n = 6) to maximize the potential for a successful trial and to assess the feasibility of the BEAR intervention. Pilot results led to minor revisions in the study- and intervention protocol. Detailed information on the study and intervention protocol can be found in our previously published paper (Snijder et al., 2022). Cluster randomization was based on the specific locations of WBCs in the area surrounding our out-patient unit in Nijmegen, the Netherlands. The WBC locations were assigned to either the experimental (BEAR) or care-as-usual (CAU) condition. As a first step in the cluster-randomization process, the WBCs were matched according to two characteristics: the number of children visiting that WBC, and the social-economic background of the respective area. This matching ensured an equitable distribution of well-baby clinics across both groups. Next, a total of 19 WBCs were randomly allocated, with the assignment determined by coin flipping, resulting in ten WBCs designated for the BEAR group and nine for the CAU group. In the end, a total of seven WBCs recruited participants in the BEAR group whereas in the CAU group only four WBCs recruited participants. The research team initially aimed to enroll 88 participants in the study (ratio 44:44), based on previous sample size calculations (see Snijder et al., 2022). However, due to slow participant recruitment we implemented an additional recruitment strategy in which participation in the study was made available for potential participants outside the Nijmegen research area as well. An extra individual arm was added to the study design where participants outside of the initial research area were individually randomized to either the BEAR or CAU group by way of a coin toss.
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