118 Chapter 6 In total, 55 toddlers and their parents were randomized to either the BEAR group (n = 40) or the CAU group (n = 15). Figure 1 presents the CONSORT participant flow diagram. In both the BEAR and CAU groups, some participants decided to discontinue the study after baseline (n = 2), during the intervention (n = 1), at endpoint (n = 4) and during follow-up assessments (n = 10). Reasons for discontinuing the study varied and included participants considering participation too time-consuming, pursuing other treatment options, and, in one case, moving abroad. This resulted in a total sample at follow up (T3) of 36 participants (nBEAR = 26 , nCAU = 10). Within the BEAR group, CoSoS scores varied from 1 to 11, with an average score of 5.8 (SD = 2.9). Within the CAU group, CoSoS scores varied from 2 to 11, with an average score of 5.6 (SD = 2.9). There was no significant difference in CoSoS scores between groups (see Table 3 in the Results section). Recruitment Issues Recruitment posed several challenges related to the COVID-19 pandemic, as well as various issues involving parents, professionals and organizations. For example, the open-label nature of the study, inherent in its cluster design (Hemming & Taljaard, 2023), necessitated considerations prior to the study. This meant that WBCs, professionals and parents were aware of treatment allocations. Specifically for the CAU group, this meant that well-baby clinics were less likely to inform potential participants of the study and found it more challenging to screen and discuss their concerns when they could not offer appropriate follow-up care. Furthermore, the open-label nature also influenced parents’ motivation to participate in the control group. Parents expressed that the additional observations and questionnaires (see Table 1) demanded too much of their time and that they preferred to explore alternatives in pursuing health care, such as a referral to a speech therapist, audiologic center or specialized mental healthcare provider. Due to time constraints, inclusion in the study concluded on April 1, 2023, unfortunately falling short of the target number of participants. Measures Demographic Data and Baseline Measures Demographic characteristics (i.e. age, sex, information about ethnics, parental psychiatry and parental education levels) were gathered via a questionnaire that parents completed online at baseline. To assess the cognitive developmental level of the child, the cognition scale of the Bayley Scales of Infant and Toddler Development (Bayley-III; Bayley, 2006) was administered, and Index scores were used in analyses. Furthermore, the BITSEA (Brief Infant-Toddler Social & Emotional Assessment-Revised; Briggs-Gowan & Carter, 2002, Dutch version adapted by Kruizinga et al., 2014) was completed at baseline, assessing social-emotional and behavioral problems. The BITSEA consists of 42 items, rated across a 3-point Likert scale. Lastly, parental traits of autism were measured by the self-report questionnaire Social Interaction in Adults (in Dutch: Sociale Omgang bij Volwassenen [SOV], Bralten et al., 2018). The SOV consists of 18 items, with a minimum score of 18 (no autistic traits) and a maximum score of 72 (full endorsement of all autistic traits).
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