162 Chapter 7 and refer infants and toddlers if they were assigned to the control group with no intervention. Namely, results of Chapter 2 and Chapter 3 showed that it can be challenging for preventive care professionals to screen children and discuss concerns regarding a very young child’s development when there is no suitable intervention possible. During the implementation of the RCT, we encountered barriers that aligned with those identified in our own research (Chapters 2 and 3). This hypothesis is supported by our observation that fewer children were referred by WBCs in the control group (4 out of 9) compared to those in the BEAR group (7 out of 10). Another limitation is related to the observations from the JERI and BOSCC (Chapters 4 and 6), which were based on parent-child interactions. Parents are not an experimental fixed factor since they were part of the intervention, but this also presents an opportunity. It allows for the disentanglement of the respective contributions of both the parent and the child to any changes in their interaction and the child’s social-communicative behavior. To further explore this, we also collected video observations of the child’s behavior in a separate BOSCC (clinician) procedure, where an ADOS2 trained professional interacted with the child. Future research should consider comparing BOSCC parent and clinician data to assess the child’s behavior in different interaction contexts. A last limitation is that the pilot and RCT studies lacked sufficient statistical power to determine predictors of response, and no long-term effects were investigated. Given these findings, it raises the question of whether an RCT design is the most appropriate for this type of study (i.e. pre-emptive) in this population (i.e. very young children with a neurodevelopmental vulnerability and their parents). While an RCT offers high internal validity and provides the strongest evidence compared to other study designs (Langendam, 2013), the challenges we encountered with this specific population may impact the generalizability of our results. Alternative research designs, for example as a multiple baseline design, a patient preference design or a stepped wedge design might be worth exploring to address the challenges experienced during this thesis . Furthermore, a multi-center study might be considered to further investigate the effects of the BEAR intervention, follow children longer and determine whether the intensity and duration of BEAR are sufficient or if additional interventions, such as booster sessions, are needed for long-term improvement. When conducting a multi-center study, we recommend that the control condition also includes some form of standardized care, such as consultations and psycho-education, as provided by the research project. Such an approach with a more active CAU condition may help minimize experienced barriers regarding inclusion in the study encountered during this thesis. Future directions and recommendations While many different types of early and pre-emptive interventions have been developed, their effectiveness varies widely, with some interventions being more effective than others (Green & Garg, 2018; Hamptom & Rodriguez, 2022; Kasari, 2019; McGlade et al., 2023;
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