Background In young children with type 1 diabetes mellitus (T1DM), parents have complete responsibility for the diabetes-management. In toddlers and (pre)schoolers, the tasks needed to achieve optimal blood glucose control may interfere with normal developmental processes and could negatively affect the quality of parent–child interaction. Several observational instruments are available to measure the quality of the parent–child interaction. However, no observational instrument for diabetes-specific situations is available. Therefore, the aim of the present study was to develop a qualitative observation instrument, to be able to assess parent–child interaction during diabetes-specific situations. Methods First, in a pilot study (n = 15), the observation instrument was developed in four steps: (a) defining relevant diabetes-specific situations; (b) videotaping these situations; (c) describing all behaviors in a qualitative observation instrument; (d) evaluating usability and reliability. Next, we examined preliminary validity (total n = 77) by testing hypotheses about correlations between the observation instrument for diabetes-specific situations, a generic observation instrument and a behavioral questionnaire. Results The observation instrument to assess parent–child interaction during diabetes-specific situations, which consists of ten domains: “emotional involvement”, “limit setting”, “respect for autonomy”, “quality of instruction”, “negative behavior”, “avoidance”, “cooperative behavior”, “child’s response to injection”, “emphasis on diabetes”, and “mealtime structure”, was developed for use during a mealtime situation (including glucose monitoring and insulin administration). Conclusions The present study showed encouraging indications for the usability and inter-rater reliability (weighted kappa was 0.73) of the qualitative observation instrument. Furthermore, promising indications for the preliminary validity of the observation instrument for diabetes-specific situations were found (r ranged between |.24| and |.45| for significant correlations and between |.10| and |.23| for non-significant trends). This observation instrument could be used in future research to (a) test whether parent–child interactions are associated with outcomes (like HbA1c levels and psychosocial functioning), and (b) evaluate interventions, aimed at optimizing the quality of parent–child interactions in families with a young child with T1DM. Keywords: Type 1 diabetes mellitus, Parent–child interaction, Behavior, Children, Parents, Mealtime, Rating scale
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