Results of The Diabetes Control and Complications Trial (DCCT) have convincingly shown that keeping blood glucose levels close to normal levels avoids or delays the onset of long-term complications of diabetes . When young children are diagnosed with type 1 diabetes mellitus (T1DM), parents get full responsibility for the diabetes-management of their child (e.g., blood glucose monitoring and administering insulin, regulation of food intake, and guarding the level of physical activity of their diabetic child). Normal and age appropriate behaviors that occur in the toddler and pre-school years (e.g. independence-seeking, refusing food, oppositional behavior) can interfere with the ability of parents to complete the tasks needed to achieve optimal blood glucose control . This interference and the full responsibility of the parents may affect family functioning and parent-child interaction [3–5].
An overview by Anderson et al.  showed that when a child suffers from a chronic condition the parent-child relationship could be affected. Most studies described in this overview have shown negative effects of a medical condition on the quality of parent-child interactions, such as more conflict situations and less solution-directed communication, less cohesion, decreased medication adherence, and impaired functioning within the family . For example, children with congenital heart disease reacted less responsive and their mothers appeared less sensitive than children and mothers in healthy families . In families with a disturbed parent-child interaction, children with various somatic diseases showed more behavioral problems, but also more disease-related outcomes, such as an increased mean glycemic control (HbA1c) in adolescents with diabetes . Higher glycosylated hemoglobin is associated with more behavioral problems in youth with type 1 diabetes . Because of these possible behavioral problems, parents want to keep their child's blood glucose values as close to normal as possible, to avoid the direct negative effect on the behavior of their child. To achieve this, the parents might need to negotiate with their child on the diabetes management tasks, but diabetes treatment is non-negotiable. These negotiations could negatively affect the interaction between parent and child. Diabetes is a 24/7 disease, so struggles on treatment tasks are not comparable with other (chronic) diseases.
Because parents are responsible for the treatment of their young child with T1DM and the child is fully dependent on his or her parents, we expect that the quality of parent-child interaction significantly contributes to both the psychosocial development and the quality of life of these children.
Given the importance of the topic, it is surprising that studies examining the quality of the parent-child interaction in families with young children with T1DM are scarce. Furthermore, the small number of studies that are available has several shortcomings. For example, most studies examining the quality of parent-child interaction or related topics, have been conducted with older children with T1DM (> 8 years) [3, 4, 8, 10, 11], or used a wide age range (from 1 - 14 years [12, 13]). As a result, specific knowledge of the quality of the parent child interaction of the youngest patient group is lacking, and no specific statements can be made about the quality of parent-child interaction in families with a young child with T1DM.
A second shortcoming is that in these studies self-report measures or semi-structured interviews were used [3, 4, 11–14]. In vivo observations and observational methods, however, appear more sensitive to subtle differences in family interactions . These differences in interaction patterns may provide important implications for improving the quality of parent-child interactions during diabetes-management. Moreover, self-report measures and interviews reflect a subjective view from the perspective of parents, while by using observational methods, the interaction patterns can be assessed more objectively.
To our knowledge, there is only one research group [2, 16–19], that has studied the quality of parent-child interaction in young children with T1DM using an observational method. However, the studies of this research group only focused on a single dimension of a disease-specific parent-child situation, namely behavioral problems during the meal, while in fact the combination of diabetes-specific actions and behaviors around mealtime will give a more complete illustration of the diabetes-specific interactions (i.e. blood glucose monitoring, carbohydrate counting, and administering insulin).
Moreover, the observations were performed with an observational method  in which the behaviors of parents and children during the meal were to be counted (e.g., how often the child was encouraged to keep eating). This has an important disadvantage. In behavior counting methods, where all behaviors are counted, applying nuances is difficult, while with the so-called "rating scales" specific behaviors can be grouped under broad categories. This way of coding observational data provides room to make many dimensions and nuances in behaviors. Moreover, the predictive value of global rating scales has proved to be more appropriate than just counting specific behaviors [15, 21]. An additional advantage of rating scales is that it costs up to 5 times less time than counting all behaviors . The use of rating scales in observational studies is not only time efficient but also gives a clinical picture which results in more specific implications for intervention purposes.
Another limitation of these studies is that generic parent-child interactions were not observed [2, 16–19]. It might be that diabetes-specific parent-child interactions affects child behavior (such as gaining independence, stubbornness, oppositional behavior) and parental behavior (such as sensitivity, respecting autonomy, having fun together)  which might negatively affect the daily family life and the generic quality of the parent-child interaction.
The results of the cross-sectional studies of Patton et al. [2, 16, 17] showed that the behavior of the children and parents during mealtime were associated with the glycemic control (HbA1c), the more family malfunctioning, the higher the glycemic control (HbA1c). However, longitudinal studies are currently lacking in this area.
We expect that the way in which parents treating their child with T1DM during these often annoying, sometimes even invasive, yet unavoidable procedures can affect blood glucose control (HbA1c) and psychosocial functioning. For example, if the mother responds anxiously when she has to monitor her child's blood glucose, the child may start to cry. If the mother then decides to postpone the finger prick this could lead to a hyperglycemia. Some parents may also have strong worries about future complications or hypoglycemic events. Because of these concerns, parents may decide monitor the child's blood glucose 15 times a day, three times per night, once at 23:00, and even once at 2:00 pm and once at 5:00 pm. These examples of non-constructive interaction patterns can be physically and emotionally stressful for the child (and parents), which might disturb the balance between effective treatment and optimal quality of life.
Because diabetes-related behaviors are usually consolidated in the first years post diagnosis [12, 23], interventions should start as early as possible. The combination of observing both generic and disease-specific interactions will identify interactional patterns to evaluate future behavioral interventions, with the aim of learning more effective parent-child interactions to optimize the glycemic control and psychosocial functioning of young children with T1DM as early as possible to prevent future problems.
In the past decades, several global rating scales have been developed for assessing different aspects of the quality of parent-child interactions, e.g., the Emotional Availability Scales (EAS)  and the scales developed by Erickson, Sroufe and Egeland . These measures were designed to cover different aspects of parent-child interaction irrespective of an underlying disease. Disease-specific measures could assess interactions between parents and children at a disease-specific level (e.g., during administering insulin, mealtime behavior). Disease-specific instruments are expected to be more responsive to small changes that are important to clinicians or patients . However, such a disease-specific observational measure is not available for children with T1DM. The main aim of the present study is to develop a disease-specific observational method, including a scoring system, to assess diabetes-specific parent-child interaction and to test the initial and preliminary psychometric properties of the pilot version of the instrument. Additional aim is to explore whether quality of parent-child interactions is associated with the glycemic control, child behaviors, and quality of life of children with T1DM.