Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol

Decades of research have demonstrated the importance of self-regulation (SR), or the capacity to control one’s thoughts, emotions, and behaviors in order to achieve a desired goal, in shaping individuals’ health outcomes [1, 2]. SR capacity has been conceptualized as including three component processes: executive functioning skills; emotion regulation strategies; and ability to delay gratification in service of achieving future goals [3, 4]. Low SR capacity has been shown to interfere with individuals’ engagement in a variety of health maintenance behaviors including engaging in regular physical activity [5], consuming a healthy diet [6‐8], and adhering to medical treatment regimens [9‐11].

Type 1 Diabetes (T1D) is a condition affecting millions worldwide. For example, in the U.S. about 17,900 children and adolescents younger than age 20 were newly diagnosed with type 1 diabetes during 2011–2012 [12]. Adhering to a recommended treatment regimen is critical in managing glycemic control and establishing long-term health among pediatric T1D patients [13‐15]. Yet, poor treatment regimen adherence is common among adolescents [16‐18]. Only 21% of adolescents meet the American Diabetes Association guidelines for Hemoglobin A1c (HbA1c) target level of 7.5% [14, 19], and treatment adherence and glycemic control decline across this developmental period [20]. Poor glycemic control places youth with T1D at substantially increased risk of acute health events including hyper and hypoglycemia and diabetic ketoacidosis, as well as serious, long-term comorbidities such as retinopathy, neuropathy, kidney disease, and cardiovascular disease [21].

To achieve and maintain optimal glycemic control, adolescents must adhere to a complex self-care regimen that includes monitoring blood glucose, administering insulin via daily injections or a pump, regulating carbohydrate intake, engaging in regular physical activity, and minimizing both hyper- and hypoglycemia [22, 23]. Each of these are daily tasks that require SR. For example, executive function (EF) skills such as working memory and planning are needed to recall and ensure adherence to dietary and exercise plans [24‐26]. Emotion regulation (ER) skills are important for coping with diabetes-related distress, combating depression, and managing feelings of anxiety that interfere with monitoring blood sugar levels [27‐29]. Future orientation (FO), or the ability to delay gratification and focus on future goals, may be particularly important for adolescents with T1D in order to adhere to their treatment regimen in the face of competing demands.

Positive associations between SR capacity and treatment adherence are consistently reported in prior work among youth with T1D [3, 30, 31] and poor SR has been suggested as a central mechanism contributing to nonadherence [23‐26, 32]. For example, in 13–17 year-olds with T1D, parent-rated EF deficits in working memory and attention were associated with poorer treatment adherence [33], with further research identifying that associations between EF and glycemic control were mediated through treatment adherence [26]. With regard to ER, findings suggest that adolescents with poorer ER skills have higher HbA1c levels, suggestive of poorer glycemic control [34, 35]. Finally, no studies have specifically examined associations between FO and treatment adherence in adolescents with T1D. However, in adults with T1D, results suggest FO skills are positively associated with treatment adherence [36, 37]. Moreover, FO is associated with engagement in several other health behaviors that promote long-term goals [38, 39], including in adolescents [40]. Given this body of research, the pervasiveness of poor treatment adherence among adolescents with T1D, and the fact that the fact that treatment regimens shift from parent-managed to adolescent managed across this period [16, 41‐43], improving adolescents’ SR capacity may be an important strategy for helping them better manage treatment adherence tasks [3, 44].

Promoting SR may increase adolescents’ ability to engage in diabetes-specific adherence behaviors and thereby improve T1D outcomes [23, 44‐46]. Specifically, improving EF skills could aid adolescents’ remembering regimen details and timing [33], enhancing ER capacity could improve metabolic control by promoting better regulation of stress hormones, reducing diabetes-related distress, and increasing capacity to focus on regimen adherence [11, 47]; and improving FO capacity may increase adherence by engaging adolescents to invest energy in behaviors that lead to long-term health [48, 49]. Yet, improving SR has not been tested as a mechanism of behavior change in this population.

Given that only about a fifth of adolescents with T1D meet recommended T1D treatment targets, there remains an urgent need to identify effective strategies to improve treatment regimen adherence among this population. As responsibility for diabetes management shifts from parent to child across the adolescent period, identifying interventions that are engaging and effective for this developmental stage is essential. Difficulties with SR may underlie poor T1D treatment regimen adherence during adolescence, a time characterized by continued SR maturation and daily challenges to SR due to typically developing demands (e.g., social, academic, emotional). Indeed, developmental neuroscience suggests adolescence is a time of uneven growth in SR skills such as EF, but is also characterized by increasing ability to take broader perspectives and envision the future, including health behaviors; thus, adolescence is a unique and compelling period for intervention [71]. Every day, adolescents with T1D must engage in tasks that require a high degree of SR, including monitoring blood sugar and carbohydrate intake, maintaining a schedule for eating as well as physical exercise, and ensuring adequate access to T1D supplies and resources in the event that blood sugars are too high or too low. Further, as psychological adjustment to and coping with T1D can also interfere with treatment adherence [27], ER strategies may play a critical role in promoting adherence. Finally, adhering to T1D regimens requires FO, which allows adolescents to understand and appreciate how achieving current adherence goals, which may be difficult, can help maintain optimal HbA1c levels in order to avoid long-term complications.

The current randomized control trial proposes to test whether the AIMS-T1D behavioral intervention can improve adolescents’ SR and treatment regimen adherence. The study takes an experimental medicine approach to behavior change by testing the impact of an intervention targeting SR as a primary outcome [72]. As prior work using similar interventions suggests that these aspects of SR are malleable [52, 54, 59], the next step in a systematic experimental medicine approach to building and testing better interventions is to test whether these early findings can generalize to a new population, specifically adolescents with T1D. A benefit of this approach is that by identifying whether the interventions designed to change SR actually do so, we will gain critical information about the utility of such interventions for future research in new populations. To our knowledge, this is one of the first studies to test a SR-focused intervention in youth in relation to a health-relevant outcome. From a prevention perspective, it is more cost-effective to prevent negative health outcomes associated with poor treatment regimen adherence than to treat the long-term sequelae of poor adherence. Further, by improving SR during adolescence, we may achieve not only better T1D treatment regimen adherence in the short term, but impact lasting improvements both in SR and the health trajectory of those with T1D. From a trans-diagnostic perspective, if this trial demonstrates meaningful improvements in adolescents’ SR, the intervention may be a novel approach to health behavior change among other populations of adolescents with medical needs that require strict adherence to treatment regimens. Therefore, findings from the AIMS-T1D study not only have the possibility of informing our understanding of SR as a mechanism of behavior change among adolescents with T1D, but also have implications, and thus the potential, for broad impact.