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

Abstract

Background: Self-regulation (SR), or the capacity to control one's thoughts, emotions, and behaviors in order to achieve a desired goal, shapes health outcomes through many pathways, including supporting adherence to medical treatment regimens. Type 1 Diabetes (T1D) is one specific condition that requires SR to ensure adherence to daily treatment regimens that can be arduous and effortful (e.g., monitoring blood glucose). Adolescents, in particular, have poor adherence to T1D treatment regimens, yet it is essential that they assume increased responsibility for managing their T1D as they approach young adulthood. Adolescence is also a time of rapid changes in SR capacity and thus a compelling period for intervention. Promoting SR among adolescents with T1D may thus be a novel method to improve treatment regimen adherence. The current study tests a behavioral intervention to enhance SR among adolescents with T1D. SR and T1D medical regimen adherence will be examined as primary and secondary outcomes, respectively. Methods: We will use a randomized control trial design to test the impact of a behavioral intervention on three SR targets: Executive Functioning (EF), Emotion Regulation (ER), and Future Orientation (FO); and T1D medical regimen adherence. Adolescents with T1D (n = 94) will be recruited from pediatric endocrinology clinics and randomly assigned to treatment or control group. The behavioral intervention consists of working memory training (to enhance EF), biofeedback and relaxation training (to enhance ER), and episodic future thinking training (to enhance FO) across an 8-week period. SR and treatment regimen adherence will be assessed at pre-and post-test using multiple methods (behavioral tasks, diabetes device downloads, self-and parent-report). We will use an intent-totreat framework using generalized linear mixed models to test our hypotheses that: 1) the treatment group will demonstrate greater improvements in SR than the control group, and 2) the treatment group will demonstrate better treatment regimen adherence outcomes than the control group.

Usage activity, perceived usefulness, and satisfaction in a web-based acceptance and commitment therapy program among Finnish ninth-grade adolescents

“…Measured in the present study in terms of temperamental effortful control, self-regulation showed associations with usage activity and perceived usefulness of the intervention. This finding supports previous results on self-regulation's role in achieving health-related outcomes ( Berg et al, 2014 ; Miller et al, 2020 ), and implies that the Youth Compass program could potentially be more beneficial to adolescents with higher self-regulation skills because they are more likely to engage with the program material and its objectives. Higher perceived usefulness of the Youth Compass program could possibly be due to higher adherence facilitated by self-regulatory mechanisms.…”

“…Adherence to treatment by adolescents has been found to be connected to factors such as self-regulation skills ( Berg et al, 2014 ; Graziano et al, 2011 ; Miller et al, 2020 ) and the perceived threat of physical disease affecting mental well-being ( Kyngäs, 2007 ). Demographic variables such as age, gender, and parents' educational level have received mixed results, with some studies finding connections to adherence and some not (see, e.g., Calear et al, 2013 , Christensen et al, 2009 , Garrido et al, 2019 , Kristensen et al, 2018 , Marko-Holguin et al, 2010 , Mattila et al, 2016 , Neil et al, 2009 , Williams et al, 2006 ).…”

Self-Regulation as a Protective Factor for Diabetes Distress and Adherence in Youth with Type 1 Diabetes During the COVID-19 Pandemic

“…Study 2, which began data collection in April 2019, was an observational study of parents of youth with T1D. For both studies, participants were recruited from pediatric endocrinology clinics at the University of Michigan and via online methods ( Miller et al, 2020 ). Study 1 eligibility criteria were: youth (a) 13–17 years old; (b) diagnosed with T1D for at least 6 months; (c) had HbA1c ≥ 7.0%; (d) resided with participating parent/legal guardian at least 50% of the time; (e) had regular access to a smartphone and Wi-Fi; (f) no psychiatric or cognitive conditions that would impede ability to participate; and (g) was sufficiently fluent in English to complete study activities.…”

Future directions of the National Institutes of Health Science of Behavior Change Program

“…Another aspect of reproductive health for which tools and findings from SOBC projects may prove useful is the developmental considerations for self-regulation investigated in a study of diabetes self-management in adolescents [ 38 ]. Self-regulation includes the capacity to control one’s thoughts, emotions, and behavior to achieve a goal, which overlaps somewhat with self-efficacy, but the emotion regulation component is unique.…”

“…SOBC-funded projects have used an experimental medicine approach to investigate a variety of mechanistic targets and health behaviors across the domains of self-regulation, interpersonal and social processes, and stress resilience and stress reactivity, with links to health outcomes relevant to multiple NIH Institutes and Centers. These health outcomes include, for example, cardiovascular health [ 7 , 8 ], sleep health [ 9 ], stress and physical activity [ 10 ], opioid use disorder [ 11 ], obesity [ 12–14 ], prediabetes and diabetes management [ 15 , 16 ], smoking cessation [ 17 ], and breast cancer survivorship among African American women [ 18 ]. Two areas of research not addressed by current SOBC-funded projects provide promising opportunities to apply a mechanisms-focused approach to behavior change research: reproductive health and COVID-19 vaccine uptake.…”