Adolescent Interventions to Manage Self-regulation of T1D (AIMS T1D)
Condition: Self-regulation; Medication Adherence
Study type: Interventional

Summary: 
      This goal of this project is to test whether self-regulation assays and interventions can be
      delivered and change self-regulation in a sample of adolescents, specifically to test in a
      small randomized clinical trial (RCT) whether self-regulation interventions lead to change in
      medication adherence. The study will focus on adolescents with Type 1 Diabetes (T1D). These
      youth have clear medication adherence goals, yet are often non adherent and at great health
      risk during this developmental period. As responsibility for diabetes management shifts from
      parent to youth during this time, intervening with adolescents directly is vital for
      prevention.
    

Detailed description: 
      The goal of this study is to test whether interventions change self-regulation (SR) targets
      most relevant for medication adherence in youth with Type 1 Diabetes (T1D). Poor
      self-regulation has been identified in youth with T1D and is proposed as a central mechanism
      contributing to high rates of nonadherence and thus long-term complications, in pediatric T1D
      populations, particularly adolescents. As responsibility for T1D management shifts from
      parent to youth during this time, addressing self-regulation in adolescence is critical.

      The study's self-regulation targets are executive functioning (EF; working memory, inhibitory
      control); emotion regulation (ER; capacity to manage stress, worry), and future orientation
      (FO; capacity to focus on future goals). The investigators posit that these self-regulation
      capacities are critical in order to engage in the multiple adherence behaviors (e.g.,
      self-monitoring blood glucose, administering insulin via daily injections or a pump,
      regulating carbohydrate intake, physical activity, minimizing hyper-/hypo-glycemia) youth
      must follow to achieve and maintain optimal glycemic control. Thus, in addition to targeting
      T1D-specific adherence, it is essential to employ an experimental medicine approach to test
      whether improving self-regulation results in improved adherence behaviors and T1D-related
      health outcomes (quality of life; HbA1C). Yet, these self-regulation targets have not been
      rigorously tested as mechanisms of behavior change to improve adherence to T1D regimens in
      youth.

      Using previously developed multimethod assays of these targets, the investigators will test
      the impact of interventions on these self-regulation targets, medical regimen adherence
      behaviors, and diabetes-related health outcomes (quality of life; HbA1C) in youth. The
      Scientific Premise is that poor self-regulation underlies poor medical regimen adherence. If
      improving self-regulation targets increase adherence in youth with T1D this approach may
      apply to other youth who must manage medical regimens. Findings will thus not only inform
      understanding of self-regulation as a mechanism of behavior change but will generate novel
      intervention strategies that may have trans-diagnostic implications and broad impact. As
      interventions to be delivered are designed to be light-touch and scalable, they may yield
      useful tools to use in future studies of behavior change mechanisms. The investigators
      propose an RCT design to test the following Specific Aims in a sample of youth with T1D (ages
      13-17 years, n=94):

      Aim 1. Test the hypothesis that the interventions developed in a prior study (NCT03060863)
      enhance identified self-regulation targets (EF, ER, FO) in a population of adolescents with
      T1D.

      Aim 2. Test whether interventions improve medical regimen adherence behaviors and T1D health
      outcomes.

      Exploratory Aim. Examine whether parents' SR modifies the effects of the UH3's bundled
      intervention to improve youth SR on youth treatment regimen adherence.
    

Intervention name(s): Self-Regulation Intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: adolescents; Type 1 Diabetes