Clinical trial NCT03688919: Adolescent Interventions to Manage Self-regulation of T1D (AIMS T1D)
Official title: Targeting Self-regulation to Promote Adherence and Health Behaviors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-regulation
Medication Adherence
Keywords: adolescents
Type 1 Diabetes
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-09-28
Enrollment: 88
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* youth must have been diagnosed with T1D for at least 6 months;
* reside with a parent;
* have HbA1c\>=7.0;
* regular access to WiFi; and
* feel comfortable speaking English enough to complete study activities; and

Exclusion Criteria:

* non-fluency in English in parent or youth;
* psychiatric or cognitive conditions (e.g., clinically significant depression assessed via phone screen at intake) that would impede ability to participate.

Primary outcomes:
measure: Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Youth Executive Function (EF-report by Parent and Self) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Youth Emotion Regulation (ER-report by Parent and Self) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks
timeFrame: baseline and 8 weeks
measure: Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks
timeFrame: baseline and 8 weeks
measure: Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score)
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alison Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Emily Fredericks, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller AL, Lo SL, Albright D, Lee JM, Hunter CM, Bauer KW, King R, Clark KM, Chaudhry K, Kaciroti N, Katz B, Fredericks EM. Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol. BMC Pediatr. 2020 Mar 7;20(1):112. doi: 10.1186/s12887-020-2012-7.