Adolescent Interventions to Manage Self-regulation of T1D (AIMS T1D)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Targeting Self-regulation to Promote Adherence and Health Behaviors in Children

Conditions
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Self-regulation, Medication Adherence

Intervention / Treatment
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* Behavioral: Self-Regulation Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Comparison<br>Adolescents and their families in this group will not receive any of the interventions. | |
| Experimental: Self-Regulation Intervention<br>This arm will use a computer-based working memory training game (NBack) targeting Executive Functioning and in-person relaxation and biofeedback training targeting Emotion Regulation. As well, adolescents will receive Future Orientation training by being asked to envision and describe future events they are looking forward to, using concrete, vivid descriptive language. | Behavioral: Self-Regulation Intervention<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score) | Behavioral EF will be measured using standard tasks (Forward/Backward Digit Span, Go No Go). In Digit Span, subjects repeat numbers presented aloud in order or reverse order (8 questions of 2 trials each; correct response is 1 point; incorrect or no response is 0 points). Scores are summed for each trial; maximum total raw score is 16 points. In Go No Go, subjects hit a key to respond when they see the 'go' stimulus (presented for 300 ms) but not when they see the no-go stimulus. Go No Go responses are scored based on reaction time (seconds) and accuracy (0-100%). Then, we will generate a composite variable indicating better EF (i.e. correct Digit Span responses, faster/more accurate Go No Go responses) by creating standardized z-scores for each task variable and calculating a mean score. The final variable analyzed will be the composite z-score that represents behavioral EF, scored such that higher scores indicate better EF and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 
| Change From Baseline in Youth Executive Function (EF-report by Parent and Self) at 8 Weeks (Z-score) | Youth EF-report will be assessed using parent- and self-report versions of The Behavior Rating Inventory of Executive Functioning, 2nd Edition (BRIEF-2), a standardized EF measure. Items assess ability to control impulses, pay attention, modulate responses, and anticipate events. Three broad indices are calculated (Behavior Regulation, or ability to control behavioral impulses; Emotion Regulation, or ability to control emotional reactions; and Cognitive Regulation, or ability to focus, pay attention, stay organized) and combined to form a Global Executive Composite (GEC) score, which is a standardized score representing overall EF difficulty (range 0-100). Youth and parent GEC scores are averaged to represent overall Global Executive Functioning. The final variable analyzed will be the composite z-score that combines youth- and parent-reported EF, scored such that higher scores indicate poorer EF and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 
| Change From Baseline in Youth Emotion Regulation (ER-report by Parent and Self) at 8 Weeks (Z-score) | ER will be measured using a composite measure of parent- and self-reports on the NIH Toolbox Perceived Stress Survey, a 10-item measure of stress in children (items are summed to indicate greater perceived stress; range: 0-40); youth self-reports of dysregulated affect using a 6-item scale based on the Structured Interview for Disorders of Extreme Stress (SIDES Affect Dysregulation Scale; items are averaged to indicate more affect dysregulation, range: 1-6); and youth reports of emotion experiences on the 20-item Positive and Negative Affect Schedule (PANAS; items are summed to indicate more negative [10 items] and fewer positive experiences [10 items]; range: 10-50). The composite ER measure will be created by standardizing and averaging PSS, SIDES, and PANAS scores. The final variable analyzed will be this composite z-score that represents ER, scored such that higher scores indicate worse ER and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 
| Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score) | Youth self-efficacy is hypothesized to promote future-oriented thinking, and is thus an aspect of Future Orientation that will be measured using a composite of the NIH Toolbox Self-Efficacy parent report form and the self-report form. Both forms consist of 10 items. Participants respond to questions about their child's or their own (in the case of the child) self-efficacy. Mean scores are generated; higher scores are indicative of greater perceived self-efficacy. The final variable analyzed will be the composite z-score that represents youth self-efficacy based on parent and youth report, standardized and averaged and scored such that higher scores indicate better Self-efficacy and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 
| Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score) | Considering the future and how one's actions can affect future consequences is an aspect of youth Future Orientation (FO) that will be measured using the Consideration of Future Consequences Scale. Youth will answer 14 questions (e.g., I think about how things would be in days to come, and try to influence those things in my daily behavior) on a 7-point scale ranging from 1=Not at all like me to 7=Neutral. Higher scores indicate a greater consideration of future consequences or forward looking behavior. The final variable analyzed will be a z-score that represents self-reported FO, scored such that higher scores indicate better FO and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 
| Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score) | The degree to which one discounts the future is an aspect of youth Future Orientation (FO) that will be objectively measured using 5-trial Delay Discounting Task. Each 5-trial version of this task uses one monetary amount per trial (e.g., $1, 000; $1, 000, 000). Participants are asked on the first trial of the task whether they would prefer to receive that amount in three weeks or half that amount now. On the next trial the question is repeated but with a different time delay according to response on the previous trial. That is, a greater delay is presented on the next trial if the participant chose now on the previous trial, whereas a lesser delay is presented if the participant chose the later time on the previous trial. The dependent measure is the steepness of the delay discounting curve. The final variable analyzed will be the z-score that represents this discount rate; higher scores indicate poorer FO and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks | Change in blood glucose monitoring (BGM) frequency will be assessed by downloading data from the prior two weeks from the adolescent's glucometer. Adherence to BGM is defined as an average of 4 blood glucose measurements/day. Note, we had missing data for the downloads due to changes in clinical care since this measure was proposed (only 30% of the sample had only meters so were not recommended by their provider to download their meters in this way; 70% of the sample had Continuous Glucose Monitors (CGM). Thus, we used the data from self-reported monitoring or CGM use, measured by youth self-report on a Type 1 Diabetes adherence measure administered to all patients in the clinic that has been linked to HbA1c level (Lee et al., 2021). | baseline and 8 weeks | 
| Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks | Insulin administration adherence is defined as at least 3 short acting insulin boluses/day vs not. This is measured by youth self-report on a Type 1 Diabetes adherence measure administered to all Type 1 Diabetes patients in the clinic and has been linked to Hemoglobin A1c (HbA1c), an indicator of blood glucose level (Lee et al., 2021). | baseline and 8 weeks | 
| Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score) | The Self-Care Inventory Revised (SCI-R) is a 14-item youth- and parent-report measure of multiple T1D self-care adherence behaviors. Items reflect main aspects of the T1D regimen, including: monitoring and recording glucose, administering and adjusting insulin, regulating meals and exercise, and keeping appointments. Respondents report on adherence behaviors on a 5-point scale (1=never do it; 5=always do this as recommended without fail; or N/A.). The final variable analyzed will be the composite z-score that represents SCI-R adherence based on youth and parent reports, standardized and averaged and scored such that higher scores indicate better adherence and with a Z-score of 0 representing the population mean. | baseline and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, Type 1 Diabetes