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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-13

Study Completion Date

2021-08-31

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.

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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.

Conditions

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Self-regulation Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Comparison

Adolescents and their families in this group will not receive any of the interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Self-Regulation Intervention

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.

Group Type EXPERIMENTAL

Self-Regulation Intervention

Intervention Type BEHAVIORAL

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).

Interventions

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Self-Regulation Intervention

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).

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No