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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688919
Recruitment Status : Suspended (Enrollment is temporarily paused due to COVID-19; interactions/interventions with current participants continue. This is not a suspension of IRB approval.)
First Posted : September 28, 2018
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Alison Miller, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Self-regulation Medication Adherence Behavioral: Self-Regulation Intervention Not Applicable

Detailed Description:

The goal of this study is to test whether interventions change self-regulation 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Targeting Self-regulation to Promote Adherence and Health Behaviors in Children
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Comparison
Adolescents and their families in this group will not receive any of the interventions.
Experimental: 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.
Behavioral: 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).




Primary Outcome Measures :
  1. Change from baseline in youth Executive Function (behavioral EF) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    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 composite variable will represent behavioral EF, scored such that higher scores indicate better EF.

  2. Change from baseline in youth Executive Function (EF-report by parent and self) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Youth EF-report will be assessed using the parent- and self-report versions of The Behavior Rating Inventory of Executive Functioning, 2nd Edition (BRIEF-2), a standardized EF measure. Theoretically and statistically derived scales assess ability to control impulses, flexibly change direction, pay attention, modulate responses, and anticipate events. Three broad indexes are calculated (Behavior Regulation, which represents child ability to control behavioral impulses; Emotion Regulation, which represents the child's ability to control emotional reactions; and Cognitive Regulation, which represents the child's ability to focus, pay attention, and stay organized) and combined to form a Global Executive Composite (GEC) score, which is a standardized score representing overall EF (range 0-100). Youth and parent scores will be averaged to represent overall Global Executive Functioning, scored such that higher scores indicate greater difficulties in EF functioning.

  3. Change from baseline in youth Emotion Regulation (ER-report by parent and self) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    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 perceived stress, affect dysregulation, and emotion experience scores. It will be scored such that higher values indicate poorer ER.

  4. Change from baseline in youth Self-Efficacy (parent- and self-reported) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    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.

  5. Change from baseline in youth Future Orientation (self-report) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Considering the future and how one's actions can affect future consequences is an aspect of youth Future Orientation 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.

  6. Change from baseline in youth Future Orientation (objective measure) at 8 weeks [ Time Frame: baseline and 8 weeks ]
    The degree to which one discounts the future is an aspect of youth Future Orientation that will be objectively measured using 5-trial Delay Discounting Task. Each 5-trial version of this task uses one monetary amount for each trial (e.g., $1, 000; $1, 000, 000). Each participant is 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 the participant's 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.


Secondary Outcome Measures :
  1. Change from baseline in blood glucose monitoring at 8 weeks [ Time Frame: baseline and 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.

  2. Change from baseline in insulin administration adherence at 8 weeks [ Time Frame: baseline and 8 weeks ]
    Insulin administration adherence is defined as at least 3 short acting insulin boluses/day vs not.

  3. Change from baseline in Self-Care Inventory Revised at 8 weeks [ Time Frame: baseline and 8 weeks ]
    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.)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688919


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Alison Miller, Ph.D. University of Michigan
Principal Investigator: Emily Fredericks, Ph.D. University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alison Miller, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03688919    
Other Study ID Numbers: UH3HD087979 ( U.S. NIH Grant/Contract )
UH3HD087979 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data (IPD) that underlie results in a publication would be made available upon reasonable request.
Time Frame: IPD that underlie results in a publication would be made available 6 months after publication upon reasonable request.
Access Criteria: The PIs will review all requests for IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alison Miller, University of Michigan:
adolescents
Type 1 Diabetes