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

NCT03688919 | Completed Results DMC

• 1 other identifier: UH3HD087979
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-regulation; Medication Adherence

Keywords

adolescents; Type 1 Diabetes

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks

  baseline and 8 weeks

• Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks

  baseline and 8 weeks

• Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score)

  baseline and 8 weeks

Study Arms (2)

Comparison

NO INTERVENTION

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

Self-Regulation Intervention

EXPERIMENTAL

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

Interventions

Self-Regulation Intervention 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).

Self-Regulation Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Choe A, Fredericks EM, Albright D, Lee JM, Sturza JM, Riley HO, Kaciroti N, Bauer KW, Miller AL. Executive Functioning, Diabetes Distress, and Diabetes Management Among Adolescents With Type 1 Diabetes: Youth and Parent Perspectives. Pediatr Diabetes. 2025 Feb 27;2025:7036544. doi: 10.1155/pedi/7036544. eCollection 2025.

  PMID: 40303942 DERIVED

• 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.

  PMID: 32145739 DERIVED

MeSH Terms

Conditions

Self-Control; Medication Adherence; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The COVID-19 pandemic occurred in the middle of our study, and we did not enroll new participants or conduct in person visits from 3/13/20-8/24/20 due to University of Michigan policies. It is possible the intervention was impacted by the pandemic. Youth also self-reported high adherence in their blood glucose monitoring and insulin administration at baseline, so this likely reduced our ability to find effects on these secondary outcomes.

Results Point of Contact

• Title: Professor Alison Miller
• Organization: University of Michigan School of Public Health

alimill@umich.edu

7346157459

Study Officials

• Alison Miller, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Emily Fredericks, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 28, 2018
• Study Start: May 13, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)