NCT03688919

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

Completed NA Results posted Last updated 7 October 2022

What this trial tests

NA trial testing Self-Regulation Intervention in Self-regulation in 88 participants. Completed in 31 August 2021.

Timeline

13 May 2019

Primary endpoint
31 August 2021

31 August 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	88
Start date	13 May 2019
Primary completion	31 August 2021
Estimated completion	31 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Self-Regulation Intervention

Conditions studied

• Self-regulation — all drugs for Self-regulation →
• Medication Adherence — all drugs for Medication Adherence →

Sponsor

University of Michigan

Who can join

Adults 13 to 17, any sex, with Self-regulation or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score) Primary · 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 comp

Group	Value	95% CI
Comparison	0.02	± 0.07
Self-Regulation Intervention	-0.02	± 0.06

Change From Baseline in Youth Executive Function (EF-report by Parent and Self) at 8 Weeks (Z-score) Primary · baseline and 8 weeks

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 stan

Group	Value	95% CI
Comparison	0.04	± 0.06
Self-Regulation Intervention	-0.08	± 0.05

Change From Baseline in Youth Emotion Regulation (ER-report by Parent and Self) at 8 Weeks (Z-score) Primary · 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 n

Group	Value	95% CI
Comparison	-0.10	± 0.05
Self-Regulation Intervention	0.07	± 0.05

Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score) Primary · 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. The final variable analyzed will be the composite z-score that represents youth self-efficacy based on parent and youth report, stan

Group	Value	95% CI
Comparison	0.23	± 0.09
Self-Regulation Intervention	0.06	± 0.08

Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score) Primary · baseline and 8 weeks

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 su

Group	Value	95% CI
Comparison	0.06	± 0.17
Self-Regulation Intervention	0.11	± 0.16

Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score) Primary · baseline and 8 weeks

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

Group	Value	95% CI
Comparison	0.09	± 0.12
Self-Regulation Intervention	0.03	± 0.11

Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks Secondary · 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. 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-r

Group	Value	95% CI
Comparison	38
Self-Regulation Intervention	42

Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks Secondary · baseline and 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).

Group	Value	95% CI
Comparison	31
Self-Regulation Intervention	36

Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score) Secondary · 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.). The final variable analyzed will be the composite z-score that represents SCI-R adherence based on youth and parent reports, standardized and av

Group	Value	95% CI
Comparison	0.23	± 0.09
Self-Regulation Intervention	0.12	± 0.08

Adverse events — posted to ClinicalTrials.gov

Time frame: Study timeframe (8 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Comparison

Serious: 3/41 (7%)

Deaths: 0/41

Self-Regulation Intervention

Serious: 1/47 (2%)

Deaths: 0/47

Serious adverse events (2 terms)

Reaction	System	Comparison	Self-Regulation Intervention
Diabetic ketoacidosis (DKA)	Endocrine disorders	—	—
Hyperglycemia	Endocrine disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Comparison	Self-Regulation Intervention
cataract surgery	Eye disorders	—	—
ER visit	General disorders	—	—
ER visit	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Diabetic ketoacidosis (DKA), Hyperglycemia.

Data from ClinicalTrials.gov NCT03688919 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol.
   Miller AL, Lo SL, Albright D, Lee JM, et al · · 2020 · cited 12× · PMID 32145739 · DOI 10.1186/s12887-020-2012-7
2. Executive Functioning, Diabetes Distress, and Diabetes Management Among Adolescents With Type 1 Diabetes: Youth and Parent Perspectives.
   Choe A, Fredericks EM, Albright D, Lee JM, et al · · 2025 · PMID 40303942 · DOI 10.1155/pedi/7036544