CompletedNot Applicable

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

United States88 participantsStarted 2019-05-13

Plain-language 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.

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline and 8 weeks

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

Timeframe: baseline and 8 weeks

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

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks

Trial details

NCT IDNCT03688919

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

Results submitted2022-08-12

View on ClinicalTrials.gov More Self-regulation trials

Plain-language summary

Who can participate

Age range

13 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: baseline and 8 weeks

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

Timeframe: baseline and 8 weeks

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

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks

Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score)

Timeframe: baseline and 8 weeks