N/A N=88 Randomized Prevention

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

Self-regulation · Medication Adherence

Bottom Line

View on ClinicalTrials.gov: NCT03688919 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Oct 2022

Primary outcome: Primary: Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score) — 0.02; -0.02 z-score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Self-Regulation Intervention (Behavioral)
Age: Pediatric · 13+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Youth Executive Function (Behavioral EF) at 8 Weeks (Z-score)	0.02; -0.02	—
PRIMARY Change From Baseline in Youth Executive Function (EF-report by Parent and Self) at 8 Weeks (Z-score)	0.04; -0.08	—
PRIMARY Change From Baseline in Youth Emotion Regulation (ER-report by Parent and Self) at 8 Weeks (Z-score)	-0.10; 0.07	—
PRIMARY Change From Baseline in Youth Self-Efficacy (Parent- and Self-reported) at 8 Weeks (Z-score)	0.23; 0.06	—
PRIMARY Change From Baseline in Youth Future Orientation (Self-report) at 8 Weeks (Z-score)	0.06; 0.11	—
PRIMARY Change From Baseline in Youth Future Orientation (Objective Measure) at 8 Weeks (Z-score)	0.09; 0.03	—
SECONDARY Change From Baseline in Number of Participants Conducting Blood Glucose Monitoring at 8 Weeks	38; 42	—
SECONDARY Change From Baseline in in Number of Participants With Insulin Administration Adherence at 8 Weeks	31; 36	—
SECONDARY Change From Baseline in Self-Care Inventory Revised at 8 Weeks (Z-score)	0.23; 0.12	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03688919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.