CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Self-Regulation Interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03688919
NCT03688919N/ACompleted

Targeting Self-regulation to Promote Adherence and Health Behaviors in Children

University of Michigan·interventional·Posted Sep 28, 2018·Updated Oct 7, 2022

In Brief

A clinical study evaluating Self-Regulation Intervention for Self-regulation and Medication Adherence. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 28, 2018
Enrollment StartMay 13, 2019
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.8 years ago

Interventions

Self-Regulation Interventionbehavioral

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).