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BMC Pediatrics
Published in: BMC Pediatrics 1/2020

Open Access 01-12-2020 | Type 1 Diabetes | Study protocol

Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol

Authors: Alison L. Miller, Sharon L. Lo, Dana Albright, Joyce M. Lee, Christine M. Hunter, Katherine W. Bauer, Rosalind King, Katy M. Clark, Kiren Chaudhry, Niko Kaciroti, Benjamin Katz, Emily M. Fredericks

Published in: BMC Pediatrics | Issue 1/2020

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Abstract

Background

Self-regulation (SR), or the capacity to control one’s thoughts, emotions, and behaviors in order to achieve a desired goal, shapes health outcomes through many pathways, including supporting adherence to medical treatment regimens. Type 1 Diabetes (T1D) is one specific condition that requires SR to ensure adherence to daily treatment regimens that can be arduous and effortful (e.g., monitoring blood glucose). Adolescents, in particular, have poor adherence to T1D treatment regimens, yet it is essential that they assume increased responsibility for managing their T1D as they approach young adulthood. Adolescence is also a time of rapid changes in SR capacity and thus a compelling period for intervention. Promoting SR among adolescents with T1D may thus be a novel method to improve treatment regimen adherence. The current study tests a behavioral intervention to enhance SR among adolescents with T1D. SR and T1D medical regimen adherence will be examined as primary and secondary outcomes, respectively.

Methods

We will use a randomized control trial design to test the impact of a behavioral intervention on three SR targets: Executive Functioning (EF), Emotion Regulation (ER), and Future Orientation (FO); and T1D medical regimen adherence. Adolescents with T1D (n = 94) will be recruited from pediatric endocrinology clinics and randomly assigned to treatment or control group. The behavioral intervention consists of working memory training (to enhance EF), biofeedback and relaxation training (to enhance ER), and episodic future thinking training (to enhance FO) across an 8-week period. SR and treatment regimen adherence will be assessed at pre- and post-test using multiple methods (behavioral tasks, diabetes device downloads, self- and parent-report). We will use an intent-to-treat framework using generalized linear mixed models to test our hypotheses that: 1) the treatment group will demonstrate greater improvements in SR than the control group, and 2) the treatment group will demonstrate better treatment regimen adherence outcomes than the control group.

Discussion

If successful, SR-focused behavioral interventions could improve health outcomes among adolescents with T1D and have transdiagnostic implications across multiple chronic conditions requiring treatment regimen adherence.

Trial registration

ClinicalTrials.gov: NCT03688919; registered September 28, 2018.
Appendix
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Metadata
Title
Adolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocol
Authors
Alison L. Miller
Sharon L. Lo
Dana Albright
Joyce M. Lee
Christine M. Hunter
Katherine W. Bauer
Rosalind King
Katy M. Clark
Kiren Chaudhry
Niko Kaciroti
Benjamin Katz
Emily M. Fredericks
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Type 1 Diabetes
Published in
BMC Pediatrics / Issue 1/2020
Electronic ISSN: 1471-2431
DOI
https://doi.org/10.1186/s12887-020-2012-7

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