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BMC Pediatr. 2020 Mar 7;20(1):112. doi: 10.1186/s12887-020-2012-7.

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

Author information

1
Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA. alimill@umich.edu.
2
Center for Human Growth and Development, University of Michigan, Ann Arbor, MI, USA. alimill@umich.edu.
3
Department of Health Behavior and Health Education, University of Michigan School of Public Health, 1415 Washington Heights, SPH I Room 3718, Ann Arbor, MI, 48109-2029, USA.
4
Center for Human Growth and Development, University of Michigan, Ann Arbor, MI, USA.
5
Department of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.
6
Susan B. Meister Child Health Evaluation and Research Center (CHEAR), University of Michigan, Ann Arbor, MI, USA.
7
Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor, MI, USA.
8
Office of Behavioral and Social Sciences Research, National Institutes of Health, Bethesda, MD, USA.
9
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
10
Department of Human Development and Family Science, Virginia Tech, Blacksburg, VA, USA.

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.

KEYWORDS:

Adolescence; Behavioral intervention; Medical regimen adherence; Self-regulation; Type 1 diabetes

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