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

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dc.contributor.authorMiller, Alison L.en
dc.contributor.authorLo, Sharon L.en
dc.contributor.authorAlbright, Danaen
dc.contributor.authorLee, Joyce M.en
dc.contributor.authorHunter, Christine M.en
dc.contributor.authorBauer, Katherine W.en
dc.contributor.authorKing, Rosalinden
dc.contributor.authorClark, Katy M.en
dc.contributor.authorChaudhry, Kirenen
dc.contributor.authorKaciroti, Nikoen
dc.contributor.authorKatz, Benjaminen
dc.contributor.authorFredericks, Emily M.en
dc.date.accessioned2020-05-13T13:29:08Zen
dc.date.available2020-05-13T13:29:08Zen
dc.date.issued2020-03-07en
dc.description.abstractBackground 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.en
dc.description.notesThis protocol was peer-reviewed as part of the grant award process. This research was supported by the National Institutes of Health (NIH) Science of Behavior Change (SOBC) Common Fund Program through awards administered by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD UH2HD087979 and UH3HD087979), and NICHD T32HD079350 and F32HD100025. The opinions expressed herein and the interpretation and reporting of these data are the responsibility of the authors and in no way should be seen as an official recommendation, interpretation, or policy of the National Institutes of Health or the US government.en
dc.description.sponsorshipNational Institutes of Health (NIH) Science of Behavior Change (SOBC) Common Fund ProgramUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USA [NICHD UH2HD087979, UH3HD087979]; NICHDUnited States Department of Health & Human ServicesNational Institutes of Health (NIH) - USANIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) [T32HD079350, F32HD100025]en
dc.format.mimetypeapplication/pdfen
dc.identifier.doihttps://doi.org/10.1186/s12887-020-2012-7en
dc.identifier.eissn1471-2431en
dc.identifier.issue1en
dc.identifier.other112en
dc.identifier.pmid32145739en
dc.identifier.urihttp://hdl.handle.net/10919/98234en
dc.identifier.volume20en
dc.language.isoenen
dc.rightsCreative Commons Attribution 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.subjectSelf-regulationen
dc.subjectBehavioral interventionen
dc.subjectMedical regimen adherenceen
dc.subjectType 1 diabetesen
dc.subjectAdolescenceen
dc.titleAdolescent Interventions to Manage Self-Regulation in Type 1 Diabetes (AIMS-T1D): randomized control trial study protocolen
dc.title.serialBMC Pediatricsen
dc.typeArticle - Refereeden
dc.type.dcmitypeTexten
dc.type.dcmitypeStillImageen

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