BREATHE-T1D: Using iterative mixed methods to adapt a mindfulness-based intervention for adolescents with type 1 diabetes: Design and development

Francesca Lupini, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: flupini@email.sc.edu.
Molly Basch, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America.
Frances Cooke, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: fcooke@childrensnational.org.
Jack Vagadori, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America. Electronic address: jvagadori@childrensnational.org.
Ana Gutierrez-Colina, Colorado State University, Fort Collins, CO, United States of America; University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America. Electronic address: ana.gutierrez_colina@colostate.edu.
Katherine Patterson Kelly, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: kakelly@childrensnational.org.
Randi Streisand, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: rstreis@childrensnational.org.
Lauren Shomaker, Colorado State University, Fort Collins, CO, United States of America; University of Colorado Anschutz Medical Campus, Aurora, CO, United States of America; Children's Hospital Colorado, Aurora, CO, United States of America. Electronic address: lauren.shomaker@colostate.edu.
Eleanor R. Mackey, Children's National Hospital, 111 Michigan Avenue, Washington, DC 20010, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America. Electronic address: emackey@childrensnational.org.

Document Type

Journal Article

Publication Date

4-29-2024

Journal

Contemporary clinical trials

Volume

142

DOI

10.1016/j.cct.2024.107551

Keywords

Intervention adaptation; Iterative design; Program development; Qualitative research; Type 1 diabetes

Abstract

BACKGROUND: Negative affect is prevalent among adolescents with type 1 diabetes (T1D) and may impact diabetes self-management and outcomes through stress-related behaviors such as disordered eating. METHODS: We describe the development of and design for the adaptation of a mindfulness-based intervention (MBI) for adolescents with T1D and negative affect. BREATHE-T1D is an MBI designed to target negative affect that has been tailored to address the unique lived experiences of adolescents with T1D. Qualitative interviews with stakeholders and participants were used to inform iterative adaptations to the intervention and control curricula over the course of the study. The primary aim of this paper is to describe the design, development, and protocol of the present pilot feasibility trial. CONCLUSIONS: Iterative, qualitative methodology throughout the adaptation of an intervention is important for ensuring the resulting intervention is relevant and meaningful for the target population. CLINICAL TRIAL REGISTRATION NUMBER: NCT05268393.

Department

Pediatrics

Link to Full Text

Share

COinS