Using Community Engagement Methods to Guide Study Protocol Decisions for School-Aged Children With Type 1 Diabetes.

Introduction: Many challenges exist in developing multisite protocols for newly diagnosed children with type 1 diabetes. Our research team engaged community members to increase the likelihood of study success during a planning grant for a longitudinal study aimed at understanding risk and protective factors for neurocognitive function in school-aged children newly diagnosed with type 1 diabetes. Methods: Two methods were used to obtain caregiver input into study protocol decisions. The first was a survey given to caregivers of children with diabetes (n = 21) about which aspects of the study protocol would make families more or less likely to participate. The second was a Community Engagement (CE) Studio to obtain recommendations from a diverse group of caregivers of children with diabetes (n = 7) on key aspects of recruitment and enrollment. Results: Results from both the survey and the CE Studio indicated that caregivers were interested and willing to participate in a longitudinal study of this nature. Both methods resulted in similar preferences for the type and amount of compensation, convenient study visits, flexible scheduling options, and receipt of neurocognitive test results. Recommendations from the CE Studio included additional strategies to minimize participant burden and enhance communication around study participation. Conclusion: Both the feasibility survey and the CE Studio were useful mechanisms to obtain caregiver input during the study's planning and design phase. Uniquely, the CE Studio approach offers researchers the ability to gain valuable community member input with minimal staff effort.

Detangling Associations Between Maternal Depressive Symptoms and Diabetes Relationship Distress With Adolescents' HbA1c.

OBJECTIVE : Previous research in families of children with type 1 diabetes demonstrates that maternal depressive symptoms are a known risk factor for poor diabetes outcomes. We sought to examine whether maternal diabetes relationship distress or maternal depressive symptoms were more strongly associated with adolescent glycemic outcomes. METHODS : Analyses were conducted using data from mothers who consented to screen for a behavioral intervention. The screener included the Patient Health Questionnaire and the Parent Diabetes Distress Scale, Parent/Teen Relationship Distress subscale. Hemoglobin A1c (HbA1c) was extracted from adolescents' medical records. RESULTS : Our sample consisted of 390 maternal caregivers of adolescents with type 1 diabetes aged 11-17. Screening data revealed that 35% of mothers reported clinically significant diabetes distress related to their relationship with their adolescents, and 14% of mothers reported clinically significant depressive symptoms. The adolescents of mothers who reported diabetes relationship distress had significantly higher mean HbA1c levels (9.7 ± 2.2%) compared to those whose mothers were not distressed (8.2 ± 1.8%, d = .72). Similarly, adolescents whose mothers reported clinically significant depressive symptoms had higher mean HbA1c levels (9.6 ± 2.4%) than those whose mothers were not depressed (8.6 ± 2.0%, d = .48). After adjusting for clinical and demographic factors, mothers' reports of diabetes relationship distress were more strongly associated with adolescents' HbA1c than maternal depressive symptoms. CONCLUSIONS : Our findings suggest that screening for maternal distress-particularly distress related to the caregiver-adolescent relationship-could match families with psychosocial support or other resources to improve both psychosocial and glycemic outcomes.

Importance of caregivers' subjective social status and neighbourhood disadvantage for adolescents with type 1 diabetes.

AIMS: Adolescents with type 1 diabetes from low-income populations are more likely to have difficulty in managing their diabetes and ultimately have poorer glycaemic outcomes, but less is known about neighbourhood-level factors or subjective social status (SSS) as risk/protective factors. We examined associations between multiple indicators of socio-economic status with diabetes outcomes. METHODS: One hundred and ninety-eight adolescents ages 13-17 (58% female, 58% White, non-Hispanic) experiencing moderate diabetes distress completed measures of diabetes management and diabetes distress, and their caregivers reported on SSS. Glycaemic indicators were extracted from medical records, and participants' addresses were used to determine area deprivation index (ADI). RESULTS: Higher levels of neighbourhood disadvantage were significantly associated with higher haemoglobin A1c levels and average glucose levels, but caregivers' SSS was more strongly associated with all glycaemic indicators, diabetes management and diabetes distress. CONCLUSIONS: Given strong associations between caregivers' SSS and glycaemic control, diabetes management, and diabetes distress, screening for caregivers' SSS may identify adolescents who would benefit from additional support.

A Pandemic Perspective: Analyzing the Impact of COVID-19 on Diabetes Management and Mood Through the Lens of Location and Family Conflict.

PURPOSE: The purpose of this study was to examine the influence of COVID-19 on teens' diabetes management and mood and their association with family conflict. METHODS: One hundred and nineteen teens ages 13 to 17 (M = 15.5 ± 1.3 years, 61.3% female, 57.1% non-Hispanic White) and 119 parents (83.2% female, 75.6% married, 63.9% non-Hispanic White) enrolled in an ongoing two-site randomized behavioral clinical trial. At baseline, dyads completed the Revised Diabetes Family Conflict scale and a survey measuring the impact of COVID-19 on teens' mood and diabetes management. RESULTS: Parent- and teen-reported impacts of COVID-19 on diabetes management and teen mood were positively correlated. Higher levels of both parent- and teen-reported family conflict were associated with greater parent-reported impact of COVID-19 on diabetes management and teen mood. In addition, teen-reported impact of COVID-19 on their mood varied by geographical location but not population density. CONCLUSIONS: COVID-19 influenced teen diabetes management and mood, and the impact of COVID-19 was related to diabetes-related family conflict and differed by geographic location. Findings lend support for mental health interventions targeting teens with T1DM affected by COVID-19 and monitoring the long-term effects of the pandemic.

Sleep Habits of Early School-Aged Children with Type 1 Diabetes and Their Parents: Family Characteristics and Diabetes Management.

STUDY OBJECTIVES: School-aged children with type 1 diabetes (T1D) and their parents are at risk for sleep disturbances, yet few studies have used objective measures to assess sleep characteristics in young children with T1D. METHODS: Forty children (ages 5-9) with T1D and their parents wore actigraph watches and completed sleep diaries for 7 nights. Parents also completed questionnaires about demographic information, diabetes distress, fear of hypoglycemia, and family routines. Children's clinical data (HbA1c and blood glucose data) were extracted from the medical record. RESULTS: Most of the children and their parents obtained insufficient sleep. Based on actigraphy data, children slept an average of 7.9 hours/night and parents slept 6.7 hours/night, below the recommendations of 9-11 and 7-9 hours of sleep, respectively. Shorter child sleep latency was significantly associated with better glycemic levels, and parents' sleep duration and efficiency were related to child's glycemic levels. Parental fear of hypoglycemia and lack of family routines were associated with poorer sleep quality in parents and children, and with parental diabetes distress. CONCLUSIONS: Sleep duration and quality is a modifiable target for potentially improving glycemic levels and parental distress in early school-aged children with T1D.

Pivoting during a pandemic: lessons learned from transitioning a multisite randomized controlled trial to a remote protocol in response to COVID-19.

THR1VE! is an ongoing multisite randomized clinical trial of a positive psychology intervention designed to treat diabetes distress and improve glycemic outcomes in teens with type 1 diabetes. Due to the COVID-19 pandemic restrictions on clinical research and changes in diabetes clinical care, THR1VE! was adapted from an in-person enrollment protocol to a remote protocol through a series of development and testing strategies. We discuss the process of transitioning the protocol and the demonstrated feasibility of ongoing recruitment, enrollment, and retention outcomes. These findings offer support for a remotely transitioned protocol that has larger applications for ongoing and future clinical research.

THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.

Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.