Using Mobile Health to Improve Asthma Self-Management in Early Adolescence: A Pilot Randomized Controlled Trial.

PURPOSE: Early adolescence is an important developmental period where youth take primary responsibility for asthma self-management. Helpful caregiver support during this time is pivotal in determining whether early adolescents successfully develop asthma self-management behaviors. AIM2ACT is a dyadic mobile health intervention designed to increase helpful caregiver support as early adolescents engage in asthma self-management behaviors. We conducted a pilot randomized controlled trial to determine the feasibility and acceptability of AIM2ACT and conduct preliminary tests of efficacy. METHODS: We randomized adolescents (12-15 years old) and a caregiver to receive AIM2ACT (n = 17) or a self-guided attention control condition (n = 16) for 20 weeks. We conducted assessment visits at baseline, postintervention, and 4-month follow-up. Outcomes included family asthma management (primary outcome), adolescent asthma control, lung function (forced expiratory volume in 1 second), asthma-related quality of life, asthma management self-efficacy, and family communication. RESULTS: We randomized 33 dyads and had 100% retention in the trial among AIM2ACT participants. Dyads frequently engaged with AIM2ACT (M = 21 days for adolescents, 32.65 days for caregivers) and reported very high satisfaction with content, functionality, and helpfulness. Participants randomized to AIM2ACT had significant improvements in asthma control scores (p = .04) compared to control that surpassed the minimally clinically important difference threshold. Although not statistically significant, the magnitude of improvements in family asthma management, asthma-related quality of life, and family communication was larger in the AIM2ACT group. CONCLUSIONS: AIM2ACT is a feasible and acceptable dyadic mobile health asthma self-management intervention that improves asthma control.

Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention.

BACKGROUND: Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. OBJECTIVE: The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. METHODS: We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. RESULTS: Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. CONCLUSIONS: If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. TRIAL REGISTRATION: ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/17877.

Mealtime insulin BOLUS score increases prior to clinic visits in youth with type 1 diabetes.

INTRODUCTION: Multiple studies confirm the occurrence of 'white coat adherence' (WCA), a term describing an increase in engagement with self-care tasks just prior to a scheduled clinic appointment, across cohorts with multiple chronic conditions. In youth with type 1 diabetes (T1D), research also shows an increase in self-monitoring blood glucose frequency ahead of youths' clinic visits. While studies show preliminary evidence for the occurrence of WCA in youth with T1D, no study has examined the effect of WCA and mealtime insulin dosing behaviors in youth with T1D. The frequency of mealtime insulin bolusing score (BOLUS) is an objective measure of mealtime insulin use in youth with T1D that could be vulnerable to WCA. To fill this gap in the literature and further our understanding of WCA in pediatric diabetes, we determined whether WCA also impacts BOLUS scores in youth with T1D. RESEARCH DESIGN AND METHODS: We extracted insulin pump records and HbA1c levels from a clinical database for 459 youth with T1D (Mage=12.5±2.9 years). We calculated mean BOLUS scores for 6-5, 4-3, and 2-0 weeks prior to youths' routine clinic visits. We used multilevel modeling to examine patterns of BOLUS scores prior to clinic visits and tested for age differences. RESULTS: Multilevel modeling showed a significant increase in BOLUS scores in the weeks prior to youths' clinic appointments (ß=0.07, p<0.001). On average, adolescents had lower BOLUS scores than school-age children (ß=-0.35, p<0.001). Post hoc analyses showed that adolescents consistently had lower BOLUS scores than children across assessments (p's<0.001). CONCLUSIONS: Youth with T1D increase their mealtime insulin use prior to clinic appointments. The BOLUS may be a viable target for intervention to drive improved glycemic control. Whether increased tendency to WCA is associated with reduced risk of diabetic complications remains to be determined.

Depression as a predictor of hypoglycemia worry in parents of youth with recent-onset type 1 diabetes.

BACKGROUND: During the recent-onset period of type 1 diabetes (T1D), parents may be at increased risk for depression, stress, and hypoglycemia fear; however, current studies have not examined the parental psychological experience and anxiety from hypoglycemia fear (ie, hypoglycemia worry) over time. This study examined the trajectory of parental hypoglycemia worry (Hypoglycemia Fear Survey-Worry [HFS-Worry]) in families of children with recent-onset T1D and the effects of baseline parental depression on parents' trajectory of HFS-Worry. METHODS: We enrolled 128 families of children ages 5- to 9-years-old with recent onset T1D in this study. At baseline, 125 parents completed measures of depression and HFS-Worry, followed by 111 at 6-month follow-up, 113 at 12-month follow-up, and 107 at 18-month follow-up. We used multilevel modeling to examine the 18-month trajectories of HFS-Worry and to examine if parental depression modified these trajectories. RESULTS: We found that parents HFS-Worry scores increased over time for parents with and without elevated depressive symptoms. Parents' baseline report of depression appeared to modify their trajectory of HFS-Worry over time such that parents with elevated depressive symptoms reported significantly higher levels of worry when compared to parents without depressive symptoms across the 18-month study period (P < .05). CONCLUSIONS: Parents of children with recent-onset T1D, who reported elevated depressive symptoms, reported higher HFS-Worry across the study period. Our findings suggest clinics should consider screening for parent depression and hypoglycemia worry following a T1D diagnosis. Integrating psychological screening for parents could help clinics to provide relevant treatment resources and tailor diabetes education for parents. Trial Registration NCT03698708.

Topical Review: Design Considerations When Creating Pediatric Mobile Health Interventions: Applying the IDEAS Framework.

OBJECTIVE: To present a guiding framework from the perspective of psychologists and technologists to develop effective mobile health (mHealth) interventions for pediatric populations. METHODS: This topical review uses the IDEAS framework as an organizational method to summarize current strategies to conceptualize, design, evaluate, and disseminate mHealth interventions. RESULTS: Incorporating theories of behavior change and feedback from target populations are essential when developing mHealth interventions. Following user-centered approaches that fully incorporate end users into design and development stages increases the likelihood that the intervention will be acceptable. Iterative design cycles and prototyping are important steps to gather user feedback to optimize an mHealth intervention. Broad sharing of knowledge and products generated during intervention development also is recommended. Assessment of behavioral principles, intervention components, or a full intervention package should be conducted to evaluate usability and efficacy. CONCLUSIONS: Pediatric health-care researchers and clinicians are increasingly using mHealth technology to target health behaviors and improve related outcomes. Pediatric psychologists should consider applying the design strategies outlined in the IDEAS framework to produce and disseminate mHealth interventions tailored to the specific needs of pediatric populations.

Medication adherence in pediatric asthma: A systematic review of the literature.

OBJECTIVE: To provide a systematic review of correlates of adherence to inhaled corticosteroids (ICS) in pediatric asthma across the individual, family, community, and healthcare system domains. METHODS: Articles assessing medication adherence in pediatric asthma published from 1997 to 2016 were identified using PsychINFO, Medline, and CINAHL. Search terms included asthma, compliance, self-management, adherence, child, and youth. Search results were limited to articles: 1) published in the US; 2) using a pediatric population (0-25 years old); and 3) presenting original data related to ICS adherence. Correlates of adherence were categorized according to the domains of the Pediatric Self-Management Model. Each article was evaluated for study quality. RESULTS: Seventy-nine articles were included in the review. Family-level correlates were most commonly reported (N = 51) and included socioeconomic status, race/ethnicity, health behaviors, and asthma knowledge. Individual-level correlates were second-most common (N = 37), with age being the most frequently identified negative correlate of adherence. Health care system correlates (N = 24) included enhanced asthma care and patient-provider communication. Few studies (N = 10) examined community correlates of adherence. Overall study quality was moderate, with few quantitative articles (26.38%) and qualitative articles (21.4%) referencing a theoretical basis for their studies. CONCLUSIONS: All Pediatric Self-Management Model domains were correlated with youth adherence, which suggests medication adherence is influenced across multiple systems; however, most studies assessed adherence correlates within a single domain. Future research is needed that cuts across multiple domains to advance understanding of determinants of adherence.

Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial.

Early adolescents have difficulties performing asthma self-management behaviors, placing them at-risk for poor asthma control and reduced quality of life. This paper describes the development and plans for testing an interactive mobile health (mHealth) tool for early adolescents, ages 12-15years, and their caregivers to help improve asthma management. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT) is informed by the Pediatric Self-management model, which posits that helpful caregiver support is facilitated by elucidating disease management behaviors and allocating treatment responsibility in the family system, and subsequently engaging in collaborative caregiver-adolescent asthma management. The AIM2ACT intervention was developed through iterative feedback from an advisory board composed of adolescent-caregiver dyads. A pilot randomized controlled trial of AIM2ACT will be conducted with 50 early adolescents with poorly controlled asthma and a caregiver. Adolescent-caregiver dyads will be randomized to receive the AIM2ACT smartphone application (AIM2ACT app) or a self-guided asthma control condition for a 4-month period. Feasibility and acceptability data will be collected throughout the trial. Efficacy outcomes, including family asthma management, lung function, adolescent asthma control, asthma-related quality of life, and self-efficacy for asthma management, will be collected at baseline, post-treatment, and 4-month follow-up. Results from the current study will inform the utility of mHealth to foster the development of asthma self-management skills among early adolescents.