Abstract
BACKGROUND: Parents of young children with type 1 diabetes (T1D) are vulnerable to experiencing fear of hypoglycemia (FH), an emotional condition that includes persistent and intense worry about hypoglycemia and/or use of unhealthful behaviors to avoid hypoglycemia. Despite greater uptake of continuous glucose monitors (CGMs) and automated insulin delivery systems, FH remains prevalent and under-addressed in parents of young children. As such, we developed Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP), a video-based telehealth intervention designed to reduce FH in parents by providing T1D education and teaching parents how to apply evidence-based strategies from cognitive behavioral therapy and behavioral parent training in their child's daily T1D care. OBJECTIVE: This study aimed to compare the REDCHiP intervention to a novel attention control condition (ATTN) to better isolate treatment effects for REDCHiP based on parents' FH and diabetes distress. METHODS: This was a multisite randomized controlled trial. We enrolled 197 families and randomized 183 to either REDCHiP or ATTN. Both REDCHiP and ATTN parents completed 10 video-based telehealth sessions. Our primary outcome was changes in parental FH; secondary outcomes included changes in parental diabetes distress and children's glycated hemoglobin A1c (HbA1c). We used a series of mixed-effects models and logistic regression to evaluate treatment effects. RESULTS: Parents in REDCHiP and ATTN attended >95% of sessions with high treatment fidelity. FH and diabetes distress decreased significantly over time in both REDCHiP and ATTN. Treatment-slope effects slightly favored REDCHiP but were not statistically significant for FH (P=.09) or distress (P=.06). However, parents receiving REDCHiP were significantly less likely to report clinically elevated diabetes distress over time compared to ATTN (P=.02). Child HbA1c showed a small, nonsignificant reduction over time (P=.06). Parents with elevated depressive symptoms consistently reported higher FH and distress across all time points. CONCLUSIONS: REDCHiP demonstrated high feasibility, acceptability, and potential clinical relevance in reducing diabetes distress among parents of young children with T1D. While overall treatment effects were modest, use of an attention control condition represents a meaningful advancement in trial rigor for pediatric behavioral interventions. Future adaptations of REDCHiP may enhance its impact, particularly for parents experiencing comorbid depressive symptoms.