RT Journal Article SR Electronic T1 Effectiveness of a structured educational intervention using psychological delivery methods in children and adolescents with poorly controlled type 1 diabetes: a cluster-randomized controlled trial of the CASCADE intervention JF BMJ Open Diabetes Research & Care JO BMJ Open Diab Res Care FD American Diabetes Association SP e000165 DO 10.1136/bmjdrc-2015-000165 VO 4 IS 1 A1 Christie, Deborah A1 Thompson, Rebecca A1 Sawtell, Mary A1 Allen, Elizabeth A1 Cairns, John A1 Smith, Felicity A1 Jamieson, Elizabeth A1 Hargreaves, Katrina A1 Ingold, Anne A1 Brooks, Lucy A1 Wiggins, Meg A1 Oliver, Sandy A1 Jones, Rebecca A1 Elbourne, Diana A1 Santos, Andreia A1 Wong, Ian C K A1 O'Neil, Simon A1 Strange, Vicki A1 Hindmarsh, Peter A1 Annan, Francesca A1 Viner, Russell M YR 2016 UL http://drc.bmj.com/content/4/1/e000165.abstract AB Introduction Type 1 diabetes (T1D) in children and adolescents is increasing worldwide with a particular increase in children <5 years. Fewer than 1 in 6 children and adolescents achieve recommended glycated hemoglobin (HbA1c) values.Methods A pragmatic, cluster-randomized controlled trial assessed the efficacy of a clinic-based structured educational group incorporating psychological approaches to improve long-term glycemic control, quality of life and psychosocial functioning in children and adolescents with T1D. 28 pediatric diabetes services were randomized to deliver the intervention or standard care. 362 children (8–16 years) with HbA1c≥8.5% were recruited. Outcomes were HbA1c at 12 and 24 months, hypoglycemia, admissions, self-management skills, intervention compliance, emotional and behavioral adjustment, and quality of life. A process evaluation collected data from key stakeholder groups in order to evaluate the feasibility of delivering the intervention.Results 298/362 patients (82.3%) provided HbA1c at 12 months and 284/362 (78.5%) at 24 months. The intervention did not improve HbA1c at 12 months (intervention effect 0.11, 95% CI −0.28 to 0.50, p=0.584), or 24 months (intervention effect 0.03, 95% CI −0.36 to 0.41, p=0.891). There were no significant changes in remaining outcomes. 96/180 (53%) families in the intervention arm attended at least 1 module. The number of modules attended did not affect outcome. Reasons for low uptake included difficulties organizing groups and work and school commitments. Those with highest HbA1cs were less likely to attend. Mean cost of the intervention was £683 per child.Conclusions Significant challenges in the delivery of a structured education intervention using psychological techniques to enhance engagement and behavior change delivered by diabetes nurses and dietitians in routine clinical practice were found. The intervention did not improve HbA1c in children and adolescents with poor control.Trial registration number ISRCTN52537669, results.