title: Maximising engagement, motivation and long term change in a Structured Intensive Education Programme in Diabetes for children, young people and their families: Child and Adolescent Structured Competencies Approach to Diabetes Education (CASCADE).
abstract: BACKGROUND
  This trial aims to evaluate effective delivery and cost effectiveness of an innovative structured psycho-educational programme (CASCADE) for young people and their families living with diabetes. The increase in numbers of people being diagnosed with diabetes is posing a challenge for both the UK and the rest of the world. The peak age for diagnosis is between 10 and 14 years of age. There is clear evidence that improved diabetes control from diagnosis in childhood can reduce the incidence and progression of long-term complications. However, despite the development of improved insulin regimens and delivery methods, the overall metabolic control in children and adolescents has improved little in the UK in the past decade. Therefore there is a need for novel interventions and health delivery mechanisms aimed at young people and their families to help improve control and reduce complications, illness burden and costs to the NHS.
  
  
  METHODS
  The CASCADE trial is a multi-centre randomised control trial with 26 clinics randomised to control or intervention groups, with 572 children and young people involved in the study. The intervention will be delivered in 4 group sessions, over a 4 month period. A developmentally appropriate curriculum will be delivered to groups of 3 - 4 families, focusing on achievement of increasing competency in self-management of diabetes. The control group will receive standard care from their clinical team, usually consisting of regular 3-monthly clinic visits and telephone contact as required with the clinical nurse specialist and consultant. The primary outcomes of the trial will be change in HbA1c between baseline and 12 months and 24 months post recruitment. Secondary outcomes will include measures related to the economic evaluation, psychosocial outcomes, outcomes related to management of diabetes outcomes, and adherence to the intervention.
  
  
  CONCLUSIONS
  The trial will be run by independent research and service delivery teams and supervised by a trial steering committee. A data monitoring and ethics committee has been put in place to monitor the trial and recommend stopping/continuation according to a Peto-Haybittle rule. The trial will be conducted according to the principles of MRC Good Clinical Practice (GCP) Guidelines and CTRU Phase III Trial Standard Operating procedures.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN52537669.
authors.affiliation: Child and Adolescent Psychological Services, University College Hospital, London, UK. Deborah.Christie@uclh.nhs.uk
authors.forename: Deborah
authors.initials: D
authors.lastname: Christie
authors.forename: Vicki
authors.initials: V
authors.lastname: Strange
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Allen
authors.forename: Sandy
authors.initials: S
authors.lastname: Oliver
authors.forename: Ian Chi Kei
authors.initials: IC
authors.lastname: Wong
authors.forename: Felicity
authors.initials: F
authors.lastname: Smith
authors.forename: John
authors.initials: J
authors.lastname: Cairns
authors.forename: Rebecca
authors.initials: R
authors.lastname: Thompson
authors.forename: Peter
authors.initials: P
authors.lastname: Hindmarsh
authors.forename: Simon
authors.initials: S
authors.lastname: O'Neill
authors.forename: Christina
authors.initials: C
authors.lastname: Bull
authors.forename: Russell
authors.initials: R
authors.lastname: Viner
authors.forename: Diana
authors.initials: D
authors.lastname: Elbourne
mesh_terms: D000293:Adolescent; D002648:Child; D003479:Curriculum; D048909:Diabetes Complications / Q000453:epidemiology / Q000517:prevention & control*; D003920:Diabetes Mellitus / Q000097:blood / Q000453:epidemiology / Q000628:therapy*; D018450:Disease Progression; D004739:England / Q000453:epidemiology; D005190:Family; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D015994:Incidence; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D010349:Patient Compliance; D010353:Patient Education as Topic / Q000379:methods*; D011379:Prognosis; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin