Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED): a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes.
BACKGROUND
Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team.


METHODS
Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT). The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c) during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period.


CONCLUSIONS
The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with type 1 diabetes. Previous research indicates the effectiveness of specialist psychological interventions in achieving sustained improvements in glycaemic control. This trial will evaluate an intervention which does not require the involvement of trained psychologists, maximising the potential feasibility of delivery in a wider NHS context.


BACKGROUND
Current Controlled Trials ISRCTN61568050.
McNamara
Rachel
R
South East Wales Trials Unit, Department of Primary Care & Public Health, School of Medicine, Cardiff University, 7th floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. mcnamara@cardiff.ac.uk
Robling
Mike
M
Hood
Kerenza
K
Bennert
Kristina
K
Channon
Susan
S
Cohen
David
D
Crowne
Elizabeth
E
Hambly
Helen
H
Hawthorne
Kamila
K
Longo
Mirella
M
Lowes
Lesley
L
Playle
Rebecca
R
Rollnick
Stephen
S
Gregory
John W
JW
D000293:Adolescent; D000294:Adolescent Behavior; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D002983:Clinical Competence; D003142:Communication; D057186:Comparative Effectiveness Research; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000523:psychology / Q000628:therapy*; D004502:Education, Medical, Continuing; D004509:Education, Nursing, Continuing; D005260:Female; D006442:Glycated Hemoglobin; D006801:Humans; D007400:Interprofessional Relations; D008297:Male; D010348:Patient Care Team; D010372:Pediatrics / Q000193:education*; D010817:Physician-Patient Relations; D011788:Quality of Life
D006442:Glycated Hemoglobin