A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescence is a period of intense physiological, psychological and social change. It can be
      a challenging period for young people with Type 1 diabetes and is associated with worsening
      blood sugar control and care disengagement. The investigators have co-designed with young
      people a psychologically modelled educational programme - Youth Empowerment Skills (YES),
      which aims to facilitate a positive adaption to living with diabetes while improving
      knowledge and self-management behaviours. Integrated programme components include social and
      peer-based learning, immersive simulations, and an outreach youth worker.

      The aim of this study is to test the feasibility of the YES programme (acceptance,
      implementability, recruitment and completion), and estimate its efficacy in relation to
      metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1
      diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with
      integrated process evaluation. Sixty young people will be randomised to either YES
      intervention or waiting-list control and evaluate outcomes at 6-months; at this point the
      waiting list participants will be offered the YES intervention with further follow-up at 12
      months.
    

Detailed description: 
      The study has been designed as a feasibility study with an integrated process evaluation
      following MRC guidance (Craig et al., 2008; Moore et al., 2015). The process evaluation data
      collection has been modelled on the COM_B and the Behaviour Change Wheel framework (BCW)
      frameworks (Michie et al., 2014; Barker et al., 2016) addressing: policy context;
      intervention functions; target behaviours; and outcomes. As part of the process evaluation
      the investigators will also use Consolidated Framework for Implementation Research (CFIR) to
      study how the programme can be optimally embedded within routine diabetes care, and to
      optimise the design of a subsequent trial (Murray et al., 2010). The investigators will
      conduct a feasibility randomised controlled trial (waiting-list design) with integrated
      process evaluation designed following the Medical Research Council's (MRC) Complex
      Intervention Evaluation Framework (Craig et al., 2008). Sixty young people will be randomised
      to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this
      point the waiting list participants will be offered the YES intervention with further
      follow-up at 12 months.

      The proportion of patients achieving the progression criteria and the target reduction in
      glycated haemoglobin (HbA1c) from baseline to follow-up (6 and 12 months) will be estimated
      in both intervention and waiting list control groups. The investigators will also estimate
      the standard deviation (SD) of the mean difference between the intervention and waiting list
      control groups in HbA1c at 6 and 12 months. These statistics will help to inform the sample
      size calculation of a larger trial.

      The process evaluation will consider the setting, implementation, and mechanisms of action of
      the programme to support interpretation of the outcomes. The process evaluation uses a
      standardised taxonomy for understanding implementation (Julious, 2005; Proctor et al., 2011),
      and will assess: the reach, fidelity and receipt of the programme; acceptability,
      appropriateness and feasibility; unintended consequences; potential sustainability; and
      implementation costs and strategies. In addition, potential mechanisms of action will be
      elicited, including changes in behaviours, and how they relate to programme delivery and
      outcomes.

      The investigators will use a mixed-method approach with validated implementation outcome
      surveys (Powell et al., 2015) and one-to-one interviews with young people, their relatives
      and healthcare professionals. The data collection tools and analytic models have been
      designed with reference to the BCW (Michie et al., 2014) and to provide the data for CFIR
      analysis, considering the barriers and facilitators to the intervention. To ensure relevance
      and feasibility, the data collection procedures will be refined with the study patient and
      public involvement groups. Data collection will be conducted at multiple time points to
      provide opportunities for data triangulation and subsequent theory generation.
    

Intervention name(s): Youth Empowerment Skills; Waiting-list control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional; Usual care for 6 months, followed by the YES programme.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study has been designed as a waiting-list randomised controlled trial (RCT). Young people will be randomised to either the phase 1 YES group or the waiting-list control group. The phase 1 YES group will then attend the programme, both groups will be followed-up initially for 6 months, at which point the waiting-list control participants will attend the YES programme in phase 2. Both groups will then be followed-up for a further 6 months.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Mellitus, Type 1; Adolescent; Psychosocial Support Systems