Participants and recruitment

The target population is 12–17 years living with a visible difference who self-identify as experiencing appearance-related distress, teasing or bullying. Charities supporting those with a visible difference (eg, http://www.changingfaces.org.uk) will be approached to ask them to advertise the study via their websites and newsletters to young people and parents. The main avenue for recruitment will be through primary care general practices that do not specialise in appearance-related issues; sites in Bristol and surrounding areas in the South West of the UK will be invited to take part. To increase representativeness of participants from a range of socioeconomic backgrounds, we will aim to include practices with a range of index of multiple deprivation scores.

Based on advice from our YP Face IT advisory group (including GPs, parents/carers and young people), patients from GP practices will be made aware of the study in three ways; through targeted letters of invitation and, to enable introduction of the study to those whose appearance-altering condition is not recorded in their medical notes, via posters/leaflets displayed in the surgery and during consultations. How participants learnt about the study will be recorded to inform recruitment for a future RCT.

With the support of the West of England NIHR Clinical Research Network, a comprehensive list of conditions/injuries known to impact appearance were used to create a specific list of READ codes (medical diagnosis coding system used by practices). GP practices recruited to take part in the study will use these codes to identify eligible patients. GPs will review this list and at their discretion remove those deemed not suitable for invitation (eg, those whose condition has resolved). Young people will be posted an information pack, including a GP invitation letter and information sheet. For those under 16 years, letters will be addressed to their parents/carers who will be asked to discuss participation with their child. A reminder will be sent 4 weeks later to non-respondents, this will include a response form for indicating why they decided not to take part and self-addressed envelope.

Doctors and nurses from GP practices will be asked to recruit young people who meet the inclusion criteria during consultations. We anticipate that the GP practices we recruit will not have extensive experience of raising the topic of appearance with young people; therefore, GPs and nurses will receive training from the YP Face IT team on how to approach and sensitively introduce the study. Staff will provide interested young people with information sheets and leaflets. These will include details for contacting the research team. Posters, designed with input from the advisory group, will be displayed in participating practices inviting young people to contact their GP if the study is of relevance.

Inclusion criteria

Young people aged 12–17 years with any appearance-altering condition, injury or treatment side effect, who self-identify as experiencing appearance-related distress, teasing or bullying and their parent/carer will be eligible. The cause, location and severity of the visible difference will not be objectively assessed, as research consistently finds physical characteristics do not relate to distress levels.11 Participants under 16 years will require a parent/carer to join the study, those aged 16 or above will be encouraged to inform and involve their parent/carer, but this is not mandatory. Participants need to be fluent in English (audio clips are built in to the programme for those who struggle reading text) with normal/corrected-to-normal vision and access to a private computer or tablet.

Exclusion criteria

We will exclude participants with a learning disability that compromises their ability to provide informed consent. Those currently receiving a psychological intervention, diagnosed with clinical depression, psychosis, eating disorder or posttraumatic stress disorder (PTSD) and those within 12 months of a traumatic injury will be excluded. PTSD is a risk for those disfigured through trauma.31 GP practices will be asked to screen for study eligibility before inviting young people to participate. Confirmation of this eligibility will rely on parent and young people's self-report when the researcher speaks to them over the telephone before informed consent is obtained. An example of the consent form can be found in online supplementary appendix 1.

Study design

The study will be a 2-year feasibility RCT starting July 2014. Remote randomisation will be provided by the Bristol Randomised Trials Collaborative based at the University of Bristol, with eligible participants randomised to ‘Treatment as Usual’ (TAU-control group) or YP Face IT in addition to TAU (intervention group). Block randomisation will help ensure equal numbers in each practice are allocated to each condition. A pragmatic parallel-groups RCT, using current practice as the control arm, was acceptable to our advisory group and is the most methodologically robust design to measure self-report psychological outcomes. Randomisation will ensure that in the definitive trial, effects due to condition progression will be equally distributed across groups. Participants who meet our inclusion criteria and their parent/carer will be consented by the research team and asked to provide demographic information. At baseline, young people and their parent/carer will be asked to complete their outcome measures, consented participants will then be randomised to the TAU-control or intervention group. Owing to the nature of the intervention, neither the participants, GP practice staff nor researchers can be blinded to allocation. Participants will be informed that this is a feasibility study and that YP Face IT has not yet been proven effective. Online supplementary appendix 2 details the feasibility trial process diagrammatically.

Treatment as usual

Participants in the control arm will continue with TAU and complete their outcome measures at baseline and 13, 26 and 52-week follow-up. Feedback from GP advisors confirms TAU varies widely, including limited advice, referral to Mood Gym32 (an online intervention ie, not appearance-specific), inpractice counsellors or onward referral to CAMHS. This is a pragmatic trial and no participants will be denied access to alternative treatments and services offered by the NHS or other organisations. Details of the type and frequency of TAU received will be collected via health economic data collection tools, note reviews and interviews.

Intervention

YP Face IT will be provided in addition to TAU for those randomised to the intervention group. Participants will also complete outcome measures at baseline and 13, 26 and 52-week follow-up. The intervention consists of 7 weekly sessions each lasting around 30–40 min, and a booster session 6 weeks later to maintain therapeutic effect. Sessions provide advice and support in written, audio and video formats and include interactive and homework activities that teach and encourage users to practise strategies such as managing staring or bullying. Social skills, anxiety-management and CBT techniques are taught to overcome social anxiety and target negative appearance-related thoughts and behaviours that reduce self-esteem. Video inserts feature adolescent actors with a visible difference, who play different roles in scenarios scripted and created for the programme. Participants can hear testimonies from celebrity role models with appearance-altering conditions, learn from others who have adjusted positively to the challenges of living with a visible difference and can reflect on their own experiences via an online diary. To facilitate adherence to the intervention, participants identify a suitable day and time to complete their next session using the YP Face IT calendar. They (and a parent/carer if they choose) receive automated emails and/or texts 24 and 1 hour before to remind them to complete the session. The content of YP Face IT is organised as follows:

• Session 1: Common problems

• Session 2: Improve your social skills

• Session 3: Don't be SCARED, REACH OUT

• Session 4: ‘Think, Feel, Do’

• Session 5: SMART goals

• Session 6: Beating anxiety

• Session 7: Looking at your progress

• Session 8: Booster quiz

Young people randomised into the intervention group will receive an email with the YP Face IT website link and a secure username and password to access the intervention. Participants complete the intervention at home or in a location of their choice using a computer/tablet. Participants' use of the intervention will be monitored by the research team who have privileged access to data stored on the website. An administration area within YP Face IT records the participant's diary entries and qualitative responses to reflective activities and homework tasks and records their engagement with the website (pages viewed and time spent on each activity). In addition, to evaluate the feasibility of primary care staff supervising young people completing YP Face IT, 5–8 practices will receive training to enable them to access data and monitor their own patients.

Trial design characteristics

We assessed the characteristics of the feasibility study using the pragmatic-explanatory continuum indicator summary (PRECIS-2)33 in relation to eligibility, recruitment, study settings, flexibility of intervention delivery and adherence, follow-up, primary outcome and primary analysis. PRECIS is an accepted tool for assessing trial design on a continuum of effectiveness versus efficacy. Pragmatic trials aim to evaluate the effectiveness of an intervention in a real-life setting and with a study population that is similar as possible to those that will use it. Exploratory trials aim to explore whether the intervention can work under ideal conditions, whereas a pragmatic approach aims to explore whether the intervention works under usual conditions.33 ,34 Figure 1 shows the current feasibility study design based on the nine criteria. Specifically, eligibility, delivery and primary analysis follow more pragmatic approaches, while recruitment, setting, organisation, adherence follow-up and primary outcome fall along the pragmatic-explanatory continuum. We will consider amendments to the domains within the PRECIS tool when designing a full RCT in order, to improve the external validity of any definitive results.

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Figure 1

PRECIS-2.

Feasibility outcome

The study aims to establish whether it is acceptable and feasible to conduct an RCT to evaluate YP Face IT as an adjunct to TAU in a primary care setting, with specific consideration of:

• Adherence and retention to treatment and outcome measures;

• Participants' experiences of using the intervention or being randomised to receive TAU only;

• The variation of TAU provided by GP practices;

• Participants' views on data collection processes and responses to self-report measures (including completion rates and time to complete) to determine the suitability of the outcome measures;

• Choice of, and ability to collect, data for a health economic evaluation;

• The feasibility of GP practice staff supervising young people's use of YP Face IT;

• The suitability of processes for ensuring participants are supported as they work through the intervention and receive onward referral, if necessary;

• Numbers of eligible participants recruited via GP practices.

Clinical outcome

We will assess the impact of YP Face IT on various psychosocial outcome measures, completed by participants online using the Qualtrics data capture tool (http://www.qualtrics.com), which have been chosen based on their scientific merit and use in appearance-related research.

Primary outcome measures

Secondary outcome measures

Self-perception profile

This self-report measure captures how one defines the self and contains nine subscales, each with five items.40 Young people are asked to choose which of two statements they are most like, and then decide whether the selected statement is ‘Really True for Me’ or ‘Sort of True for Me’. Only the Romantic Appeal (YP Face IT addresses common romantic concerns) and Global Self-Worth subscales have been selected for the current study. The measure was chosen because romantic issues and concerns are highly relevant to this group41 and are addressed within YP Face IT.

Perceived Stigmatisation Questionnaire6 This self-report measure assesses the extent to which young people experience stigmatising social behaviour. It has three subscales: the absence of friendly behaviour, confused and staring behaviour and hostile behaviour by others. Young people are asked to rate how often people act in a certain way towards them on a 5-point scale ranging from 1 (never) to 5 (always). This measure was selected to establish whether the strategies included within YP Face IT will impact on young people's perceived stigmatisation, as young people regard this outcome as highly salient to their quality of life.42

EQ-5D-5L

This self-report measure assesses health status in order to provide a simple, generic measure of health for clinical and economic evaluation of healthcare.43 It was selected as it is suitable for those aged 12 years and over. The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It includes a visual analogue scale which asks respondents to self-rate their health from 0 (the worst health you can imagine) to 100 (the best health you can imagine).

Qualitative outcomes

After completing the intervention (or at 13 weeks for the control group), a purposeful sample of 15–20 young people and parents/carers will be invited to participate in semistructured interviews lasting 20–30 min. We will offer the option of telephone interviews and continue to interview until data saturation has been reached. Using interview guides (see online supplementary appendix 3) developed with input from the advisory group, we will explore views on the acceptability and feasibility of recruitment processes, randomisation, retention and outcome measures. Intervention group interviews will also investigate experiences of completing YP Face IT. After 12 months, interviews will be conducted with a range of 10–12 young people (from the intervention and control group) to explore their experiences of the full study, including all follow-ups. Interviews will be digitally recorded and transcribed verbatim, before template data analysis44 is conducted by the researcher who will keep a reflective journal throughout.

Practice staff supervising young people completing the intervention will be invited for interview when all of their patients randomised to YP Face IT have finished the intervention. This will explore the feasibility of GP practice staff supervising young people completing the programme, and their views on recruitment processes, barriers and facilitators to recruitment and retention.

Health economic data collection and analysis

We will prepare the data collection methods needed to undertake an economic evaluation in a definitive trial, from a patient and parent/carer perspective. In the future, we expect YP Face IT to follow a commercialisation pattern such as that used by ‘Beating the Blues’, an online intervention for depression45 which is currently offered in primary care for a yearly licence fee per practice. We will collect the resource use required by the GP practice to deliver and support the running of YP Face IT in trial records, including staff grades and time necessary, and use hourly wages, on-costs and indirect costs to value staff's time. We will liaise with companies providing similar computerised healthcare to estimate licence fee cost. Other resource use will be collected from baseline until 12-month follow-up by reviewing GP records and parent-completed resource use questionnaires. Participant questionnaires will be completed online at 13, 26 and 52-week follow-up by the YP or parent, and will include resource use required to deliver healthcare in the community, use of social services, private expenses (eg, make up, wigs) and productivity losses, including parent/carer time off work and children's days off school. We will further cross check patient-reported community healthcare resource use by asking participating GP practices to review young people's GP records at 52 weeks. Resources will be valued using unit costs for health and social care,46 ,47 the British National Formulary,48 ONS average weekly earnings,49 the AA (travel costs) or local sources (eg, computerised healthcare companies). We will employ sensitivity analysis to account for uncertainty in our costing assumptions (eg, cost of delivering the intervention). We will examine distributions and trends in costs and quality-adjusted life years to determine potential cost drivers and reduce sources of missing data in the future trial. If results from this study indicate a longer time frame is required to capture all health benefits and costs from the intervention, then we will plan for a decision analytical model in the future economic evaluation.

Proposed sample size and data analysis

Quantitative data will be collected throughout the feasibility study to better understand the number of eligible young people, estimate willingness of young people and parents/carers to participate and the proportion finding randomisation acceptable. No formal power calculations are undertaken in feasibility studies; instead, a suitable number of participants are recruited to gain knowledge about factors such as attrition and recruitment in relation to feasibility outcomes.50 Using 10 sites, it is estimated a minimum of 100 young people would be eligible, with more than 60 providing consent for participation. These projected feasibility sample sizes allow consent percentage to be estimated with 95% confidence to within ±11%. Under a worst-case scenario, the projected feasibility sample sizes would allow acceptability rates and completion rates to be estimated with error margins of ±13%. Low participation in the TAU group would be a concern and a sample of 30 allocated to this group would have in excess of 80% power for detecting a 50% or lower participation rate against an anticipated rate 75% or higher and would therefore confidently discriminate between low and good participation rates.

Percentage missing values will be determined at each data collection stage and used to inform acceptability of the chosen outcome measures. Estimated participation rate per practice patient population and questionnaire completion percentages will be used to project the number of practices and sampling duration necessary for the sample size in an RCT. Simulation using participation rate information and response completion profiles of participants will inform these calculations. A feasibility sample size of 60 will ensure variation in individual questionnaire completion will be factored into the projected sample size determination. Findings will determine sensitivity to change of the proposed outcome measures and establish confidence in intervention effect. For a medium effect (Cohen's d=0.5), sample mean values for outcome measures based on 30 per group should align in the hypothesised direction of patient benefit ∼98% of the time. Sample sizes will permit SD of outcomes to be estimated within 25% of the true SD.

Trial status

Recruitment of participants is completed. The first participant was enrolled in September 2014. The last participant will complete follow-up in September 2016.

Ethical and safety considerations