Online Psychosocial Support for Young People With a Visible Difference: A Randomised Control Study

Study Overview
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Brief Summary
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A visible difference can have a profound impact in a society with a massive emphasis on appearance and looks. A vulnerable group is adolescents with a condition affecting their appearance as a result of injuries (burns, accidents), treatment (cancer), skin conditions or congenital anomalies (birthmarks, craniofacial conditions). Research has identified potential psychological difficulties, which, if not addressed, can lead to anxiety, depression, and eating disorders. In addition to medical treatment options, aiming at diminishing a difference that may be visible to others, young people with appearance concerns also need self-management skills. However, evidence-based interventions are scarce and specialised psychological treatment is difficult to reach. The Centre for Appearance Research (Bristol, UK) has developed an online intervention for adolescents, now translated into Norwegian (www.ungfaceit.no). UNG Face IT provides easy access to specialist advice and support via a home computer, using information, videos, and interactive activities. It provides advice, teaches coping and social skills, strengthening psychological adjustment to a visible difference. A systematic evaluation of the Norwegian version is needed. UNG Face IT could potentially address unmet needs, provide a cost-effective tool to reduce the need for face-to-face psychological and surgical/medical services, and contribute to make online health care available for young people with a visible difference.

Official Title
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Online Psychosocial Support for Young People Distressed by Appearance-altering Conditions: A Randomised Control Trial (RCT)

Conditions
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Skin Condition, Cleft Lip and Palate, Burns, Other Conditions Leading to a Visible Difference, Craniofacial Abnormalities

Intervention / Treatment
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* Other: Ung Face IT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 12-17 with an appearance-altering condition, and experiencing appearance-related distress, teasing, or bullying Access to a home computer/tablet and internet Reading level > 12 years of age. Audio recordings for all written text available on the website for those who may struggle with reading Normal/corrected-to-normal vision Exclusion Criteria: Clinical depression, psychosis, eating disorder (alternative support necessary) Post-traumatic stress disorder (PTSD) or within 12 months of traumatic injury (alternative support necessary) Learning disability that would impede understanding of the programme's content Currently receiving psychological intervention

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>The intervention group will go through the intervention programme (Ung Face IT) after T1 and randomisation. Programme takes 7 weeks to complete + Treatment as usual (local health care services). Questionnaires after the 7 weeks (T2) and after three months (T3) and 6 months (T4). | Other: Ung Face IT<br>* Ung Face IT is an online intervention tool (programme) that provides easy access to specialist advice and support via a home computer/tablet, using illustrations, information, videos, and interactive activities, and a discussion forum for participants only (supervised by the research team). Through these tools, it provides advice and teaches coping skills based on cognitive behavioural therapy and social interaction skills training.<br>* Other names: English name: Young People Face IT (YP Face IT);|
| Other: Control group<br>Treatment as usual for three months after T1 and randomisation, with local health care support if needed. Questionnaires at T2 and T3 before participants are given access to the intervention (Ung Face IT) after three months. Questionnaire at T4 (post-intervention). | Other: Ung Face IT<br>* Ung Face IT is an online intervention tool (programme) that provides easy access to specialist advice and support via a home computer/tablet, using illustrations, information, videos, and interactive activities, and a discussion forum for participants only (supervised by the research team). Through these tools, it provides advice and teaches coping skills based on cognitive behavioural therapy and social interaction skills training.<br>* Other names: English name: Young People Face IT (YP Face IT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Esteem Scale (BES) | Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life Engagement Scale (LES) | Social experiences and social engagement (10 items) | 6 months | 
| Perceived Stigmatisation Questionnaire | Three subscales: Absence of friendly behaviour, confused and staring behaviour, and hostile behaviour by others. These communicate social acceptance, social discomfort, and social rejection respectively. | 6 months | 
| Harter's Self-Perception Profile for Adolescents | Two subscales are used: Romantic concerns and general self-esteem | 6 months | 
| EQ-5D-5L | Indicator of the impact of UNG Face IT on Health related quality of life and to provide Health economic data | 6 months | 
| Resource Use Questionnaire (Parents) | Assessing time out of School, use of Health care Resources and expenses in relation to the child's condition. | 6 months |