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

Burns Clinical Trial

— UNGFaceIT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03165331
• Other study ID #: 2015/2440-4
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Ung Face IT
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.

Locations

Country	Name	City	State
Norway	Centre for Rare Disorders	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Centre for Appearance Research, University of the West of England, UK

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Esteem Scale (BES)	Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance.	6 months
Secondary	Life Engagement Scale (LES)	Social experiences and social engagement (10 items)	6 months
Secondary	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
Secondary	Harter's Self-Perception Profile for Adolescents	Two subscales are used: Romantic concerns and general self-esteem	6 months
Secondary	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
Secondary	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