Clinical trial NCT03165331: Online Psychosocial Support for Young People With a Visible Difference: A Randomised Control Study
Official title: Online Psychosocial Support for Young People Distressed by Appearance-altering Conditions: A Randomised Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Condition
Cleft Lip and Palate
Burns
Other Conditions Leading to a Visible Difference
Craniofacial Abnormalities
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Centre for Appearance Research, University of the West of England, UK
First posted: 2017-05-24
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Body Esteem Scale (BES)
timeFrame: 6 months
Secondary outcomes:
measure: Life Engagement Scale (LES)
timeFrame: 6 months
measure: Perceived Stigmatisation Questionnaire
timeFrame: 6 months
measure: Harter's Self-Perception Profile for Adolescents
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: 6 months
measure: Resource Use Questionnaire (Parents)
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Centre for Rare Disorders
Study officials:
affiliation: Centre Director
name: Olve Moldestad, PhD
role: STUDY_DIRECTOR
References: