Online Psychosocial Support for Young People With a Visible Difference: A Randomised Control Study (UNGFaceIT)
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|ClinicalTrials.gov Identifier: NCT03165331|
Recruitment Status : Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : August 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Condition Cleft Lip and Palate Burns Other Conditions Leading to a Visible Difference Craniofacial Abnormalities||Other: UNG Face IT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Online Psychosocial Support for Young People Distressed by Appearance-altering Conditions: A Randomised Control Trial (RCT)|
|Actual Study Start Date :||April 1, 2016|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2021|
The intervention group will go through the intervention programme (UNG Face IT) - 7 weeks + post-intervention questionnaires + Treatment as usual
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.
Other Name: English name: Young People Face IT (YP Face IT)
No Intervention: Control group
Treatment as usual, which may mean some support locally.
- Body Esteem Scale (BES) [ Time Frame: 6 months ]Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance.
- Social Anxiety Scale [ Time Frame: 6 months ]Three subscales from this measures will be used: Fear of negative evaluations by others, Social avoidance and distress in new or unfamiliar situations, and Social avoidance and distress in the company of peers.
- Perceived Stigmatisation Questionnaire [ Time Frame: 6 months ]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.
- Harter's Self-Perception Profile for Adolescents [ Time Frame: 6 months ]Two subscales are used: Romantic concerns and general self-esteem
- EQ-5D-5L [ Time Frame: 6 months ]Indicator of the impact of UNG Face IT on Health related quality of life and to provide Health economic data
- Social Anxiety Scale (Parents) [ Time Frame: 6 months ]Same as above, but parent version
- Resource Use Questionnaire (Parents) [ Time Frame: 6 months ]Assessing time out of School, use of Health care Resources and expenses in relation to the child's condition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165331
|Centre for Rare Disorders|
|Study Director:||Olve Moldestad, PhD||Centre Director|