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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Burns; Cleft Lip and Palate; Craniofacial Abnormalities; Skin Condition; Other Conditions Leading to a Visible Difference
• Intervention / Treatment: Other: Ung Face IT

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Centre for Rare Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention group; 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; 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 Names: English name: Young People Face IT (YP Face IT)
Other: Control group; 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; 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 Names: English name: Young People Face IT (YP Face IT)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Centre for Appearance Research, University of the West of England, UK

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 30, 2021
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Musculoskeletal Abnormalities; Disease; Cleft Lip; Skin Diseases; Craniofacial Abnormalities
• Other Study ID Numbers: 2015/2440-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data from the UK and Nethelands will be shared anonymously with the Norwegian Research team. No Norwegian data will be shared with international collaborators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No