CClinicalTrials.gg
Status unknownNCT03165331UNGFaceITUpdated Mar 31, 2023

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

An interventional study of Ung Face IT in Skin Condition, Cleft Lip and Palate and Burns, sponsored by Oslo University Hospital. Status unknown at 1 site in Norway. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Condition
  • Cleft Lip and Palate
  • Burns
  • Other Conditions Leading to a Visible Difference
  • Craniofacial Abnormalities
03

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherUng 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.

    Also known as: English name: Young People Face IT (YP Face IT)

05

What researchers measure

Primary outcomes

  1. Body Esteem Scale (BES)

    Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance.

    Time frame: 6 months

Secondary outcomes

  1. Life Engagement Scale (LES)

    Social experiences and social engagement (10 items)

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. Harter's Self-Perception Profile for Adolescents

    Two subscales are used: Romantic concerns and general self-esteem

    Time frame: 6 months

  4. EQ-5D-5L

    Indicator of the impact of UNG Face IT on Health related quality of life and to provide Health economic data

    Time frame: 6 months

  5. Resource Use Questionnaire (Parents)

    Assessing time out of School, use of Health care Resources and expenses in relation to the child's condition.

    Time frame: 6 months

06

Study locations

1 site
  • Centre for Rare Disorders
    Oslo, Norway
07

References and documents

Individual participant data

Plan to share: No — Data from the UK and Nethelands will be shared anonymously with the Norwegian Research team. No Norwegian data will be shared with international collaborators.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03165331
Lead sponsor
Oslo University Hospital
Collaborators
Centre for Appearance Research, University of the West of England, UK
Responsible party
Kristin Billaud Feragen (Research Coordinator at the Centre for Rare Disorders, Oslo University Hospital) — Principal investigator
First posted
May 24, 2017
Start date
Apr 1, 2016
Primary completion
Jun 30, 2021
Completion
Sep 30, 2023 (estimated)
Last update
Mar 31, 2023

Study contacts

Olve Moldestad, PhD
study director · Centre Director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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