Skin ConditionUNGFaceITNCT03165331
Online Psychosocial Support for Young People With a Visible Difference: A Randomised Control Study
A study testing Ung Face IT in people with Skin Condition and Cleft Lip and Palate, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Condition, Cleft Lip and Palate, Burns
- What is being tested?
- Ung Face IT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- 1 Apr 2016to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Skin Condition, Cleft Lip and Palate, Burns, Other Conditions Leading to a Visible Difference, Craniofacial Abnormalities
- Being tested
- Ung Face IT
- Medical subject headings
- Skin Diseases, Cleft Lip, Burns, Craniofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ung Face ITOther
Also called English name: Young People Face IT (YP 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | 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). Receives: Other: Ung Face IT |
| Control group | Other | 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). Receives: Other: Ung Face IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Esteem Scale (BES)
Includes three subscales, only the subscale BE_Appearance used in this study. Measures general feelings about appearance.
Measured: 6 months
Secondary outcomes (5)
Life Engagement Scale (LES)
Social experiences and social engagement (10 items)
Measured: 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.
Measured: 6 months
Harter's Self-Perception Profile for Adolescents
Two subscales are used: Romantic concerns and general self-esteem
Measured: 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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Apr 2016
- Primary completion30 Jun 2021
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Appearance Research, University of the West of England, UK
- Responsible party
- Principal investigator, Kristin Billaud Feragen, Oslo University Hospital
- Investigators
- Olve Moldestad, PhD, Study director, Centre Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165331
- Sponsor's protocol ID
- 2015/2440-4
- Acronym
- UNGFaceIT
- Status last verified
- Mar 2023
- First submitted
- 23 May 2017
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Zelihic D, Feragen KJB, Pripp AH, Nordgreen T, Williamson H, Kling J. Predictors of Adolescents' Response to a Web-Based Intervention to Improve Psychosocial Adjustment to Having an Appearance-Affecting Condition (Young Person's Face IT): Prospective Study. JMIR Form Res. 2023 Jan 18;7:e35669. doi: 10.2196/35669.
PubMed 36652281Millgard M, Feragen KB, Ullmann Miller J, Arfa S, Williamson H, Kling J. Adolescents and parents' perception of Young Person's Face IT: An online intervention for adolescents struggling with conditions affecting their appearance. Digit Health. 2022 Dec 25;8:20552076221147110. doi: 10.1177/20552076221147110. eCollection 2022 Jan-Dec.
PubMed 36601286
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Psychosocial Support for Young People Distressed by Appearance-altering Conditions: A Randomised Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT03165331
- Acronym / sponsor ID
- UNGFaceIT / 2015/2440-4
- Conditions
- Skin Condition, Cleft Lip and Palate, Burns, Other Conditions Leading to a Visible Difference, Craniofacial Abnormalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Centre for Appearance Research, University of the West of England, UK
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Other: Ung Face ITThe 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). |
| Control group | Other | Other: Ung Face ITTreatment 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). |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ung Face ITAlso: English name: Young People Face IT (YP 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 | Control group, Intervention group |
Primary outcome
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.
5 secondary outcomes
Life Engagement Scale (LES)
Time frame: 6 months
Perceived Stigmatisation Questionnaire
Time frame: 6 months
Harter's Self-Perception Profile for Adolescents
Time frame: 6 months
EQ-5D-5L
Time frame: 6 months
Resource Use Questionnaire (Parents)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 36652281Zelihic D, Feragen KJB, Pripp AH, Nordgreen T, Williamson H, Kling J. Predictors of Adolescents' Response to a Web-Based Intervention to Improve Psychosocial Adjustment to Having an Appearance-Affecting Condition (Young Person's Face IT): Prospective Study. JMIR Form Res. 2023 Jan 18;7:e35669. doi: 10.2196/35669.
- Derived from this study: PubMed 36601286Millgard M, Feragen KB, Ullmann Miller J, Arfa S, Williamson H, Kling J. Adolescents and parents' perception of Young Person's Face IT: An online intervention for adolescents struggling with conditions affecting their appearance. Digit Health. 2022 Dec 25;8:20552076221147110. doi: 10.1177/20552076221147110. eCollection 2022 Jan-Dec.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olve Moldestad, PhD study director
Centre Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ung Face IT in people with Skin Condition and Cleft Lip and Palate, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Esteem Scale (BES) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.