NCT03165331

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

May 23, 2017

Last Update Submit

March 30, 2023

Conditions

Skin ConditionCleft Lip and PalateBurnsOther Conditions Leading to a Visible DifferenceCraniofacial Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Body Esteem Scale (BES)

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

    6 months

Secondary Outcomes (5)

  • Life Engagement Scale (LES)

    6 months

  • Perceived Stigmatisation Questionnaire

    6 months

  • Harter's Self-Perception Profile for Adolescents

    6 months

  • EQ-5D-5L

    6 months

  • Resource Use Questionnaire (Parents)

    6 months

Study Arms (2)

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).

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).

Other: Ung Face IT

Interventions

Ung Face ITOTHER

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)
Control groupIntervention group

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Rare Disorders

Oslo, Norway

Location

Related Publications (2)

  • 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.

    PMID: 36652281DERIVED

  • Millgard 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.

    PMID: 36601286DERIVED

MeSH Terms

Conditions

Skin DiseasesCleft LipBurnsCraniofacial Abnormalities

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesLip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesMusculoskeletal AbnormalitiesMusculoskeletal Diseases

Study Officials

  • Olve Moldestad, PhD

    Centre Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator at the Centre for Rare Disorders

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 24, 2017

Study Start

April 1, 2016

Primary Completion

June 30, 2021

Study Completion

September 30, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Data from the UK and Nethelands will be shared anonymously with the Norwegian Research team. No Norwegian data will be shared with international collaborators.

Locations

NO(1)