Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165331
Recruitment Status : Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Centre for Appearance Research, University of the West of England, UK
Information provided by (Responsible Party):
Kristin Billaud Feragen, Oslo University Hospital

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention group
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Harter's Self-Perception Profile for Adolescents [ Time Frame: 6 months ]
    Two subscales are used: Romantic concerns and general self-esteem

  4. 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

  5. Social Anxiety Scale (Parents) [ Time Frame: 6 months ]
    Same as above, but parent version

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Norway
Centre for Rare Disorders
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Centre for Appearance Research, University of the West of England, UK
Investigators
Layout table for investigator information
Study Director: Olve Moldestad, PhD Centre Director

Layout table for additonal information
Responsible Party: Kristin Billaud Feragen, Research Coordinator at the Centre for Rare Disorders, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03165331     History of Changes
Other Study ID Numbers: 2015/2440-4
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Norwegian data may be shared anonymously with the collaborating Centre for Appearance Research, Bristol, UK.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Craniofacial Abnormalities
Cleft Lip
Skin Diseases
Disease
Pathologic Processes
Congenital Abnormalities
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases