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

NCT ID: NCT03165331

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Ung Face IT

Intervention Type OTHER

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.

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).

Group Type OTHER

Ung Face IT

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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English name: Young People Face IT (YP Face IT)

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Appearance Research, University of the West of England, UK

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kristin Billaud Feragen

Research Coordinator at the Centre for Rare Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olve Moldestad, PhD

Role: STUDY_DIRECTOR

Centre Director

Locations

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Centre for Rare Disorders

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 36652281 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36601286 (View on PubMed)

Other Identifiers

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2015/2440-4

Identifier Type: -

Identifier Source: org_study_id

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