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Craniofacial DifferencesNCT00340964

Positive Exposure: A Photography and Video Intervention for Individuals With Craniofacial Differences

An observational study of Craniofacial Differences, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will describe the use of an intervention, developed by an organization called Positive Exposure, to improve self-perceptions among adolescents and young adults who may encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots and video interviews will be used. Read more about this study

Who is it for?
Ages 12 to 20 years
Conditions the study is for
Craniofacial Differences
How many people
44 participants
Where
1 siteUnited States
Study dates
13 Jun 2005to 6 Jan 2014
Phase
Observational
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 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Participants must be at least 12 years old.
  • Participants must have a clinically diagnosed craniofacial condition.
  • Participants must be able to speak and write in English. However, if individuals have trouble writing (i.e. dyslexia or dysgraphia), they can tape record their personal reflections, which will be transcribed verbatim for analysis.

Who cannot join

  • If the individual is younger than 12 years of age.
  • If the individual does not speak English.
  • If the individual has been photographed by Rick Guidotti or another professional photographer in the past.
  • If the individual has been video-interviewed by Diane McLean.
  • If the individual has cognitive impairments that would preclude successfully completing the various steps of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

This study will describe the use of an intervention, developed by an organization called Positive Exposure, to improve self-perceptions among adolescents and young adults who may encounter the stigma, or negative effect, of differences in their head and face. Photo-shoots and video interviews will be used. The combined use of those techniques is a new way to address aspects such as self-esteem, body image, and feelings of social awkwardness and anxiety-that is, a way that has never been systematically explored with people who have craniofacial differences. The conditions that participants in this study have will include cleft lip and palate, Apert syndrome, hemifacial microsomia, Treacher Collins syndrome, Mobius syndrome and Sturge-Weber syndrome. Among the goals of photography and video interviews are to help people to define themselves by their strengths rather than by their conditions; visually confront discrimination by others; investigate the possibilities for social support, networking, and creative problem-solving that can be developed for people with craniofacial conditions; and promote hopefulness for the future. Positive Exposure is a nonprofit organization founded in 1997. It investigates the psychosocial experiences of people who have genetic, physical, and mental conditions, among all ages and ethnic and cultural backgrounds of people. According to experiences of people with several conditions, participation with Positive Exposure has enhanced their feelings about themselves as attractive, capable individuals.

Patients ages 12 years and older who have craniofacial conditions may be eligible for this pilot study. About 30 people will participate. Participants will be asked to provide the diagnosis of their craniofacial conditions. They will also be asked how many surgeries and what kinds they have had over the years, and how old they were at the time of the surgeries. This information will not be connected to participants' names and will be stored in a database protected by password.

Read more

There are three parts to the study. In Part 1, patients will be asked to write a personal reflection (for as long as they wish) on their experiences of having their picture taken and being video taped. They will also fill out a brief survey, taking about 15 minutes. They are able to do this at home and will mail their responses to the researchers. In Part 2, they will take part in a photo-shoot (about 1 hour) conducted by the founder and program director of Positive Exposure and then take part in a video interview (about 30 minutes) conducted by a co-investigator from that organization. In Part 3, to take place 1 month following the photo-shoot, participants will write a final reflection that describes their experiences with Positive Exposure and then fill out another brief survey (about 10 minutes). Surveys used in the study will be the Self-Esteem Scale, Perceived Social Stigma Scale, and State Hope Scale. Photo-shoots and video interviews will be held at the studio of Positive Exposure in New York City or, if necessary, at a location closer to the participant's home. The projected time line of this pilot study is 10 months.

Direct benefits are not the goal of participation in this study. However, participants may enjoy the photo-shoots and video interviews, as well as the process of reflecting and sharing their life and photo experiences with others. This pilot study will be a starting point for future research into Positive Exposure for adolescents and adults with visible genetic conditions.

Read the detailed description

This proposed pilot study aims to describe the use of an intervention, developed by Positive Exposure, for adolescents and young adults who may be challenged by the stigma associated with craniofacial differences. This non-profit organization uses professional photo-shoots and video interviews to explore the psychosocial experiences of people living with genetic conditions. The combined use of professional photo-shoots and video interviews is an innovative way to address issues such as self-esteem, body image and feelings of social awkwardness and anxiety that has never been systematically explored with individuals who have craniofacial differences. According to the experiences of individuals with albinism, Proteus syndrome, and Marfan syndrome, interacting with Positive Exposure has resulted in enhanced feelings about oneself as an attractive, capable person. This study will ascertain how individuals with craniofacial differences think and feel about being photographed and videoed and what specific benefits the Positive Exposure intervention may have had for them. This study uses a mixed methods design coupling qualitative analysis with quantitative measures of perceived social stigma, self-esteem, and hope. Data will be gathered through two written personal reflections, one completed before research volunteers participate in a professional photo shoot and video-interview and the second completed after the experience. The qualitative data will be subject to content analysis and the quantitative data will be scored to describe perceived effects of the intervention and to document differences in outcome measures. This pilot study will not be powered to achieve statistical significance but rather will generate descriptive data suggesting whether using these measures in larger populations may feasibly capture desired outcomes. This pilot study will provide the foundation for future research exploring the use of photo-shoots and video-interviews as an intervention in a variety of populations with genetic differences, powered to answer specific hypotheses.

Keywords
Photography, Self-Esteem, Perceived Social Stigma, Hopefulness, Cleft Lip and Palate, Hemifacial Microsomia, Treacher Collins Syndrome, Mobius Syndrome, Apert Syndrome, Videography, Craniofacial Differences, Self -Esteem
Medical subject headings
Cleft Lip, Goldenhar Syndrome, Mandibulofacial Dysostosis, Mobius Syndrome, Acrocephalosyndactylia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start13 Jun 2005
  3. Study completion6 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00340964
Sponsor's protocol ID
999905173
Other IDs
05-HG-N173
Status last verified
6 Jan 2014
First submitted
19 Jun 2006
Last updated
12 Dec 2019
Results posted
No

Publications

  • Dollinger SJ. Physical attractiveness, social connectedness, and individuality: an autophotographic study. J Soc Psychol. 2002 Feb;142(1):25-32. doi: 10.1080/00224540209603882.

    PubMed 11913832
  • Eiserman W. Unique outcomes and positive contributions associated with facial difference: expanding research and practice. Cleft Palate Craniofac J. 2001 May;38(3):236-44. doi: 10.1597/1545-1569_2001_038_0236_uoapca_2.0.co_2.

    PubMed 11386431
  • Jones B. 'Drop 'em Blossom'--clinical photography and patient dignity. J Audiov Media Med. 1996 Jun;19(2):85-6. doi: 10.3109/17453059609023011. No abstract available.

    PubMed 8945853

Questions about this trial

What is this clinical trial studying?

An observational study of Craniofacial Differences, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 12 Dec 2019. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00340964, which also lists 3 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 12 Dec 2019.

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