Neurofibromatosis 1 Clinical Trial
Official title:
Effects of an Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
Verified date | January 29, 2019 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Studies show that Internet Support Groups (ISGs) can help parents of children with chronic
conditions. Researchers want to find out if ISGs can help parents of a child with the genetic
disorder Neurofibromatosis Type 1 (NF1).
Objective:
- To see if an ISG for parents with a child with NF1 can give the parents more social support
and less anxiety.
Eligibility:
- Adults age 18 and older with a child (age 0 25 years) with NF1.
Design:
- Participants will register for the study on a website hosted by the Children s Tumor
Foundation.
- Participants will complete 5 questionnaires. These will be about their emotional
well-being, their child s health status, and their contact information.
- The ISG will include a Discussion Forum that participants can enter 24 hours a day, 7
days a week. A professional moderator will post questions and discussion topics. The
moderator can also respond to questions. They will be a psychologist, a psychology
associate, or a nurse-practitioner. Each one will be highly experienced at working with
young people with NF1 and their families.
- The ISG also will contain a chat room. Here participants can chat with other users in
real time. The chat room will be open for one 90-minute session per week.
- The ISG will remain open for 8 weeks. Then participants will retake 4 of the
questionnaires from the beginning of the study. They will also complete 1 other
questionnaire about their experiences with the ISG. Information from any messages
participants post on the ISG website will be collected.
- Three months after the ISG closes, participants will complete the questionnaires one
final time.
Status | Completed |
Enrollment | 33 |
Est. completion date | January 29, 2019 |
Est. primary completion date | April 6, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- ELIGIBILITY CRITERIA INCLUSION CRITERIA FOR PARENT PARTICPANT: Participants must self-report being the primary caregiver of one or more children ages 0 to 25 with a confirmed diagnosis of NF1. Participants must report being at least 18 years of age. Participants must report living in the same home as the child(ren) with NF1 a majority of the time. Participants must report having regular access to a computer and internet connection. Participants will indicate they do not have any plans to start any other internet support group for parents of children with NF during the study time period. Participants must have the ability to read and communicate in the English language. Participants must have the ability to understand and the willingness to provide an online informed consent document. EXCLUSION CRITERIA FOR PARENT PARTICIPANT: Although individuals will be allowed to participate if they currently are part of another internet forum for NF, they will be excluded if they report they plan to start a new internet support group during the study period. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ISG effects on perceived support | To determine the effects of an ISG on perceived social support among parents of a child with NF1 from baseline to 8 weeks and frombaseline to 3 months postintervention. | 3 months | |
Secondary | ISG effects on depression and anxiety | To determine the effects of an ISG on perceived social support among parents of a child with NF1 from baseline to 8 weeks and frombaseline to 3 months post-intervention. | 3 months | |
Secondary | Identify themes and needs of chat room support | 2 years |
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