Internet Support Group for Parents of a Child With Neurofibromatosis Type 1

NCT02153931 | Completed

• 2 other identifiers: 14011314-C-0113
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurofibromatosis 1

Keywords

Children's Tumor Foundation; Social Support; Online; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ISG effects on depression and anxiety

  3 months

• Identify themes and needs of chat room support

  2 years

Study Arms (1)

Volunteers

Parents of children with NF1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Staci M Peron, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2014
• First Posted: June 3, 2014
• Study Start: May 31, 2014
• Primary Completion: April 6, 2015
• Study Completion: January 29, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01-29

Locations

US (1)