Neurofibromatosis 1NCT02153931
Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
An observational study of Neurofibromatosis 1, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neurofibromatosis 1
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2014to 29 Jan 2019
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Effects of an Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
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).
Read more
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.
Read the detailed description
BACKGROUND:
- The complex symptom profile in NF1 puts children and adolescents with this condition at risk for a variety of physical, cognitive, and social-emotional difficulties. Thus, caring for a child with a chronic medical condition such as NF1 can be challenging.
- Over the last two decades, researchers have been examining the use of internet support groups (ISGs) as a means of connecting individuals with similar conditions, diagnoses, or challenges to provide emotional and informational support.
- While the benefits of ISGs have been well documented in many studies of medical patients, very few have examined the use of ISGs in parents of children with chronic medical conditions. Further, no studies have been conducted on an ISG in parents of a child with NF1.
OBJECTIVES:
- The primary objective of this pilot study is to assess the effectiveness of an ISG designed for parents of children with NF1 on a measure of perceived social support.
- Secondary objectives are to assess effects of the ISG on self-efficacy, depression, and anxiety, and to explore themes and topics discussed in the ISG.
ELIGIBILITY:
Eligible participants must self-report:
- Being greater than or equal to 18 years of age
- Having a child with a diagnosis of NF1 between 0 and 25 years of age
- Living in the same home as the child with NF1
- Having regular access to a computer with internet capability
DESIGN:
- Parents of children with NF1 will be recruited through Dr. Widemann s NF1 patient database and through the Children s Tumor Foundation s (CTF) NF registry.
- Eligible participants will be emailed a link to access the study website through the CTF website. Due to the nature of the study, consent will be obtained online.
- After consenting, participants will be administered (electronically) baseline measures of perceived social support, self-efficacy, depression, and anxiety. After 8 weeks, participants will complete the measures again via the same website, as well as a post-study questionnaire assessing their experiences with participation. Measures will be repeated at 3-months post-intervention.
- Content analyses will be performed to identify themes and needs of the participants
- Conditions
- Neurofibromatosis 1
- Keywords
- Children's Tumor Foundation, Social Support, Online, Anxiety, Depression
- Medical subject headings
- Neurofibromatosis 1, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Parents of children with NF1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 3 months
Identify themes and needs of chat room support
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study start31 May 2014
- Primary completion6 Apr 2015
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurofibromatosis 1Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Staci M Peron, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153931
- Sponsor's protocol ID
- 140113
- Other IDs
- 14-C-0113
- Status last verified
- 29 Jan 2019
- First submitted
- 31 May 2014
- Last updated
- 31 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Internet Support Group for Parents of a Child With Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT02153931
- Acronym / sponsor ID
- 140113
- Conditions
- Neurofibromatosis 1
- Keywords
- Children's Tumor Foundation, Social Support, Online, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 31 May 2014
- Primary completion
- 6 Apr 2015 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND:
- The complex symptom profile in NF1 puts children and adolescents with this condition at risk for a variety of physical, cognitive, and social-emotional difficulties. Thus, caring for a child with a chronic medical condition such as NF1 can be challenging.
- Over the last two decades, researchers have been examining the use of internet support groups (ISGs) as a means of connecting individuals with similar conditions, diagnoses, or challenges to provide emotional and informational support.
- While the benefits of ISGs have been well documented in many studies of medical patients, very few have examined the use of ISGs in parents of children with chronic medical conditions. Further, no studies have been conducted on an ISG in parents of a child with NF1.
OBJECTIVES:
- The primary objective of this pilot study is to assess the effectiveness of an ISG designed for parents of children with NF1 on a measure of perceived social support.
- Secondary objectives are to assess effects of the ISG on self-efficacy, depression, and anxiety, and to explore themes and topics discussed in the ISG.
ELIGIBILITY:
Eligible participants must self-report:
- Being greater than or equal to 18 years of age
- Having a child with a diagnosis of NF1 between 0 and 25 years of age
- Living in the same home as the child with NF1
- Having regular access to a computer with internet capability
DESIGN:
- Parents of children with NF1 will be recruited through Dr. Widemann s NF1 patient database and through the Children s Tumor Foundation s (CTF) NF registry.
- Eligible participants will be emailed a link to access the study website through the CTF website. Due to the nature of the study, consent will be obtained online.
- After consenting, participants will be administered (electronically) baseline measures of perceived social support, self-efficacy, depression, and anxiety. After 8 weeks, participants will complete the measures again via the same website, as well as a post-study questionnaire assessing their experiences with participation. Measures will be repeated at 3-months post-intervention.
- Content analyses will be performed to identify themes and needs of the participants
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –Parents of children with NF1 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ISG effects on perceived support
Time frame: 3 months
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.
2 secondary outcomes
ISG effects on depression and anxiety
Time frame: 3 months
Identify themes and needs of chat room support
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staci M Peron, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurofibromatosis 1, run by National Cancer Institute (NCI) 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 7 inclusion and 1 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 31 Jan 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.
What does the primary outcome measure?
ISG effects on perceived support (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.