The Well Being of Parents of Children With Food AllergiesNCT03529747
Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
A study testing Online self-help in people with The Well Being of Parents of Children With Food Allergies, run by Canterbury Christ Church University at 1 site in United Kingdom.
Trial summary
This study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Well Being of Parents of Children With Food Allergies
- What is being tested?
- Online self-help
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2018to 4 Feb 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a parent of at least one child (under the age of 18) who has a food allergy.
- Adequate understanding of written English.
Who cannot join
- Having consulted on the design of the self-help website.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salomons Centre for Applied Psychology, Canterbury Christ Church University
Royal Tunbridge Wells, Kent, TN1 2YG
About this study
This study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies.
Read the detailed description
This study is a pilot randomised controlled trial (RCT) comparing online self-help for parents of children with food allergies with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 4) and at follow-up (week 8).
- Being tested
- Online self-help
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online self-helpOther
As detailed in experimental arm description.
| Study group | Role | What they receive |
|---|---|---|
| Online self-help | Experimental | A website providing information and psycho-education aimed at parents and carers of children with food allergies. Receives: Other: Online self-help |
| Wait list control | No intervention | A waiting list control group, who will receive access to the online self-help once the RCT is complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale
This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
Measured: Post-intervention (4-weeks after baseline)
Secondary outcomes (7)
Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale
This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
Measured: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8
This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Measured: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8
This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.
Measured: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale
This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Measured: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale
This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.
Measured: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Perceived Stress Scale (10 items)
This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.
Measured: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Perceived Stress Scale (10 items)
This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.
Measured: Follow-up (8-weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start7 Sep 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Well Being of Parents of Children With Food AllergiesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canterbury Christ Church University
- Sponsor type
- University, hospital or other
- Collaborators
- Brighton & Sussex Medical School
- Responsible party
- Sponsor
- Investigators
- Naomi Sugunasingha, BSc, PGCert, Principal investigator, Canterbury Christ Church UniversityFergal Jones, PhD, PsychD, Study director, Canterbury Christ Church UniversityChristina Jones, PhD, Study director, Brighton & Sussex Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529747
- Sponsor's protocol ID
- NaomiSugunasinghaMRP2017
- Status last verified
- Oct 2019
- First submitted
- 8 May 2018
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
- ClinicalTrials.gov ID
- NCT03529747
- Acronym / sponsor ID
- NaomiSugunasinghaMRP2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Canterbury Christ Church UniversityUniversity, hospital or other
- Collaborators
- Brighton & Sussex Medical School
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 18 May 2018 (actual)
- 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.
This study aims to conduct an initial evaluation of whether online self-help can improve the quality of life of parents of children with food allergies.
Detailed description
This study is a pilot randomised controlled trial (RCT) comparing online self-help for parents of children with food allergies with a wait-list control. A battery of self-report measures will be administered online at baseline (week 0), post-intervention (week 4) and at follow-up (week 8).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online self-help | Experimental | Other: Online self-helpA website providing information and psycho-education aimed at parents and carers of children with food allergies. |
| Wait list control | No intervention | –A waiting list control group, who will receive access to the online self-help once the RCT is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a parent of at least one child (under the age of 18) who has a food allergy.
- Adequate understanding of written English.
Key exclusion criteria (1 listed)
- Having consulted on the design of the self-help website.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online self-helpAs detailed in experimental arm description. | Other | Online self-help |
Primary outcome
Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale
Time frame: Post-intervention (4-weeks after baseline)
This measures parental burden when caring for a food-allergic child, producing a score between 17 and 119, with higher scores indicating greater burden.
7 secondary outcomes
Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale
Time frame: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8
Time frame: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8
Time frame: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale
Time frame: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale
Time frame: Follow-up (8-weeks after baseline)
Change from baseline at 4-weeks on the Perceived Stress Scale (10 items)
Time frame: Post-intervention (4-weeks after baseline)
Change from baseline at 8-weeks on the Perceived Stress Scale (10 items)
Time frame: Follow-up (8-weeks after baseline)
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 21 Aug 2020.
- Individual participant dataSharing planned: Undecided
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.
Naomi Sugunasingha, BSc, PGCert principal investigator
Canterbury Christ Church University
Fergal Jones, PhD, PsychD study director
Canterbury Christ Church University
Christina Jones, PhD study director
Brighton & Sussex Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online self-help in people with The Well Being of Parents of Children With Food Allergies, run by Canterbury Christ Church University at 1 site in United Kingdom.
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 2 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 21 Aug 2020. 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 Kingdom. 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?
Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale (time frame: Post-intervention (4-weeks after baseline)). 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 21 Aug 2020.