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CompletedNCT03529747Updated Aug 21, 2020

Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies

An interventional study of Online self-help in The Well Being of Parents of Children With Food Allergies, sponsored by Canterbury Christ Church University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by Canterbury Christ Church University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

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Conditions studied

  • The Well Being of Parents of Children With Food Allergies
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 205 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Canterbury Christ Church University is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being a parent of at least one child (under the age of 18) who has a food allergy.
  • Adequate understanding of written English.

Exclusion criteria

Exclusion Criteria:

  • Having consulted on the design of the self-help website.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
205 participants (actual)

Study arms

  • Experimental
    Online self-help

    A website providing information and psycho-education aimed at parents and carers of children with food allergies.

    Other: Online self-help

  • No intervention
    Wait list control

    A waiting list control group, who will receive access to the online self-help once the RCT is complete.

Interventions

  • OtherOnline self-help

    As detailed in experimental arm description.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Post-intervention (4-weeks after baseline)

Secondary outcomes

  1. 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.

    Time frame: Follow-up (8-weeks after baseline)

  2. 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.

    Time frame: Post-intervention (4-weeks after baseline)

  3. 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.

    Time frame: Follow-up (8-weeks after baseline)

  4. 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.

    Time frame: Post-intervention (4-weeks after baseline)

  5. 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.

    Time frame: Follow-up (8-weeks after baseline)

  6. 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.

    Time frame: Post-intervention (4-weeks after baseline)

  7. 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.

    Time frame: Follow-up (8-weeks after baseline)

Other outcomes

  1. Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents

    This measures a parent's confidence in managing their child's food allergy, producing a score between 0 and 100, with higher scores indicating greater confidence.

    Time frame: Post-intervention (4-weeks after baseline)

  2. Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents

    This measures a parent's confidence in managing their child's food allergy, producing a score between 0 and 100, with higher scores indicating greater confidence.

    Time frame: Follow-up (8-weeks after baseline)

  3. Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale

    This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.

    Time frame: Post-intervention (4-weeks after baseline)

  4. Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale

    This measures participants' ability to tolerate uncertainty, producing scores between 27 and 135, with higher scores indicating lower tolerance of uncertainty.

    Time frame: Follow-up (8-weeks after baseline)

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Study locations

1 site
  • Salomons Centre for Applied Psychology, Canterbury Christ Church University
    Tunbridge Wells, Kent TN1 2YG, United Kingdom
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03529747
Lead sponsor
Canterbury Christ Church University
Collaborators
Brighton & Sussex Medical School
Responsible party
Sponsor
First posted
May 18, 2018
Start date
Sep 7, 2018
Primary completion
Feb 4, 2019
Completion
Feb 4, 2019
Last update
Aug 21, 2020

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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