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

Sponsor
Canterbury Christ Church University (Other)
Overall Status
Completed
CT.gov ID
NCT03529747
Collaborator
Brighton & Sussex Medical School (Other)
205
1
2
4.9
41.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Online self-help
N/A

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

Study Type:
Interventional
Actual Enrollment :
205 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Actual Study Start Date :
Sep 7, 2018
Actual Primary Completion Date :
Feb 4, 2019
Actual Study Completion Date :
Feb 4, 2019

Arms and Interventions

Arm Intervention/Treatment
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
As detailed in experimental arm description.

No Intervention: Wait list control

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale [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.

Secondary Outcome Measures

  1. Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale [Follow-up (8-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.

  2. Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8 [Post-intervention (4-weeks after baseline)]

    This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.

  3. Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8 [Follow-up (8-weeks after baseline)]

    This measures symptoms of depression, producing a score between 0 and 24, with higher scores indicating greater symptomatology.

  4. Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale [Post-intervention (4-weeks after baseline)]

    This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.

  5. Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale [Follow-up (8-weeks after baseline)]

    This measures symptoms of generalised anxiety disorder, producing a score between 0 and 21, with higher scores indicating greater symptomatology.

  6. Change from baseline at 4-weeks on the Perceived Stress Scale (10 items) [Post-intervention (4-weeks after baseline)]

    This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.

  7. Change from baseline at 8-weeks on the Perceived Stress Scale (10 items) [Follow-up (8-weeks after baseline)]

    This produces a score between 0 and 40, with higher scores indicating higher levels of perceived stress.

Other Outcome Measures

  1. Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents [Post-intervention (4-weeks after baseline)]

    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.

  2. Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents [Follow-up (8-weeks after baseline)]

    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.

  3. Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale [Post-intervention (4-weeks after baseline)]

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

  4. Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale [Follow-up (8-weeks after baseline)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • Having consulted on the design of the self-help website.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salomons Centre for Applied Psychology, Canterbury Christ Church University Tunbridge Wells Kent United Kingdom TN1 2YG

Sponsors and Collaborators

  • Canterbury Christ Church University
  • Brighton & Sussex Medical School

Investigators

  • Principal Investigator: Naomi Sugunasingha, BSc, PGCert, Canterbury Christ Church University
  • Study Director: Fergal Jones, PhD, PsychD, Canterbury Christ Church University
  • Study Director: Christina Jones, PhD, Brighton & Sussex Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Canterbury Christ Church University
ClinicalTrials.gov Identifier:
NCT03529747
Other Study ID Numbers:
  • NaomiSugunasinghaMRP2017
First Posted:
May 18, 2018
Last Update Posted:
Aug 21, 2020
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2020