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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529747
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Brighton & Sussex Medical School
Information provided by (Responsible Party):
Canterbury Christ Church University

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
The Well Being of Parents of Children With Food Allergies Other: Online self-help Not Applicable

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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Study Type : Interventional  (Clinical Trial)
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 : September 7, 2018
Actual Primary Completion Date : February 4, 2019
Actual Study Completion Date : February 4, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529747


Locations
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United Kingdom
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
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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
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Responsible Party: Canterbury Christ Church University
ClinicalTrials.gov Identifier: NCT03529747    
Other Study ID Numbers: NaomiSugunasinghaMRP2017
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate