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Completed

NCT Number: NCT03529747

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

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.

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Key information

Conditions

The Well Being of Parents of Children With Food Allergies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salomons Centre for Applied Psychology, Canterbury Christ Church University

Royal Tunbridge Wells, Kent, TN1 2YG, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Online self-help

Other

As detailed in experimental arm description.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Collaborators

  • Brighton & Sussex Medical School

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 18, 2018
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.