NCT03529747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 7, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
Last Updated

August 21, 2020

Status Verified

October 1, 2019

Enrollment Period

5 months

First QC Date

May 8, 2018

Last Update Submit

August 19, 2020

Conditions

The Well Being of Parents of Children With Food Allergies

Outcome Measures

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.

    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

    Follow-up (8-weeks after baseline)

  • Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8

    Post-intervention (4-weeks after baseline)

  • Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8

    Follow-up (8-weeks after baseline)

  • Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale

    Post-intervention (4-weeks after baseline)

  • Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale

    Follow-up (8-weeks after baseline)

  • +2 more secondary outcomes

Other Outcomes (4)

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

    Post-intervention (4-weeks after baseline)

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

    Follow-up (8-weeks after baseline)

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

    Post-intervention (4-weeks after baseline)

  • +1 more other outcomes

Study Arms (2)

Online self-help

EXPERIMENTAL

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

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.

Interventions

Online self-helpOTHER

As detailed in experimental arm description.

Online self-help

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salomons Centre for Applied Psychology, Canterbury Christ Church University

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

Location

Study Officials

  • Naomi Sugunasingha, BSc, PGCert

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

  • Fergal Jones, PhD, PsychD

    Canterbury Christ Church University

    STUDY DIRECTOR

  • Christina Jones, PhD

    Brighton & Sussex Medical School

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

May 18, 2018

Study Start

September 7, 2018

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

August 21, 2020

Record last verified: 2019-10

Locations

GB(1)