Clinical trial NCT03529747: Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Official title: Exploring the Effectiveness of Online Self-help for Parents of Children With Food Allergies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Well Being of Parents of Children With Food Allergies
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Brighton & Sussex Medical School
First posted: 2018-05-18
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility 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.

Primary outcomes:
measure: Change from baseline at 4-weeks on the Food Allergy Quality of Life Parental Burden scale
timeFrame: Post-intervention (4-weeks after baseline)
Secondary outcomes:
measure: Change from baseline at 8-weeks on the Food Allergy Quality of Life Parental Burden scale
timeFrame: Follow-up (8-weeks after baseline)
measure: Change from baseline at 4-weeks on the Patient Health Questionnaire depression scale 8
timeFrame: Post-intervention (4-weeks after baseline)
measure: Change from baseline at 8-weeks on the Patient Health Questionnaire depression scale 8
timeFrame: Follow-up (8-weeks after baseline)
measure: Change from baseline at 4-weeks on the Generalised Anxiety Disorder 7 scale
timeFrame: Post-intervention (4-weeks after baseline)
measure: Change from baseline at 8-weeks on the Generalised Anxiety Disorder 7 scale
timeFrame: Follow-up (8-weeks after baseline)
measure: Change from baseline at 4-weeks on the Perceived Stress Scale (10 items)
timeFrame: Post-intervention (4-weeks after baseline)
measure: Change from baseline at 8-weeks on the Perceived Stress Scale (10 items)
timeFrame: Follow-up (8-weeks after baseline)
Other outcomes:
measure: Change from baseline at 4-weeks on the Food Allergy Self-Efficacy Scale for Parents
timeFrame: Post-intervention (4-weeks after baseline)
measure: Change from baseline at 8-weeks on the Food Allergy Self-Efficacy Scale for Parents
timeFrame: Follow-up (8-weeks after baseline)
measure: Change from baseline at 4-weeks on the Intolerance of Uncertainty Scale
timeFrame: Post-intervention (4-weeks after baseline)
measure: Change from baseline at 8-weeks on the Intolerance of Uncertainty Scale
timeFrame: Follow-up (8-weeks after baseline)
Locations:
city: Tunbridge Wells
country: United Kingdom
facility: Salomons Centre for Applied Psychology, Canterbury Christ Church University
state: Kent
Study officials:
affiliation: Canterbury Christ Church University
name: Naomi Sugunasingha, BSc, PGCert
role: PRINCIPAL_INVESTIGATOR
affiliation: Canterbury Christ Church University
name: Fergal Jones, PhD, PsychD
role: STUDY_DIRECTOR
affiliation: Brighton & Sussex Medical School
name: Christina Jones, PhD
role: STUDY_DIRECTOR
References: