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Hypersensitivity, Food | Evaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food Allergy

Hypersensitivity, Food research study

What is the primary objective of this study?

The objective of this research is to evaluate the effectiveness of a handbook for parents of children newly diagnosed with food allergy. The handbook was developed to provide information and strategies to support families in effectively managing food allergies while maintaining positive quality of life. Parents of children newly diagnosed with food allergy (within the past year) will be randomized into either the treatment condition (handbook) or a control condition (management of food allergy as usual). Participants will complete study questionnaires online at three time points: baseline (this will be before receiving the handbook for the treatment group), post-intervention (2-3 weeks after baseline), and follow-up (2-3 months after baseline). Data will be analyzed for change on study outcome measures and satisfaction with the handbook. Parents in the control group will receive the handbook following the conclusion of their participation in the study.

Who is eligible to participate?

Inclusion Criteria: - Parents of children ages 0 to 18 years newly diagnosed with food allergy (within the past 12 months) - Child's food allergy has been diagnosed by a physician - Child has been prescribed an epinephrine auto-injector Exclusion Criteria: - Non-English speakers, as the handbook (study intervention) is only available in English at this time.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypersensitivity, Food

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Food allergy handbook for parentsThe food allergy handbook was designed to be a reliable resource to supplement physician management of food allergy, addressing key topics central to effective allergy management and maintenance of positive quality of life. The handbook includes evidence-based information about food allergies and their management, practical strategies for transferring allergy management skills into daily life, strategies for educating others about allergies, strategies for coping with common emotional challenges associated with food allergy, and strategies for teaching children and involving them in allergy management.

Other:Food allergy treatment as usual

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HandbookFood allergy handbook for parents

Treatment as usualFood allergy treatment as usual

Study Status

Completed

Start Date: July 2013

Completed Date: November 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in food allergy-specific quality of life score

Secondary Outcome: Changes in food allergy knowledge score

Study sponsors, principal investigator, and references

Principal Investigator: Jennifer S LeBovidge, PhD

Lead Sponsor: Boston Children’s Hospital

Collaborator: McMaster University

More information:https://clinicaltrials.gov/show/NCT01914978

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