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

Living Confidently With Food Allergy: Evaluating the Effectiveness of a Handbook for the Newly Diagnosed

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity, Food
• Intervention / Treatment: Other: Food allergy handbook for parents; Other: Food allergy treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Handbook; Food allergy handbook for parents	Other: Food allergy handbook for parents; The 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.
Placebo Comparator: Treatment as usual; Food allergy treatment as usual	Other: Food allergy treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in food allergy-specific quality of life score	Food Allergy-specific quality of life measured on the Food Allergy Quality of Life-Parental Burden Questionnaire (total score)	2 week and 2-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in food allergy knowledge score	Food allergy knowledge questions will include a subset of questions from the Chicago Food Allergy Research Survey for Parents of Children with Food Allergy (CFAR-PRNT) and questions developed by the investigators	2-week and 2-month follow-up
Change in confidence in allergy management skills score	This questionnaire was developed for the current study, to assess parent's level of confidence in various allergy management skills (e.g., understanding food labels, knowing the symptoms of an allergic reaction, teaching babysitters, relatives and other caregivers how to take care of your child's allergies, etc)	2-week and 2-month follow-up
Change in food allergy outcome expectations score	The Food Allergy Independent Measure (FAIM) consists of four questions assessing the parents' expectations of outcomes related to a child's food allergy (i.e., likelihood of the child accidentally ingesting an allergenic food, experiencing a severe reaction, dying following accidental ingestion, and receiving effective treatment in the event of accidental ingestion), which have been associated with health-related quality of life associated with food allergy.	2-week and 2-month follow-up
Parent satisfaction with study handbook (study intervention)	Defined by at least 80% of parents indicating positive ratings of usefulness, novelty of content, clarity of content, and [lack of] distress associated with content, [lack of] distress associated with content, and [lack of] barriers to use of the handbook.	2-week follow-up

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: McMaster University
• Investigators: Principal Investigator: Jennifer S LeBovidge, PhD, Boston Children's Hospital

Publications and helpful links

General Publications

• LeBovidge JS, Michaud A, Deleon A, Harada L, Waserman S, Schneider L. Evaluating a handbook for parents of children with food allergy: a randomized clinical trial. Ann Allergy Asthma Immunol. 2016 Mar;116(3):230-236.e1. doi: 10.1016/j.anai.2016.01.001. Epub 2016 Feb 3.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 31, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 2, 2013

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: IRB-P00007167