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

NCT01914978 | Completed

• 1 other identifier: IRB-P00007167
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypersensitivity, Food

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in food allergy knowledge score

  2-week and 2-month follow-up

• Change in confidence in allergy management skills score

  2-week and 2-month follow-up

• Change in food allergy outcome expectations score

  2-week and 2-month follow-up

• Parent satisfaction with study handbook (study intervention)

  2-week follow-up

Study Arms (2)

Handbook

EXPERIMENTAL

Food allergy handbook for parents

Other: Food allergy handbook for parents

Treatment as usual

PLACEBO COMPARATOR

Food allergy treatment as usual

Other: Food allergy treatment as usual

Interventions

Food allergy handbook for parents OTHER

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.

Handbook

Food allergy treatment as usual OTHER

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-English speakers, as the handbook (study intervention) is only available in English at this time.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• McMaster University: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 26851890 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jennifer S LeBovidge, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (1)