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

Hypersensitivity, Food Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914978
• Other study ID #: IRB-P00007167
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: July 28, 2015
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity
• Hypersensitivity, Food

Intervention

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.
• Food allergy treatment as usual

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	McMaster University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No