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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Children's Hospital Boston
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01914978
First received: July 31, 2013
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Hypersensitivity, Food
Other: Food allergy handbook for parents
Other: Food allergy treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Living Confidently With Food Allergy: Evaluating the Effectiveness of a Handbook for the Newly Diagnosed

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Change in food allergy-specific quality of life score [ Time Frame: 2 week and 2-month follow-up ] [ Designated as safety issue: No ]
    Food Allergy-specific quality of life measured on the Food Allergy Quality of Life-Parental Burden Questionnaire (total score)


Secondary Outcome Measures:
  • Changes in food allergy knowledge score [ Time Frame: 2-week and 2-month follow-up ] [ Designated as safety issue: No ]
    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

  • Change in confidence in allergy management skills score [ Time Frame: 2-week and 2-month follow-up ] [ Designated as safety issue: No ]
    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)

  • Change in food allergy outcome expectations score [ Time Frame: 2-week and 2-month follow-up ] [ Designated as safety issue: No ]
    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.

  • Parent satisfaction with study handbook (study intervention) [ Time Frame: 2-week follow-up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 180
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914978

Contacts
Contact: Jennifer S LeBovidge, PhD 617-355-8557 jennifer.lebovidge@childrens.harvard.edu
Contact: Sara Spielman, BS 617-355-6127 sara.spielman@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
McMaster University
Investigators
Principal Investigator: Jennifer S LeBovidge, PhD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01914978     History of Changes
Other Study ID Numbers: IRB-P00007167
Study First Received: July 31, 2013
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014