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Completed

NCT Number: NCT01914978

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

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.

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Key information

Conditions

Hypersensitivity, Food Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Food allergy treatment as usual

Other

Primary outcomes

  1. Change in food allergy-specific quality of life score

    Time frame: 2 week and 2-month follow-up

    Food Allergy-specific quality of life measured on the Food Allergy Quality of Life-Parental Burden Questionnaire (total score)

Secondary outcomes

  1. Changes in food allergy knowledge score

    Time frame: 2-week and 2-month follow-up

    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. Change in confidence in allergy management skills score

    Time frame: 2-week and 2-month follow-up

    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)

  3. Change in food allergy outcome expectations score

    Time frame: 2-week and 2-month follow-up

    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.

  4. Parent satisfaction with study handbook (study intervention)

    Time frame: 2-week follow-up

    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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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