Evaluating the Effectiveness of a Handbook for Parents of Children Newly Diagnosed With Food Allergy
- Conditions
- Hypersensitivity, Food
- Interventions
- Other: Food allergy handbook for parentsOther: Food allergy treatment as usual
- Registration Number
- NCT01914978
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- Non-English speakers, as the handbook (study intervention) is only available in English at this time.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Handbook Food allergy handbook for parents Food allergy handbook for parents Treatment as usual Food allergy treatment as usual Food allergy treatment as usual
- Primary Outcome Measures
Name Time Method Change in food allergy-specific quality of life score 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 Outcome Measures
Name Time Method Changes in food allergy knowledge score 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
Change in confidence in allergy management skills score 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)
Change in food allergy outcome expectations score 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.
Parent satisfaction with study handbook (study intervention) 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.
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States