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

Boston Children's Hospital logo

Boston Children's Hospital

Status

Completed

Conditions

Hypersensitivity, Food

Treatments

Other: Food allergy handbook for parents
Other: Food allergy treatment as usual

Study type

Interventional

Funder types

Other

Identifiers

NCT01914978
IRB-P00007167

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups, including a placebo group

Handbook
Experimental group
Description:
Food allergy handbook for parents
Treatment:
Other: Food allergy handbook for parents
Treatment as usual
Placebo Comparator group
Description:
Food allergy treatment as usual
Treatment:
Other: Food allergy treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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