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Behavioral Intervention

Cognitive Behavioral Therapy for Parents of Children With Food Allergies

N/A

Recruiting

Led By Jessica Hellings, MD

Research Sponsored by University of Missouri, Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child must be aged 6-17 years with medically diagnosed serious food allergy(ies)

Meets cut-offs for anxiety and/or depression on the Hospital Anxiety and Depression Scale

Must not have

Using OTC anxiety or depression relief, or CBD or medical marijuana

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if virtual CBT can help parents of kids with food allergies reduce anxiety, depression, and improve quality of life.

Who is the study for?

This trial is for parents over 18 with a child aged 6-17 who has a serious food allergy diagnosed by a doctor. Parents should show signs of anxiety or depression but can be on stable medication for these conditions. They must commit to weekly sessions and follow-ups without current psychiatric treatment changes, substance abuse, or use of certain over-the-counter remedies.

What is being tested?

The study tests if group Cognitive Behavioral Therapy (CBT) via virtual meetings helps reduce anxiety and depression in parents of children with food allergies. Participants are randomly placed into either the CBT group or a wait-list group to compare outcomes.

What are the potential side effects?

While CBT isn't typically associated with physical side effects, participants may experience emotional discomfort as they address personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child, aged 6-17, has a serious food allergy diagnosed by a doctor.

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My anxiety or depression scores are high based on a hospital test.

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I use over-the-counter remedies or CBD/medical marijuana for anxiety or depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Score of Food Allergy Quality of Life-Parent Burden Questionnaire (FAQL-PB)

Secondary study objectives

Change in Score of Hospital Anxiety and Depression Scale (HADS)

Change in Score of Pediatric Food Allergy Quality of Life Scale

Subject Satisfaction Questionnaire

Side effects data

From 2009 Phase 2 & 3 trial • 162 Patients • NCT00248612

13%

suicidal ideation

vertigo

agitation/restlessness

nausea

depression

anxiety

profuse sweating

100%

80%

60%

40%

20%

Study treatment Arm

Venlafaxine & CBT

Placebo & CBT

Venlafaxine & PMR

Placebo & PMR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Cognitive Behavioral Therapy (CBT) groupExperimental Treatment1 Intervention

The Cognitive Behavioral Therapy (CBT) groups will be 6 weekly one-hour parent groups run by a Cognitive Behavioral Therapy (CBT) therapist according to a Cognitive Behavioral Therapy (CBT) manual focusing on anxiety and depression related to having a child with food allergies.

Group II: Waitlisted groupActive Control1 Intervention

The comparator groups will be waitlisted groups of parents of children with food allergies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBT

2013

Completed Phase 3

~4220

0 / 4Eligibility criteria met