← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

I am over 18 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri, Kansas CityLead Sponsor

69 Previous Clinical Trials

32,584 Total Patients Enrolled

Jessica Hellings, MDPrincipal InvestigatorUniversity of Missouri-Kansas City and University Health Behavioral Health

1 Previous Clinical Trials

18 Total Patients Enrolled

Stephen Jarvis, MDStudy ChairUniversity Health Behavioral Health, and UMKC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in the current research study?

"Affirmative. According to clinicaltrials.gov, this experimental research began on June 19th 2023 and is currently looking for 60 volunteers from a single site. The study was last updated on November 13th 2023."

Answered by AI

Is the research team actively seeking participants?

"Affirmative. According to clinicaltrials.gov, this medical experiment was first posted on June 19th 2023 and is actively recruiting individuals for participation. 60 participants must be secured from a single site for the trial to commence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Group CBT in Parents of Children With Food Allergy

Jessica Hellings 2023. "Group CBT in Parents of Children With Food Allergy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138431.

All > Penicillin Allergy > Food Allergy