Group CBT in Parents of Children With Food Allergy

NCT06138431 | Recruiting

• 1 other identifier: 2016886
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Parents of children with food allergies that are medically established will be able to participate in 6 one-hour weekly virtual Cognitive Behavioral Therapy (CBT) groups, and outcomes will be measured for anxiety, depression and quality of life. Possible benefits include improvement in psychological functioning and quality of life of families, as well as improved understanding of the use of group Cognitive Behavioral Therapy (CBT) for parents of children with medically established food allergies.

Conditions

Parents

Keywords

parents; children; food; allergies; CBT; cognitive; therapy

Outcome Measures

Primary Outcomes (1)

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

  17-item instrument, using a 7-point Likert scale ranging from 1 (not troubled) to 7 (extremely troubled) anxieties over the past week.

  14 weeks

Secondary Outcomes (3)

• Subject Satisfaction Questionnaire

  14 weeks

• Change in Score of Pediatric Food Allergy Quality of Life Scale

  14 weeks

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

  14 weeks

Study Arms (1)

Virtual Cognitive Behavioral Therapy (CBT) group

EXPERIMENTAL

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.

Behavioral: CBT

Interventions

CBT BEHAVIORAL

Virtual CBT groups

Virtual Cognitive Behavioral Therapy (CBT) group

Eligibility Criteria

• Age: 18 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent, age \>18yrs
• All genders
• Child must be aged 18 months - 17yrs with serious food allergy(ies), medically diagnosed
• Meets cut-offs for anxiety and/or depression on the Hospital Anxiety and Depression Scale (need to define)
• Parent can be on stable doses of antidepressants or anxiety medications but all doses must remain stable for 1 month before study and during it as well as for 2 months after the groups are completed: to fill out final questionnaires
• Both parents of a child may enroll but will need to agree to fill out all questionnaires separately without discussing them with each other

You may not qualify if:

• Parental history of recent suicidal ideation / suicide attempt
• Current Suicidal ideation
• Current substance abuse
• Parent currently in psychiatric treatment and medications being adjusted
• Using OTC anxiety or depression relief, or CBD or medical marijuana
• Parent receiving other therapies or group supports
• Parent unable to attend 6 consecutive weekly group sessions and fill out questionnaires online also 2 months later or does not have access to WiFi.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

University Health Behavioral Health Canvas Building

Kansas City, Missouri, 64108, United States

RECRUITING

Related Publications (1)

• Knibb RC, Barnes C, Stalker C. Parental self-efficacy in managing food allergy and mental health predicts food allergy-related quality of life. Pediatr Allergy Immunol. 2016 Aug;27(5):459-64. doi: 10.1111/pai.12569. Epub 2016 May 3.

  PMID: 27019307 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jessica Hellings, MD

  University of Missouri-Kansas City and University Health Behavioral Health

  PRINCIPAL INVESTIGATOR

• Stephen Jarvis, MD

  University Health Behavioral Health, and UMKC

  STUDY CHAIR

Central Study Contacts

Jessica Hellings, MD

CONTACT

816-404-6202; Jessica.Hellings@uhkc.org

Carrie Kriz, MS

CONTACT

816-238-1808; mckinleycr@umkc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: One group of approximately 10 parents of children with food allergies will receive virtual CBT group therapy via Zoom.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: November 18, 2023
• Study Start: June 19, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)