Recruiting

CBT

Sponsor:

University of Missouri, Kansas City

Code:

NCT06138431

Conditions

Parents

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Interventions

CBT

Study Details

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

Study ID

NCT06138431

Start date

Jun 19, 2023

Status verified date

Jan, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Parent, age >18yrs
2. All genders
3. Child must be aged 18 months - 17yrs with serious food allergy(ies), medically diagnosed
4. Meets cut-offs for anxiety and/or depression on the Hospital Anxiety and Depression Scale (need to define)
5. 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
6. Both parents of a child may enroll but will need to agree to fill out all questionnaires separately without discussing them with each other

Exclusion Criteria:

1. Parental history of recent suicidal ideation / suicide attempt
2. Current Suicidal ideation
3. Current substance abuse
4. Parent currently in psychiatric treatment and medications being adjusted
5. Using OTC anxiety or depression relief, or CBD or medical marijuana
6. Parent receiving other therapies or group supports
7. 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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Cognitive Behavioral Therapy (CBT) group

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.

Interventions

CBT

Virtual CBT groups

Primary outcome measure

  • Change in Score of Food Allergy Quality of Life-Parent Burden Questionnaire (FAQL-PB) [ Time Frame: 14 weeks ]

Central Contacts and Locations

Central contacts

Locations

University Health Behavioral Health Canvas Building

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

More Information

Sponsor

University of Missouri, Kansas City

Last update posted

Apr 16, 2025

Last verified

Jan, 2025

Keywords

  • parents
  • children
  • food
  • allergies
  • CBT
  • cognitive
  • therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri, Kansas City on 2025-04-16.