ClinicalTrials.gg
RecruitingNCT06138431Updated Apr 16, 2025

Group CBT in Parents of Children With Food Allergy

An interventional study of CBT in Parents, sponsored by University of Missouri, Kansas City. Recruiting at 1 site in United States. Open to participants aged 18 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by University of Missouri, Kansas City · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Months to 17 Years
Sex
All
01

Study 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.

Read the detailed description

This will be a non-blinded, prospective cohort study. Scores related to quality of life, depression, and anxiety will be measured at baseline, upon completion of the respective interventions, and 2 months after completion in parents of food allergic children. Instruments used will include the Patient Health Questionnaire-9 (PHQ-9) (baseline screening), Generalized Anxiety Disorder-7 (GAD-7) (baseline screening), Food Allergy Quality of Life - Parental Burden Scale (FAQL-PB) the Pediatric Food Allergy Quality of Life Questionnaire (PFA-QL) parent form, the Food Allergy Self-Efficacy Scale for Parents (FASE-P) and the Hospital Anxiety and Depression Scale (HADS). Scores on these questionnaires will be collected at the beginning of the study, at the last session of the intervention, and 2 months after the end of the intervention.

For additional baseline and demographic characteristics, the investigators will also collect child's age, sex, parental educational level, food allergy factors, and comorbid physical and psychiatric conditions. Also, at baseline, the investigators will screen for bullying given its prevalence among the food allergic population. The investigators referred to existing literature on bullying in children with food allergies for a general question, "Has the food-allergic individual ever been bullied, teased, or harassed because of food allergy?" To target the parent who will be answering this question, the investigators will change "food-allergic individual" to "your child." The group Cognitive Behavioral Therapy (CBT) sessions will occur on a weekly basis at over Zoom meetings. Each session will last 1 hour. There will be a total of 6 sessions of intervention, and an additional session 2 months after the 6th session for parents to complete the follow-up questionnaire (no intervention during the 7th session).

A research staff member will take attendance and coordinate group logistics of the groups, as well as check fidelity of what is covered, according to a manual written for the study detailing each session. A Cognitive Behavioral Therapy (CBT)-certified practitioner will be leading the sessions. Parents will complete study questionnaires online before the beginning of the first session, after the end of the last session, and 8 weeks after the completion of the interventions. Study materials for each session will be emailed to parents before the session and the therapist will assign homework practice based on the handouts to be done between sessions. Only parents attend the zoom groups in order to minimize introducing heterogeneity and potential distractions by children. Furthermore, prior studies have suggested that the child's own anxiety is often mediated by parental anxiety.

Subjects will be recruited from multiple locations in the community through recruitment flyers posted in clinics. These clinics will include University Health (Truman) Hospital Hill outpatient medical clinics, University Health (Truman) Lakewood Hospitals outpatient medical clinics, University Health Behavioral Health outpatient adult and child clinics at the Healing Canvas, University Health Behavioral Health outpatient adult and child clinics at Lakewood Counseling Services, Children's Mercy outpatient clinics in downtown Kansas City (Broadway Boulevard), and Children's Mercy outpatient clinics in Overland Park, Kansas.

Flyers will provide email contact information for the research coordinator so that interested parents can obtain more information about the study and, if they remain interested in participating, reviewing the consent form with the research staff. Those who consent to participate will be further screened per inclusion and exclusion criteria. Subjects will then participate in group Cognitive Behavioral Therapy (CBT) via Zoom meetings.

Analysis:

Statistical analysis will examine any significant differences in baseline scores, score changes, and retention of effect post-intervention for the group. All analyses will be two-tailed with alpha set at 0.05. If scale scores are not normally distributed, non-parametric tests will be used.

02

Conditions studied

  • Parents

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Keywords

  • parents
  • children
  • food
  • allergies
  • CBT
  • cognitive
  • therapy
03

In context

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

This study's planned enrollment of 10 is below the median of 73 across 691 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University of Missouri, Kansas City is the lead sponsor of 48 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study 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.

    Behavioral: CBT

Interventions

  • BehavioralCBT

    Virtual CBT groups

06

What researchers measure

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.

    Time frame: 14 weeks

Secondary outcomes

  1. Subject Satisfaction Questionnaire

    An 11-question scale, each item scored 1 (not satisfied at all) to 5 (very satisfied). Scores range from 5 to 55, with a higher score indicating higher subject satisfaction

    Time frame: 14 weeks

  2. Change in Score of Pediatric Food Allergy Quality of Life Scale

    A 25-question scale, each item scored 1 (never) to 4 (always). Scores range from 25 to 100, with a higher score indicating poorer quality of life

    Time frame: 14 weeks

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

    A 14 item-scale, of which 7 items measure anxiety and 7 measure depression, each item is scored from 0 to 3

    Time frame: 14 weeks

07

Study locations

1 of 1 sites recruiting
  • University Health Behavioral Health Canvas Building
    Kansas City, Missouri 64108, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 27019307 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Dec 2025, 30 months after the start.

Of 150 non-industry interventional studies with no phase under Hypersensitivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 30 months is above that.

Counting every sponsor, half of 174 studies reached it within 20 months; a quarter within 5 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2023
First posted
Nov 18, 2023
StartActual
Jun 19, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Apr 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06138431
Lead sponsor
University of Missouri, Kansas City
Responsible party
Jessica Hellings (Professor of Psychiatry, University of Missouri, Kansas City) — Principal investigator
First posted
Nov 18, 2023
Start date
Jun 19, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 16, 2025

Study contacts

Jessica Hellings, MD
Contact
Jessica.Hellings@uhkc.org
816-404-6202
Carrie Kriz, MS
Contact
mckinleycr@umkc.edu
816-238-1808
Jessica Hellings, MD
principal investigator · University of Missouri-Kansas City and University Health Behavioral Health
Stephen Jarvis, MD
study chair · University Health Behavioral Health, and UMKC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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