Cognitive Behavioral Therapy for Parents of Children With Food Allergies

Overseen By Carrie Kriz, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri, Kansas City

Must be taking: Antidepressants, Anxiety medications

Must not be taking: OTC anxiety, CBD, Marijuana

Disqualifiers: Suicidal ideation, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how group Cognitive Behavioral Therapy (CBT) can help parents manage anxiety and depression related to their child's medically diagnosed food allergies. Participants will join six weekly one-hour virtual sessions to determine if these therapies can improve their mental health and overall family quality of life. It is ideal for parents with children who have serious food allergies and who experience anxiety or depression. As an unphased trial, this study offers a unique opportunity for parents to potentially enhance their mental well-being and family life through innovative therapy.

Will I have to stop taking my current medications?

You can continue taking your current antidepressants or anxiety medications, but the doses must stay the same for one month before the study, during the study, and for two months after it ends. If your medications are being adjusted, you cannot participate.

What prior data suggests that Cognitive Behavioral Therapy is safe for parents of children with food allergies?

Research has shown that Cognitive Behavioral Therapy (CBT) is safe for parents of children with food allergies. Studies have found that CBT reduces anxiety and depression and is well-tolerated. It effectively lowers food allergy-related anxiety for both children and parents.

Previous research demonstrated that CBT works well for mothers facing similar issues. The therapy sessions are supportive and manageable, focusing on improving mental well-being. Overall, CBT is a non-invasive treatment with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy (CBT) for parents of children with food allergies because it directly addresses the anxiety and depression these parents often face. Unlike the standard of care, which typically involves medications and support groups aimed at managing children's allergies, CBT focuses on improving the mental health of parents through structured therapy sessions. This approach is unique in that it is delivered virtually, offering flexibility and accessibility for parents who might struggle to attend in-person sessions. By empowering parents with coping strategies, CBT has the potential to improve the overall well-being of both parents and their children.

What evidence suggests that Cognitive Behavioral Therapy is effective for parents of children with food allergies?

Research has shown that Cognitive Behavioral Therapy (CBT) can assist parents of children with food allergies. Studies have found that CBT reduces anxiety and depression in these parents, improving their mental health. One study even found that CBT enhanced the quality of life for these families. This is important because having a child with food allergies can be very stressful for parents. In this trial, participants will engage in virtual group CBT sessions. Early results suggest these sessions provide a supportive space that helps parents manage their stress and emotions more effectively. ^{1 2 4 6 7}

Who Is on the Research Team?

Jessica Hellings, MD

Principal Investigator

University of Missouri-Kansas City and University Health Behavioral Health

Stephen Jarvis, MD

Principal Investigator

University Health Behavioral Health, and UMKC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Both parents of a child can join the study, but they have to answer questions separately without talking to each other about them.

My gender does not affect my eligibility.

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

Exclusion Criteria

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

Current Suicidal ideation

Current substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants engage in 6 weekly one-hour virtual Cognitive Behavioral Therapy (CBT) sessions

6 weeks

6 visits (virtual)

Follow-up

Participants complete follow-up questionnaires to assess retention of effect post-intervention

8 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• CBT

Trial Overview 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.

How Is the Trial Designed?

Group I: Virtual Cognitive Behavioral Therapy (CBT) group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4934639/

Effectiveness of Cognitive Behaviour Therapy for Mothers ... Conclusions: CBT appears to be appropriate and effective in mothers of children with food allergy and a larger randomised control trial now ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04774796

Group CBT Intervention for Parents of Children With Food Allergy Food allergy has been found to have a profound impact on parents of children with food allergy, with caregivers experiencing poorer psychological outcomes ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120622017690

Feasibility, acceptability, and proof-of-concept in children All children were rated as very much improved or much improved on the Clinician Global Impression scale at posttreatment. Anxiety severity scores on the Scale ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pai.14108

Psychological support needs for children with food allergy ... This systematic review aimed to review the evidence for psychological support for children with food allergies and their families

5. trials.foodallergy.org trials.foodallergy.org/trials/NCT06138431

Group CBT in Parents of Children With Food Allergy - Food Allergy ... Possible benefits include improvement in psychological functioning and quality of life of families, as well as improved understanding of the use of group ...

6. acaai.org acaai.org/news/children-with-food-allergy-related-anxiety-can-benefit-from-cognitive-behavioral-therapy/

Children with Food Allergy-Related Anxiety Can Benefit ... Targeted cognitive behavioral therapy (CBT) can significantly lessen food allergy-related anxiety (FAA) for both children and parents.

7. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(25)00419-2/fulltext

New Delivery Models of Cognitive Behavioral Therapy– ... Effective management of anxiety is important because if left unaddressed, food allergy anxiety (FAA) affects outcomes along the continuum of care (Figure 1).