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ARFID Therapies for Picky Eating

N/A

Waitlist Available

Led By Nancy L Zucker, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Underweight

Child is between 60 and 119 months (5 years and up to 9 years, 11 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-treatment (up to 30 weeks), 3-months post-treatment

Awards & highlights

Study Summary

This trial is testing out two possible treatments for ARFID in young children to see if they help and to learn more about how they work.

Who is the study for?

This trial is for children aged 5 to almost 10 years with ARFID, who rely on supplements for calories and show significant picky eating. They must be English-speaking and not taking appetite-affecting meds, have no severe intellectual disability or other eating disorders like anorexia or bulimia, and not be in another ARFID treatment study.Check my eligibility

What is being tested?

The study tests two programs: Family Assisted Diet (FAD) and Feeling & Body Investigator_ARFID Division, designed to help young kids with ARFID eat better. It aims to find out if these treatments can improve the variety of foods they eat without causing stress.See study design

What are the potential side effects?

Since this trial involves dietary interventions rather than medication, side effects may include initial resistance to new foods or mealtime stress but are expected to be minimal compared to drug-related trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am considered underweight for my height.

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My child is between 5 and 9 years old.

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I have been diagnosed with ARFID.

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I speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-treatment (up to 30 weeks), 3-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-treatment (up to 30 weeks), 3-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-treatment (up to 30 weeks), 3-months post-treatment 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 the number of clinically severe symptoms of Avoidant Restrictive Food Intake Disorder (ARFID) as measured by the PARDI (Pica, ARFID, and Rumination Diagnostic Interview)

Secondary outcome measures

Body Mass Index (BMI) as measured by height and weight

Nutrition Quality as measured by 3-day 24-hour dietary recalls

Nutrition Quantity as measured by 3-day 24-hour dietary recalls

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Feeling and Body Investigator_ARFID Division (FBI-ARFID)Experimental Treatment1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of 4 components: 1) psychoeducation of somatic body sensations and sensory features of foods using playful characters (e.g., Aftertaste Anthony); 2) in-session exercises that expose family members to different body and food sensations so they can learn something new about their body and food; 3) body brainstorm worksheets that help them generalize what they learn in session to outside of treatment; and 4) Decision-tree practice worksheets that help them map body sensations to meanings and actions and to track explorations with food.

Group II: Family Assisted Diet (FAD)Active Control1 Intervention

This is a 20-session intervention with a child and the child's parents that consists of helping parents set goals around their child's renourishment; consider barriers to implementing proposed plans; thinking through strategies to avoid barriers; and providing ongoing support for plan implementation.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,419,866 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,782 Previous Clinical Trials

2,688,904 Total Patients Enrolled

Nancy L Zucker, PhDPrincipal InvestigatorDuke University

1 Previous Clinical Trials

18 Total Patients Enrolled

Media Library

Family Assisted Diet (FAD) Clinical Trial Eligibility Overview. Trial Name: NCT05105308 — N/A

Frequently Asked Questions

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

Is this research program available for enrollment at the present time?

"According to the clinicaltrials.gov record, this trial is actively recruiting patients and has been since its initial posting on February 10th 2022. The listing was last modified on June 17th 2022."

Answered by AI

Are there specific qualifications for participants in this research endeavor?

"To apply for this trial, applicants must be between five and ten years of age with a picky eating habit. This medical research is recruiting up to 170 people in total."

Answered by AI

Are adults of all ages eligible to join this experiment?

"This medical research project is considering participants between 5 and 10 years of age."

Answered by AI

What is the recruitment rate for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently in search of participants and was first posted on February 10th 2022 with the most recent update occurring June 17th 2022. This study requires 170 individuals from one location for completion."

Answered by AI

Recent research and studies

Behaviour Research and TherapyJournal

Acceptance-based Interoceptive Exposure for Young Children with Functional Abdominal Pain

Zucker, Nancy, Christian Mauro, Michelle Craske, H. Ryan Wagner, Nandini Datta, Hannah Hopkins, Kristen Caldwell, et al.. 2017. “Acceptance-based Interoceptive Exposure for Young Children with Functional Abdominal Pain”. Behaviour Research and Therapy. Elsevier BV. doi:10.1016/j.brat.2017.07.009.

International Journal of Eating DisordersJournal

Feeling and Body Investigators (FBI): ARFID Division—an Acceptance‐based Interoceptive Exposure Treatment for Children with ARFID

Zucker, Nancy L., Maria C. LaVia, Michelle G. Craske, Martha Foukal, Adrianne A. Harris, Nandini Datta, Erik Savereide, and Gary R. Maslow. 2018. “Feeling and Body Investigators (FBI): ARFID Division—an Acceptance‐based Interoceptive Exposure Treatment for Children with ARFID”. International Journal of Eating Disorders. Wiley. doi:10.1002/eat.22996.

clinicaltrials.govStudy

Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)

2022. "Chompions! A Treatment Study for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05105308.