A Two-Session Exposure Treatment and Parent Training for ARFID (ARFID-PTP)

A Pilot Trial of A Two-Session Exposure Treatment and Parent Training for Picky Eating Consistent With an Avoidant-Restrictive Food Intake Disorder (ARFID) Diagnosis

This study aims to assess the acceptability, feasibility, and preliminary efficacy of a two-session, virtual parent-training exposure protocol for children ages 5-12 who experience picky eating consistent with an Avoidant-Restrictive Food Intake Disorder (ARFID) diagnosis.

Study Overview

• Status: Recruiting
• Conditions: Avoidant Restrictive Food Intake Disorder
• Intervention / Treatment: Behavioral: ARFID-PTP

Detailed Description

Potential subjects aged 5 to 12 years with picky eating symptoms consistent with an ARFID diagnosis, as determined by the Pica, ARFID, Rumination Disorder Interview, a semi-structured diagnostic interview, will be recruited via social media and local doctor's offices. Eligible subjects will complete informed consent and an intake session. Participants will then be randomized to an immediate treatment group, in which they will begin treatment the following week, or a 4-week waitlist condition, in which they will wait four weeks to begin treatment. All participants will have the opportunity to receive the treatment, ARFID Parent Training Program or "ARFID-PTP." ARFID-PTP was adapted from a seven-session parent-training for extremely picky eating behaviors to examine the efficacy of a two-session, virtual protocol on increasing food intake and decreasing selective eating. The two virtual treatment sessions will include psychoeducation, parent-training skills, and exposure protocol. There will be 5 major assessment time points: intake, end of treatment, 4-weeks post-treatment, 3-months post-treatment, and 6-months post-treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Courtney E Breiner, MA; Phone Number: 518-376-2543; Email: cbreiner@albany.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12222
      • Recruiting
      • University at Albany, State University of New York
      • Contact: Adrienne Bonilla, Esq; Phone Number: 518-437-3850; Email: abonilla@albany.edu
      • Principal Investigator: Courtney E Breiner, MA
      • Principal Investigator: Julia M Hormes, PhD
      • Sub-Investigator: McKenzie Miller, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children ages 5-12
• Child meets criteria for ARFID using the Pica, ARFID, Rumination Disorder Interview
• Established care with a primary care provider
• Not engaging in other medication or psychotherapy for ARFID during this treatment trial
• Fluently speak and read English

Exclusion Criteria:

• Child or parent experiencing suicidal thoughts
• Child or parent experiencing psychotic symptoms
• Child has a cognitive functioning disability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Treatment; Participants in this arm will receive the intervention within 2 weeks of completing the intake session.	Behavioral: ARFID-PTP; ARFID-PTP is a two-session virtual protocol using psychoeducation, parent training skills, and exposure to decrease picky eating symptoms consistent with an ARFID diagnosis.
Other: Waitlist Control; Participants in this arm will not receive any intervention for two weeks. Participants will complete the treatment after 4-6 weeks of being on the waitlist after their intake session.	Behavioral: ARFID-PTP; ARFID-PTP is a two-session virtual protocol using psychoeducation, parent training skills, and exposure to decrease picky eating symptoms consistent with an ARFID diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Feasibility	Recruitment rates will be measured by the average number of participants recruited each month.	Enrollment
Retention Feasibility	Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.	Through study completion, up to 9 months
Acceptability of exposure protocol	Acceptability of exposure will be measured as a percentage of number of daily food exposures the family completes at all follow-up time points.	Through study completion, up to 9 months
Credibility of treatment	The Credibility and Expectancy Questionnaire is a 6-item measure of treatment credibility and how much participants think and feel treatment will work.	After week 2 of treatment
Acceptability of treatment	Parents will self-report the acceptability of treatment by selecting the extent to which they agree with statements such as "I would refer this treatment to a friend" or "I am satisfied with this treatment."	After week 2 of treatment
Acceptability of treatment at 1-month follow-up	Parents will self-report the acceptability of treatment by selecting the extent to which they agree with statements such as "I would refer this treatment to a friend" or "I am satisfied with this treatment."	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pica, ARFID, Rumination Disorder Interview (PARDI)	The PARDI is a semi-structured interview assessing for diagnostic criteria of ARFID, as well as subtype classification and severity ratings. Parents will be assessed using the PARDI.	Change between intake and 3-month follow-up
Treatment Efficacy: Foods in Regular Rotation	Parents will self-report the number of new foods a child has included in "regular rotation" i.e., is able to eat a full serving size regularly.	Through study completion, up to 9 months
Behavioral Pediatric Feeding Assessment Scale	The Behavioral Pediatric Feeding Assessment Scale is a well-validated measure of child's eating behaviors and parental perception of eating behaviors.	Through study completion, up to 9 months
Treatment Efficacy: Goal Progress	Treatment goals will be assessed using the ARFID-specific treatment goal checklist established by Bryant-Waugh in 2020 via the Maudsley Centre for Child and Adolescent Eating Disorders.	Through study completion, up to 9 months

Collaborators and Investigators

• Sponsor: University at Albany
• Investigators: Principal Investigator: Courtney E Breiner, MA, University at Albany, State University of New York

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ARFID; Brief intervention; Exposure; Parent training; Virtual intervention; Picky eating
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder
• Other Study ID Numbers: 21E001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No