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
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 12, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2023
CompletedJune 16, 2022
June 1, 2022
1.9 years
April 12, 2021
June 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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 Outcomes (4)
Pica, ARFID, Rumination Disorder Interview (PARDI)
Change between intake and 3-month follow-up
Treatment Efficacy: Foods in Regular Rotation
Through study completion, up to 9 months
Behavioral Pediatric Feeding Assessment Scale
Through study completion, up to 9 months
Treatment Efficacy: Goal Progress
Through study completion, up to 9 months
Study Arms (2)
Immediate Treatment
EXPERIMENTALParticipants in this arm will receive the intervention within 2 weeks of completing the intake session.
Waitlist Control
OTHERParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Child or parent experiencing suicidal thoughts
- Child or parent experiencing psychotic symptoms
- Child has a cognitive functioning disability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University at Albany, State University of New York
Albany, New York, 12222, United States
Related Publications (1)
Breiner CE, Miller ML, Hormes JM. ARFID Parent Training Protocol ("ARFID-PTP"): Results of a Randomized Pilot Trial Evaluating a Brief, Parent-Training Program for Avoidant/Restrictive Food Intake Disorder. Int J Eat Disord. 2024 Nov;57(11):2306-2317. doi: 10.1002/eat.24269. Epub 2024 Jul 19.
PMID: 39031449DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Courtney E Breiner, MA
University at Albany, State University of New York
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
June 4, 2021
Study Start
February 15, 2021
Primary Completion
December 31, 2022
Study Completion
June 15, 2023
Last Updated
June 16, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share