CClinicalTrials.gg
Status unknownNCT04913194ARFID-PTPUpdated Jun 16, 2022

A Two-Session Exposure Treatment and Parent Training for ARFID

An interventional study of ARFID-PTP in Avoidant Restrictive Food Intake Disorder, sponsored by University at Albany. Status unknown at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by University at Albany · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Avoidant Restrictive Food Intake Disorder

Keywords

  • Parent training
  • Exposure
  • ARFID
  • Picky eating
  • Brief intervention
  • Virtual intervention
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In context

Avoidant Restrictive Food Intake Disorder

35 studies on the registry are indexed under Avoidant Restrictive Food Intake Disorder; 12 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 25 interventional studies indexed under Avoidant Restrictive Food Intake Disorder.

Browse Avoidant Restrictive Food Intake Disorder studies →

Lead sponsor

University at Albany is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Immediate Treatment

    Participants in this arm will receive the intervention within 2 weeks of completing the intake session.

    Behavioral: ARFID-PTP

  • 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

Interventions

  • BehavioralARFID-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.

06

What researchers measure

Primary outcomes

  1. Recruitment Feasibility

    Recruitment rates will be measured by the average number of participants recruited each month.

    Time frame: Enrollment

  2. Retention Feasibility

    Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.

    Time frame: Through study completion, up to 9 months

  3. 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.

    Time frame: Through study completion, up to 9 months

  4. 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.

    Time frame: After week 2 of treatment

  5. 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."

    Time frame: After week 2 of treatment

  6. 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."

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: Change between intake and 3-month follow-up

  2. 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.

    Time frame: Through study completion, up to 9 months

  3. 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.

    Time frame: Through study completion, up to 9 months

  4. 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.

    Time frame: Through study completion, up to 9 months

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Study locations

1 of 1 sites recruiting
  • University at Albany, State University of New York
    Albany, New York 12222, United States
    • Adrienne Bonilla, Esq · Contact · abonilla@albany.edu · 518-437-3850
    • Courtney E Breiner, MA · Principal investigator
    • Julia M Hormes, PhD · Principal investigator
    • McKenzie Miller, MA · Sub investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04913194
Lead sponsor
University at Albany
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Feb 15, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Jun 15, 2023 (estimated)
Last update
Jun 16, 2022

Study contacts

Courtney E Breiner, MA
Contact
cbreiner@albany.edu
518-376-2543
Courtney E Breiner, MA
principal investigator · University at Albany, State University of New York

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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