A Two-Session Exposure Treatment and Parent Training for ARFID (ARFID-PTP)
Primary Purpose
Avoidant Restrictive Food Intake Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARFID-PTP
Sponsored by
About this trial
This is an interventional treatment trial for Avoidant Restrictive Food Intake Disorder focused on measuring Parent training, Exposure, ARFID, Picky eating, Brief intervention, Virtual intervention
Eligibility Criteria
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
Sites / Locations
- University at Albany, State University of New YorkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Treatment
Waitlist Control
Arm Description
Participants in this arm will receive the intervention within 2 weeks of completing the intake session.
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.
Outcomes
Primary Outcome Measures
Recruitment Feasibility
Recruitment rates will be measured by the average number of participants recruited each month.
Retention Feasibility
Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.
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.
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.
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."
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."
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04913194
Brief Title
A Two-Session Exposure Treatment and Parent Training for ARFID
Acronym
ARFID-PTP
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University at Albany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avoidant Restrictive Food Intake Disorder
Keywords
Parent training, Exposure, ARFID, Picky eating, Brief intervention, Virtual intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm waitlist control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Treatment
Arm Type
Experimental
Arm Description
Participants in this arm will receive the intervention within 2 weeks of completing the intake session.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ARFID-PTP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Feasibility
Description
Recruitment rates will be measured by the average number of participants recruited each month.
Time Frame
Enrollment
Title
Retention Feasibility
Description
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
Title
Acceptability of exposure protocol
Description
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
Title
Credibility of treatment
Description
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
Title
Acceptability of treatment
Description
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
Title
Acceptability of treatment at 1-month follow-up
Description
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 Outcome Measure Information:
Title
Pica, ARFID, Rumination Disorder Interview (PARDI)
Description
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
Title
Treatment Efficacy: Foods in Regular Rotation
Description
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
Title
Behavioral Pediatric Feeding Assessment Scale
Description
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
Title
Treatment Efficacy: Goal Progress
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney E Breiner, MA
Phone
518-376-2543
Email
cbreiner@albany.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney E Breiner, MA
Organizational Affiliation
University at Albany, State University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Albany, State University of New York
City
Albany
State/Province
New York
ZIP/Postal Code
12222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrienne Bonilla, Esq
Phone
518-437-3850
Email
abonilla@albany.edu
First Name & Middle Initial & Last Name & Degree
Courtney E Breiner, MA
First Name & Middle Initial & Last Name & Degree
Julia M Hormes, PhD
First Name & Middle Initial & Last Name & Degree
McKenzie Miller, MA
12. IPD Sharing Statement
Plan to Share IPD
No
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A Two-Session Exposure Treatment and Parent Training for ARFID
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