Avoidant Restrictive Food Intake DisorderARFID-PTPNCT04913194
A Two-Session Exposure Treatment and Parent Training for ARFID
A study testing ARFID-PTP in people with Avoidant Restrictive Food Intake Disorder, run by University at Albany at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Avoidant Restrictive Food Intake Disorder
- What is being tested?
- ARFID-PTP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Child or parent experiencing suicidal thoughts
- Child or parent experiencing psychotic symptoms
- Child has a cognitive functioning disability
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University at Albany, State University of New York
Albany, New York, 12222
Adrienne Bonilla, Esq, 518-437-3850, abonilla@albany.edu
Courtney E Breiner, MA
About this study
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
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.
- Being tested
- ARFID-PTP
- Keywords
- Parent training, Exposure, ARFID, Picky eating, Brief intervention, Virtual intervention
- Medical subject headings
- Avoidant Restrictive Food Intake Disorder, Food Fussiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARFID-PTPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Participants in this arm will receive the intervention within 2 weeks of completing the intake session. Receives: Behavioral: ARFID-PTP |
| Waitlist Control | Other | 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. Receives: Behavioral: ARFID-PTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Recruitment rates will be measured by the average number of participants recruited each month.
Measured: Enrollment
Retention Feasibility
Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 1 month
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avoidant Restrictive Food Intake DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm waitlist control trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney E Breiner, MA, Principal investigator, University at Albany, State University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913194
- Sponsor's protocol ID
- 21E001
- Acronym
- ARFID-PTP
- Status last verified
- Jun 2022
- First submitted
- 12 Apr 2021
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39031449
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04913194
- Acronym / sponsor ID
- ARFID-PTP / 21E001
- Keywords
- Parent training, Exposure, ARFID, Picky eating, Brief intervention, Virtual intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm waitlist control trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: ARFID-PTPParticipants in this arm will receive the intervention within 2 weeks of completing the intake session. |
| Waitlist Control | Other | Behavioral: ARFID-PTPParticipants 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Child or parent experiencing suicidal thoughts
- Child or parent experiencing psychotic symptoms
- Child has a cognitive functioning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARFID-PTPARFID-PTP is a two-session virtual protocol using psychoeducation, parent training skills, and exposure to decrease picky eating symptoms consistent with an ARFID diagnosis. | Behavioural | Immediate Treatment, Waitlist Control |
Primary outcome
Recruitment Feasibility
Time frame: Enrollment
Recruitment rates will be measured by the average number of participants recruited each month.
Retention Feasibility
Time frame: Through study completion, up to 9 months
Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points.
Acceptability of exposure protocol
Time frame: Through study completion, up to 9 months
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
Time frame: After week 2 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
Time frame: After week 2 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
Time frame: 1 month
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."
4 secondary outcomes
Pica, ARFID, Rumination Disorder Interview (PARDI)
Time frame: Change between intake and 3-month follow-up
Treatment Efficacy: Foods in Regular Rotation
Time frame: Through study completion, up to 9 months
Behavioral Pediatric Feeding Assessment Scale
Time frame: Through study completion, up to 9 months
Treatment Efficacy: Goal Progress
Time frame: Through study completion, up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 39031449Breiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney E Breiner, MA principal investigator
University at Albany, State University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARFID-PTP in people with Avoidant Restrictive Food Intake Disorder, run by University at Albany at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Courtney E Breiner, MA (518-376-2543, cbreiner@albany.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04913194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.