A Two-Session Exposure Treatment and Parent Training for ARFID

NCT ID: NCT04913194

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Avoidant Restrictive Food Intake Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm waitlist control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Immediate Treatment

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

Group Type EXPERIMENTAL

ARFID-PTP

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

ARFID-PTP

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University at Albany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Courtney E Breiner, MA

Role: PRINCIPAL_INVESTIGATOR

University at Albany, State University of New York

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University at Albany, State University of New York

Albany, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Courtney E Breiner, MA

Role: CONTACT

518-376-2543

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Adrienne Bonilla, Esq

Role: primary

518-437-3850

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39031449 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21E001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

iEAT 2.0 Open Trial
NCT03383029 COMPLETED NA