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Clinical Trials/NCT04913194
NCT04913194
Unknown
Not Applicable

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

University at Albany1 site in 1 country40 target enrollmentFebruary 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Avoidant Restrictive Food Intake Disorder
Sponsor
University at Albany
Enrollment
40
Locations
1
Primary Endpoint
Acceptability of treatment at 1-month follow-up
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
June 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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."

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.

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."

Recruitment Feasibility

Time Frame: Enrollment

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

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.

Secondary Outcomes

  • 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 Sites (1)

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