A Two-Session Exposure Treatment and Parent Training for ARFID

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Avoidant Restrictive Food Intake Disorder

Intervention / Treatment
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* Behavioral: ARFID-PTP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm waitlist control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>Participants in this arm will receive the intervention within 2 weeks of completing the intake session. | Behavioral: ARFID-PTP<br>* 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.<br>|
| Other: Waitlist Control<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Feasibility | Recruitment rates will be measured by the average number of participants recruited each month. | Enrollment | 
| Retention Feasibility | Retention rates will be measured as the percentage of families who begin treatment and complete all follow-up time points. | 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. | 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. | 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. | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Through study completion, up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent training, Exposure, ARFID, Picky eating, Brief intervention, Virtual intervention