Clinical trial NCT04913194: A Two-Session Exposure Treatment and Parent Training for ARFID
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
Overall status: UNKNOWN
Phase: NA
Conditions: Avoidant Restrictive Food Intake Disorder
Keywords: Parent training
Exposure
ARFID
Picky eating
Brief intervention
Virtual intervention
Lead sponsor: University at Albany
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm waitlist control trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: Enrollment
measure: Retention Feasibility
timeFrame: Through study completion, up to 9 months
measure: Acceptability of exposure protocol
timeFrame: Through study completion, up to 9 months
measure: Credibility of treatment
timeFrame: After week 2 of treatment
measure: Acceptability of treatment
timeFrame: After week 2 of treatment
measure: Acceptability of treatment at 1-month follow-up
timeFrame: 1 month
Secondary outcomes:
measure: Pica, ARFID, Rumination Disorder Interview (PARDI)
timeFrame: Change between intake and 3-month follow-up
measure: Treatment Efficacy: Foods in Regular Rotation
timeFrame: Through study completion, up to 9 months
measure: Behavioral Pediatric Feeding Assessment Scale
timeFrame: Through study completion, up to 9 months
measure: Treatment Efficacy: Goal Progress
timeFrame: Through study completion, up to 9 months
Other outcomes:
Locations:
city: Albany
country: United States
facility: University at Albany, State University of New York
state: New York
Study officials:
affiliation: University at Albany, State University of New York
name: Courtney E Breiner, MA
role: PRINCIPAL_INVESTIGATOR
References: