A Two-Session Exposure Treatment and Parent Training for ARFID
- Conditions
- Avoidant Restrictive Food Intake Disorder
- Interventions
- Behavioral: ARFID-PTP
- Registration Number
- NCT04913194
- Lead Sponsor
- University at Albany
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- Child or parent experiencing suicidal thoughts
- Child or parent experiencing psychotic symptoms
- Child has a cognitive functioning disability
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist Control ARFID-PTP 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. Immediate Treatment ARFID-PTP Participants in this arm will receive the intervention within 2 weeks of completing the intake session.
- Primary Outcome Measures
Name Time Method Acceptability of treatment at 1-month follow-up 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 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 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 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 Enrollment Recruitment rates will be measured by the average number of participants recruited each month.
Acceptability of exposure protocol 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 Outcome Measures
Name Time Method Pica, ARFID, Rumination Disorder Interview (PARDI) Change between intake and 3-month follow-up 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.
Treatment Efficacy: Foods in Regular Rotation Through study completion, up to 9 months 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.
Behavioral Pediatric Feeding Assessment Scale Through study completion, up to 9 months The Behavioral Pediatric Feeding Assessment Scale is a well-validated measure of child's eating behaviors and parental perception of eating behaviors.
Treatment Efficacy: Goal Progress Through study completion, up to 9 months 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.
Trial Locations
- Locations (1)
University at Albany, State University of New York
🇺🇸Albany, New York, United States