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
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptability of treatment at 1-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Child or parent experiencing suicidal thoughts
- •Child or parent experiencing psychotic symptoms
- •Child has a cognitive functioning disability
结局指标
主要结局
Acceptability of treatment at 1-month follow-up
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Enrollment
Recruitment rates will be measured by the average number of participants recruited each month.
Acceptability of exposure protocol
时间窗: 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.
次要结局
- 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)