METHODS: Families of children ages 5-12 with ARFID (n = 30) were randomized to immediate or waitlist treatment groups, with both groups ultimately receiving ARFID-PTP. ARFID-PTP consists of two, 2-h individual treatment sessions with an optional booster session at 4-week follow-up. Families completed acceptability and feasibility measures at end-of-treatment, as well as preliminary efficacy measures at 4-week, 3-month, and 6-month follow-up.
RESULTS: Of 30 families who completed an intake session, 27 (90%) completed treatment. Families rated acceptability as high (MCEQ-C = 7.75). Treatment was feasible by participant retention. Exposure adherence was lower than expected, and booster session requests were higher than expected, indicating that achieving feasibility across measures may require treatment modifications. Regarding preliminary efficacy, children in the immediate treatment group had a decrease in ARFID symptoms compared to those on the waitlist. Overall, at 6-month follow-up linear mixed models showed participants had significantly reduced ARFID symptoms by presentation (p < 0.05) and in follow-up completers, children incorporated eight new foods on average.
CONCLUSIONS: ARFID-PTP is acceptable and preliminarily efficacious. The protocol may benefit from modifications to increase feasibility; however, booster session content and treatment outcomes suggest a priori feasibility markers may not accurately capture the utility of ARFID-PTP. Further work should continue to examine the efficacy ARFID-PTP, particularly in diverse samples where treatment accessibility is urgently needed.
BACKGROUND: ClinicalTrials.gov identifier: NCT04913194.
方法:将使用ARFID的5-12岁儿童家庭(n=30)随机分为直接或等待治疗组,两组最终均接受ARFID-PTP。ARFID-PTP由两个组成,在4周的随访中,2小时的单独治疗疗程与可选的加强疗程。家庭在治疗结束时完成了可接受性和可行性措施,以及4周的初步疗效测量,3个月,6个月随访。
结果:在30个完成了一次入学的家庭中,27(90%)完成医治。家庭评价可接受性高(MCEQ-C=7.75)。通过保留参与者,治疗是可行的。暴露依从性低于预期,助推器会话请求高于预期,这表明实现跨措施的可行性可能需要修改治疗方法。关于初步疗效,与等待治疗组儿童相比,立即治疗组儿童的ARFID症状有所减轻.总的来说,在6个月的随访线性混合模型显示,参与者通过表现(p<0.05)和随访完成者,ARFID症状显着减少,儿童平均摄入八种新食物。
结论:ARFID-PTP是可接受的,初步有效。该协议可能会受益于修改以提高可行性;然而,加强疗程内容和治疗结果提示先验可行性标记物可能无法准确捕获ARFID-PTP的效用.进一步的工作应继续检查疗效ARFID-PTP,特别是在迫切需要治疗可及性的不同样本中。
背景:ClinicalTrials.gov标识符:NCT04913194。