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临床试验/NCT03992118
NCT03992118已完成不适用

Delivering Specialty Care Access Through Use of an Innovative Telehealth-home Based Intervention Feeding Program (Telefeeding) to Address Food Selectivity in Autism Spectrum Disorder

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Parent Satisfaction Scale

研究概览

简要总结

The investigators are trying to determine if delivery a feeding intervention program using videoconferencing technology is feasible.

详细描述

The investigators hope to recruit 10 participants who have a diagnosis of autism spectrum disorder and food selectivity. A Multidisciplinary feeding assessment will be conducted and factors which contribute to the participant's feeding challenges will be identified. Treatment goals will be identified using the Canadian Occupational Performance Measure (COPM). Intervention geared to address the goals identified by parents will be delivered by the clinician(s) via videoconferencing. Participants will participate in up to 12 weekly 1hr visits over the study period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 2-5 years of age
  • Diagnosed with Autism Spectrum Disorder
  • History of mild to moderate food selectivity
  • Access to internet service
  • Access to a Windows based laptop with a web camera
  • One Parent is available to participate in a 1 hour intervention program within the home environment once per week over a 12 week period.
  • English speaking participants
  • Parent consents to use of Ontario Telemedicine Network (OTN) technology within in the home.
  • Parent is able to use a laptop
  • Access to a telephone in order to trouble shoot problems that may arise in setting up OTN technology.

排除标准

  • Age: > 6 year of age (rationale being most children will be enrolled in school during the week thus not available for intervention services).
  • History of severe food selectivity
  • No access to internet service and/or laptop
  • History of dysphagia or other swallowing difficulties
  • Oro-motor abnormalities such as cleft lip and palate, macroglossia
  • Presently has a G-tube insitu
  • Participants on medications that may significantly alter appetite such as stimulants and antipsychotic medications.
  • Currently enrolled in a feeding intervention program.

结局指标

主要结局

Parent Satisfaction Scale

时间窗: 12 weeks

A questionnaire was developed for the study to obtain parent feedback at week 12 on the quality of the block of intervention. Questions rated the length of the sessions, number of sessions, the usefulness of teaching tools (for e.g. homework), and participants confidence in handling future feeding challenges. Scores range from 0(strongly disagree) to 4 (strongly agree).

Treatment Fidelity Scale

时间窗: 12 weeks

A treatment fidelity checklist was developed for this study. Treatment fidelity will be measured using a questionnaire to rate if the intervention session goals were met during the session. This will be done using a 3 point likert scale. After completion of each session the therapists will rate themselves as: 0= Goal was not achieved; 1- Goal was partially achieved; 2= Goal was fully achieved for each treatment goal for that session.

Parent Treatment Adherence Scale

时间窗: 12 weeks

Parent Treatment Adherence scale will be used to rate parent engagement and understanding of in session materials. The scale will be completed by the therapists at the end of each intervention session to rate parent engagement and understanding of instructions and assignment on a three point likert scale.

次要结局

  • Change in number of foods eaten from baseline to week 12 (or end of intervention whichever comes first)(12 weeks)
  • Change from baseline in performance scores on the COPM scale at 12 weeks(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Smile

Developmental Paediatrician

Holland Bloorview Kids Rehabilitation Hospital

研究点 (2)

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