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临床试验/NCT05852548
NCT05852548已完成不适用

Parent-Mediated Intervention for Families With Children With Autism and Feeding Challenges, Australia Cohort

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月24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
20
试验地点
1
主要终点
Change in Sensory Experiences Questionnaire (SEQ 3.0)

研究概览

简要总结

The goal is to expand a parent-mediated intervention for feeding challenges in children with autism with an Australian cohort, building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.

详细描述

Fifty families with a child with Autism spectrum disorder (ASD) will be asked to participate in 24 parent-mediated feeding intervention visits over approximately six-months. In addition, parents will be asked to participate in 6 to 8 parent training sessions in their home or by phone. Enrollment with two groups of families will be staggered to allow for any further adaptation and refinement of the protocol based on feedback from enrolled families.

All families will be asked to participate in an initial intake session that will include an overview of the intervention program, assessment of the intervention targets, parent interview, observation/videotape of a family mealtime, and complete standardized questionnaires on specific variables (e.g., developmental level, autism severity and sensory processing) that can influence feeding behaviors to further describe the population and explore potential confounding variables. The assessments and mealtime observation will assist in determining the child's current feeding challenges and targeted goals. Both parent and child will be asked to participate in a video-taped mealtime and free play time during a laboratory session at pre and post-intervention time points. During the laboratory session, both parent and child will be asked to wear a heart rate activity monitor that attached to their chest via a harness and an electrodermal skin conductance wrist band to allow for wireless physiological data collection. In addition, parents and children will also be requested to wear the heart rate activity monitor two times in their home environment during family mealtime. Hair samples will be taken from both the parent and the child to assess recent stress levels. Parents will collaborate in Goal Attainment Scaling to allow for a pre- and post-test comparison of child specific goals. In addition, feeding assessments as well as a parent stress measure, heart rate variability, and hair cortisol measurement will be used for a pre- and post-test comparison. Parents will participate in brief structured interviews before, one time during, and immediately following completion of the program to provide feedback on the intervention.

Intervention:

  1. Parents will attend 8 group sessions that will be clustered in the first three quarters of the program focused on topics related to feeding challenges (e.g. goal setting, feeding development, parent-child interactions, sensory processing, behavior management, nutrition, the gastrointestinal system, and family mealtimes). Education sessions will be facilitated by the principal investigator and research team members.
  2. Parents will receive 6-10 individual sessions with a feeding interventionist that will support targeted goal setting, problem solving and individual coaching and feedback through video review of parent-led intervention.
  3. Parent-child dyads will receive 24 weekly sessions in the home that demonstrate modeling of intervention strategies and provide direct feedback of parent-led intervention. Parent satisfaction and burden will be assessed after each weekly session using a brief Likert scale questionnaire.
  4. Parents will be asked to commit 10-15 hours per week in the home setting to directly support targeted feeding goals and related challenges such as sensory processing that may be a barrier to successful eating. Two trained individuals with experience working with children with ASD will be hired to support facilitation of the parent-mediated intervention. Several steps will be taken to train and supervise the interventionists. In addition, a minimum of 20% of their interactions will be video-taped reviewed by the principal investigator to monitor treatment fidelity.

Analysis:

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 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with a confirmed diagnosis of ASD (ages 2-7 years)
  • Parent reported feeding problems
  • English Speaking

排除标准

  • Any conditions co-morbid with ASD (e.g., fragile X)
  • Significant visual, hearing or physical impairments
  • Children who receive any non-oral nutritional supplementation (e.g. gastrostomy tubes)

结局指标

主要结局

Change in Sensory Experiences Questionnaire (SEQ 3.0)

时间窗: Pre/post measure through study completion, an average of 6 months

Caregiver report instrument designed to characterize sensory features in children ages 2-12 years with ASD. This is a 105-item questionnaire, the scoring is based on the first 97: scored on a 5 point scale from 1 (almost never) to 5 (almost always). The remaining items are qualitative and provide context. Total possible range of scores is 97-485, higher scores indicate greater intensity of sensory behaviors.

Change in Goal Attainment Scaling (GAS)

时间窗: Pre/Post measure through study completion, an average of 6 months

Assesses the effectiveness of psycho-social interventions in the community setting in ASD. The total possible range of standardized T scores is 23.56 - 76.44, where a score of 50 means all goals were met and higher scores indicate goals were exceeded.

Change in Feeding and Eating in AutiSm Together Questionnaire

时间窗: Pre/Post measure through study completion, an average of 6 months

Measures feeding challenges across domains of sensory, behavior, oral motor, and gastrointestinal as well as how feeding challenges present in daily life and family routines. The total possible range of scores for each domain is from 32-160 with higher scores indicating increased feeding challenge.

次要结局

  • Change in the Caregiver Involvement Scale Score(Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months))
  • Change in Parent effort scale(Pre/Post intervention session measure through study completion, an average of 1 time per month (for up to 6 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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