Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Child Behaviors Targeted by Intervention
研究概览
简要总结
Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
详细描述
Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible. However, this is currently not the case for the majority of families. There are no empirically validated treatment programs for infants showing ASD risk. The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
- •and Infant Toddler Checklist (ITC) scores in the autism concern range
- •Expression of clinical concern about ASD risk by the assessor and caregiver
- •Caregivers must be identified as the infants' primary caregivers
- •Caregivers be English speaking
- •Caregivers must have access to wired or wireless network technology to access the internet in their homes.
排除标准
- •Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
- •Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
- •Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
- •Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
- •A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).
结局指标
主要结局
Child Behaviors Targeted by Intervention
时间窗: 7 months
Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.
次要结局
- Autism Observation Scale for Infants(7 months)
- Ages and Stages Questionnaires, 3rd Edition(7 months)
- Individual Growth and Development Indices(7 months)
- Working Alliance Scale for Interventions with Children(7 months)
- Caregiver Fidelity of Treatment Implementation(7 months)
- Vineland Adaptive Behavior Scales, 2nd edition(7 months)
- Parent Satisfaction Rating(7 months)