Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time to initiation of autism specific intervention
研究概览
简要总结
The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for toddlers under the age of 4 living in Rural NC after their initial diagnosis of autism.
The main questions it aims to answer are:
Does Family Navigation decrease the time to initiation of intervention for rural toddlers with autism?
Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?
Does Family Navigation improve caregiver well-being?
Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children up to 48 months who have a new diagnosis of autism (within the last month) or who are waiting for a diagnosis of autism AND their caregiver.
- •Live in North Carolina, in one of the 78 rural counties.
- •Caregiver must be over the age of 18
- •The caregiver must speak conversationally fluent English.
排除标准
- •No access to a telephone or internet connection for phone calls or video conferencing.
- •Diagnosis of autism spectrum disorder is ruled out in the child.
研究组 & 干预措施
Family Navigation
Participants randomized to the Family Navigation condition will receive up to 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
干预措施: Virtual Family Navigation (Behavioral)
Educational Materials
The comparison condition ("Educational Materials") consists of providing the child's caregivers with information about early intervention and community-based supports (i.e., infant-toddler programs, transition to school-based supports, family support groups, local organizations). Families in this condition will receive this information throughout 4 timepoints in the first 3 months after enrolling.
干预措施: Educational Materials (Behavioral)
结局指标
主要结局
Time to initiation of autism specific intervention
时间窗: Diagnosis to 18 months post
The date of initiation (date 1) of autism-specific intervention will be the date that families report the first session with a therapist following the diagnosis (date 2). Time will be calculated as the number of days elapsed between these two dates (date 2 - date 1).
次要结局
- Caregiver Well-Being Score(6 months post diagnosis)
- Change in Raw Scores on Visual Reception domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Expressive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Receptive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Fine Motor domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains(Baseline and 18 months post diagnosis)
- Caregiver Well-Being Score(6 months post diagnosis)
- Change in Raw Scores on Visual Reception domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Expressive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Receptive Language domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on Fine Motor domain of the MSEL(Baseline and 18 months post diagnosis)
- Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains(Baseline and 18 months post diagnosis)