Resources for Optimizing Outcomes in Toddlers on the Spectrum

Официальное название

Expediting Access to Autism Specific Intervention for Young Autistic Children Living in Rural North Carolina: a Pilot Study

Обзор

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.

Вмешательства

• Поведенческое Virtual 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.
• Поведенческое Educational Materials
  The comparison condition ("Educational Materials") consists of providing the participant's caregivers 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.

Первичные конечные точки

• Time to initiation of autism specific intervention [Срок оценки: Diagnosis to 18 months post]

Вторичные конечные точки (6)

• Caregiver Well-Being Score [Срок оценки: 6 months post diagnosis]
• Change in Raw Scores on Visual Reception domain of the MSEL [Срок оценки: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Expressive Language domain of the MSEL [Срок оценки: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Receptive Language domain of the MSEL [Срок оценки: Baseline and 18 months post diagnosis]
• Change in Raw Scores on Fine Motor domain of the MSEL [Срок оценки: Baseline and 18 months post diagnosis]
• Change in Raw Scores on ABAS-3 Conceptual, Social and Practical Domains [Срок оценки: Baseline and 18 months post diagnosis]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Carolina Institute for Developmental Disabilities — Carrboro

Идентификаторы

NCT: NCT07086781 · 25-1164

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗