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Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 years 11 months later Jun 30, 2026 → May 31, 2033
See other at-risk trials from University of California, Davis

Record History

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  1. Primary completion pushed from Jun 30, 2026 to May 31, 2033
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026v8
  3. Primary completion date: Jun 30, 2024 to Jun 30, 2025v7
  4. Primary completion date: May 31, 2023 to Jun 30, 2024v6
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    • Collaborators: 2 to 1
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study Status, Referencesv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  3. Start date: Jun 1, 2021 to Sep 1, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.
Trial Details
NCT Number NCT04881656
Lead Sponsor University of California, Davis
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov