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Project AFECT (Autism Family Empowerment Coaching and Training Program)

Study acronym: AFECT
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 5 more changesShow less
    • Final enrollment: 143 participants (planned 200)
    • Study completion date changed from estimate of Dec 31, 2026 to Dec 12, 2025
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 5 words
  2. Primary completion date changed from estimate of Nov 30, 2025 to Dec 12, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v5
  3. Enrollment target: 120 to 200v4 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 30, 2025 to Nov 30, 2025
    • Study completion date: Jun 30, 2026 to Dec 31, 2025
    • Secondary endpoints revised (3)
    • Study description shortened, about 10 words
    • Site details revised at 2 of 2 sites
    • Study arms: 2 to 1
  4. Start date changed from estimate of Jun 2023 to Sep 19, 2023
    • Collaborators shortened, about 5 words
    v3
  5. Secondary endpoints: details revised at 1 of 3 entriesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are: * Age greater than 1 and up to 5 years old; * Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND * Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma). The main questions it aims to answer are: * Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence; * Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments; * Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention. Participants will be asked to: * Complete surveys at enrollment and 3 and 6 months later. * Work with Project AFECT Coach. Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.
Trial Details
NCT Number NCT05910502
Lead Sponsor Stanford University
Conditions
(from sponsor)		 Autism Spectrum Disorder, Autism, Autism Spectrum Disorders, Autistic Disorder, Autistic Spectrum Disorder, Autistic Spectrum Disorders, Autistic Disorders Spectrum
Related terms Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
Enrollment 143 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov