Clinical trial Recruiting at 1 site Interventional Ages 1 Year and up

Telehealth parent coaching and provider training to improve care access for young children with autism

Official title: Improving Barriers to Care Access for Children With Autism and Related Needs Via Telehealth for Evaluation, Care Navigating, and Caregiver Coaching

Run by University of Minnesota · NCT07520838 · Data updated 2026-11-12

This project will test whether provider training plus short telehealth parent coaching can help children ages 1–5 who are waiting for an autism diagnosis or services and reduce caregiver stress.

More Autism Spectrum Disorder trials

Quick facts

Study typeInterventional
Ages1 Year and up
SexAll
Enrollment90 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedJuly 25, 2025
Main results expectedJuly 31, 2028
Study endsJuly 31, 2028
Registry record updatedApril 9, 2026
Trial IDNCT07520838 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are children aged 1–5 who are waiting for an autism diagnosis or services, have at least one caregiver able to join telehealth sessions, and are not currently receiving intensive EIBI.

Probably not a fit

Children already receiving intensive early intervention (10+ hours per week) or families unable to participate in telehealth sessions are unlikely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The program trains community providers in a supplemental Naturalistic Developmental Behavioral Intervention (NDBI) delivered by telehealth and offers brief parent coaching sessions. Providers in lead or supervising roles will be prepared to support caregivers, and enrolled families will complete about three 30-minute coaching sessions over 12 weeks plus pre- and post-intervention measures. Eligible children are ages 1–5 who are awaiting diagnosis or intervention and are not currently receiving intensive (≥10 hours/week) EIBI. The project also tests telehealth delivery models to reach geographically dispersed, highly mobile, or military-connected families.

Why it matters

Potential benefit: If successful, this approach could expand access to early coaching, improve child communication and behavior, and reduce caregiver stress for families who have trouble reaching in-person services.

How similar studies have gone: Previous telehealth parent coaching and NDBI-based programs have shown promising improvements in child communication and parent outcomes, though evidence is less robust for geographically dispersed and military-connected populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Provider Inclusion Criteria:

* Providers to participate who are in "lead" or supervising roles (e.g., clinical supervisors, lead therapists, level II/level I EIDBI providers),
* Participating providers are encouraged to have a master's degree or higher, be level I, or serve as a level II provider with established experience (e.g.,supporting families who speak another language or be certified by a tribal government) however, this decision is up to the participating organization

Child/Caregiver Inclusion Criteria:

* Child between ages 1 to 5
* Waiting for either ASD diagnosis or intervention,
* At least one caregiver (approved by the parent) willing to participate
* Ability to complete approximately three, 30 min sessions over 12 weeks and to complete pre and post study measures
* Child may not be currently receiving intensive (10 or more hours a week) or early intensive behavioral intervention (EIBI), but may be on a waitlist for these services, and can be enrolled in Early Childhood Special Education services Parts B and C, and auxiliary services such as speech, physical, and occupational therapy.

Child/Caregiver Exclusion Criteria:

* Children will be assessed through an eligibility screener to determine if they have challenging behavior that may be dangerous. Families will be assessed to determine eligibility through a screener, several of the questions will be aimed to identify challenging behavior severity, behaviors including topographies such as eye gouging and other forms of severe self-injury or aggression that cause significant or dangerous tissue damage (e.g., such as breaking the skin, drawing blood, open wounds that could be infected, or leaves a contusion, visits to an emergency room or hospitalization due to challenging behavior) to a child or others may be considered too severe to participate in the study.
* Families will also be asked if a participating caregiver is pregnant, if they indicate yes, they will still be eligible to participate with their child, but certain activities may be skipped if the child engages in challenging behavior, such as aggressive behavior.

Where it's running

  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Jessica Simacek, PhD — University of Minnesota
  • Study coordinator: Jessica Simacek, PhD
  • Email: sima0034@umn.edu
  • Phone: 612-624-1450

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.