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

The objectives of the current project are to develop and implement training with community providers to evaluate a supplemental parent coaching intervention delivered via telehealth to improve child communication and behavioral outcomes, parental stress outcomes, and to investigate telehealth models to reach children in geographically dispersed or highly mobile locations and/or from military connected families.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: NDBI

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Simacek, PhD; Phone Number: 612-624-1450; Email: sima0034@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Jessica Simacek, PhD; Phone Number: 612-624-1450; Email: sima0034@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Naturalistic Developmental Behavioral Intervention (NDBI); NDBIs are embedded with developmental principles and practices with an emphasis placed on naturalistic intervention elements (e.g., targeting skills within a developmentally appropriate sequence). In addition to adhering to recommended early intervention practices involving naturalized, routines-based, and family-centered interventions, NDBIs may be easier for parents to implement and may promote child skill acquisition in a natural manner and therefore promote generalization and maintenance of skills.	Other: NDBI; The NDBI strategies (e.g., behavioral principles such as reinforcement) embedded within family-centered routines will be used to target child communication, social reciprocity, and parental responsivity. Collateral effects of the supplemental treatment package will be observed in terms of parental stress/efficacy and family quality of life as well. NDBI strategies and methodology provide a powerful tool to increase (and maintain via reinforcement) adaptive behaviors by teaching new skills and promoting generalization of these skills across settings and contexts.
No Intervention: Waitlist; Families randomized to this condition have a 12-week waiting period, after which point they rollover to the NDBI intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Observation of Social Communication Change (BOSCC)	15 items, each scored from 0 (abnormality is not present) to 5 (abnormality is present and significantly impairs functioning. Minimum score = 0 Maximum score = 75 Higher score = higher impact on functioning (worse outcome)	Week 12
Change in Repetitive Behavior Scale for Early Childhood	4 items across 4 subscales; scored from 0 (bx does not occur) to 4 (bx occurs many times per day) Minimum score = 0 Maximum score = 136 Higher score = more frequent/severe repetitive behaviors (worse outcome)	Week 12
Change in Autism Impact Measure	41 items Individual subdomains (frequency and intensity) Minimum score: 41 Maximum score: 205 Higher score = poorer outcomes Total score: Minimum score: 82 Maximum score: 410 Higher score = poorer outcomes	Week 12
Change in Autism Family Experience Questionnaire	48 items, each scored on a 1-5 scale Minimum score = 48 Maximum score = 240 Higher score = poor outcomes	Week 12
Change in Measure of NDBI Strategy Implementation-Caregiver Change	21 items on a 1-5 scale Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation	Week 12
Measure Fidelity	Completed weekly until community provider participants reach 80% fidelity. The form consists of a 15 point questionnaire completed by the trainer, which was created by the study team. The score for each item = NA, 0, 1 or 2. Max fidelity score 24-30 (3 items can be scored as NA meaning not applicable or no opportunity.)	Week 12
Provider Knowledge Gain	Administered before and after synchronous training session conducted by study intervention team to measure community provider participant's knowledge of the training topics. The measure consists of 8 multiple choice questions and 15 short answer questions. Completion of the questionnaires informs provider baseline knowledge as well as future modifications to the training curriculum.	Week 12

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jessica Simacek, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: ICI-2024-33129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No