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

NCT07520838 | Recruiting

• 1 other identifier: ICI-2024-33129
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Naturalistic Developmental Behavioral Intervention (NDBI)

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

Families randomized to this condition have a 12-week waiting period, after which point they rollover to the NDBI intervention.

Interventions

NDBI OTHER

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.

Naturalistic Developmental Behavioral Intervention (NDBI)

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jessica Simacek, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Simacek, PhD

CONTACT

612-624-1450; sima0034@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: April 9, 2026
• Study Start: July 25, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)