Recruiting

Telehealth Coaching

Sponsor:

University of Minnesota

Code:

NCT07520838

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

NDBI

Study Details

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

Study ID

NCT07520838

Start date

Jul 25, 2025

Status verified date

Apr, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Waitlist

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

Interventions

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.

Primary outcome measure

  • Change in Brief Observation of Social Communication Change (BOSCC) [ Time Frame: Week 12 ]
  • Change in Repetitive Behavior Scale for Early Childhood [ Time Frame: Week 12 ]
  • Change in Autism Impact Measure [ Time Frame: Week 12 ]
  • Change in Autism Family Experience Questionnaire [ Time Frame: Week 12 ]
  • Change in Measure of NDBI Strategy Implementation-Caregiver Change [ Time Frame: Week 12 ]
  • Measure Fidelity [ Time Frame: Week 12 ]
  • Provider Knowledge Gain [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Jessica Simacek, PhD

612-624-1450sima0034@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Jessica Simacek, PhD

612-624-1450sima0034@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-09.