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NCT Number: NCT07520838

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Jessica Simacek, PhD

CONTACT

[email protected]

612-624-1450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Brief Observation of Social Communication Change (BOSCC)

    Time frame: Week 12

    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)

  2. Change in Repetitive Behavior Scale for Early Childhood

    Time frame: Week 12

    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)

  3. Change in Autism Impact Measure

    Time frame: Week 12

    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

  4. Change in Autism Family Experience Questionnaire

    Time frame: Week 12

    48 items, each scored on a 1-5 scale

    Minimum score = 48 Maximum score = 240 Higher score = poor outcomes

  5. Change in Measure of NDBI Strategy Implementation-Caregiver Change

    Time frame: Week 12

    21 items on a 1-5 scale

    Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation

  6. Measure Fidelity

    Time frame: Week 12

    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.)

  7. Provider Knowledge Gain

    Time frame: Week 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Simacek, PhD

CONTACT

[email protected]

612-624-1450

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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