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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07520838
Enrollment
90
Registered
2026-04-09
Start date
2025-07-25
Completion date
2028-07-31
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

OTHERNDBI

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.

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Brief Observation of Social Communication Change (BOSCC)Week 1215 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)
Change in Repetitive Behavior Scale for Early ChildhoodWeek 124 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)
Change in Autism Impact MeasureWeek 1241 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
Change in Autism Family Experience QuestionnaireWeek 1248 items, each scored on a 1-5 scale Minimum score = 48 Maximum score = 240 Higher score = poor outcomes
Change in Measure of NDBI Strategy Implementation-Caregiver ChangeWeek 1221 items on a 1-5 scale Minimum score: 21 Maximum score: 105 Lower score = poorer strategy implementation
Measure FidelityWeek 12Completed 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.)
Provider Knowledge GainWeek 12Administered 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.

Countries

United States

Contacts

CONTACTJessica Simacek, PhD
sima0034@umn.edu612-624-1450
PRINCIPAL_INVESTIGATORJessica Simacek, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026