NCT05176808 Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
| NCT ID | NCT05176808 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2022-02-07 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2022-02-07 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social communication delays by increasing access to clinically validated early behavioral intervention through a telehealth parent coaching model. The investigators will test the hypothesis that telehealth-delivered Naturalistic Developmental Behavioral Intervention parent coaching (TC) is non-inferior to in-person coaching (IPC) for the treatment of core social-communication symptoms in toddlers with either a social communication delay or ASD.
Eligibility Criteria
Inclusion Criteria: * Meeting study criteria for ASD based on: * Autism Diagnostic Observation Schedule(ADOS) criteria for mild-to- moderate concern or greater (for children between 18 and 30 months) or algorithm cut-offs for ASD or autism (31-33 months), * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD) * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts * Meeting study criteria for social communication delay based on: * Scoring a T score of \<35 on Expressive Language and/or Receptive Language subscales, Nonverbal developmental quotient of \> 50 (Visual Reception and Fine Motor subscales averaged) AND Visual reception \> 12 months * Nonverbal developmental quotient (DQ) of \> 63 based on the Visual Reception and Fine Motor subscales * Gestational age of 36-42 weeks; * Birth weight of \> 2,500 grams; * Absence of identifiable neurological (e.g., epilepsy), genetic (e.g., Down syndrome, fragile X, tuberose sclerosis, neurofibromatosis) or severe sensory- motor (e.g., cerebral palsy) conditions. * Able to walk independently. * Children must produce at least three different types of intentional directed (with eye contact or pairing vocalization and gesture) nonverbal or verbal communicative acts per day, with clear and specific examples, per parent report in the Eligibility Interview. Exclusion Criteria: * Having a primary language other than English * Family lives \>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site. * Child lives in foster care.
Contact & Investigator
Rebecca Landa, PhD
PRINCIPAL INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Frequently Asked Questions
Who can join the NCT05176808 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 42 Months, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05176808 currently recruiting?
Yes, NCT05176808 is actively recruiting participants. Contact the research team at landa@kennedykrieger.org for enrollment information.
Where is the NCT05176808 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05176808 clinical trial?
NCT05176808 is sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The principal investigator is Rebecca Landa, PhD at Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. The trial plans to enroll 188 participants.