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Search / Trial NCT05176808

Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)

Launched by HUGO W. MOSER RESEARCH INSTITUTE AT KENNEDY KRIEGER, INC. · Jan 3, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Social Communication Language Engagement

ClinConnect Summary

This clinical trial is investigating a new way to help young children with Autism Spectrum Disorder (ASD) improve their social and communication skills. The study is comparing two methods of parent coaching: one that happens in person and another that takes place online through telehealth. The researchers want to see if the online coaching can be just as effective as traditional in-person coaching for helping children express themselves and interact with others.

To be eligible for this trial, children should be between 18 months and 3 years old and diagnosed with ASD by a qualified clinician. They should be able to walk independently and communicate in some way, like using gestures or simple words. If families are interested, they will participate in coaching sessions, which may be done online or in person, and will need to follow some guidelines, like wearing masks during visits. This study aims to make helpful therapies more accessible to families, especially those who might find it hard to travel to a clinic.

Gender

ALL

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.

About Hugo W. Moser Research Institute At Kennedy Krieger, Inc.

The Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is a leading research institution dedicated to advancing the understanding and treatment of neurodevelopmental disorders. With a strong focus on innovative scientific research, the Institute fosters collaboration among experts in various fields, including neuroscience, genetics, and rehabilitation. By conducting rigorous clinical trials and studies, the Institute aims to translate findings into effective interventions that improve the quality of life for individuals with disabilities. Its commitment to excellence in research and patient care positions it as a pivotal player in the advancement of pediatric healthcare and therapeutic solutions.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Rebecca Landa, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Rachel Reetzke, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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