NCT05176808Completed
Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 8 Dec 2021
- Start date
- 7 Feb 2022
- Primary completion date
- 10 Apr 2026
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Diseases
- Autism
- NCT number
- NCT05176808
What you commit to
- Study type: Interventional
- Participants enrolled: 117
- From 7 Feb 2022 to the primary completion date, 10 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 months to 42 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kennedy Krieger Institute Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.