Telehealth intervention for young children with autism
Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD
This study tests if a telehealth coaching program can help young children with autism improve their social skills just as well as traditional in-person coaching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Months to 42 Months |
| Sex | All |
| Sponsor | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05176808 on ClinicalTrials.gov |
What this trial studies
This research aims to enhance social-communication outcomes for young children with Autism Spectrum Disorder (ASD) by utilizing a telehealth model for parent coaching. The study will compare the effectiveness of telehealth-delivered Naturalistic Developmental Behavioral Intervention (TC) against traditional in-person coaching (IPC) to determine if TC is equally effective. Participants will be randomized into either the TC or IPC group, receiving twice weekly coaching sessions over a 12-week period. The study will also explore factors that may influence treatment response, such as child behavioral dysregulation and parent stress levels.
Who should consider this trial
Good fit: Ideal candidates are toddlers aged 18 to 33 months diagnosed with mild-to-moderate ASD who meet specific developmental and health criteria.
Not a fit: Patients with severe neurological, genetic, or sensory-motor conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could provide greater access to effective behavioral therapies for children with ASD, improving their social-communication skills.
How similar studies have performed: Previous studies have shown promise in telehealth interventions for ASD, suggesting that this approach could be effective, though this specific model is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Kennedy Krieger Institute — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Landa, PhD — Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study coordinator: Rebecca Landa, PhD
- Email: landa@kennedykrieger.org
- Phone: 443-923-7591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.