NCT05176808 · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Early Achievements- Parent Coaching Intervention
Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
Primary outcome measures
Child Duration of Joint Attention
Time frame: 8-12 weeks
10 minute caregiver/child play samples will be coded using an engagement coding schema. The schema differentiates different levels of engagement. This data will be used to compare duration of engagement states at pre- and post-testing.
Parent Fidelity of Implementation
Time frame: 8-12 weeks
Parent fidelity of implementation will be coded from the parent-child interaction sample obtained within the home at baseline and post-intervention by trained (to reliability) research assistants blind to group membership and timing of sample. This form consists of 26-items, where each item is rated using a 3-point Likert-type scale. Items reflect the key elements of Natural Developmental Behavioral Interventions (NDBI) which have been assessed in parent-implemented NDBI studies found to improve child social-communication outcomes. Ratings are based on effectiveness (well-timed, variety, developmental appropriateness) and frequency/consistency.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Baltimore, Maryland
Collaborators
United States Department of Defense, Johns Hopkins Bloomberg School of Public Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2026 · Source of record for eligibility and locations