About this trial
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
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Early Achievements- Parent Coaching Intervention
BehavioralChildren, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.
Treatment groups
Trial outcomes
Primary outcomes
Child Duration of Joint Attention
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
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.
Sponsors and contacts
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Lead sponsor
United States Department of Defense
Collaborator
Johns Hopkins Bloomberg School of Public Health
Collaborator