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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

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

Qualifiers

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

Treatments tested in this trial

  • Early Achievements- Parent Coaching Intervention

Treatment groups

188 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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