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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Early Achievements- Parent Coaching Intervention

    Behavioral

    Children, along with a caregiver, will be randomized into one of two conditions to receive parent coaching guided by NDBI principles.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Telehealth Parent Coaching (TC)Active comparator 1 intervention
Group B: In-person Coaching(IPC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
8-12 weeks
2

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.

Time frame
8-12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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