RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Telehealth Parent-Implemented Intervention to Improve Social- Communication Outcomes in Young Children With ASD

Quick Facts

Study Start:2022-02-07
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05176808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 42 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Meeting study criteria for ASD based on:
  2. * 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),
  3. * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)( criteria for ASD)
  4. * ASD diagnosis by clinician (clinical best estimate) by study team clinical research experts
  5. * Meeting study criteria for social communication delay based on:
  6. * 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
  7. * Nonverbal developmental quotient (DQ) of \> 63 based on the Visual Reception and Fine Motor subscales
  8. * Gestational age of 36-42 weeks;
  9. * Birth weight of \> 2,500 grams;
  10. * 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.
  11. * Able to walk independently.
  12. * 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.
  1. * Having a primary language other than English
  2. * Family lives \>40 miles from a Kennedy Krieger Institute-Center for Autism Services, Sciences, and Innovation (CASSI) site.
  3. * Child lives in foster care.

Contacts and Locations

Study Contact

Rebecca Landa, PhD
CONTACT
443-923-7591
landa@kennedykrieger.org
Rachel Reetzke, PhD
CONTACT
443-923-7395
reetzke@kennedykrieger.org

Principal Investigator

Rebecca Landa, PhD
PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Rachel Reetzke, PhD
PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Locations (Sites)

Kennedy Krieger Institute
Baltimore, Maryland, 21211
United States

Collaborators and Investigators

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  • Rebecca Landa, PhD, PRINCIPAL_INVESTIGATOR, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  • Rachel Reetzke, PhD, PRINCIPAL_INVESTIGATOR, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-07
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-02-07
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • Social Communication
  • Language
  • Engagement

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder
  • Autistic Disorder
  • Active Autistic Disorder
  • Autism
  • Asperger Syndrome
  • PDD-NOS
  • Social Communication Delay
  • Mixed Expressive Receptive Language Disorder
  • Other Symbolic Dysfunctions