Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder

NCT03592654 | Completed

• 1 other identifier: 1249018
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Caregiver coaching will be provided using telehealth technology, in order to determine the efficacy and effectiveness of the telehealth medium of intervention delivery for caregivers of infants with concern for ASD.

Conditions

Autism Spectrum Disorder; Developmental Delay

Outcome Measures

Primary Outcomes (1)

• Child Behaviors Targeted by Intervention

  Treatment-targeted child behaviors (e.g., visual fixations on objects, abnormal repetitive behaviors, lack of age-appropriate phonemic development, lack of coordination of gaze, affect, and voice in reciprocal, turn-taking interactions) will be coded from 10-minute caregiver-infant dyad intervention video probes taken throughout all phases of the study.

  7 months

Secondary Outcomes (7)

• Autism Observation Scale for Infants

  7 months

• Ages and Stages Questionnaires, 3rd Edition

  7 months

• Individual Growth and Development Indices

  7 months

• Vineland Adaptive Behavior Scales, 2nd edition

  7 months

• Parent Satisfaction Rating

  7 months

Study Arms (1)

infant telehelp condition

EXPERIMENTAL

caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder

Behavioral: infant telehelp

Interventions

infant telehelp BEHAVIORAL

Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention

infant telehelp condition

Eligibility Criteria

• Age: 5 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants must exhibit early symptoms of ASD as indicated by a combination of Autism Observation Scale for Infants (AOSI) scores of 7 or higher
• and Infant Toddler Checklist (ITC) scores in the autism concern range
• Expression of clinical concern about ASD risk by the assessor and caregiver
• Caregivers must be identified as the infants' primary caregivers
• Caregivers be English speaking
• Caregivers must have access to wired or wireless network technology to access the internet in their homes.

You may not qualify if:

• Infants may not have had significant abnormalities in the pre-, peri-, and postnatal period or gestational age younger than 34 weeks
• Infants may not have serious medical conditions involving repeated or lengthy hospitalizations, head injuries, seizures, cerebral palsy or impaired hand use
• Infants may not have multiple daily administrations of medical treatment (e.g., nebulizers daily)
• Infants may not have known genetic syndrome associated with ASD (e.g., fragile X syndrome) Infants may not have moderate to severe visual, auditory, or motor impairments
• A caregiver may be excluded from participation if the caregiver is engaging in the majority of all possible caregiver treatment target behaviors at therapeutic levels during intake (Fidelity of Implementation scores of 80% or higher on each caregiver target behavior).

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

MIND institute

Sacramento, California, 95834, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Dufek, PhD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single subject multiple baseline design

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 19, 2018
• Study Start: July 1, 2018
• Primary Completion: September 18, 2019
• Study Completion: October 1, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)