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

NCT ID: NCT03592654

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-10-01

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.

Detailed Description

Ideally, all caregivers with an infant identified with concern for ASD would have immediate access to good quality caregiver coaching provided in the most natural environment possible. However, this is currently not the case for the majority of families. There are no empirically validated treatment programs for infants showing ASD risk. The proposed research project will use Applied Behavior Analysis-based single-subject experimental designs to further develop a promising caregiver-mediated intervention designed for infants showing early signs of ASD. Caregiver coaching will be provided using telehealth technology, in order to maximize recruitment opportunities and 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

infant telehelp condition

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

Group Type: EXPERIMENTAL

infant telehelp

Intervention Type: BEHAVIORAL

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

Interventions

infant telehelp

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Dufek, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Davis

Locations

MIND institute

Sacramento, California, United States

Countries

United States

Other Identifiers

1249018

Identifier Type: -

Identifier Source: org_study_id