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

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Autism Spectrum Disorder
Developmental Delay

Treatments

Behavioral: infant telehelp

Study type

Interventional

Funder types

Other

Identifiers

NCT03592654
1249018

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

5 to 12 months old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

12 participants in 1 patient group

infant telehelp condition
Experimental group
Description:
caregiver coaching to improve infant behaviors that indicate they are at risk for autism spectrum disorder
Treatment:
Behavioral: infant telehelp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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