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Clinical Trials/NCT03592654
NCT03592654
Completed
N/A

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

University of California, Davis1 site in 1 country12 target enrollmentJuly 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University of California, Davis
Enrollment
12
Locations
1
Primary Endpoint
Child Behaviors Targeted by Intervention
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
October 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Child Behaviors Targeted by Intervention

Time Frame: 7 months

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.

Secondary Outcomes

  • Autism Observation Scale for Infants(7 months)
  • Ages and Stages Questionnaires, 3rd Edition(7 months)
  • Individual Growth and Development Indices(7 months)
  • Working Alliance Scale for Interventions with Children(7 months)
  • Caregiver Fidelity of Treatment Implementation(7 months)
  • Vineland Adaptive Behavior Scales, 2nd edition(7 months)
  • Parent Satisfaction Rating(7 months)

Study Sites (1)

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