Clinical trial NCT03592654: Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder
Official title: Pilot Study: A Telehealth Intervention for Caregivers of Infants With Early Signs of Autism Spectrum Disorder- Infant TeleHelp Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Developmental Delay
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 12
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: single subject multiple baseline design
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Child Behaviors Targeted by Intervention
timeFrame: 7 months
Secondary outcomes:
measure: Autism Observation Scale for Infants
timeFrame: 7 months
measure: Ages and Stages Questionnaires, 3rd Edition
timeFrame: 7 months
measure: Individual Growth and Development Indices
timeFrame: 7 months
measure: Vineland Adaptive Behavior Scales, 2nd edition
timeFrame: 7 months
measure: Parent Satisfaction Rating
timeFrame: 7 months
measure: Working Alliance Scale for Interventions with Children
timeFrame: 7 months
measure: Caregiver Fidelity of Treatment Implementation
timeFrame: 7 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: MIND institute
state: California
Study officials:
affiliation: UC Davis
name: Sarah Dufek, PhD
role: PRINCIPAL_INVESTIGATOR
References: