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

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"We hope to learn how to support families concerned with their infants’ development."
Age: 5 months - 12 months
Gender:
Any
Healthy Volunteers: No
Keywords: early signs of autism spectrum disorder, autism, autism spectrum disorder, developmental disorder, early autism
Type: Behavioral study
Target:
20 Participants
Investigator:
Description
We hope to learn how to support families concerned with their infants’ development.

We want to see if we can support families using telehealth technology.

We hope to develop assessments to track infant developmental progress. If needed, we will coach primary caregivers on how to address their infant's developmental concerns.
This study requires

All of the procedures will be done for research and will take place at your home through the use of telehealth technology. The following procedures are not part of regular care and will only be done if you join the study.

1) Primary caregivers will complete the following measures at their first visit and final visit:

  • The Infant-Toddler Checklist (ITC; Wetherby & Prizant, 2002). This is a 5-minute questionnaire which assesses infant’s developing social communication skills.

  • The Ages and Stages Questionnaires, 3rd Edition (ASQ-3; Squires & Bricker, 2015). These questionnaires are designed to assess the developmental performance of infants. The ASQ-3 takes approximately 15 minutes to be completed.

  • The Vineland Adaptive Behavior Scales, 2nd edition (VABS-II; Sparrow et al., 2005). This is a caregiver interview designed to assess infant’s behavior in real life, everyday settings. It takes approximately 30 minutes or less to complete.

  • Family Information, Demographic, and Satisfaction Forms. These take approximately 20 minutes to complete.

  • The Parenting Stress Index Short Form (4th Edition, PSI-4-SF), Beck Depression Inventory (2nd Edition, BDI-2), and the Beck Anxiety Inventory (BEI). These are questionnaires designed to identify sources of parent stress and/or anxious or depressive feelings. In total, they take about 20 minutes to complete.

  • The IGDI Individual Growth and Development Indices – Early Communication Index (IGDIs; Carta et al, 2010). This was developed to assess gains in communication abilities over time. The ECI takes approximately 6 minutes to complete. Our adapted version consists of a play interaction between the infant and his/her primary caregiver.

  • The Autism Observation Scale for Infants (AOSI; Bryson et al., 2006). This was developed to assess social communication and play behaviors in infants. Our adapted version is a play interaction between the infant and his/her primary caregiver. This takes approximately 20 minutes to complete.

2) Between the first and final visit, infants and their primary caregivers may have additional play sessions. The caregiver may be coached by a psychologist to address their developmental concerns about their infants. These sessions will last no more than an hour each, occur no more than three times a week, for no more than six months.

3) All assessment and, if needed, intervention sessions will be digitally recorded. Video recordings will be used by members of the research team to code infant and caregiver behavior. Video recording is a necessary part of the research project.

Who can participate

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).
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you up to $50 for your time and effort. Your will receive a $25 e-gift card at the completions of the initial visit(s) and another gift card of the same value at the completion of the final visit(s).
Resources
Schedule
Study duration and period
We expect that you will be in this research study for a maximum of 7 months.
Recruitment period
From June 26, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Autism Spectrum Disorder
  • Developmental Delay

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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