Back to resultsEvaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes
Primary Purpose
Autism Spectrum Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Help is in Your Hands
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring autism, telehealth
Eligibility Criteria
Inclusion Criteria:
Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Exclusion Criteria:
No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Sites / Locations
- University of California Davis Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HIIYH
Comparison
Arm Description
Help is in Your Hands is a series of online modules for parents with narrated videos of specific interactive strategies for supporting toddlers' communication development.
No additional materials
Outcomes
Primary Outcome Measures
Parent Stress Index 4th Edition, Short Form
Mean Score
Parent Sense of Competence
Mean Score
Telehealth Usability Questionnaire
Mean Score
Secondary Outcome Measures
Full Information
NCT ID
NCT04881656
First Posted
May 6, 2021
Last Updated
September 13, 2023
Sponsor
University of California, Davis
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04881656
Brief Title
Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes
Official Title
Evaluating the Impact of Telehealth-Based Autism Spectrum Disorder Assessments and Supports on Child and Caregiver Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
May 31, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall goal of this study is to evaluate telehealth and internet-based approaches to meet accessibility challenges for families with concerns about ASD in their infants. In this study, we will gather exploratory data related to the potential of two telehealth tools: 1) The Telehealth Evaluation of Development for Infants (TEDI); and 2) "Help is in Your Hands" (HIIYH), a set of video materials and information on interactive strategies parents can use to support their child's communication development. We will recruit families participating in an ongoing study using the TEDI (R21 HD100372, PI: Talbott) to evaluate infants' behavioral development. As families exit the parent TEDI study and enter the current study, we will ask parents to complete online questionnaires, and randomize them to either receive immediate access to additional online materials (HIIYH) for parents or no additional materials. After 12 weeks, parents will complete online questionnaires and all families will then be given access to the online materials. When children reach 30 months, we will collect additional questionnaires, complete a live telehealth behavioral session with toddlers and their caregivers, and conduct an exit interview with parents to gather feedback about their experience.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, telehealth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIIYH
Arm Type
Experimental
Arm Description
Help is in Your Hands is a series of online modules for parents with narrated videos of specific interactive strategies for supporting toddlers' communication development.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
No additional materials
Intervention Type
Other
Intervention Name(s)
Help is in Your Hands
Other Intervention Name(s)
HIIYH
Intervention Description
HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.
Primary Outcome Measure Information:
Title
Parent Stress Index 4th Edition, Short Form
Description
Mean Score
Time Frame
Change from baseline at 12 weeks
Title
Parent Sense of Competence
Description
Mean Score
Time Frame
Change from baseline at 12 weeks
Title
Telehealth Usability Questionnaire
Description
Mean Score
Time Frame
Change from baseline at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Exclusion Criteria:
No previous enrollment in the parent R21 project (R21 HD100372, PI: Talbott).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meagan Talbott, Ph.D.
Organizational Affiliation
University of California Davis, MIND Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://studypages.com/s/telehealth-evaluation-of-development-for-toddlers-372508/
Description
Learn more or sign up for the study here!
Learn more about this trial
Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes
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