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Evaluating the Impact of Telehealth-Based ASD Assessments and Supports on Child and Caregiver Outcomes

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ClinicalTrials.gov Identifier: NCT04881656
Recruitment Status : Recruiting
First Posted : May 11, 2021
Last Update Posted : February 2, 2022
Sponsor:
Collaborators:
National Center for Advancing Translational Sciences (NCATS)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Help is in Your Hands Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Telehealth-Based Autism Spectrum Disorder Assessments and Supports on Child and Caregiver Outcomes
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2033

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HIIYH
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.
 Other: Help is in Your Hands
HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.
Other Name: HIIYH
No Intervention: Comparison
No additional materials


Outcome Measures
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Primary Outcome Measures :
  1. Parent Stress Index 4th Edition, Short Form [ Time Frame: Change from baseline at 12 weeks ]
    Mean Score

  2. Parent Sense of Competence [ Time Frame: Change from baseline at 12 weeks ]
    Mean Score

  3. Telehealth Usability Questionnaire [ Time Frame: Change from baseline at 12 weeks ]
    Mean Score


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04881656


Contacts
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Contact: Meagan Talbott, Ph.D. 916-703-0479 mtalbott@ucdavis.edu

Locations
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United States, California
University of California Davis Health Recruiting
Sacramento, California, United States, 95817
Contact: Omar Garcia, B.A.         
Sponsors and Collaborators
University of California, Davis
National Center for Advancing Translational Sciences (NCATS)
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Meagan Talbott, Ph.D. University of California Davis, MIND Institute
More Information
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Additional Information:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04881656    
Other Study ID Numbers: 1749700
First Posted: May 11, 2021    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, Davis:
autism
telehealth
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders