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Telehealth Support for Autism

N/A
Waitlist Available
Led By Meagan Talbott, Ph.D.
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test two online tools to help families with infants who might have autism. One tool checks how babies are developing, and the other gives parents videos and tips to help their babies communicate better. The study will see if these tools make it easier for families to get the help they need.

Who is the study for?
This trial is for families who were previously enrolled in a study evaluating infants' behavioral development (R21 HD100372). It's designed to help those with concerns about Autism Spectrum Disorder (ASD) in their infants by using telehealth tools.
What is being tested?
The study tests two telehealth tools: 'Telehealth Evaluation of Development for Infants' (TEDI) and 'Help is in Your Hands' (HIIYH), which provides videos and information to support child communication. Families will be randomly chosen to either receive HIIYH immediately or after 12 weeks.
What are the potential side effects?
Since this trial involves educational materials and questionnaires, there are no direct medical side effects. However, participants may experience stress or fatigue from the time commitment required.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parent Sense of Competence
Parent Stress Index 4th Edition, Short Form
Telehealth Usability Questionnaire

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HIIYHExperimental Treatment1 Intervention
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.
Group II: ComparisonActive Control1 Intervention
No additional materials

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Autism Spectrum Disorder (ASD) often focus on improving social communication and adaptive behaviors through structured, evidence-based strategies. Interventions like the Telehealth Evaluation of Development for Infants (TEDI) and 'Help is in Your Hands' (HIIYH) use technology to enhance parent-child interactions and provide consistent, individualized support. These methods are crucial as they address core deficits early in development, potentially leading to better long-term outcomes in social, cognitive, and adaptive functioning for ASD patients.
Clinician Knowledge, Confidence, and Treatment Practices in Their Provision of Psychotherapy to Autistic Youth and Youth with ADHD.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Telehealth and autism: A systematic search and review of the literature.

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Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,892 Previous Clinical Trials
2,722,647 Total Patients Enrolled
83 Trials studying Autism Spectrum Disorder
40,500 Patients Enrolled for Autism Spectrum Disorder
University of California, DavisLead Sponsor
936 Previous Clinical Trials
4,719,649 Total Patients Enrolled
14 Trials studying Autism Spectrum Disorder
5,821 Patients Enrolled for Autism Spectrum Disorder
National Center for Advancing Translational Sciences (NCATS)NIH
354 Previous Clinical Trials
410,782 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
553 Patients Enrolled for Autism Spectrum Disorder

Media Library

Help is in Your Hands Clinical Trial Eligibility Overview. Trial Name: NCT04881656 — N/A
Autism Spectrum Disorder Research Study Groups: HIIYH, Comparison
Autism Spectrum Disorder Clinical Trial 2023: Help is in Your Hands Highlights & Side Effects. Trial Name: NCT04881656 — N/A
Help is in Your Hands 2023 Treatment Timeline for Medical Study. Trial Name: NCT04881656 — N/A
~20 spots leftby Oct 2025