What side effects are associated with this type of intervention?

Telehealth tools like the Telehealth Evaluation of Development for Infants (TEDI) and 'Help is in Your Hands' (HIIYH) focus on supporting behavioral and communication development in infants with ASD. These interventions generally have minimal physical side effects since they are non-invasive and primarily involve behavioral strategies and parent training. However, potential challenges may include increased screen time, which could lead to eye strain or reduced physical activity. Additionally, the effectiveness of these interventions can be influenced by the caregiver's ability to consistently implement the strategies, which may cause stress or frustration for some families.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the core symptoms of Autism Spectrum Disorder (ASD). The focus of many interventions, including those studied in the Telehealth Evaluation of Development for Infants (TEDI) and 'Help is in Your Hands' (HIIYH), is on behavioral and communication development rather than pharmacological treatment. These telehealth tools aim to support early behavioral interventions and communication strategies for infants with ASD, which are critical areas of focus in non-pharmacological ASD management.

What other types of research exist?

Promising alternatives to TEDI and HIIYH for supporting behavioral and communication development in infants with ASD include: 1) AIM HI (Individualized Mental Health Intervention for ASD), which is a collaborative, caregiver-mediated intervention aimed at reducing challenging behaviors; 2) Spartan Caregiver Support, which provides on-demand telehealth services to caregivers for social and behavioral support; and 3) Integrative models that combine developmental and behavioral approaches, such as the Denver model and DIR/Floortime, which focus on social communication and emotional relationships.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 12 weeks

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

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

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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

2,869 Previous Clinical Trials

2,777,456 Total Patients Enrolled

83 Trials studying Autism Spectrum Disorder

40,517 Patients Enrolled for Autism Spectrum Disorder

University of California, DavisLead Sponsor

928 Previous Clinical Trials

4,720,938 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

342 Previous Clinical Trials

410,388 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 Sep 2025

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