Telehealth Support for Autism

Overseen By Meagan Talbott, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: No previous enrollment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on telehealth tools and does not mention medication changes.

What data supports the effectiveness of the treatment Help is in Your Hands for autism?

Research shows that telehealth can be effective for delivering interventions for autism, such as training caregivers and conducting language assessments. Studies have found high satisfaction rates among caregivers using telehealth for autism-related services, suggesting it can be a useful way to support families. ^{1 2 3 4 5}

Is telehealth support for autism safe for humans?

The research articles do not provide specific safety data for telehealth support for autism or similar treatments like 'Help is in Your Hands.' However, they discuss general systems for tracking adverse events (unwanted effects) in healthcare, which can help identify and address safety issues in various treatments. ^{6 7 8 9 10}

How does telehealth support for autism differ from other treatments?

Telehealth support for autism is unique because it allows for remote caregiver training and virtual visits, making it more accessible and cost-effective compared to traditional in-person treatments. It also offers flexibility and can be adapted to individual needs, although it may require some technological familiarity. ^{1 11 12 13 14}

Research Team

Meagan Talbott, Ph.D.

Principal Investigator

University of California Davis, MIND Institute

Eligibility Criteria

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.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Randomization

Parents complete online questionnaires and are randomized to receive immediate access to additional online materials or no additional materials

1 week

Online

Intervention

Parents receive access to 'Help is in Your Hands' online materials or no additional materials for 12 weeks

12 weeks

Online

Follow-up

Parents complete online questionnaires and participate in a live telehealth behavioral session with toddlers and caregivers

4 weeks

Online

Treatment Details

Interventions

• Help is in Your Hands

Trial Overview 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.

Participant Groups

Group I: HIIYH Experimental Treatment 1 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: Comparison Active Control 1 Intervention

No additional materials

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Findings from Research

Therapist-assisted telehealth interventions significantly improved parent learning compared to self-directed programs, indicating that support from a therapist enhances the effectiveness of parent-mediated strategies for autistic children.

While both intervention types did not significantly reduce parenting stress or improve self-efficacy, parents who completed the program reported a more positive perception of their child's impact, suggesting that engagement is key to realizing benefits from self-directed programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative Efficacy of Self-directed and Therapist-assisted Telehealth Models of a Parent-mediated Intervention for Autism: Examining Effects on Parent Intervention Fidelity, Well-being, and Program Engagement. Ingersoll, B., Frost, KM., Straiton, D., et al.[2023]

A survey of 640 caregivers at Cincinnati Children's Hospital Medical Center revealed that 92% were satisfied with telehealth appointments for Psychology and Psychiatry services after the COVID-19 pandemic, indicating high acceptance and effectiveness of this approach.

Despite overall satisfaction, there were significant drops in satisfaction among caregivers of patients in Group Therapy and those with diagnoses classified as 'Other', suggesting areas for improvement in telehealth services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Telehealth Satisfaction Among Caregivers of Pediatric and Adult Psychology and Psychiatry Patients with Intellectual and Developmental Disability in the Wake of Covid-19. Rosen, V., Blank, E., Lampert, E., et al.[2022]

Adverse events occurred in 1% of pediatric hospitalizations, with 0.6% being preventable, indicating that a significant number of children experience harm due to medical management rather than their underlying conditions.

The most common types of preventable adverse events were birth-related (32.2%) and diagnostic-related (30.4%), highlighting the need for targeted research and interventions in these areas to improve patient safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. Woods, D., Thomas, E., Holl, J., et al.[2007]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

Most parents were unaware of the adverse events following immunization (AEFI) surveillance system but expressed interest in participating, indicating a potential for increased reporting through parental involvement.

Parents preferred online reporting over paper forms due to its convenience and speed, and they would be more likely to report AEFI if the website was endorsed by their vaccine provider and offered secure, interactive features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Factors determining utilization of a Web site by parents in order to report side effects of vaccines]. Kimpton, A., Dubé, E., Sauvageau, C., et al.[2021]

The telehealth system established between the Autism Resource Centre of Brittany and Vannes' Hospital has improved diagnostic precision and support for autistic patients and their families, demonstrating effective collaboration despite geographical distances.

Families reported high satisfaction with the telehealth meetings, which facilitated communication between health professionals and provided timely access to specialized care, while also reducing travel costs and environmental impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telepsychiatry at the service of autism]. Saint-André, S., Neira Zalentein, W., Robin, D., et al.[2011]

Telehealth services for individuals with autism spectrum disorder (ASD) have been shown to be as effective as traditional face-to-face services, based on a review of 14 studies involving 284 participants ranging from 19 months to adulthood.

The use of telehealth in ASD interventions not only matches in-person services but also outperforms groups that did not receive telehealth, indicating potential benefits for families and educators, though more research is needed for direct applications with children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth and autism: A systematic search and review of the literature. Sutherland, R., Trembath, D., Roberts, J.[2019]

Caregiver training interventions for children with autism can effectively enhance social interaction, communication, and positive behaviors, and these interventions can be successfully delivered via telehealth, showing similar positive outcomes as in-person training.

Telehealth methods offer advantages such as cost-effectiveness and increased accessibility, making them a promising solution to address the global treatment gap for families of children with autism, although further research is needed to evaluate their effectiveness across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-delivered caregiver training for autism: Recent innovations. Pacione, L.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

"Giving the patients less work": A thematic analysis of telehealth use and recommendations to improve usability for autistic adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Relative Efficacy of Self-directed and Therapist-assisted Telehealth Models of a Parent-mediated Intervention for Autism: Examining Effects on Parent Intervention Fidelity, Well-being, and Program Engagement. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Telehealth and autism: Are telehealth language assessments reliable and feasible for children with autism? [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Telehealth Training Package to Remotely Teach Caregivers to Conduct Discrete-Trial Instruction. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Telehealth Satisfaction Among Caregivers of Pediatric and Adult Psychology and Psychiatry Patients with Intellectual and Developmental Disability in the Wake of Covid-19. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. [2007]

7. Canada pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Factors determining utilization of a Web site by parents in order to report side effects of vaccines]. [2021]

11. France pubmed.ncbi.nlm.nih.gov

[Telepsychiatry at the service of autism]. [2011]

12. England pubmed.ncbi.nlm.nih.gov

Telehealth and autism: A systematic search and review of the literature. [2019]

13. England pubmed.ncbi.nlm.nih.gov

'The key to this is not so much the technology. It's the individual who is using the technology': Perspectives on telehealth delivery for autistic adults during the COVID-19 pandemic. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Telehealth-delivered caregiver training for autism: Recent innovations. [2023]