28 Participants NeededMy employer runs this trial

FANS-EI for Autism

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called FANS-EI, an educational intervention, to evaluate its impact on caregivers of young children with autism. The study examines caregivers' engagement in early interventions and their feelings of support and confidence. Two groups participate: one receives usual early intervention services, while the other receives additional support through educational text messages and materials. Families with a child aged 12 to 60 months who likely has autism and a supportive family member or friend interested in participating may be a good fit. Participants must speak English. As an unphased trial, this study provides a unique opportunity to enhance understanding and support for caregivers of children with autism.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FANS-EI program is safe for caregiver engagement in early interventions for young children with autism?

Research shows that participants generally tolerate the FANS-EI program well. Studies suggest that people with Autism Spectrum Disorder may experience mild side effects. Thus, those joining the trial are likely to find side effects manageable. However, specific details about side effects are unavailable. This trial phase typically doesn't focus on safety testing and likely relies on earlier safety data. Participants should always discuss any concerns with the trial team.12345

Why are researchers excited about this trial?

Unlike traditional autism treatments that often involve in-person therapy sessions, FANS-EI offers a unique approach by integrating technology and family support. This treatment involves sending educational and motivational text messages to both caregivers and supporters, providing them with valuable insights about autism and child behavior. This method stands out because it allows for flexible, asynchronous learning and engagement, making it accessible and potentially less stressful for families. Researchers are excited because this could empower families, improve understanding, and enhance the effectiveness of early interventions at home.

What evidence suggests that the FANS-EI program is effective for autism?

Research has shown that early support for young children with autism can lead to significant improvements. For example, studies have found that early intervention can enhance thinking skills, with one study noting an average IQ increase of about 18 points. Early support also correlates with better everyday skills and social communication. Specifically, another study found that 87% of children showed developmental progress after 18 months of early support. This trial will compare the FANS-EI program, which emphasizes caregiver involvement in early support, with treatment as usual. Programs like FANS-EI could effectively help children with autism learn important skills.678910

Are You a Good Fit for This Trial?

This trial is for caregivers of children aged 1 to 5 years who have been diagnosed with or are likely to have autism. Caregivers must be receiving early intervention services that include coaching, speak English, and have a family member or friend willing to support them in the study.

Inclusion Criteria

My caregivers and supporters speak English.
I am currently receiving early intervention services with caregiver coaching.
Providers' eligibility criteria
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families receive early intervention as usual or FANS-EI plus EI, with supporters receiving text messages three times a week

6 months
Weekly interactions via text messages

Follow-up

Participants are monitored for caregiver engagement, social support, and intervention outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • FANS-EI

Trial Overview

The study tests the FANS-EI program, which aims to help caregivers become more engaged in early interventions for young children with autism. It looks at how well the program works and how acceptable it is compared to usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: FANS-EIExperimental Treatment1 Intervention
Group II: Treatment as usualActive Control1 Intervention

Find a Clinic Near You

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+

Citations

The Efficacy of Early Interventions for Children with Autism ...

Early interventions led to positive outcomes for cognitive ability (g = 0.32; 95% CI: 0.05, 0.58; p = 0.02), daily living skills (g = 0.35; 95% CI: 0.08, 0.63; ...

Study finds autism early intervention highly effective

At the conclusion of the study, the IQs of the children in the intervention group had improved by an average of approximately 18 points, ...

Evidence About Early Intensive ABA Treatment for Children ...

(2017). An evaluation of the effects of intensity and duration on outcomes across treatment domains for children with autism spectrum disorder. Translational ...

Early Intervention Autism: New Research Shows 87 ...

Early Intervention Autism: New Research Shows 87% Success Rate at 18 Months -

Early Intervention in Severe Autism: Positive Outcome ...

Twenty-nine children improved in cognitive domains, with 66% of children improving in at least three cognitive domains. Autistic symptomatology evaluated in one ...

FANS-EI for Autism · Info for Participants

... FANS-EI will have tolerable side effects & efficacy for patients with Autism Spectrum Disorder and Autism. Learn more about the study.

ANZCTR - Registration

The intervention being studied is a Virtual Reality (VR)-based Emotional Intelligence (EI) training program for children with autism. The primary focus of this ...

The effects of early autism intervention on parents and family ...

This review describes the effects of intervention for young children with autism spectrum disorder (ASD) on parents.

9.

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University of California Health Autism Clinical Trials for 2026

The purpose of this study is to determine cross-sectional and longitudinal medical, behavioral, and cognitive differences between PTEN ASD and ...

Reducing Time to Autism Diagnosis for Toddlers Enrolled in ...

The research team will calculate descriptive statistics of the following outcomes: reliability, fidelity, and EI diagnostic team member agreement. They will ...