OPT-In-Early for Autism Spectrum Disorder

Not yet recruiting at 1 trial location

Overseen By Luis A Rivas Vazquez, B.S.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Down syndrome, Hearing impairment, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Latinx and rural-living families with young children who have, or might have, autism. It provides a free, online program called the Opt-In Early Latinx Intervention or Opt-In Early Rural Intervention. This program teaches parents how to enhance their child's development while awaiting formal diagnosis or services. Available in Spanish and English, it focuses on improving communication and reducing challenging behaviors. Families with children aged 15-42 months who primarily speak Spanish or live in rural areas might find this trial suitable. As an unphased trial, it offers families a unique opportunity to access valuable resources and support early in their child's development.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the OPT-In-Early program is safe for children with autism?

Research has shown that programs like Opt-In Early can assist Latino children with autism and their families. However, specific safety data for the Opt-In Early program is not available. This program serves as an online tool for parents to independently learn ways to support their child's development, using simple language and videos for easy comprehension.

The trial is marked as "Not Applicable" for phase, so specific safety evidence is lacking. However, the program's educational and online nature generally indicates low risk. Parents who have used it provided positive feedback, noting it helped them learn to better support their children without any negative effects.

In summary, while specific safety data is absent, the program's educational nature and positive feedback suggest it is safe for parents seeking early intervention strategies for their children with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Opt-In Early programs because they offer a fresh approach to supporting families of children with new or suspected autism diagnoses. Unlike traditional in-person therapies that often require scheduled visits and can be inaccessible to some families, these programs are online and self-directed, making them highly accessible via smartphones, tablets, or PCs. They are available in multiple languages and designed to fill the gap between initial autism identification and access to more comprehensive services. This flexibility and accessibility make the Opt-In Early programs particularly beneficial for Latinx and rural communities, who might face additional barriers to traditional care.

What evidence suggests that the OPT-In-Early program is effective for autism?

Studies have shown that early support can significantly benefit children with autism by improving their communication, social skills, and adaptability. This trial evaluates the Opt-In Early program, which teaches parents essential skills to support their children. Participants in the "Intervention Now - Rural" arm will receive the Opt-In Early online curriculum designed for rural families, while those in the "Intervention Now - Latinx" arm will receive a version tailored for Latinx families. An initial trial revealed that parents using the program observed positive changes in their behavior and their children's skills. Specifically, interventions that respect Latinx culture have led to better outcomes for both children and parents. Overall, the Opt-In Early program aims to empower parents and enhance their children's development during these crucial early years, especially while waiting for other services. ^{1 2 3 6 7}

Who Is on the Research Team?

Katharine Zuckerman, MD MPH

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for Latinx and rural-living children with diagnosed or suspected autism who face long wait times for intervention. It's designed to help parents use mobile devices to teach their kids important skills while waiting for professional help.

Inclusion Criteria

Rural arm participants would ideally reside in primarily rural communities (identified with RUCA codes; RUCA score >5)

My child has been diagnosed with autism.

My child is between 15 and 42 months old.

Exclusion Criteria

Diagnosed with another major developmental condition (e.g., Down Syndrome, Hearing Impairment)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the Opt-In-Early online program, a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with autism.

6 months

Self-paced online access

Follow-up

Participants are monitored for changes in parent fidelity, child social communication, autism symptoms, and developmental delays.

6 months

2 assessments (baseline and 6-month follow-up)

What Are the Treatments Tested in This Trial?

Interventions

• Opt-In Early Latinx intervention
• Opt-In Early Rural Intervention

Trial Overview The study tests a bilingual Spanish/English online program, OPT-In-Early, that trains parents in behavior analysis and naturalistic interventions. The pilot RCT will compare immediate access to the program against delayed access (wait-list control).

How Is the Trial Designed?

Group I: Intervention Now - Rural Experimental Treatment 1 Intervention

Families assigned to the Intervention Now group will receive the Opt-in Early online curriculum/website in their preferred language(s). Opt-in Early is a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with new or suspected autism diagnoses. It is a mobile-device compatible website that can be accessed on any smart phone, tablet, or PC. The program is designed to bridge the time between when autism is first identified and when a child accesses more definitive services. It can also be used by parents who do not desire, or who cannot access in-person services. The program is publicly available and has 6 core modules and 6 optional modules, each of which takes \~1 hour to complete, as well as a detailed resource guide. It can be offered by primary care practices, autism specialty clinics, and educational programs, and requires minimal family support.

Group II: Intervention Now - Latinx Experimental Treatment 1 Intervention

Families assigned to the Intervention Now group will receive the Opt-in Early online curriculum/website in their preferred language(s). Opt-in Early is a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with new or suspected autism diagnoses. It is a mobile-device compatible website that can be accessed on any smart phone, tablet, or PC. The program is designed to bridge the time between when autism is first identified and when a child accesses more definitive services. It can also be used by parents who do not desire, or who cannot access in-person services. The program is publicly available and has 6 core modules and 6 optional modules, each of which takes \~1 hour to complete, as well as a detailed resource guide. It can be offered by primary care practices, autism specialty clinics, and educational programs, and requires minimal family support.

Group III: Intervention Later (Control) Active Control 1 Intervention

Families randomized to Intervention Later (control arm) will be offered (a) viewing of a 7-minute English or Spanish Youtube video about autism evaluation and treatment options (b) print educational materials (5th-grade reading level) about developmental delays, the meaning of screening positive for possible autism, and how to navigate the Early Intervention system in their state (Oregon or Connecticut), and (c) English or Spanish versions of the Autism Speaks First Concerns to Action Kit.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Connecticut Children's Medical Center

Collaborator

Trials

76

Recruited

30,000+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Published Research Related to This Trial

Involving parents in interventions for children with Autism Spectrum Disorder (ASD) is crucial, especially for Latinx families, as it enhances education about ASD, improves parent-child interactions, and provides access to resources.

Cultural factors such as language, family dynamics, community support, and the therapeutic relationship must be considered when designing interventions for Latinx families to ensure effective participation and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Ecological Validity Model to adapt parent-involved interventions for children with Autism Spectrum Disorder in the Latinx community: A conceptual review. Martinez-Torres, K., Boorom, O., Nogueira Peredo, T., et al.[2023]

Out of 150 studies on non-medication interventions for young autistic children, only 11 reported any adverse events, highlighting a significant gap in safety reporting in this area of research.

Among the studies that did report on participant withdrawal, 10 identified reasons that could be classified as adverse events, suggesting that researchers need to improve their methods for tracking and reporting these occurrences to better inform families and professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. Bottema-Beutel, K., Crowley, S., Sandbank, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06908187

Study Details | NCT06908187 | Opt-In Early Pilot Study Opt-in Early is a self-directed parent-training program targeting cognitive, language, social, and adaptive behaviors in children with new or suspected autism ...

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11065424

Parent Training for Latinx Autistic Toddlers In pilot the RCT, parents (half of whom were self-identified as Latinx) rated the program very highly and showed positive changes in behavior and knowledge. The ...

3. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-11-2025-da216

OPT-In-Early for Autism Spectrum Disorder Research shows that culturally tailored interventions, like the Opt-In Early treatment, can improve outcomes for Latino children with autism and their families.

4. opyacare.com opyacare.com/blog/review-of-the-efficacy-of-early-initiation-of-speech-therapy-and-its-positive-impact-on-autism-spectrum-disorder/

Early Initiation of Speech Therapy and Its Positive Impact ... The key improvements reported were a substantial increase in cognitive ability, effective communication, better social skills, and, most ...

5. researchgate.net researchgate.net/publication/373590431_Meta-analysis_of_effectiveness_of_parent-mediated_telehealth_interventions_in_children_with_Autism_spectrum_disorder

Meta-analysis of effectiveness of parent-mediated ... Telehealth training may benefit parents' use of early intervention for children with autism spectrum disorder (ASD). This study is one of the few randomized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4180801/

Conceptualization of Autism in the Latino Community and ... Early identification of autism spectrum disorders (ASD) has been linked to improved long-term developmental outcomes. However, Latino children are diagnosed ...

7. discoveryaba.com discoveryaba.com/aba-therapy/autism-in-spanish?8936781b_page=21

Autism in Spanish Unveiled Research indicates that Latino children are diagnosed with Autism Spectrum Disorder (ASD) approximately 2.5 years later than their white non-Latino counterparts ...