OPT-In-Early for Autism Spectrum Disorder

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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the Opt-In Early treatment 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. A study found that a similar culturally adapted program increased maternal confidence and improved child social communication. ^{1 2 3 4 5}

Is the OPT-In-Early intervention safe for humans?

The available research on interventions similar to OPT-In-Early for autism spectrum disorder does not provide specific safety data, but a study on adverse event reporting in autism interventions found that only a small number of studies reported adverse events or effects. This suggests a need for more systematic safety reporting in future research. ^{5 6 7 8 9}

What makes the Opt-In Early treatment for Autism Spectrum Disorder unique?

The Opt-In Early treatment is unique because it focuses on culturally and linguistically sensitive interventions for Latinx and rural communities, involving parents in the process to improve interactions and access to resources, which is not commonly emphasized in other treatments. ^{7 10 11 12 13}

What is the purpose of this trial?

Latinx and Rural-living children with diagnosed or suspected autism have especially long wait times for diagnoses and intervention, up to a year or even more. This delayed access to intervention is likely to prevent children from reaching their full potential in skills and adaptive functioning. A comprehensive, online mobile device-based, free intervention that can be used by parents while on these wait lists may optimize their child's development. The investigators have developed such a program, the Online Parent Training in Early Intervention (OPT-In-Early) program. It teaches parents the fundamental principles of both applied behavior analysis and naturalistic interventions, uses non-technical language, video demonstrations, guidance in selecting appropriate skills to teach, embedding teaching into daily routines, and reducing interfering behaviors. It is a self-paced, individualized platform giving parents strategies to strengthen the parent-child relationship, to teach basic skills, such as simple communication, to reduce interfering behaviors, and to establish helpful routines. 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 goal of the current project is to develop, and pilot test a bilingual Spanish/English culturally tailored version of OPT-In-Early for Latinx families in the US, as well as tailoring and testing the program for rural communities of Oregon. First, the investigators will obtain detailed, iterative feedback from bilingual Latinx parents with an autistic child regarding OPT-In-Early. Similar feedback will also be obtained from participants from rural communities of Oregon who also have an autistic child. The investigators will use this feedback to culturally adapt the program content and format. Next, the adapted program will be modified via user testing with Spanish speaking parents and English speaking parents. Finally, the bilingual version will be tested in a six-month pilot RCT, in preparation for a fully powered R01 trial. The investigators will use a wait-list control design: the Intervention Now arm will be given the online program and the Intervention Later arm (controls) will be given educational material about autism. All children will receive a baseline and 6-month follow-up assessment, which will measure parent fidelity in using the intervention principles (the primary outcome), child social communication, level of autism symptoms, impact of autism symptoms, and degree of developmental delays. The Intervention Now group will have two subgroups. One will test the online program with an emphasis placed on the Spanish version, while the other will focus on the English version and complete the program through a rural lens. At the conclusion of this research, the investigators will have developed an evidence-based, comprehensive, freely available, parent-delivered intervention that can be used by US Latinx and rural families on their mobile devices as they await diagnosis and intervention. This will increase parent efficacy and reduce their stress, accelerate children's skills, reduce interfering behavior, and enhance PCPs' willingness to implement universal autism screening.

Research Team

Katharine Zuckerman, MD MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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)

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

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

Cultural Adaptations to Parent-Mediated Autism Spectrum Disorder Interventions for Latin American Families: A Scoping Review. [2022]

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

Feasibility and Outcomes of the Early Start Denver Model Implemented with Low Intensity in a Community Setting in Austria. [2020]

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

Analysis of a Statewide Early Intervention Program for Young Children with ASD. [2022]

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

In Search of Culturally Appropriate Autism Interventions: Perspectives of Latino Caregivers. [2021]

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

A Randomized Waitlist-Control Group Study of a Culturally Tailored Parent Education Intervention for Latino Parents of Children with ASD. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Revisiting an RCT study of a parent education program for Latinx parents in the United States: Are treatment effects maintained over time? [2023]

7. United States 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in intervention research for young autistic children. [2023]

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

Brief Report: The Feasibility and Effectiveness of an Advocacy Program for Latino Families of Children with Autism Spectrum Disorder. [2021]

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

Examining Cultural and Linguistic Sensitivity of Pathways Early Autism Intervention with Hispanic Families. [2023]

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

Enhancing early identification and coordination of intervention services for young children with autism spectrum disorders: report from the Act Early Regional Summit Project. [2019]

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

Effectiveness of Screening in Early Intervention Settings to Improve Diagnosis of Autism and Reduce Health Disparities. [2023]

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

Autism and developmental screening in a public, primary care setting primarily serving Hispanics: challenges and results. [2021]