Opt-In Early Pilot Study

NCT ID: NCT06908187

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Now - Latinx

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 Type: EXPERIMENTAL

Opt-In Early Latinx intervention

Intervention Type: OTHER

Participants will access to the Opt-In Early training program website, but will be able to access the Spanish language version as well. Families will fill out a usage diary to record their experience.

Intervention Later (Control)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Now - Rural

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 Type: EXPERIMENTAL

Opt-In Early Rural Intervention

Intervention Type: OTHER

Participants will access to the Opt-In Early training program website. Parents will be able to interact with the rural community-oriented aspects of the program. Families will fill out a usage diary to record their experience.

Interventions

Opt-In Early Latinx intervention

Participants will access to the Opt-In Early training program website, but will be able to access the Spanish language version as well. Families will fill out a usage diary to record their experience.

Intervention Type: OTHER

Opt-In Early Rural Intervention

Participants will access to the Opt-In Early training program website. Parents will be able to interact with the rural community-oriented aspects of the program. Families will fill out a usage diary to record their experience.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Parent-child dyads where the child has a definitive or provisional diagnosis of autism
• Children must be aged 15 - 42 months
• Latinx arm parents must be primarily Spanish-speaking or balanced bilinguals
• Rural arm participants would ideally reside in primarily rural communities (identified with RUCA codes; RUCA score >5)

Exclusion Criteria

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

• Minimum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Connecticut Children's Medical Center

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Katharine Zuckerman, MD MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharine Zuckerman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Central Contacts

Katharine Zuckerman, MD MPH

Role: CONTACT

zuckerma@ohsu.edu

503-494-6513

Luis A Rivas Vazquez, B.S.

Role: CONTACT

rivasvaz@ohsu.edu

503-494-5745

Facility Contacts

Thyde Dumont-Mathieu, MD

Role: primary

TDumont@connecticutchildrens.org

860-837-5758

Katharine E Zuckerman, MD MPH

Role: primary

zuckerma@ohsu.edu

503-494-6726

Luis Rivas Vazquez

Role: backup

503-494-5745

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 29344761 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 23748386 (View on PubMed)

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Reference Type: BACKGROUND

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Guimond, A. B., Wilcox, M. J., & Lamorey, S. G. (2008). The Early Intervention Parenting SelfEfficacy Scale (EIPSES) scale construction and initial psychometric evidence. Journal of Early Intervention, 30(4), 295-320

Reference Type: BACKGROUND

Grzadzinski R, Lord C. Commentary: Insights into the Development of the Brief Observation of Social Communication Change (BOSCC). J Ment Health Clin Psychol. 2018;2(5):15-18. doi: 10.29245/2578-2959/2018/5.1166. Epub 2018 Oct 9. No abstract available.

Reference Type: BACKGROUND

PMID: 30854524 (View on PubMed)

Grzadzinski R, Carr T, Colombi C, McGuire K, Dufek S, Pickles A, Lord C. Measuring Changes in Social Communication Behaviors: Preliminary Development of the Brief Observation of Social Communication Change (BOSCC). J Autism Dev Disord. 2016 Jul;46(7):2464-79. doi: 10.1007/s10803-016-2782-9.

Reference Type: BACKGROUND

PMID: 27062034 (View on PubMed)

Dai YG, Thomas RP, Brennan L, Luu ML, Hughes-Lika J, Reilly M, Moreno P, Obe B, Ahmed KB, Berry LN, Goin-Kochel RP, Helt MS, Barton ML, Dumont-Mathieu T, Robins DL, Fein DA. An initial trial of OPT-In-Early: An online training program for caregivers of autistic children. Autism. 2023 Aug;27(6):1601-1615. doi: 10.1177/13623613221142408. Epub 2022 Dec 15.

Reference Type: BACKGROUND

PMID: 36519775 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 33527164 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31275428 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

R34MH132712

Identifier Type: NIH

Identifier Source: secondary_id

View Link

no number

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00025956

Identifier Type: -

Identifier Source: org_study_id