๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-04-01

Opt-In Early Pilot Study (NCT06908187)

Parent Training for Autistic Toddlers: Development and Preliminary Testing

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Oregon Health and Science University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Connecticut Children's Medical Center โ€” Hartford, Connecticut

Age range: 15 Months

๐Ÿงช Interventions in This Study

  • Opt-In Early Latinx intervention (OTHER)
  • Opt-In Early Rural Intervention (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Connecticut Children's Medical Center โ€” Hartford, Connecticut
  • Oregon Health & Science University โ€” Portland, Oregon

๐Ÿ“ž Contact the Study Coordinator

Phone: (503) 494-6513

Email: zuckerma@ohsu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—