OPT-In-Early for Autism Spectrum Disorder
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
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.12345
What makes the Opt-In Early treatment for Autism Spectrum Disorder unique?
What data supports the effectiveness of the Opt-In Early treatment for Autism Spectrum Disorder?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for changes in parent fidelity, child social communication, autism symptoms, and developmental delays.
What Are the Treatments Tested in This Trial?
Interventions
- Opt-In Early Latinx intervention
- Opt-In Early Rural Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oregon Health and Science University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Connecticut Children's Medical Center
Collaborator
University of Connecticut
Collaborator
University of Texas at Austin
Collaborator