Clinical trial NCT06908187: Opt-In Early Pilot Study
Official title: Parent Training for Autistic Toddlers: Development and Preliminary Testing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Connecticut Children's Medical Center
name: University of Connecticut
name: University of Texas at Austin
First posted: 2025-04-03
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Social Interaction Rating Scale (SIRS)
timeFrame: It is administered pre- and post-six months of intervention to both groups.
Secondary outcomes:
measure: Autism Impact Measure (AIM)
timeFrame: Once at baseline evaluation and a second at the end of the six months of intervention.
measure: Brief Observation of Social Communication Change (BOSCC)
timeFrame: It is administered at the baseline evaluation and after the six months of intervention or psycho-education.
measure: Early Intervention Parenting Self-Efficacy Scale (EIPSES)
timeFrame: Responses are averaged across items to produce a single parenting self-efficacy score at the baseline evaluation and at the six month post-treatment evaluation.
measure: Parenting Stress Index (PSI-4)
timeFrame: It is administered at the baseline evaluation and at the six month post-treatment evaluation.
Other outcomes:
measure: Treatment Evaluation Inventory - Short Form (TEI-SF)
timeFrame: It will be administered to parents in the intervention group after they have 6-month access to the material.
measure: System Usability Scale (SUS)
timeFrame: Completed at the end of the intervention.
measure: Intervention Uptake via Usage Diary
timeFrame: Multiple times throughout intervention.
measure: Initial Autism Severity measured via the Toddler Autism Symptom Inventory (TASI)
timeFrame: . It will be administered as part of the baseline evaluation and again after the six months of intervention.
measure: Vineland Adaptive Behavior Scales, Third Edition: Survey Interview Form
timeFrame: Administered six months after receiving intervention.
measure: Opt-In-Early Knowledge Check
timeFrame: Completed at baseline and immediately after the intervention.
measure: Child and Family Demographics
timeFrame: Obtained by survey on enrollment.
measure: Initial Concern adapted from the ADI-R
timeFrame: All participants will receive these measures at the beginning of the study.
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Katharine Zuckerman, MD MPH
role: PRINCIPAL_INVESTIGATOR
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