Opt-In Early Pilot Study for Autism Spectrum Disorder

This study is testing the Opt-In Early training program, an online tool designed to help parents of young children with autism. It aims to provide support while families wait for diagnoses or interventions, which can often take a long time. The study has two versions: one for Latinx families (available in Spanish) and one for rural families. Researchers want to see if using this program helps improve children's social interaction skills. You might be able to join if you have a child aged 15 to 42 months with a confirmed or suspected autism diagnosis. For the Latinx group, parents should primarily speak Spanish or be balanced bilinguals. For the rural group, families should ideally live in rural communities. The study plans to enroll 120 parent-child pairs.

Study design
This is an interventional pilot study planning to enroll 120 parent-child pairs. It is not specified if it is randomized or blinded.
What's involved
Families will access the Opt-In Early training program website and fill out a usage diary to record their experience. Social interaction skills will be measured before and after six months of using the program.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months after starting the intervention to measure social interaction skills.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06908187

Opt-In Early Pilot Study

Not Yet Recruiting
NAAges 15+InterventionalSupportive care
Oregon Health and Science University
~120 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:Opt-In Early Latinx interventionOpt-In Early Rural Intervention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Social Interaction Rating Scale (SIRS)
Measured over It is administered pre- and post-six months of intervention to both groups.
Autism Spectrum Disorder

NCT06908187

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Connecticut Children's Medical Center

    Hartford, Connecticutstudy coordinator listed

  • Oregon Health & Science University

    Portland, Oregonstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Katharine Zuckerman, MD MPH · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Diagnosed with another major developmental condition (e.g., Down Syndrome, Hearing Impairment)
  • Social Interaction Rating Scale (SIRS)It is administered pre- and post-six months of intervention to both groups.

    It is a measure of observed parent use of intervention strategies, to assess Parent Fidelity. This is observational measure is videotaped and coded by a trained rater blind to group. Parents are asked to do 4 activities with their child, keeping the child as engaged as possible: (1) Work on a puzzle (2) Teach your child to imitate you doing a simple behavior that you haven't already taught them to imitate; (3) Play with your child using bubbles. (4) Feed your child a snack. Each activity is recorded for 3 minutes. Parents' responsivity to the child based on behavioral and affective principles emphasized throughout OPT-In- Early are coded: positive affect, contingent reinforcement, appropriate directiveness, promotion of eye contact, and appropriate level of prompting. Each item is scored on a 5-point Likert scale Scores on the 5 items are also summed to yield a total score. OPT-In-Early pilot data demonstrated good-to-excellent ICC's for between-rater reliability for these SIRS items.