Opt-In early intervention program for young children waiting for an autism diagnosis.
Official title: Opt In - Implementation and Evaluation of an Early Intervention Program for Children Waiting to Receive an Autism Diagnosis
Run by Drexel University · NCT07081724 · Data updated 2026-11-12
This program tests an online parent-training course to help toddlers (16–48 months) showing signs of autism whose families are on a waitlist for a formal diagnosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Months to 48 Months |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Drexel University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | August 25, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | January 28, 2026 |
| Trial ID | NCT07081724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking caregivers of children aged 16–48 months who are on a waitlist for a formal autism evaluation and screen positive on the M-CHAT-R/F but do not yet have a formal autism diagnosis.
✕Probably not a fit
Children who already have a formal autism diagnosis, are receiving more than 5 hours per week of evidence-based autism-specific intervention, or have major medical, motor, sensory, or genetic conditions listed in the exclusions may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized intervention offers an online, parent-mediated early behavioral intervention (OPT-In-Early) to families of children awaiting an autism diagnostic evaluation. Eligible children are 16–48 months old, identified as at-risk on the M-CHAT-R/F, and have not yet received a formal autism diagnosis or intensive autism-specific therapy. Participants are randomized to receive the online parent training promptly or to continue usual care/waitlist procedures, with outcomes measured in child social-communication and parent implementation of strategies. The approach aims to deliver evidence-based practices sooner by teaching caregivers skills they can use while diagnostic and service access delays are resolved.
Why it matters
Potential benefit: If successful, the program could give families practical tools to improve early social and communication skills before a formal diagnosis and reduce lost time waiting for services.
How similar studies have gone: Prior clinical trials of parent-mediated early interventions have demonstrated benefits, so this program builds on an evidence base that shows promise for early caregiver-delivered approaches.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 16-48 months, * parental consent * being on a waitlist to receive a formal diagnostic evaluation at the time of parent consent due to autism concerns * parents speak English * an initial score of 8 or greater or Follow-Up score of 2 or greater on the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F; Robins et al., 2014) as an indication of autism likelihood. Exclusion Criteria: * having already received a formal diagnosis of autism * enrollment in early intervention programs delivering more than 5 h per week of evidence-based autism-specific interventions at the time of consent * child has a gestational age less than 36 weeks associated with a birth weight less than 2500 g * the child is not yet walking, or has severe hearing and/or vision impairment that is uncorrected with aids, or known neurological disorder or genetic syndrome (e.g., Down syndrome).
Where it's running
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A.J. Drexel Autism Institute
Philadelphia, Pennsylvania, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.