Study Summary
This trial tests if Social ABCs virtual group-based model is an effective early intervention for toddlers with ASD or related social communication challenges.
- Autism
- Social Communication Disorder
- Autism Spectrum Disorder (ASD)
- Autism Spectrum Disorder with Impaired Functional Language
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 12 Weeks (Time 0 - Time 1- Time 2)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Active Control Condition
1 of 2
Virtual Group Social ABCs
1 of 2
Active Control
Experimental Treatment
120 Total Participants · 2 Treatment Groups
Primary Treatment: Virtual Group Social ABCs · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 12 - 42 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Biggs K, Hind D, Gossage-Worrall R, Sprange K, White D, Wright J, Chatters R, Berry K, Papaioannou D, Bradburn M, Walters SJ, Cooper C. Challenges in the design, planning and implementation of trials evaluating group interventions. Trials. 2020 Jan 29;21(1):116. doi: 10.1186/s13063-019-3807-4.
- Brian J, Drmic I, Roncadin C, Dowds E, Shaver C, Smith IM, Zwaigenbaum L, Sacrey LR, Bryson SE. Effectiveness of a parent-mediated intervention for toddlers with autism spectrum disorder: Evidence from a large community implementation. Autism. 2022 Oct;26(7):1882-1897. doi: 10.1177/13623613211068934. Epub 2022 Jan 15.
- Brian J, Solish A, Dowds E, Roth I, Bernardi K, Perry K, Daoud S, Jilderda S, MacWilliam S, Smith IM, Zwaigenbaum L, Bryson S. "Going Mobile"-increasing the reach of parent-mediated intervention for toddlers with ASD via group-based and virtual delivery. J Autism Dev Disord. 2022 Dec;52(12):5207-5220. doi: 10.1007/s10803-022-05554-7. Epub 2022 May 24. Erratum In: J Autism Dev Disord. 2022 Jul 25;:
- Brian JA, Smith IM, Zwaigenbaum L, Bryson SE. Cross-site randomized control trial of the Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder. Autism Res. 2017 Oct;10(10):1700-1711. doi: 10.1002/aur.1818. Epub 2017 Jun 2.
- Brian JA, Smith IM, Zwaigenbaum L, Roberts W, Bryson SE. The Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder: Feasibility, acceptability, and evidence of promise from a multisite study. Autism Res. 2016 Aug;9(8):899-912. doi: 10.1002/aur.1582. Epub 2015 Dec 21.
- Penner M, Anagnostou E, Ungar WJ. Practice patterns and determinants of wait time for autism spectrum disorder diagnosis in Canada. Mol Autism. 2018 Mar 6;9:16. doi: 10.1186/s13229-018-0201-0. eCollection 2018.
- Jessica Brian 2022. "Virtual Group Social ABCs - Multi-site Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05663970.
Frequently Asked Questions
Is this research endeavor accepting elderly participants above the age of eighty-five?
"This trial stipulates that patients must between the ages of 1 and 3.5 years in order to qualify for enrollment." - Anonymous Online Contributor
How many subjects are being observed for this experiment?
"Yes, according to clinicaltrials.gov, this research is still searching for qualified individuals. First posted on June 27th 2022 and most recently updated in December 15th 2022 the trial needs 120 patients at one site location." - Anonymous Online Contributor
Is this experiment presently accepting participants?
"Verified. According to the clinicaltrials.gov, this medical trial is presently recruiting participants with initial postings occurring on June 27th 2022 and most recent updates arriving December 15th of that same year. In total, 120 patients are needed from one location for completion of the study." - Anonymous Online Contributor
Are there any eligibility criteria to participate in this research project?
"This research initiative looks to enrol up to 120 toddlers between 12 and 42 months of age with a confirmed diagnosis of social communication disorder. To qualify, participants must have basic English comprehension abilities, access to high-speed internet for virtual participation in the study, be born between 36 and 42 weeks' gestation (with birthweight greater than 2,500g) without neurological or genetic issues as well as limited sensory or motor impairments. Moreover, they need to reside within Ontario, Alberta or Nova Scotia while agreeing not to exceed one hour per week on other interventions if randomized into the Treatment Group. In addition, subjects ought to consent to video recorded data" - Anonymous Online Contributor