Virtual group program to support toddlers with autism
Parent-mediated Intervention for Toddlers With Early Social Communication Challenges or Emerging Autism: A Multi-site Randomized Controlled Trial of a Group-based Virtual Program That Empowers Parents as Change Agents
NA · Holland Bloorview Kids Rehabilitation Hospital · NCT05663970
This study is testing a six-week online program to see if it can help toddlers with autism improve their communication skills with the support of their caregivers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Months to 42 Months |
| Sex | All |
| Sponsor | Holland Bloorview Kids Rehabilitation Hospital (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05663970 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a six-week virtual group-based intervention called Social ABCs, designed for toddlers with autism spectrum disorder (ASD) or related social communication challenges. The program is caregiver-mediated and focuses on enhancing child skills in vocalizations and shared interactions through a combination of group discussions and one-on-one coaching via a virtual platform. The study aims to address barriers to accessing early interventions, particularly in light of COVID-19 restrictions, by providing a more accessible and efficient model of care. Participants will be randomly assigned to either the intervention or control group to assess the program's impact on child and parent outcomes.
Who should consider this trial
Good fit: Ideal candidates are toddlers aged between 36 and 42 weeks' gestation with a confirmed diagnosis of ASD or signs of social communication challenges, who can communicate in English and have access to high-speed internet.
Not a fit: Patients with severe neurological, genetic, or sensory-motor conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly improve communication skills and social interactions in toddlers with autism, enhancing their developmental outcomes.
How similar studies have performed: Previous studies have shown positive results with the in-person version of the Social ABCs program, and a pilot study indicated promise for the virtual group-based adaptation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ability to comprehend and communicate in English * access to high-speed internet for virtual participation * a confirmed diagnosis of ASD made by a qualified professional, or expert clinician impression of red flags for autism spectrum disorder (ASD) or related social communication challenges * born between 36 and 42 weeks' gestation * birthweight \>2,500g * no neurological, genetic, or severe sensory or motor conditions * willing to limit other interventions to 1-hour per week max. if randomized to Treatment Group * consent to collect video recorded data * live within the boundaries of clinical supervisors supervision requirements (Ontario, Alberta or Nova Scotia) Exclusion Criteria: * failure to meet inclusion criteria
Where this trial is running
Toronto, Ontario
- Holland Bloorview Kids Rehabilitation Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Jessica A Brian, PhD, C Psych — Holland Bloorview Kids Rehabilitation Hospital
- Study coordinator: Jessica A Brian, PhD, C Psych
- Email: jbrian@hollandbloorview.ca
- Phone: 4164256220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Social Communication Disorder, Autism or Autistic Traits, Autism Spectrum Disorder With Impaired Functional Language, Autism-Related Speech Delay