Virtual Group Social ABCs for Autism

Overseen By Kate Bernardi, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Holland Bloorview Kids Rehabilitation Hospital

Disqualifiers: Neurological, Genetic, Severe sensory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a virtual, group-based program called Social ABCs (or VG Social ABCs) to support toddlers showing early signs of autism or social communication challenges. The researchers aim to determine if this program improves skills like vocalization and smiling compared to a general child development group. It targets toddlers with signs of autism or confirmed diagnoses, whose parents seek practical, early intervention strategies. Participants must understand English, have internet access, and reside in specific Canadian provinces. As an unphased trial, it offers families access to innovative early intervention strategies that could benefit their child's development.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are in the Treatment Group, you must limit other interventions to 1-hour per week.

What prior data suggests that the Virtual Group Social ABCs model is safe for toddlers with ASD?

Research shows that the Social ABCs program is generally easy for families to use. In past studies, this program helped toddlers with autism improve their social communication skills. These studies found no major negative effects, indicating that the program is safe for young children. Additionally, since the program is offered online, families can safely participate from their homes. Previous experiences with different versions of the Social ABCs program confirmed its safety, making it a promising choice for caregivers who want to support their child's development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Group Social ABCs for autism because it offers a fresh approach to improving social communication skills. Unlike traditional one-on-one therapy sessions, this method uses virtual group sessions, allowing parents to learn together and support each other in a community setting. This approach is not only more flexible and accessible, eliminating geographical barriers, but it also empowers parents with the skills to facilitate their child's development in a natural environment. By fostering peer interaction and parental involvement, Virtual Group Social ABCs has the potential to enhance the social-communication skills of children with autism in a more holistic and engaging way.

What evidence suggests that the VG Social ABCs could be an effective early intervention for autism?

Research shows that the Social ABCs program may improve social communication skills in toddlers with autism or those showing early signs of it. A previous study of the in-person version found it increased vocal interactions and shared smiles between children and their caregivers. In this trial, participants in the Virtual Group Social ABCs arm will complete the online group version, which early pilot study results suggest could be effective. The online format retains the program's main components but is shorter and more accessible. Overall, these studies support the idea that the Social ABCs can help young children with autism develop early communication skills. ^{1 2 3 4 6}

Who Is on the Research Team?

Jessica A Brian, PhD, C Psych

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for toddlers aged 12-42 months with a confirmed diagnosis of ASD or showing early signs, who can understand and speak English. They must have internet access, be born full-term with normal birth weight, and not have severe neurological or sensory conditions. Participants should live in Ontario, Alberta, or Nova Scotia and agree to limit other interventions if assigned to the treatment group.

Inclusion Criteria

You were born between 36 and 42 weeks of pregnancy.

Access to high-speed internet for virtual participation

You weighed more than 2,500 grams at birth.

Exclusion Criteria

Failure to meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Social ABCs virtual group-based intervention or participate in the active control condition over 6 weeks

6 weeks

3 bi-weekly virtual group-based sessions

Follow-up

Participants are monitored for changes in target behaviors and caregiver strategies after the treatment phase

6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VG Social ABCs

Trial Overview

The study tests the Social ABCs program delivered virtually over six weeks to improve communication in toddlers with autism spectrum disorder (ASD). It compares a group receiving this intervention against a control group that discusses general child development. The effectiveness will be measured through changes in behavior and caregiver strategies.

How Is the Trial Designed?

Group I: Virtual Group Social ABCs Experimental Treatment 1 Intervention

\- Participants complete the Group Social ABCs intervention program

Group II: Active Control Condition Active Control 1 Intervention

* Participants complete the active control condition: * 3 bi-weekly (virtual) group-based sessions (i.e., groups of 4-8 parents, over 6 weeks) * psychoeducational curriculum not related to social-communication delivered by study personnel not directly involved in the intervention arm * Families may access any available services in their communities (i.e., treatment as usual), which are recorded * Families will be offered the option to do Group Social ABCs intervention program after completing the Control phase

VG Social ABCs is already approved in Canada for the following indications:

Approved in Canada as Social ABCs for:

• Autism Spectrum Disorder (ASD)
• Social communication challenges

Who Is Running the Clinical Trial?

Holland Bloorview Kids Rehabilitation Hospital

Lead Sponsor

Trials

69

Recruited

14,100+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

IWK Health Centre

Collaborator

Trials

131

Recruited

112,000+

Glenrose Foundation

Collaborator

Trials

10

Recruited

2,500+

Published Research Related to This Trial

In a study of 66 children with autism receiving parent-managed behavioral interventions over an average of 31.6 months, there was no significant change in IQ scores, indicating limited cognitive improvement.

However, there was a notable increase in adaptive behavior scores by 8.9 points, suggesting some progress in daily living skills, although no children over 72 months achieved normal functioning in terms of IQ or mainstream school placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and outcomes for children with autism receiving parent-managed intensive interventions. Bibby, P., Eikeseth, S., Martin, NT., et al.[2019]

The use of speech-generating devices (SGDs) significantly improved the communicative effectiveness of four children with autism during specific home activities, such as mealtime and story reading.

Parental instruction on how to effectively use SGDs in communication with their children played a crucial role in enhancing the children's engagement and interaction during these activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children with autistic spectrum disorders and speech-generating devices: communication in different activities at home. Thunberg, G., Ahlsén, E., Sandberg, AD.[2011]

In a study involving 22 caregiver-child dyads, the PEERS® for Preschoolers (P4P) program showed that 60% of participants improved their social skills after treatment, with 53.85% maintaining these improvements at follow-up (4-16 weeks later).

The program also indicated that fewer social communication difficulties were linked to better social skills and reduced behavioral issues, suggesting that addressing specific autistic traits can enhance the effectiveness of social skills interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PEERS® for Preschoolers preliminary outcomes and predictors of treatment response. Antezana, L., Albright, J., Scarpa, A., et al.[2023]

The Social ABCs intervention significantly improved child vocal responsiveness and initiations, as well as parent behaviors like smiling, in a study of 63 parent-toddler dyads with suspected autism spectrum disorder over 24 weeks.

Parents who participated in the treatment reported increased self-efficacy, suggesting that the intervention not only benefits children but also empowers parents, making it a promising low-resource option for early intervention in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-site randomized control trial of the Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder. Brian, JA., Smith, IM., Zwaigenbaum, L., et al.[2018]

The implementation of a digital screening form for autism risk significantly improved the accuracy of documentation of screening results from 54% to 92%, indicating enhanced quality of care for children at risk for autism spectrum disorders (ASD).

Appropriate actions taken for children who screened positive also increased dramatically from 25% to 85%, showing that the digital tool not only improved documentation but also led to better follow-up care and support for those identified at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Digital Modified Checklist for Autism in Toddlers - Revised with Follow-up to Improve Quality of Screening for Autism. Campbell, K., Carpenter, KLH., Espinosa, S., et al.[2018]

A pilot program in Ontario tested two approaches for coaching caregivers of children with autism, showing that both observation followed by coaching and immediate coaching led to significant improvements in children's social engagement, play, and communication skills.

The intervention was effectively delivered by practitioners, achieving an average success rate of 83%, but attendance for follow-up booster sessions was inconsistent, highlighting the need for more research to tailor interventions to diverse caregiver needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring coaching and follow-up supports in community-implemented caregiver-mediated JASPER intervention. Shire, SY., Shih, W., Barriault, T., et al.[2022]

In a study of 66 young children with autism receiving parent-managed behavioral interventions over an average of 31.6 months, there was a significant increase in adaptive behavior scores by 8.9 points, although IQ scores did not change.

Despite some progress in mental age and language skills, no children over 72 months achieved normal functioning, highlighting that parent-managed interventions may not be as effective as professionally directed programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress and outcomes for children with autism receiving parent-managed intensive interventions. Bibby, P., Eikeseth, S., Martin, NT., et al.[2019]

A social skills intervention for young children with autism showed that both direct teaching and play activities increased prosocial behaviors, but the direct teaching group had greater improvements in social skills.

The study involved 25 children aged 4 to 6, who participated in the intervention for 5 weeks, meeting three times a week, indicating that structured teaching methods can be more effective for skill development in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two group-delivered social skills programs for young children with autism. Kroeger, KA., Schultz, JR., Newsom, C.[2022]

The Incredible Years® Parent Program, adapted for children with autism or language delays (IY-ASLD®), aims to improve developmental outcomes and reduce parental stress, and is being tested for feasibility in the Spanish Public Health System through a pilot trial involving approximately 70 families.

The FIRST STEPS study will assess the acceptability and preliminary effectiveness of the IY-ASLD® program over 22 online sessions, potentially paving the way for evidence-based interventions for families with young children facing neurodevelopmental challenges in Spain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD® program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Valencia, F., Urbiola, E., Romero-González, M., et al.[2021]

The Social ABCs intervention, a 12-week parent-mediated program for toddlers with suspected autism spectrum disorder, was found to be feasible and highly acceptable to parents, with significant improvements in children's functional communication and language skills.

Parents who effectively implemented the techniques showed a positive correlation with their child's responsivity, suggesting that training parents can be a promising and cost-effective early intervention strategy for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder: Feasibility, acceptability, and evidence of promise from a multisite study. Brian, JA., Smith, IM., Zwaigenbaum, L., et al.[2019]

Video modeling, combined with applied behavior analysis, is an effective and low-cost method for improving social skills in children with autism spectrum disorder, as demonstrated in a 22-week study involving 67 parents.

The study showed that while compliance with the training varied, the approach is feasible and offers a valuable resource for parents, especially in areas with limited access to treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedures and compliance of a video modeling applied behavior analysis intervention for Brazilian parents of children with autism spectrum disorders. Bagaiolo, LF., Mari, JJ., Bordini, D., et al.[2018]

A study involving 80 preschool children with autism spectrum disorder (ASD) found that interactive group sandplay significantly improved social withdrawal and overall behavior compared to individual sandplay after three months of treatment.

Both treatment methods were effective, but the interactive group sandplay led to greater improvements in sociability, emotional responses, and reductions in stereotypic behaviors, highlighting its potential as a more beneficial intervention for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. Wang, YX., Lu, GB., Ge, P., et al.[2020]

Citations

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Published Papers

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Virtual Group Social ABCs - Multi-site Randomized Control...

This three-year, multi-site project uses a randomized control trial (RCT) design to evaluate an innovative early intervention program for ...

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The Social ABCs is a parent-mediated intervention for toddlers with suspected or confirmed autism spectrum disorder (ASD).

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clinicaltrials.gov/study/NCT05663970

Study Details | NCT05663970 | Virtual Group Social ABCs

The goal of this randomized control trial is to test the efficacy of the Social ABCs 6 week, group-based model using a virtual delivery platform.

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frontiersin.org

frontiersin.org/journals/child-and-adolescent-psychiatry/articles/10.3389/frcha.2025.1689781/full

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The Social ABCs has been shown to improve early social communication in toddlers with autism or early signs thereof, as demonstrated in a cross- ...

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centerwatch.com/clinical-trials/listings/NCT05663970/virtual-group-social-abcs-multi-site-randomized-controlled-trial

Virtual Group Social ABCs - Multi-site Randomized ...

The goal of this randomized control trial is to test the efficacy of the Social ABCs 6 week, group-based model using a virtual delivery ...