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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The Social ABCs is a caregiver-mediated early intervention program, aiming to increase child skills in directed, intentional vocalizations, and shared smiling with a primary caregiver for toddlers identified as early signs or a confirmed diagnosis of autism spectrum disorder (ASD), or having related social communication challenges. A positive RCT was previously completed using the program's in-person individual, 12-week model, and a pilot study showing preliminary promise of the virtual group-based model has also been published. This adaptation to a virtual, group-based model maintains the core components of the intervention, but allows caregivers to meet and discuss the content as a group from their home environments and complete the program in a shorter timeframe. The main questions it aims to answer are: * Is the Social ABCs virtual group-based model an effective early intervention program for toddlers aged 12-42 months with probable or confirmed ASD, or experiencing social communication challenges, when compared to an active control condition? * Can primary caregivers of these toddlers achieve implementation fidelity in the Social ABCs intervention strategies using the 6-week virtual delivery model? Participants will be randomized into the treatment condition (A) where they will receive the Social ABCs virtual group-based intervention or, into a Control condition (B), where they meet virtually with other caregivers in the control groups over the course of 6 weeks, viewing and discussing 3 didactic presentations around general child development content (not autism- or Social ABCs-specific). Video and questionnaire data will be collected before (Time 0) and after (Time 1) the 6 week period. After an additional 6-8 weeks, the same data will be collected from both groups as a follow-up time point (Time 2). Researchers will compare the Treatment group and the Control group to measure change in the target behaviours for the child, the caregiver's use of strategies, as well as caregiver stress and self-efficacy, across time-points.

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 data supports the idea that Virtual Group Social ABCs for Autism is an effective treatment?

The available research shows that the Social ABCs treatment, which is similar to Virtual Group Social ABCs, is effective for young children with autism. In a study, children who received the Social ABCs treatment showed significant improvements in how they responded to their parents and how often they started conversations. Parents also reported feeling more confident in helping their children. This suggests that the treatment can be a cost-effective way to help children with autism improve their social skills. ^{1 2 3 4 5}

What safety data exists for the Virtual Group Social ABCs for Autism treatment?

The Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder has been evaluated for feasibility and acceptability in a multi-site pilot study. The study involved 20 parent-toddler dyads and showed that parents successfully learned the techniques and rated the intervention as highly acceptable. Significant gains in children's functional communication and language were observed, indicating the promise of this intervention. However, specific safety data was not detailed in the provided research abstracts. ^{6 7 8 9 10}

Is the treatment VG Social ABCs a promising treatment for autism?

Yes, VG Social ABCs is a promising treatment for autism. It helps young children improve communication and social skills by training parents to use effective techniques. Studies show that children make significant progress in communication and social interactions, and parents find the program easy to follow and beneficial. ^{3 5 8 11 12}

Research Team

Jessica A Brian, PhD, C Psych

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Progress and outcomes for children with autism receiving parent-managed intensive interventions. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

PEERS® for Preschoolers preliminary outcomes and predictors of treatment response. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Exploring coaching and follow-up supports in community-implemented caregiver-mediated JASPER intervention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Progress and outcomes for children with autism receiving parent-managed intensive interventions. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Cross-site randomized control trial of the Social ABCs caregiver-mediated intervention for toddlers with autism spectrum disorder. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A comparison of two group-delivered social skills programs for young children with autism. [2022]

7. United States 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. [2018]

8. United States 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. [2019]

9. England 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. [2021]

10. China pubmed.ncbi.nlm.nih.gov

[Clinical efficacy of interactive group sandplay versus individual sandplay in the treatment of preschool children with autism spectrum disorder]. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Children with autistic spectrum disorders and speech-generating devices: communication in different activities at home. [2011]

12. England 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. [2018]