Virtual Group Social ABCs - Multi-site Randomized Controlled Trial

NCT05663970 | Active Not Recruiting

• 1 other identifier: 0405
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Social Communication Disorder; Autism or Autistic Traits; Autism Spectrum Disorder With Impaired Functional Language; Autism-Related Speech Delay

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Vocal Responsiveness at 6 and 12 Weeks

  Changes in toddlers' vocal responsiveness to their primary caregivers verbal prompts. Ten minute video recordings coded by blinded research coder in one minute intervals. Data from Baseline (Time 0) compared to data at Week 6 (Time 1) and Week 12 (Time 2).

  12 weeks

Secondary Outcomes (7)

• Change from Baseline Parent Implementation Fidelity at 6 and 12 Weeks

  12 Weeks (Time 0 - Time 1- Time 2)

• Change from Baseline Caregiver Self-Efficacy at 6 and 12 Weeks

  12 Weeks

• Change from Baseline Parent Stress at 6 and 12 Weeks

  12 Weeks

• Change from Baseline Vocal Initiations at 6 and 12 Weeks

  12 Weeks

• Change from Baseline Social Orienting at 6 and 12 Weeks

  12 Weeks

Study Arms (2)

Virtual Group Social ABCs

EXPERIMENTAL

\- Participants complete the Group Social ABCs intervention program

Behavioral: VG Social ABCs

Active Control Condition

NO 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

Interventions

VG Social ABCs BEHAVIORAL

The Social ABCs is an evidence-based caregiver-mediated early intervention. This trial examines the 6-week Virtual Group Social ABCs; an adapted model of the existing evidence-based Social ABCs. The targets are functional directed vocalizations and positive emotion sharing with a caregiver. It is provided to small groups of parents (4-8 per group) who meet virtually for a series of 6 didactic learning sessions led by two trained Coaches, supported by the programs Parent Manual, PowerPoint slides, facilitated discussion, reflection, and idea generation. Each family is assigned a Coach, and one parent per family receives 9 individualized, 1:1 live coaching sessions over a 6-week period via the virtual platform with the goal of learning to implement the Social ABCs strategies with their child. 10-min video recordings of caregiver and child are taken at baseline(time 0), post intervention (time 1),and follow up (time 2) as a measurement of fidelity of implementation and child responsivity.

Also known as: Social ABCs, Group-based Social ABCs

Virtual Group Social ABCs

Eligibility Criteria

• Age: 12 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• IWK Health Centre: collaborator
• Glenrose Foundation: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator
• University of Toronto: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Centre

Toronto, Ontario, M4G1R8, Canada

Location

Related Publications (6)

• 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.

  PMID: 31996259 BACKGROUND

• 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.

  PMID: 35037520 BACKGROUND

• 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.

  PMID: 35608785 BACKGROUND

• 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.

  PMID: 28574669 BACKGROUND

• 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.

  PMID: 26688077 BACKGROUND

• 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.

  PMID: 29541438 BACKGROUND

Related Links

• Social ABCs Program Website

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Communication Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders

Study Officials

• Jessica A Brian, PhD, C Psych

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 23, 2022
• Study Start: June 27, 2022
• Primary Completion: April 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

CA (1)