Group Social ABCs: Early Intervention for Toddlers With Suspected ASD

Study Overview
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Brief Summary
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The Social ABCs is an evidence-based, developmentally informed, caregiver-mediated behavioural intervention for toddlers with suspected or confirmed Autism Spectrum Disorder (ASD). It is based on principles of Pivotal Response Treatment (PRT, grounded in Applied Behavioural Analysis), and responsive parenting. The two key targets of this program are functional verbal communication and positive caregiver-child affect sharing. This intervention takes place in the context of play and daily routines, and in all contexts is made to be fun. In both a pilot study and a recently completed randomized control trial, toddlers whose caregivers received training in the Social ABCs intervention showed significant gains in early language development (both responsivity and initiations), increased child smiling (mediated by parent smiling), and a trend toward increased social orienting (one important manifestation of social attention). In an effort to make the Social ABCs more feasible for community service providers to provide this intervention to higher number families, an abbreviated version of the Social ABCs intervention is being offered in a mixed group/individual format in a clinic setting. The primary goal of this pilot project is to assess feasibility of this abbreviated program in the novel format and setting. The secondary goal is to train clinical service providers to facilitate this intervention, thus introducing the program into community practice.

Detailed Description
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The Social ABCs intervention was developed to meet the need for evidence-based, feasible, and sustainable interventions for toddlers with emerging ASD. Unlike other more comprehensive programs, the Social ABCs selectively targets only two key developmental areas (i.e., functional spoken language and positive affect). These domains were selected in order to promote developmental progress in areas thought to be central at this developmental stage in ASD. By targeting only two core domains, this program maximizes feasibility and portability (i.e., reduces resource demand) while effecting meaningful change with potential for collateral effects in untargeted, but related, areas. Bolstered by evidence of acceptability, feasibility, and promise from a pilot study, the Social ABCs was subsequently evaluated in a large two-site RCT, demonstrating the efficacy of this caregiver-mediated intervention for toddlers with suspected or confirmed ASD. This study found child-level increases in vocal responsiveness, vocal initiations, child and parent smiling, and a trend toward increased social orienting in toddlers with suspected or confirmed ASD. Findings also demonstrated that caregivers attained fidelity relatively quickly, rated the intervention as highly acceptable, reported increased feelings of self-efficacy, and did not report increased stress associated with the burden of learning and providing the intervention. Although the original Social ABCs model has demonstrated positive outcomes for children and their caregivers, it requires a large time commitment from both the Social ABCs coach and the family. Because of this, only a small number of children can receive the intervention at any given time in the original program. Given the urgent need for access to early interventions in ASD, a modified version of the Social ABCs (Group Social ABCs) will be piloted and evaluated in order to increase access for more families in the community than the existing Social ABCs model. This new model has been carefully adapted to reach more families without sacrificing the meaningful aspects of the program. In the Group Social ABCs project, the Social ABCs intervention itself remains the same as previous versions in terms of targeted skills, content, the parent coaching manual, and evaluation of fidelity and child responsivity. The difference is specifically in the delivery format. While the standard Social ABCs model was designed to be delivered exclusively in families' homes over a 12-week period, the Group Social ABCs model is shortened to 6 weeks and incorporates group informational sessions at Holland Bloorview along with some individualized live coaching sessions that also occur in clinic. By condensing the length of the program, incorporating group sessions, and offering this as a clinic-based program, the researchers hope to provide an intervention that is comparable in efficacy but able to reach a larger number of children than the original model. Specifically, a Social ABCs coach will facilitate the intervention to small groups of 3-5 parents at a time in a clinic setting*, rather than the family's home. This new format allows the program to be completed in 6 weeks, versus the current 12-week model, and also offers the potential benefit of creating a parent support network within the program. Parents will still get live, one-on-one coaching for strategies to use with their child over the course of the program. *In response to the 2020 global COVID-19 pandemic, study activities including both the group didactic and individual coaching sessions have shifted to an online format, with sessions being completed virtually. The protocol, delivery schedule, and session design remain the same. Baseline and follow-up data collection take place via mail and recorded video teleconference. This project is highly relevant to early intervention, and thus outcomes, for children with ASD. This study has the potential to validate a model that will increase access to the Social ABCs for a greater number of families than the original program and will be more accessible to busy families who may not have had time for the original program. This means families who would otherwise not be able to access early intervention will now be able to participate. The primary objective of this pilot study is to understand the impact of the Social ABCs in a condensed group format on child and caregiver outcomes, such as children's vocal communication, children's shared smiling with a caregiver, and caregiver implementation fidelity. The secondary objective is to identify any differences in the current project from previous Social ABCs findings. This may include child and/or caregiver outcomes as well as caregiver feelings of satisfaction with the Social ABCs training. The primary hypothesis predicts that vocal responsivity to caregiver prompts will increase over the course of training. Secondary hypotheses predict the following will increase over the course of the training: child-initiated vocalizations, positive emotion sharing with a caregiver, orienting to caregiver, and caregiver fidelity of implementation.

Official Title
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Group Social ABCs: Early Intervention for Toddlers With Suspected ASD

Conditions
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Autism Spectrum Disorder, Autism

Intervention / Treatment
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* Behavioral: Group Social ABCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The child is a client of Holland Bloorview Kids Rehabilitation Hospital The child has clinically significant concerns of ASD The child participates in a maximum of 1 hour per week (monthly average) of the following interventions: speech/language, occupational, infant development, and physical therapy, and the family agrees to maintain this limit for the study duration The child's diet and medications are stable prior to starting the study, with plans to maintain relatively constant throughout the study. The caregiver is conversant in English and could be coached in English Exclusion Criteria: The child has other neurological disorders or genetic syndromes that have known association with ASD (e.g., Fragile X syndrome) The child has significant uncorrected sensory impairments (vision, hearing, etc.) The child was born preterm (before 36 weeks' gestation) The child is experiencing an active regression of skills The child is involved in other behavioural interventions, such as ABA/IBI and the Hanen programs The child's diet and medications are undergoing drastic changes The caregiver has previously been trained in the Social ABCs or other PRT-based intervention program

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Social ABcs<br>Participants receiving Group Social ABCs intervention | Behavioral: Group Social ABCs<br>* Social ABCs coach will facilitate the intervention to small groups of parents in a clinic setting, rather than the family's home. This new format allows the program to be completed in 6 weeks, versus the current 12-week model, and also offers the potential benefit of creating a parent support network within the program. Parents will still get live, one-on-one coaching for strategies to use with their child over the course of the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal Responsivity | Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal Initiations | Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute | Baseline, Week 6 | 
| Social Orienting | Change in percentage of intervals with instances of social orienting (child looking at parent) per 10-minute video observation | Baseline, Week 6 | 
| Caregiver Fidelity of Implementation | Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation | Baseline, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social ABCs, Naturalistic Developmental Behaviour Intervention, Autism, Early Identification, Early Intervention, Autism Spectrum Disorder (ASD), Toddler, Pivotal Response Treatment (PRT), Group Intervention, Parent-Mediated, Caregiver-Mediated, Social Communication, Positive Affect, Social Smiling, Social Orienting, NDBI