Group Social ABCs: Early Intervention for Toddlers With Suspected ASD
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ClinicalTrials.gov Identifier: NCT03499262 |
Recruitment Status :
Completed
First Posted : April 17, 2018
Last Update Posted : July 23, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autism Spectrum Disorder Autism | Behavioral: Group Social ABCs | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Group Social ABCs: Early Intervention for Toddlers With Suspected ASD |
Actual Study Start Date : | March 26, 2018 |
Actual Primary Completion Date : | December 23, 2020 |
Actual Study Completion Date : | December 23, 2020 |

Arm | Intervention/treatment |
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Experimental: Group Social ABcs
Participants receiving Group Social ABCs intervention
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Behavioral: Group Social ABCs
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. |
- Vocal Responsivity [ Time Frame: Baseline, Week 6 ]Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation
- Vocal Initiations [ Time Frame: Baseline, Week 6 ]Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute
- Social Orienting [ Time Frame: Baseline, Week 6 ]Change in percentage of intervals with instances of social orienting (child looking at parent) per 10-minute video observation
- Caregiver Fidelity of Implementation [ Time Frame: Baseline, Week 6 ]Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation

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Ages Eligible for Study: | 12 Months to 36 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499262
Canada, Ontario | |
Holland Bloorview Kids Rehabilitation Hospital | |
Toronto, Ontario, Canada, M4G1R8 |
Principal Investigator: | Jessica A Brian, PhD | Holland Bloorview Kids Rehabilitation Hospital |
Responsible Party: | Jessica Brian, Clinical Psychologist, Holland Bloorview Kids Rehabilitation Hospital |
ClinicalTrials.gov Identifier: | NCT03499262 |
Other Study ID Numbers: |
17-745 |
First Posted: | April 17, 2018 Key Record Dates |
Last Update Posted: | July 23, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Social ABCs 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 Naturalistic Developmental Behaviour Intervention NDBI Autism Early Identification |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |