Group Social ABCs: Early Intervention for Toddlers With Suspected ASD
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|ClinicalTrials.gov Identifier: NCT03499262|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : July 28, 2020
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)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Group Social ABCs: Early Intervention for Toddlers With Suspected ASD|
|Actual Study Start Date :||March 26, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Group Social ABcs
Participants receiving Group Social ABCs intervention
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
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
|Contact: Jessica A Brian, PhD||416 425 6220 ext email@example.com|
|Contact: Kate Bernardi, BAH||416 425 6220 ext firstname.lastname@example.org|
|Holland Bloorview Kids Rehabilitation Hospital||Recruiting|
|Toronto, Ontario, Canada, M4G1R8|
|Contact: Jessica Brian, PhD 416-425-6220 ext 3716 email@example.com|
|Contact: Kate Bernardi, BAH 416-425-6220 ext 3410 firstname.lastname@example.org|
|Principal Investigator: Jessica Brian, PhD|
|Principal Investigator:||Jessica A Brian, PhD||Holland Bloorview Kids Rehabilitation Hospital|