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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 : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
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
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Vocal Responsivity [ Time Frame: Baseline, Week 6 ]
    Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation


Secondary Outcome Measures :
  1. Vocal Initiations [ Time Frame: Baseline, Week 6 ]
    Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute

  2. 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

  3. Caregiver Fidelity of Implementation [ Time Frame: Baseline, Week 6 ]
    Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jessica A Brian, PhD 416 425 6220 ext 3716 jbrian@hollandbloorview.ca
Contact: Marianna L Healey, MSW 416 425 6220 ext 3522 mhealey@hollandbloorview.ca

Locations
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Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G1R8
Contact: Jessica Brian, PhD    416-425-6220 ext 3716    jbrian@hollandbloorview.ca   
Contact: Marianna Healey, MSW    416-425-6220 ext 3522    mhealey@hollandbloorvie.ca   
Principal Investigator: Jessica Brian, PhD         
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
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Principal Investigator: Jessica A Brian, PhD Holland Bloorview Kids Rehabilitation Hospital

Publications:
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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03499262     History of Changes
Other Study ID Numbers: 17-745
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Naturalistic Developmental Behaviour Intervention
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
NDBI
Autism
Early Identification
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders