Group Social ABCs: Early Intervention for Toddlers With Suspected ASD

NCT03499262 | Completed

• 1 other identifier: 17-745
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Vocal Responsivity

  Change in proportion of appropriate child vocal responses following a caregiver prompt in 10-minute video observation

  Baseline, Week 6

Secondary Outcomes (3)

• Vocal Initiations

  Baseline, Week 6

• Social Orienting

  Baseline, Week 6

• Caregiver Fidelity of Implementation

  Baseline, Week 6

Study Arms (1)

Group Social ABcs

EXPERIMENTAL

Participants receiving Group Social ABCs intervention

Behavioral: Group Social ABCs

Interventions

Group Social ABCs BEHAVIORAL

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.

Group Social ABcs

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

Related Publications (6)

• 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

• Landry SH, Smith KE, Swank PR. Responsive parenting: establishing early foundations for social, communication, and independent problem-solving skills. Dev Psychol. 2006 Jul;42(4):627-42. doi: 10.1037/0012-1649.42.4.627.

  PMID: 16802896 BACKGROUND

• Brian JA, Bryson SE, Zwaigenbaum L. Autism spectrum disorder in infancy: developmental considerations in treatment targets. Curr Opin Neurol. 2015 Apr;28(2):117-23. doi: 10.1097/WCO.0000000000000182.

  PMID: 25695137 BACKGROUND

• Zwaigenbaum L, Bryson S, Rogers T, Roberts W, Brian J, Szatmari P. Behavioral manifestations of autism in the first year of life. Int J Dev Neurosci. 2005 Apr-May;23(2-3):143-52. doi: 10.1016/j.ijdevneu.2004.05.001.

  PMID: 15749241 BACKGROUND

• Smith IM, Koegel RL, Koegel LK, Openden DA, Fossum KL, Bryson SE. Effectiveness of a novel community-based early intervention model for children with autistic spectrum disorder. Am J Intellect Dev Disabil. 2010 Nov;115(6):504-23. doi: 10.1352/1944-7558-115.6.504.

  PMID: 20946003 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Communication

Condition Hierarchy (Ancestors)

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

Study Officials

• Jessica A Brian, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: April 17, 2018
• Study Start: March 26, 2018
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)