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Autism Spectrum DisorderNCT03499262

Group Social ABCs: Early Intervention for Toddlers With Suspected ASD

A study testing Group Social ABCs in people with Autism Spectrum Disorder and Autism, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 36 months
Conditions the study is for
Autism Spectrum Disorder, Autism
What is being tested?
Group Social ABCs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteCanada
Study dates
26 Mar 2018to 23 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 36 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G1R8

Other trials in Canada

About this study

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.

Read the detailed description

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.

Being tested
Group Social ABCs
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
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Social ABCsBehavioural

    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.

Study groups in NCT03499262
Study groupRoleWhat they receive
Group Social ABcsExperimentalParticipants receiving Group Social ABCs intervention
Receives: Behavioral: Group Social ABCs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vocal Responsivity

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

    Measured: Baseline, Week 6

Secondary outcomes (3)
  1. Vocal Initiations

    Change in rate of appropriate child-initiated vocalizations (Initiations); number per minute

    Measured: Baseline, Week 6

  2. Social Orienting

    Change in percentage of intervals with instances of social orienting (child looking at parent) per 10-minute video observation

    Measured: Baseline, Week 6

  3. Caregiver Fidelity of Implementation

    Change in percent of correct strategy implementation by parents (Fidelity) per 10-minute video observation

    Measured: Baseline, Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2018
  2. Study start26 Mar 2018
  3. Primary completion23 Dec 2020
  4. Study completion23 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03499262
Sponsor's protocol ID
17-745
Status last verified
Jul 2021
First submitted
22 Feb 2018
Last updated
23 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28574669
  • 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.

    PubMed 26688077
  • 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.

    PubMed 16802896
  • 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.

    PubMed 25695137
  • 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.

    PubMed 15749241
  • 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.

    PubMed 20946003

Questions about this trial

What is this clinical trial studying?

A study testing Group Social ABCs in people with Autism Spectrum Disorder and Autism, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vocal Responsivity (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03499262, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.

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