Evaluation of Social ABCs With Attention Training Intervention for Toddlers With Suspected Autism

NCT03215394 | Completed

• 1 other identifier: 16-666
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 4

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 Behaviour 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, natural and motivating for the child. 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). Despite the social-communication benefits demonstrated through the Social ABCs, the research team is also motivated to foster the attentional abilities of toddlers with emerging ASD in response to compelling evidence that early attentional control abilities may play a central role in the emergence of ASD. Based on this knowledge, the current study targets not only social-communication challenges and affect sharing (as per the existing Social ABCs intervention), but also attentional control in toddlers with suspected or confirmed ASD. Using a structured, computerized attention-training protocol, this RCT evaluates the impact of supplementing the standard Social ABCs intervention with pre-intervention attentional control training.

Conditions

Autism Spectrum Disorder

Keywords

Social ABCs; autism; autism spectrum disorder; Early Intervention; Toddler; Early Identification; Pivotal Response Treatment; ASD; PRT; Control Group; treatment Group; At Risk; Social Communication; Positive Affect; Smiling; Social Orienting; Attentional Control; Attentional Disengagement; Naturalistic Developmental Behaviour Intervention; NDBI

Outcome Measures

Primary Outcomes (5)

• Improved Attentional Flexibility

  Reaction time in Gap-Overlap task (milliseconds)

  Week 1 (baseline) and Week 6

• Improved Attentional Control

  Percentage of correct trials in a computer-based attention task (%)

  Week 1 (baseline) and Week 6

• Increased Social Orienting to Parent

  Percentage of intervals in which child is oriented to caregiver (%)

  Week 1 (baseline), Week 6, Week 18, and Week 30

• Increased Child Smiling

  Percentage of intervals in which caregiver and child are smiling together (%)

  Week 1 (baseline), Week 6, Week 18, and Week 30

• Increased Child Responsivity to Parent Prompt

  Gains in proportion of appropriate child vocal responses, following a caregiver prompt (reported as percentage).

  Week 1 (baseline), Week 6, Week 18, and Week 30

Secondary Outcomes (4)

• Parent Fidelity of Implementation

  Week 6, Week 18, and Week 30

• Receptive Language

  Week 0 and Week 30

• Expressive Language

  Week 0 and Week 30

• Joint Attention

  Week 0 and Week 30

Study Arms (3)

Enhanced Social ABCs

EXPERIMENTAL

Receive 4-week attention training program, followed by 12-week Social ABCs intervention. The stimuli include four gaze-contingent training tasks that will be presented on a laptop screen using custom MATLAB scripts. Each task will be presented until the infant becomes inattentive, at which point they will go to the next task or take a break. Training stimuli will be presented until toddlers become fidgety or distressed.

Behavioral: Attention Training Program; Behavioral: Social ABCs

Standard Social ABCs

SHAM COMPARATOR

Receive 4-week sham attention program, followed by 12-week Social ABCs intervention. Sham attention condition will use identical hardware, administered by the same research staff for the same frequency and duration as the attention training intervention. Infants are exposed to non-gaze contingent visual stimuli that offer no adaptive difficulty levels (infant appropriate television clips and animations). Sham attention stimuli will be presented until toddlers become fidgety or distressed.

Behavioral: Social ABCs; Behavioral: Sham Attention Training

Treatment As Usual

OTHER

A convenience sample of age-equivalent toddlers who meet clinical eligibility criteria but are otherwise unable or unwilling to participate in the interventions, will be used as a Treatment as Usual comparison group. The same assessments will be administered at parallel time points through an existing research study. Receive no attention training program and no Social ABCs.

Other: Treatment As Usual

Interventions

Attention Training Program BEHAVIORAL

The attention training involves 8 visits over 4 weeks with pre/post data collection before and after the training, and a follow-up 6 months later. Pre/post data collection involves the ESCS and a Laboratory Temperament Assessment Battery (LabTAB), and a series of on-screen assessment tasks that measure cognitive control, distraction tolerance, sustained attention, habituation, gap-overlap, disengagement, and attention to static images. Training runs from Wk 2-5 with 2 visits per week and is completed in home with the child sitting on the parents lap in front of a monitor. The parent and child are inside a tent to reduce environmental stimuli. The research trainer is outside the tent running the program from a laptop. The program consists of a battery of 9 gaze-contingent training tasks using custom MATLAB scripts. The animated tasks are designed to engage the child and present as developmentally appropriate games. At each visit 6 of the 9 tasks will run for a total of 4min each(24min).

Enhanced Social ABCs

Social ABCs BEHAVIORAL

The 6-month Social ABCs parent-mediated intervention consists of 12 weeks of parent training and a 12 week implementation phase. 15 training (parent coaching) sessions are provided by a Research Trainer. Each session with the trainer includes a review of the program manual, practice of the techniques in the child's home, and a 15 min video of the parent-child dyad practicing the intervention. Week 9 and 11 are phone consultations. After the active training is complete, the parent enters the 12-week implementation phase, which includes practicing the techniques on their own, with no trainer instruction or contact. The trainer re-visits the parent and child at Week 24 to collect three 15 min videos; 2 generalization videos are also taken with an untrained examiner.

Enhanced Social ABCs; Standard Social ABCs

Treatment As Usual OTHER

The Treatment as Usual group acts as a pre-existing convenience sample, consisting of families currently enrolled in a different approved research study run by the same group of investigators. Children in this group have comparable clinical concerns for ASD, and complete the same standardized measures (ADOS, MSEL, ESCS, AOSI) as the Baseline assessment in this RCT, but will not receive Social ABCs or the Attention Training Program. They are able to access any programs or interventions available to them in the general community. This is tracked on a Services Log form, included as part of that study's protocol. Families in this group will have consented to their child's data being shared across studies in this research group.

Treatment As Usual

Sham Attention Training BEHAVIORAL

The sham attention condition will use identical hardware, administered by the same research staff for the same frequency and duration as the attention training program (8 visits over 4 weeks including pre/post data collection). In this condition, infants will be exposed to non-gaze contingent visual stimuli that offer no adaptive difficulty levels (ie. clips of age appropriate television shows). Placebo stimuli will be presented until toddlers become fidgety or distressed.

Standard Social ABCs

Eligibility Criteria

• Age: 12 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child must be 12-30 months of age with clinically significant signs of ASD (must be under 30 months at study enrollment to be included)
• The toddler and parents must live together, and no more than 50km from the study site
• Child is at home with the caregiver at least 50% of the time (no more than 2.5 days a week in child care, nanny, family care, etc.)
• The child must not be involved in other behavioural interventions, such as ABA/IBI and the Hanen programs, for the duration of the study
• The child may participate in no more than 1 hour per week (monthly average) of the following interventions: speech/language, occupational, and physical therapy, for the duration of the study
• The child's diet and medications have not recently been drastically altered, and are not intended to be altered throughout the study.
• The child does not have other neurological disorders (including epilepsy), genetic syndromes that have known association with ASD (e.g., Fragile X syndrome), significant uncorrected sensory impairments (vision, hearing, etc.), or low birth weight (under 2500g).
• The child is not actively experiencing a regression of skills
• The caregiver is conversant in English and could be coached in English
• The child's eyes are successfully tracked with the eye-tracking technology used throughout the study.

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• IWK Health Centre: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator
• University of East London: collaborator
• University of London: collaborator

Study Sites (4)

University of Alberta - Autism Research Centre

Edmonton, Alberta, T5G 0B7, Canada

Location

IWK Health Centre / Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

University of East London

London, E16 2RD, United Kingdom

Location

Related Publications (4)

• 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, 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

• 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

• Wass S, Porayska-Pomsta K, Johnson MH. Training attentional control in infancy. Curr Biol. 2011 Sep 27;21(18):1543-7. doi: 10.1016/j.cub.2011.08.004. Epub 2011 Sep 1.

  PMID: 21889346 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Communication; Smiling

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior; Facial Expression; Nonverbal Communication

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, Clinician Investigator

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: July 12, 2017
• Study Start: April 1, 2017
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (3)