Evaluation of Social ABCs With Attention Training Intervention for Toddlers With Suspected Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

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 two-site RCT, demonstrating the efficacy of this
      caregiver-mediated intervention for toddlers with suspected or confirmed ASD. This study
      found increases in child vocal responsiveness, vocal initiations, 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.

      While the Social ABCs intervention effectively targets social-communication skills and
      positive caregiver-child affect sharing, the previous RCT demonstrated a promising, but
      non-significant trend toward increased social attention (orienting), which depends on
      attentional control; the investigators argue that this is another important developmental
      domain often impaired in ASD. Improving attentional control may reduce or even prevent
      expression of ASD-related impairments such as emotion dysregulation and impaired social
      engagement, due to hypothesized relationships in both typical development and ASD. By
      targeting early attentional control abilities, this research not only also has the potential
      to enhance understanding of the fundamental mechanisms that drive behavioural dysregulation
      in ASD, but also to enhance early development in high-risk toddlers.

      Wass and Johnson (2011) have successfully used a brief battery of gaze-contingent computer
      tasks to enhance cognitive control, sustained attention, and attentional disengagement of
      typically developing infants. This attention training paradigm has now been adapted for use
      with toddlers with suspected or confirmed ASD, and its impact will be evaluated as part of
      this study. Participants will be randomized into one of two groups: Enhanced Social ABCs
      (Social ABCs plus attention training) or Standard Social ABCs (Social ABCs with placebo). A
      third group, comprised of 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.

      Toddlers in the Enhanced Social ABCs group will receive eight attention training sessions,
      taking place in-home or in-clinic, which will be twice weekly for four weeks prior to
      beginning the Social ABCs. The attention training sessions use a computer-based program that
      is designed to provide practice in disengaging and shifting attention between competing
      visual stimuli. The Standard Social ABCs group will be allocated to an adjunct sham computer
      attention training condition in which they will interact with study staff and be exposed to
      identical computer equipment for the same schedule and duration of visits. However, this
      paradigm will involve a display of interesting moving on-screen objects without a
      gaze-contingent component (i.e., placebo). Both programs track the toddlers' gaze behaviours.
      Toddlers in both conditions will complete the same pre- and post-training testing
      assessments. The caregivers will be blind to whether children received the attention training
      or placebo.

      Following the attention/placebo phase, caregivers of both groups will receive Social ABCs
      caregiver coaching with a Social ABCs coach blind to the participants' attention training
      (vs. placebo) condition. Social ABCs intervention will include 12 weeks of 1.5-hour home
      visits of tapering frequency, with follow-up visits at key time points. Home visits include a
      didactic session based on the Social ABCs manual, followed by practice and live coaching (see
      Brian et al., 2016, for further information).

      In response to the 2020 global COVID-19 pandemic, the intervention has shifted to an online
      format, with sessions being completed virtually with participant families. The delivery
      schedule and session design remains the same. Follow-up assessment protocol measures that can
      be collected via mail or virtually are completed at the original time points.

      Data from the Treatment as Usual group will be used to compare Standard and/or Enhanced
      Social ABCs to developmental trajectories of those not receiving this active intervention.
      These data include scores from standardized measures and eye-tracking data from one portion
      of the pre- and post-attention training assessments (i.e., a gap-overlap task).

      This project is highly relevant to improving early treatment models, and thus, outcomes for
      toddlers with emerging ASD. Early action capitalizes on brain plasticity, potentially
      interrupting the negative developmental cascade, and optimizing outcomes in this high-risk
      group.
    

Intervention name(s): Attention Training Program; Social ABCs; Treatment As Usual; Sham Attention Training
Intervention type(s): Behavioral; Behavioral; Other; Behavioral
Intervention description(s): 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).; 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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