Social ABCs for Toddlers With Signs of Autism Spectrum Disorder: Trial of a Parent-Mediated Intervention
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      The Social ABCs is an innovative parent-mediated intervention for toddlers with confirmed or
      suspected Autism Spectrum Disorder (ASD). The intervention draws on what is known about core,
      early emerging impairments in ASD, and on evidence-based Pivotal Response Treatment (PRT) and
      associated parent training programs for enhancing development in children with ASD.
      Completion of a comprehensive pilot study set the stage for a randomized control trial (RCT)
      of the Social ABCs. The purpose of this RCT is to evaluate the efficacy of the Social ABCs
      intervention program on improving spoken language skills and positive parent-child emotion
      sharing in toddlers with signs of or a diagnosis of ASD.
    

Detailed description: 
      With funding from Autism Speaks (2007-10), the investigators have developed and conducted a
      pilot evaluation of an autism-specific intervention for toddlers with ASD. The Social ABCs,
      developed by the investigators, is an innovative parent-mediated intervention for toddlers
      with confirmed or suspected ASD. The Social ABCs draws on what is known about core, early
      emerging impairments in ASD, on evidence-based Pivotal Response Treatment (PRT) and
      associated parent training programs for enhancing development in children with ASD, and on
      the literature on effective parent training programs for at risk infants. The investigators
      also draw on their demonstrated success implementing a province-wide PRT-based early
      intervention program for preschoolers with ASD, and developing effective brief training in
      PRT for parents of newly diagnosed children with ASD.

      The Social ABCs intervention incorporates the principles and procedures of Applied Behaviour
      Analysis (ABA), represented in the natural language paradigm of PRT, supplemented by those of
      Responsive Parenting. Targets of intervention focus on two areas of early impairment in ASD -
      functional spoken language and positive parent-child emotion sharing.

      Data are collected from both parents and children. Measures of key targeted child behaviours
      (i.e., vocal responsivity and initiations) and shared positive emotion are coded from videos
      of child-parent play interactions recorded in the family home on 3 separate days at each of 3
      time points: (1) study entry (Baseline/ pre-Training), (2) Post-Training (Week 12) and (3)
      Follow-up (Week 24). For each time point, data coded from the videos of child-parent
      interactions are averaged across 2 days to increase the probability that they are
      representative of the key child targets and parent variables under study (i.e., that they do
      not represent either a particularly "good" or "bad" day).

      To provide a strong test of generalization of child learning, the same measures of functional
      behaviours are coded from videos of child-examiner play interactions recorded in the family
      home on 2 separate days at Follow-up; this examiner is blind to treatment group, not trained
      in PRT, and is unfamiliar to the child. Standardized child measures are collected at study
      entry and Week 24. These include the Autism Diagnostic Observation Schedule, Autism
      Observation Scale for Infants, Mullen Scales of Early Learning - AGS Edition, Preschool
      Language Scale-4, and Vineland Adaptive Behavior Scales, 2nd ed. Child and parent
      questionnaires are also completed at these time points. For both the Treatment group and the
      Control group, a Service Log is completed to record the services and interventions in which
      the child is currently participating. This Service Log is updated throughout the duration of
      the family's participation in our trial. A child and family's data is considered "useable" as
      long as the child is enrolled in the study up to and including week 4. If a child and family
      drop out of the study for any reason prior to their completion of week 4, we will not
      consider their data to be useable.

      The 6-month Social ABCs parent-mediated intervention consists of 3 months of in-home live
      parent coaching and a 3-month period during which the parent implements the strategies with
      no further coaching. Parents implement the procedures in vivo, as they play with and follow
      routines of daily life with their toddlers. Research Trainers train parents using positive
      teaching procedures in which feedback and suggestions focus on parents' strengths (i.e.,
      correct or close-to-correct implementation of the intervention procedures). The 3-month
      parent training program consists of 8 consecutive weeks of "Active Training" followed by 4
      consecutive weeks of "Consultation and Refresher". During the 8-week "Active Training" phase,
      individual 1.5-hour sessions are provided three times on separate days in Week 1, twice on
      separate days in Week 2 and once in each of Weeks 3-8, for a total of 11 training sessions.
      Parents are provided with written modules that form the Social ABC's Intervention Manual,
      through which they are led by their Research Trainer. Each visit begins with a discussion of
      the module and intervention targets. For the remainder of the session, parents implement the
      procedures with their child, while receiving feedback (in vivo coaching) from their Trainer.
      During the 4-week "Consultation and Refresher" phase (Weeks 9-12), parents are contacted
      weekly by their Trainer via telephone/ email to trouble-shoot specific issues as needed, and
      the Trainer makes 2 home visits (Weeks 10 and 12) in which additional video recordings of in
      vivo coaching are taken.

      For the control group, treatment is that typically provided by local services (e.g., visits
      from a community early interventionist/speech and language pathologist; see Eligibility
      Criteria). Upon completion of Week 24, the control group is offered the same intervention
      received by the experimental group.

      Primary Aims and Hypotheses:

      (1) It is predicted that, relative to controls, toddlers in the Social ABC's (experimental)
      treatment group will show greater post-training and follow-up changes in functional speech
      (i.e., responsivity and initiations) and positive emotion sharing with their caregiver.
      Secondary Aim: It is predicted that (1) parents in the treatment group will achieve fidelity
      of implementation, and (2) the experimental group will also show greater gains than the
      control group on standardized measures of receptive and expressive language. Exploratory
      Aims: Investigators predict that (1) post-training and follow-up child gains in shared
      positive emotion will be related to high levels of parental (facial) positive emotion, (2)
      post-training and follow-up child gains in functional vocalizations will be a) moderated by
      better receptive language at baseline, and b) related, in the experimental group, to parents'
      fidelity of PRT implementation post-training.
    

Intervention name(s): Social ABCs parent-mediated intervention program
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Social ABCs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; Autism SPectrum Disorder; early intervention; infant; toddler; early identification; pivotal response training (PRT); control group; treatment group; at risk; social communication; positive affect; smiling