Comparing Behavioral Assessments Using Telehealth for Children With Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The main purpose of this study is to determine the most efficient way for families to reduce
      problem behavior in their children with an autism spectrum disorder. Parents will be trained
      using telehealth to use applied behavior analysis (ABA) procedures to improve child behavior
      and communication. The study compares an established type of ABA assessment and treatment to
      a briefer, more streamlined version of this same type of assessment/treatment.
    

Detailed description: 
      Managing challenging behavior in autism spectrum disorders (ASD) can profoundly improve
      quality of life for children and families. However, many families lack access to
      research-based treatment, such as applied behavior analysis (ABA). This study is a randomized
      trial comparing outcomes of treatment for ASD using either a standard Functional Analysis
      Plus Functional Communication Training (FA+FCT) package or a pragmatic version that offers a
      briefer, less time-intensive model of FA+FCT. Both types of FA+FCT are provided via
      telehealth in family homes to maximize generalizability to real-life settings. Providing ABA
      through telehealth makes an effective treatment accessible across geographic barriers so that
      no child is excluded based on where they live. The study also examines key family factors
      that influence successful outcomes.

      The study has 3 primary aims: (1) To assess outcomes for ABA telehealth by assigning children
      to either a Pragmatic FA+FCT group or to a group receiving Standard FA+FCT. Outcomes will be
      compared based on the percent reduction in problem behavior, communication increases, time to
      achieve outcomes, treatment fidelity, family acceptance of treatment, and generalization and
      maintenance of treatment gains. (2) The study will assess the relation of family factors to
      treatment efficacy and acceptability by assessing parent stress, mood, and social support in
      relation to outcomes. (3) Cost effectiveness will be assessed in relation to the treatment
      methods used and the efficiency of ABA telehealth.

      The study will include 102 children who meet eligibility criteria from among a larger sample
      of 150 children. Thirty-six children will receive intervention in each of three states: Iowa,
      Georgia, and Texas. Study design is a randomized trial using an intent-to-treat analysis.
      Half of the sample will be randomized to Pragmatic FA+FCT and half to Standard FA+FCT.
      Treatment will be provided via telehealth using FCT, which is a function-based ABA technique
      in which parents are trained to be therapists under the direction of behavior consultants.
      Study procedures typically are completed within 6 months, and follow-up assessments occur 6
      months after treatment completion. Data analyses include comparisons between assessment
      groups, single-case designs examining responses in individual children, cost analyses, and
      regression analyses of the effects of family factors on outcomes.

      The investigators prior research shows that problem behavior can be reduced by over 90% in
      most children with ASD after 4-6 months of telehealth treatment. If Pragmatic FA+FCT can
      reduce problem behavior at rates comparable to Standard FA+FCT, then treatment can be started
      sooner and families can achieve successful outcomes at lower cost. Although pragmatic FA+FCT
      provides less behavioral information, it may be more resistant to treatment relapse because
      it does not involve reinforcing high rates of problem behavior.
    

Intervention name(s): Standard FA+FCT; Pragmatic FA+FCT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard Functional Analysis and Functional Communication Training; Pragmatic Functional Analysis and Functional Communication Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Telehealth; Applied behavior analysis