Shared Decision Making to Improve Care and Outcomes for Children With Autism
Condition: Autistic Disorder; Pervasive Developmental Disorder; Child Development Disorders, Pervasive; Asperger Syndrome; Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Developmental Disabilities; Child Development Disorders, Pervasive; Asperger Syndrome
Study type: Interventional

Summary: 
      Children with Autism Spectrum Disorder (ASD) commonly experience behavioral challenges that
      may be improved with pharmacotherapy, including difficulties with sleep, attention,
      hyperactivity, impulsivity, anxiety, obsessive-compulsive behavior, mood swings, self-injury,
      and aggression. While 34-58% of children with ASD take medication for such behaviors, there
      is wide practice variation nationally and a lack of evidence to support the use of most
      commonly prescribed agents. Complex clinical situations such as this where there is no clear
      "best choice" regarding which behaviors to target and which medications to use lend
      themselves well to the use of a Shared Decision Making (SDM) tool to ensure that
      well-informed parent preferences shape every treatment plan.

      The primary goal of this study is to modify a previously published decision aid about use of
      medication to manage challenging behaviors in children with autism to make it easy to
      implement in practice and then evaluate this version in terms of proximal decisional outcomes
      and parent/child outcomes 3 months later. Providers in a Developmental-Behavioral Pediatric
      clinic will be enrolled and randomly allocated to intervention or control (treatment as
      usual) groups. Initially, providers randomized to the intervention group will test and refine
      the modified intervention. Once the intervention is finalized, eligible patients of
      participating providers will be enrolled in the randomized controlled trial to test the
      efficacy of the intervention. Following the trial, control group providers will be crossed
      over and receive the intervention. Both proximal decisional outcomes (e.g. parent decisional
      conflict, provider amount of SDM, parent knowledge of treatment options) and outcomes 3
      months later (e.g. parenting stress, decisional conflict, and change in child behavioral
      symptoms) will be assessed.

      Approximately 10 providers and 240 of their patients with autism will be included in the
      study. Chart reviews, parental surveys, and recordings of provider-parent-patient
      interactions during the index visit will be collected at baseline (prior to physician
      allocation), during the intervention trial, and after the control group has crossed over.
      Between- and within-group analyses will examine factors associated with parental decisional
      conflict and whether the intervention produces significant improvements in outcomes over and
      above typical autism care. Analyses will include multiple linear regression modeling and
      general linear models / repeated measure models, accounting for data clustered by provider.
    

Detailed description: 
      SDM involves clinicians sharing information about treatment options and parents sharing their
      goals, concerns, and preferences to ensure that treatment plans are based on what matters
      most to well-informed parents. SDM often incorporates use of decision aids, which are
      balanced sources of information about treatment options for a particular condition. Decision
      aids consistently increase knowledge, improve treatment expectations, increase active
      participation in decision making, reduce uncertainty about the appropriate course of action,
      and help patients reach decisions that are more aligned with their stated values.
    

Intervention name(s): Decision Aid
Intervention type(s): Other
Intervention description(s): Parents will receive an intervention modified from the previously published tool called "Autism: Should My Child Take Medicine for Challenging Behavior?" This packet provides parents with educational information, elicits parent ratings of particular behavioral domains, describes behaviors that are and are not amenable to medication treatment, and elicits parent preferences regarding treatment. Providers will be trained on use of the intervention in practice to promote shared decision making during clinical encounters.
Other intervention name(s): Use of Medication to Treat Challenging Behavior in Autism
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Autistic Disorder; Decision Making; Medication Therapy Management