Shared Decision Making to Improve Care and Outcomes for Children With Autism

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.

Conditions

• Autistic Disorder
• Pervasive Developmental Disorder
• Child Development Disorders, Pervasive
• Asperger Syndrome
• Autism Spectrum Disorder
• Autism

Interventions

OTHER

Decision Aid

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati

  lead OTHER

Principal Investigators

• Julia Anixt, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

4 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• United States

Study Locations