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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providers Providers must be a licensed professional, either a physician (MD) or a nurse practitioner (APN) in the Division of Developmental and Behavioral Pediatrics at Cincinnati Children's Hospital. Provider must regularly treat patients within the age range and for the diagnoses of interest in this study (Autism Spectrum Disorders). Parents Participants must be a parent or legal guardian who self-identifies as the primary caregiver of a child or adolescent with Autism Spectrum Disorder cared for by an enrolled provider in the Division of Developmental and Behavioral Pediatrics at Cincinnati Children's Hospital. Participants must be able to speak and read English in order to complete the surveys Children Child or adolescent must have a clinical diagnosis of Autism Spectrum Disorder including one of the following diagnoses: a) Pervasive Developmental Disorder (PDD), b) Asperger's Syndrome, c) Autism Spectrum Disorder, d) Autism, e) Infantile Autism Child or adolescent must be between the ages of 4 years 0 months and 15 years 11 months Child or adolescent must be scheduled for a follow up visit with a Developmental-Behavioral Pediatric provider enrolled in the study. Exclusion Criteria: -Parents who are unable to speak and read English are not eligible for the study.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Approximately 120 families will be asked to participate as usual care subjects and will complete surveys before and immediately after their visit, and approximately 3 months after the visit. These families will not receive the decision aid nor will their provider have been trained how to use the decision aid. All participating providers will have up to 10 usual care patients enrolled at baseline prior to allocation. During the trial, the control group [usual care providers] will have up to 10 additional patients enrolled for ongoing usual care data collection. After the trial is complete, the control group providers will cross over to the intervention arm. | |
| Experimental: Intervention<br>Approximately 80 families/patients with regularly scheduled clinic follow-up visits in the Division of Developmental and Behavioral Pediatrics (DDBP) at Cincinnati Childrens with providers trained on shared decision making will receive the decision aid prior to their index visit and complete surveys before and immediately after their visit, and approximately 3 months later. | Other: Decision Aid<br>* 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.<br>* Other names: Use of Medication to Treat Challenging Behavior in Autism;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict | The primary outcome of interest for this study is decisional conflict as measured immediately at the end of the Day 1 initial study clinic visit. This measure will also be collected before the Day 1 visit to be able to compare pre- and post- visit levels of decisional conflict. Additionally, this measure will be collected 3 months after the Day 1 visit to determine levels of ongoing decisional conflict that parents of children with autism experience. This will be measured using the Decisional Conflict Scale. This is a validated 16-item questionnaire which reports on the uncertainty experienced when feeling uninformed about the alternatives, benefits and risks, unclear about personal values, or unsupported in making a choice. | At the end of the Day 1 (initial study) visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent-physician interaction | The OPTION scale (validated 12-item measure) will be used to score parent-physician interactions developing a treatment plan based on coding of audio or video recordings of the clinic visit. | During the Day 1 (initial study) visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autistic Disorder, Decision Making, Medication Therapy Management