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

February 4, 2016 updated by: Children's Hospital Medical Center, Cincinnati

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual Care
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
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
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 Names:
  • Use of Medication to Treat Challenging Behavior in Autism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict
Time Frame: At the end of the Day 1 (initial study) visit

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
Time Frame: During the Day 1 (initial study) visit
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Knowledge of Medications for Challenging Behaviors in ASD
Time Frame: At the end of the Day 1 (initial study) visit
Assess parents' knowledge of medications for challenging ASD behaviors with an 18-item checklist developed for this study. This includes questions on general knowledge about the role of medication in ASD treatment and assesses caregiver expectations of whether medication might improve specific challenging behaviors.
At the end of the Day 1 (initial study) visit
Parenting Stress
Time Frame: Before or at the time of the Day 1 (initial study) visit and at the 3 month interval follow up
Will be measured using the Parenting Stress Index- Short Form. This is a validated 36-item questionnaire pertaining to the demands of taking care of a child. It includes 3 subscales and a total score: parental distress, parent-child dysfunctional interaction, and difficult child.
Before or at the time of the Day 1 (initial study) visit and at the 3 month interval follow up
Shared Decision Making
Time Frame: At the end of the Day 1 (initial study) visit
Parental perception of shared decision making during the clinical encounter will be assessed using the CollaboRATE. This is a brief, 3-question survey that assesses parent-reported shared decision making.
At the end of the Day 1 (initial study) visit
Child Behavioral Symptoms
Time Frame: Before or at the time of the Day 1 (initial study) visit and 3 month interval follow up

Child behavioral symptoms will be measured at the time of the Day 1 (initial study) visit and 3 months later using:

  1. The Child Behavior Checklist (CBCL) will be used to assess behavioral functioning by domains of treatment. The CBCL is a commonly used clinical and research measure. The 120 scale items map onto Diagnostic and Statistical Manual(DSM)-oriented scales and will be used as a standardized measure of behavioral symptoms.
  2. Aberrant Behavior Checklist (ABC): 58-item caregiver report form developed to assess maladaptive behaviors in individuals with developmental disabilities and commonly used to assess behavior in studies of children with ASD.
Before or at the time of the Day 1 (initial study) visit and 3 month interval follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Julia Anixt, MD, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 9, 2013

First Posted (ESTIMATE)

August 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP00005038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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