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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01921244
First received: August 5, 2013
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Autistic Disorder
Pervasive Developmental Disorder
Child Development Disorders, Pervasive
Asperger Syndrome
Autism Spectrum Disorder
Autism
Other: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Shared Decision Making to Improve Care and Outcomes for Children With Autism

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Decisional Conflict [ Time Frame: At the end of the Day 1 (initial study) visit ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Parent-physician interaction [ Time Frame: During the Day 1 (initial study) visit ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Parental Knowledge of Medications for Challenging Behaviors in ASD [ Time Frame: At the end of the Day 1 (initial study) visit ] [ Designated as safety issue: No ]
    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.

  • Parenting Stress [ Time Frame: Before or at the time of the Day 1 (initial study) visit and at the 3 month interval follow up ] [ Designated as safety issue: No ]
    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.

  • Shared Decision Making [ Time Frame: At the end of the Day 1 (initial study) visit ] [ Designated as safety issue: No ]
    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.

  • Child Behavioral Symptoms [ Time Frame: Before or at the time of the Day 1 (initial study) visit and 3 month interval follow up ] [ Designated as safety issue: No ]

    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.


Estimated Enrollment: 240
Study Start Date: August 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Use of Medication to Treat Challenging Behavior in Autism

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.

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01921244

Contacts
Contact: Julia Anixt, MD 513-803-2398 Julia.Anixt@cchmc.org
Contact: Halley Estridge, BA 513-709-0281 halley.estridge@cchmc.og

Locations
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Julia Anixt, MD Cincinnati Children's Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01921244     History of Changes
Other Study ID Numbers: FP00005038
Study First Received: August 5, 2013
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Autistic Disorder
Decision Making
Medication Therapy Management

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Asperger Syndrome
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014