Shared Decision Making to Improve Care and Outcomes for Children With Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01921244|
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : February 5, 2016
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 or disease||Intervention/treatment||Phase|
|Autistic Disorder Pervasive Developmental Disorder Child Development Disorders, Pervasive Asperger Syndrome Autism Spectrum Disorder Autism||Other: Decision Aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Shared Decision Making to Improve Care and Outcomes for Children With Autism|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921244
|United States, Ohio|
|Cincinnati Children's Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Julia Anixt, MD||Children's Hospital Medical Center, Cincinnati|