Asperger Syndrome, Autism, Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive, Pervasive Developmental Disorder
Conditions
Keywords
Autistic Disorder, Decision Making, Medication Therapy Management
Brief 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.
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.
Interventions
OTHERDecision 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
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent-physician interaction | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parental Knowledge of Medications for Challenging Behaviors in ASD | 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 | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed