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NCT01921244 · ClinicalTrials.gov registry record · NA
Shared Decision Making to Improve Care and Outcomes for Children With Autism
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 142
- Enrollment target
NCT01921244 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 142 participants.
The verdict
NCT01921244, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 142 participants
- Enrollment target
Study 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 s
Interventions
- OTHER Decision Aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01921244
The ClinicalTrials.gov registry entry for NCT01921244 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Decision Aid is the first listed.
NCT01921244 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01921244 about?
NCT01921244 is a clinical study titled "Shared Decision Making to Improve Care and Outcomes for Children With Autism". 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% o...
What is the current status of trial NCT01921244?
This trial is currently completed. It is a NA study. The enrollment target is 142 participants. The study started on 2013-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01921244?
The interventions under investigation include: Decision Aid (OTHER).
Who is sponsoring clinical trial NCT01921244?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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