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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: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01921244 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 142 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

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 C

Interventions

  • OTHER Decision Aid

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2013-08
Est. Completion 2015-07
Phase NA

What the finished NCT01921244 record still lists

NCT01921244 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Decision Aid is the first listed.

NCT01921244 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01921244's enrollment target sits among peer trials

142 711th of 2000 higher than 1,289 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01921244, the US trial registry maintained by the National Library of Medicine. NCT01921244 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.