NCT05048186|CompletedResults
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Sponsor study identifier
observational
512
1 country
1
Study Start
February 24, 2021
Actual (reported)Primary Completion
March 23, 2021
Actual (reported)Study Completion
April 13, 2021
Actual (reported)This is a retrospective observational survey study. We will survey a sample of adult parents or legal guardians who have a child who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and who discussed ADHD treatment options for their child with a health care provider within the last 2 years. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions parents make about their children with ADHD. A third goal is to assess the impact of a Decision Aid on participant knowledge of ADHD treatment options. Participants will be randomized to one of two arms: participants in the intervention arm will review a Decision Aid (patient educational tool) partway through the survey and those in the control arm will not receive any educational materials. All participants will complete survey that includes the Shared Decision Making process survey along with a few other measures. A subset of respondents will also complete a retest survey about two weeks after the initial survey.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 13, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2021
Actual (reported)March 23, 2021
Actual (reported)March 29, 2021
Actual (reported)April 13, 2021
Actual (reported)September 17, 2021
Actual (reported)November 21, 2024
Actual (reported)Shared Decision Making Process Score
The Shared Decision Making Process scale is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
baseline survey (reflecting on the last 24 months)
ADHD Knowledge
baseline survey
Decisional Conflict Tool (SURE)
baseline survey
Single-item Measure of Decision Regret
baseline survey
Treatment Choice
baseline survey
National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale
baseline survey
Adherence
baseline survey
Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
Participants in this group will not receive any educational materials.
The parent pre-visit cards from the Cincinnati Children's Hospital's Attention Deficit Hyperactivity Disorder (ADHD) Treatment for School Age Children Decision Aid were used in this study. The 6 pre-visit cards provide an overview of ADHD treatment options, the respective benefits and downsides of each option, and questions to elicit goals/preferences. The four different treatment options presented were: (1) watchful waiting, (2) behavioral treatment, (3) medication treatment, and (4) combined treatment (behavioral and medication together).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sample was an online non-probability panel of adults living in the United States. Marketing Systems Group, the sample vendor, invited potential respondents from an online panel of adults who had a child with ADHD, and who discussed treatment options for their child's ADHD in the past 2 years.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karen Sepucha, PhD
Massachusetts General Hospital
512 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2021
First Posted
September 17, 2021
Study Start
February 24, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 23, 2021
Actual (reported)Study Completion
April 13, 2021
Actual (reported)Last Updated
November 21, 2024
Results First Posted
November 21, 2024
Record last verified: 2024-10
The study team will create a complete, cleaned, de-identified copy of the final dataset. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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