Refining the Shared Decision Making Process Survey in ADHD Medication Decisions

NCT05048186 | Completed Results

• 1 other identifier: 2019P001434-3
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD

Keywords

shared decision making

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• 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

Other Outcomes (1)

• Adherence

  baseline survey

Study Arms (2)

Decision Aid Arm

Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.

Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid

Control Arm

Participants in this group will not receive any educational materials.

Interventions

Attention Deficit Hyperactivity Disorder Treatment Decision Aid BEHAVIORAL

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).

Decision Aid Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult parent or legal guardian of a child between the ages of 5 and 13 who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD)
• Read English
• Have talked with a health care provider about medication for treatment of ADHD for the child in the past 2 years

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Massachusetts, Boston: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Karen R. Sepucha
• Organization: Massachusetts General Hospital

KSEPUCHA@mgh.havard.edu

617-724-3350

Study Officials

• Karen Sepucha, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Health Decision Sciences Center

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: September 17, 2021
• Study Start: February 24, 2021
• Primary Completion: March 23, 2021
• Study Completion: April 13, 2021
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 3 months after the main results have been published.
• Access Criteria: Investigators from other sites will be able to request the data from the principal investigator 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.

Locations

US (1)