Refining the Shared Decision Making Process Survey in ADHD Medication Decisions

Mass General Brigham

Status: Completed

Conditions: ADHD

Treatments: Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid

Study type: Observational

Funder types: Other

Identifiers

NCT05048186

2019P001434-3

Details and patient eligibility

About

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.

Full description

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.

Study staff are working with a national sampling firm to recruit subjects and obtain 500 responses. The sample size was determined to ensure 80% power to detect difference of 0.25SD at 0.05 significant between intervention and control arm on participant knowledge scores. The decision aid intervention consists of a set of pre-visit summary cards for parents that cover the different treatment options and was developed by the Cincinnati Children's Hospital Medical Center.

For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items and knowledge scores for the two arms. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.

Enrollment: 512 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• None

Trial design

512 participants in 2 patient groups

Decision Aid Arm

Description:

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

Treatment:

Behavioral: Attention Deficit Hyperactivity Disorder Treatment Decision Aid

Control Arm

Description:

Participants in this group will not receive any educational materials.