Personalized Attention-Deficit/Hyperactivity Disorder (ADHD) Medication Experiment Study

NCT06305078 | Completed Results

• 1 other identifier: 2023-0528
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the project is to test personalized medication experiments to inform decisions about future medication use. Our central hypothesis is that our intervention will lead to within subject increases in adolescent involvement in decision making and decreases in uncertainty about future medication use. The investigators view this open label trial as a pilot study to test the feasibility, acceptability, and preliminary efficacy of the medication experiment intervention and therefore warrants further testing in a future larger trial.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (8)

• Decision Making Involvement Scale [Parent Seek] - Reported by Child

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.

• Decision Making Involvement Scale [Parent Seek] - Parent Report

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.

• Decision Making Involvement Scale [Child Express] - Child Report

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.

• Decision Making Involvement Scale [Child Express] - Parent Report

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.

• Decisional Conflict - Parent Report

  The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue \[medication regimen from experiment\], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other \[write in\]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.

  The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)

• Decisional Conflict - Child Report

  The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected. Options presented will be: continue \[medication regimen from experiment\], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other \[write in\]. The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale. The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.

  The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)

• Decision Making Involvement Scale - Joint/Options

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.

• Decision Making Involvement Scale - Child Express

  A 30-item scale to measure adolescent involvement in a decision. The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child). Each subscale has a range of 1-4, with higher scores indicating higher involvement. Subscales are scored by calculating the average of pertinent questions.

  The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.

Secondary Outcomes (5)

• Difference in Intention to Give/Take Medication on School Days

  Collected at study visit 1 and 4-12 weeks later at study visit 2.

• Difference in Intention to Give/Take Medication on Weekend Days

  Collected at study visit 1 and 4-12 weeks later at study visit 2.

• Difference in Intention to Give/Take Medication on School Vacation Days

  Collected at study visit 1 and 4-12 weeks later at study visit 2.

• System Usability Scale Total Score

  Collected at study visit 2 (which is 4-12 weeks after study visit 1).

• Implementation of Decision

  3 months after study visit 2 (which is 4-12 weeks after study visit 1).

Study Arms (1)

Intervention

EXPERIMENTAL

All will choose one of five medication experiment options to complete.

Other: Personalized ADHD Medication Experiment

Interventions

Personalized ADHD Medication Experiment OTHER

All parent/adolescent dyads will select and complete a medication experiment.

Intervention

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Consent: A parent or legal guardian must provide written informed consent
• Assent: Adolescents must provide written assent to participate in the study
• Ages 11-15
• Treated for ADHD by pediatrician
• First prescribed ADHD medicine more than one year prior to enrollment
• Filled at least one prescription for a stimulant medication in the past year
• Uncertainty about continued ADHD medication use
• Only one child per household can participate in the study. For families who have more than one child who is potentially eligible, they may decide which of their children would be the best fit for the study.

You may not qualify if:

• Do not have reliable access to the internet at their home or another location.
• Will not permit their child to access the internet for study related activities.
• Are not able or willing to send or receive text messages.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size with multiple comparisons

Results Point of Contact

• Title: Alyssa Banister - Clinical Research Coordinator
• Organization: Cincinnati Children's Hospital Medical Center

alyssa.banister@cchmc.org

5138031931

Study Officials

• William Brinkman, MD, MEd, MSc

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None (open-label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 12, 2024
• Study Start: November 10, 2023
• Primary Completion: May 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-02

Locations

US (1)