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

NCT ID: NCT06305078

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2025-05-01

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.

Detailed Description

The investigators will conduct a pilot, single-arm, open-label trial of the medication experiment intervention among 30 adolescents and parents experiencing uncertainty about continued medicine use. Because the medication experiment intervention is not clinically relevant for adolescents taking a non-stimulant ADHD medication, they will be excluded. At the time of enrollment, families will complete baseline measures electronically and schedule an in-person visit. The investigators will verify the medication prescribed and the number of days covered with medicine in the past year using dispensing data. During the visit, parents and adolescents will choose one of five medication experiments to complete together and track the effects for the desired amount of time.

1. Make no changes. Track current state: continue to take medication as it is currently prescribed.

2. Take medication on non-school days. Track effects: If not currently taking medication on non-school days, start taking medication on those days and track the effects.

3. Stop taking medication on non-school days. Track effects. If currently taking medication on non-school days, stop taking medication on those days and track the effects.

4. Do a formal trial off of medication. Take current medication as currently prescribed for 2 weeks while tracking, then stop taking medication for 2-4 weeks while continuing to track.

5. Change dose or change medication. Consider a different medication or different dose of current medication in consultation with study doctor. Track the effects.

Once dyads have completed the medication experiment, they will complete a follow-up study visit to review the results from the experiment, discuss feasibility of the software, and complete end of study measures.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Personalized ADHD Medication Experiment

Intervention Type: OTHER

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

Interventions

Personalized ADHD Medication Experiment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Consent: A parent or legal guardian must provide written informed consent

2. Assent: Adolescents must provide written assent to participate in the study

3. Ages 11-15

4. Treated for ADHD by pediatrician

5. First prescribed ADHD medicine more than one year prior to enrollment

6. Filled at least one prescription for a stimulant medication in the past year

7. Uncertainty about continued ADHD medication use

8. 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.

Exclusion Criteria

1. Do not have reliable access to the internet at their home or another location.

2. Will not permit their child to access the internet for study related activities.

3. Are not able or willing to send or receive text messages.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Brinkman, MD, MEd, MSc

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2023-0528

Identifier Type: -

Identifier Source: org_study_id