Tools to Improve Medication Continuity in Adolescents With ADHD

NCT04173000 | Completed Results

• 1 other identifier: 2019-0172
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Medication is an efficacious treatment strategy for adolescents with attention-deficit/hyperactivity disorder (ADHD), however use significantly declines during adolescence when the consequences of ADHD are most severe (e.g. dropping out of school, delinquency, etc.). The Unified Theory of Behavior Change (UTBC) has been proposed as a conceptual model to explain the mechanism underlying ADHD medication adherence and to guide the development of interventions to improve the continuity of treatment. The UTBC is a well-established and empirically tested model that identifies factors that influence an individual's intention to perform a behavior as well as factors that influence whether a behavior is actually carried out. Indeed, the research team's preliminary data support the relevance of pre-intention factors and implementation factors for medication continuity among adolescents with ADHD. Currently, no evidence-based interventions target medication continuity for adolescents with ADHD. The objective of this study is to test a multi-component intervention that systematically identifies and targets aspects of the UTBC model most relevant for each adolescent with poor ADHD medication continuity. The central hypothesis is that the tailored intervention will support ADHD medication continuity. The study will conduct an open label trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Proportion of Days Covered With Medicine

  This will be calculated based pharmacy dispensing records

  An average of 4 months

Secondary Outcomes (7)

• Fidelity to Intended Use of Intervention Components

  An average of 4 months

• Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity

  At baseline and 4 months later

• Change in Intention to Take/Give ADHD Medicine Regularly

  At baseline and 4 months later

• Change in Adolescent Report of Medication Barriers

  At baseline and 4 months later

• Change in Parent Report of Medication Barriers

  At baseline and 4 months later

Study Arms (1)

Intervention

EXPERIMENTAL

All adolescent/parent dyads enrolled at each practice will have access to the meHealth for ADHD software without medication continuity tools prior to being given access to the medication continuity tools.

Other: Mehealth for ADHD software with medication continuity tools; Other: Mehealth for ADHD software without medication continuity tools

Interventions

Mehealth for ADHD software with medication continuity tools OTHER

Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.

Intervention

Mehealth for ADHD software without medication continuity tools OTHER

The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician "report card"; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems.

Intervention

Eligibility Criteria

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

You may qualify if:

• First prescribed ADHD medicine more than one year prior to enrollment
• Registered on myADHDportal.com at practice participating in study
• Filled at least one prescription for a stimulant medication in the past year

You may not qualify if:

• More than 80% of days covered with medicine over past one year
• Poor understanding level: The participant and parent cannot understand or follow instructions given in the study.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, 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. William B. Brinkman
• Organization: Cincinnati Children's

bill.brinkman@cchmc.org

513-636-2576

Study Officials

• William Brinkman, MD

  Cincinnati Children's

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label Trial

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 21, 2019
• Study Start: July 2, 2019
• Primary Completion: February 16, 2021
• Study Completion: May 24, 2021
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Locations

US (1)