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Clinical Trials/NCT04173000
NCT04173000
Completed
Not Applicable

Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

Children's Hospital Medical Center, Cincinnati1 site in 1 country10 target enrollmentJuly 2, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
10
Locations
1
Primary Endpoint
Proportion of Days Covered With Medicine
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2, 2019
End Date
May 24, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Proportion of Days Covered With Medicine

Time Frame: An average of 4 months

This will be calculated based pharmacy dispensing records

Secondary Outcomes

  • 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)
  • Change in Medication Diversion(At baseline and 4 months later)
  • Change in Decision Making Involvement Scale(At baseline and 4 months later)

Study Sites (1)

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