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Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder
Adherence, Medication

Treatments

Other: Mehealth for ADHD software with no medication continuity tools
Other: Mehealth for ADHD software with medication continuity tools

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04386096
R34MH112648 (U.S. NIH Grant/Contract)
2020-0236

Details and patient eligibility

About

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 objectively test the central hypothesis by conducting a randomized controlled trial among adolescents with poor medication continuity to test whether the intervention engages the mechanism underlying medication continuity and improves outcomes.

Enrollment

40 patients

Sex

All

Ages

11 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • First prescribed ADHD medicine more than one year prior to enrollment
  • Treated by pediatrician 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.
  • Do not have reliable access to the internet at their home or another location.
  • Parent will not permit their child to access the internet for study related activities
  • Are not able or willing to send or receive text messages for study related activities

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Mehealth for ADHD software with medication continuity tools
Experimental group
Treatment:
Other: Mehealth for ADHD software with medication continuity tools
Mehealth for ADHD software with no medication continuity tools
Active Comparator group
Treatment:
Other: Mehealth for ADHD software with no medication continuity tools

Trial documents
3

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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