Adherence, Medication, Attention Deficit Hyperactivity Disorder
Conditions
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 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.
Interventions
Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend 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.
OTHERMehealth for ADHD software with no medication continuity tools
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) an online pediatrician report card; and 6) 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.
Sponsors
National Institute of Mental Health (NIMH)
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Days Covered With Medicine | An average of 4 months | This will be calculated based pharmacy dispensing records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pre-intention Factors of Unified Theory of Behavior Change | At baseline and approximately 4 months later | Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4). |
| Change in Intention to Take/Give ADHD Medicine Regularly | At baseline and approximately 4 months later | Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4). |
| Change in Adolescent-report of Medication Barriers | At baseline and approximately 4 months later | Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4). |
| Fidelity to Intended Use of Intervention Components | An average of 4 months | Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery. |
| Change in Medication Diversion | At baseline and approximately 4 months later | Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed. |
| Change in Decision Making Involvement Scale | At baseline and approximately 4 months later | Adolescent and Parent self-report. The scale contains the following subscales: Child Seek (e.g. child asks for an opinion or information from the parent), Child Express (e.g. child expresses an opinion or information to the parent), Parent Seek (e.g. parent asks for an opinion or information from child), Parent Express (e.g. parent expresses advice, an opinion, or information to the child), and Joint/Options (e.g. negotiation and brainstorming between child and parent). Each subscale produces a score which ranges from 1 to 4 with higher scores indicating more of that behavior. |
| Change in Parent-report of Medication Barriers | At baseline and approximately 4 months later | Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools Mehealth for ADHD software with medication continuity tools: Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend 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. | 20 |
| Mehealth for ADHD Software With no Medication Continuity Tools Mehealth for ADHD software with no medication continuity tools: 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) an online pediatrician report card; and 6) 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Mehealth for ADHD Software With Medication Continuity Tools | Mehealth for ADHD Software With no Medication Continuity Tools | Total |
|---|---|---|---|
| Age, Continuous Adolescent | 13.17 years STANDARD_DEVIATION 1.28 | 13.49 years STANDARD_DEVIATION 1.14 | 13.33 years STANDARD_DEVIATION 1.2 |
| Age, Continuous Parent | 37.14 years STANDARD_DEVIATION 6.58 | 38.81 years STANDARD_DEVIATION 7.07 | 37.98 years STANDARD_DEVIATION 6.79 |
| Ethnicity (NIH/OMB) Adolescent Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino | 17 Participants | 20 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 19 Participants | 20 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Black or African American | 15 Participants | 17 Participants | 32 Participants |
| Race (NIH/OMB) Adolescent More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent White | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Black or African American | 15 Participants | 14 Participants | 29 Participants |
| Race (NIH/OMB) Parent More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Parent White | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Adolescent Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Adolescent Male | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Parent Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Parent Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Proportion of Days Covered With Medicine
This will be calculated based pharmacy dispensing records
Time frame: An average of 4 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Proportion of Days Covered With Medicine | 0.24 proportion of days covered with medicine |
| Mehealth for ADHD Software With no Medication Continuity Tools | Proportion of Days Covered With Medicine | 0 proportion of days covered with medicine |
p-value: 0.08Wilcoxon (Mann-Whitney)
Secondary
Change in Adolescent-report of Medication Barriers
Adolescent self-report on Adolescent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 8 items. Range of change score is (-4) to (+4).
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Adolescent-report of Medication Barriers | 0.08 score on a scale | Standard Deviation 0.76 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Adolescent-report of Medication Barriers | 0.19 score on a scale | Standard Deviation 0.8 |
p-value: 0.64t-test, 2 sided
Secondary
Change in Decision Making Involvement Scale
Adolescent and Parent self-report. The scale contains the following subscales: Child Seek (e.g. child asks for an opinion or information from the parent), Child Express (e.g. child expresses an opinion or information to the parent), Parent Seek (e.g. parent asks for an opinion or information from child), Parent Express (e.g. parent expresses advice, an opinion, or information to the child), and Joint/Options (e.g. negotiation and brainstorming between child and parent). Each subscale produces a score which ranges from 1 to 4 with higher scores indicating more of that behavior.
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Child Seek | -0.02 score on a scale | Standard Deviation 1.02 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Child Express | 0 score on a scale | Standard Deviation 1.12 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Parent Seek | 0.16 score on a scale | Standard Deviation 0.82 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Parent Express | 0.13 score on a scale | Standard Deviation 0.9 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Joint/Options | 0.02 score on a scale | Standard Deviation 0.91 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Child Seek | -0.05 score on a scale | Standard Deviation 0.96 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Child Express | -0.07 score on a scale | Standard Deviation 1.02 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Parent Seek | -0.10 score on a scale | Standard Deviation 0.66 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Parent Express | -0.11 score on a scale | Standard Deviation 0.82 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Joint/Options | -0.05 score on a scale | Standard Deviation 0.88 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Parent Seek | -0.22 score on a scale | Standard Deviation 0.79 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Child Seek | -0.02 score on a scale | Standard Deviation 1.2 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Child Seek | -0.07 score on a scale | Standard Deviation 0.85 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Child Express | 0.24 score on a scale | Standard Deviation 1.12 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Joint/Options | -0.04 score on a scale | Standard Deviation 0.8 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Parent Seek | 0.10 score on a scale | Standard Deviation 1.16 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Child Express | -0.15 score on a scale | Standard Deviation 0.81 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Parent Express | 0.10 score on a scale | Standard Deviation 1.04 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Parent: Parent Express | -0.11 score on a scale | Standard Deviation 0.71 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Decision Making Involvement Scale | Adolescent: Joint/Options | 0.27 score on a scale | Standard Deviation 1.01 |
Comparison: Change in Adolescent: Child Seekp-value: 0.1t-test, 2 sided
Comparison: Change in Adolescent: Child Expressp-value: 0.51t-test, 2 sided
Comparison: Change in Adolescent: Parent Seekp-value: 0.84t-test, 2 sided
Comparison: Change in Adolescent: Parent Expressp-value: 0.93t-test, 2 sided
Comparison: Change in Adolescent: Joint/Optionsp-value: 0.43t-test, 2 sided
Comparison: Change in Parent: Child Seekp-value: 0.94t-test, 2 sided
Comparison: Change in Parent: Child Expressp-value: 0.79t-test, 2 sided
Comparison: Change in Parent: Parent Seekp-value: 0.61t-test, 2 sided
Comparison: Change in Parent: Parent Expressp-value: 0.1t-test, 2 sided
Comparison: Change in Parent: Joint/Optionsp-value: 0.98t-test, 2 sided
Secondary
Change in Intention to Take/Give ADHD Medicine Regularly
Adolescent and parent self-report on a 1-7-point scale. Items were re-scaled to a 1 (signifying less intention) to 5 (signifying stronger intention) scale. Items were coded so that higher scores aligned with stronger intention to take ADHD medicine every school day, weekend day, and during school vacations. We calculated the average score of the 3 items. Range of change score is (-4) to (+4).
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Intention to Take/Give ADHD Medicine Regularly | Adolescent | -0.51 score on a scale | Standard Deviation 1.4 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Intention to Take/Give ADHD Medicine Regularly | Parent | 0.03 score on a scale | Standard Deviation 1.19 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Intention to Take/Give ADHD Medicine Regularly | Adolescent | -0.01 score on a scale | Standard Deviation 1.43 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Intention to Take/Give ADHD Medicine Regularly | Parent | -0.42 score on a scale | Standard Deviation 0.86 |
Comparison: Change in Adolescent Intention to take/give ADHD medicine regularlyp-value: 0.29t-test, 2 sided
Comparison: Change in Parent Intention to take/give ADHD medicine regularlyp-value: 0.19t-test, 2 sided
Secondary
Change in Medication Diversion
Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed.
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Medication Diversion | 0 Events | Standard Deviation 0 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Medication Diversion | 0 Events | Standard Deviation 0 |
Secondary
Change in Parent-report of Medication Barriers
Parent self-report on Parent Medication Barriers Scale using a 1-5-point Likert Scale. 1 indicates strong agreement and 5 indicates strong disagreement, with higher scores indicating less barriers. Items were coded so that higher scores aligned with increased adolescent organizational skills, salience of behavior, and routine around taking ADHD medicine. We calculated the average score of the 9 items. Range of change score is (-4) to (+4).
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group. One participant in the Mehealth for ADHD software with no medication continuity tools group did not respond to one survey item.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Parent-report of Medication Barriers | -0.11 score on a scale | Standard Deviation 0.5 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Parent-report of Medication Barriers | -0.07 score on a scale | Standard Deviation 0.61 |
p-value: 0.81t-test, 2 sided
Secondary
Change in Pre-intention Factors of Unified Theory of Behavior Change
Adolescent and parent self-report on a 1-5 or 1-7-point scale, depending on the item. Items were re-scaled to a 1 (signifying less belief) to 5 (signifying stronger belief) scale. Individual items measure specific attitudes, subjective norms, and perceived behavioral control. Items were coded so that higher scores aligned with increased perceived advantages of performing the behavior and behavioral control around taking ADHD medicine. We calculated the average score of the total items (Adolescent report = 19 items; Parent report = 17 items). Range of change score is (-4) to (+4).
Time frame: At baseline and approximately 4 months later
Population: Missing data for 2 participants in the Mehealth for ADHD software with no medication continuity tools group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Pre-intention Factors of Unified Theory of Behavior Change | Adolescent | -0.08 score on a scale | Standard Deviation 0.55 |
| Mehealth for ADHD Software With Medication Continuity Tools | Change in Pre-intention Factors of Unified Theory of Behavior Change | Parent | -0.24 score on a scale | Standard Deviation 0.46 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Pre-intention Factors of Unified Theory of Behavior Change | Adolescent | 0.14 score on a scale | Standard Deviation 0.72 |
| Mehealth for ADHD Software With no Medication Continuity Tools | Change in Pre-intention Factors of Unified Theory of Behavior Change | Parent | -0.18 score on a scale | Standard Deviation 0.54 |
Comparison: Change in Adolescent Pre-Intention Factorsp-value: 0.3t-test, 2 sided
Comparison: Change in Parent Pre-Intention Factorsp-value: 0.71t-test, 2 sided
Secondary
Fidelity to Intended Use of Intervention Components
Proportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery.
Time frame: An average of 4 months
Population: Data were only collected for the Mehealth for ADHD software with medication continuity tools group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mehealth for ADHD Software With Medication Continuity Tools | Fidelity to Intended Use of Intervention Components | 0.07 Proportion of intervention components |