Trial Outcomes & Findings for Tools to Improve Medication Continuity in Adolescents With ADHD (NCT NCT04173000)
NCT ID: NCT04173000
Last Updated: 2024-09-05
Results Overview
This will be calculated based pharmacy dispensing records
COMPLETED
NA
16 participants
An average of 4 months
2024-09-05
Participant Flow
Participant milestones
| Measure |
Intervention
All parent/adolescent 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.
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 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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tools to Improve Medication Continuity in Adolescents With ADHD
Baseline characteristics by cohort
| Measure |
Intervention
n=8 Participants
All parent/adolescent 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.
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 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.
|
|---|---|
|
Age, Continuous
Adolescent
|
13.60 years
STANDARD_DEVIATION 1.70 • n=5 Participants
|
|
Age, Continuous
Parent
|
44.62 years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
|
Sex: Female, Male
Adolescent · Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Adolescent · Male
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Parent · Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Parent · Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of 4 monthsPopulation: Missing data for 1 adolescent
This will be calculated based pharmacy dispensing records
Outcome measures
| Measure |
Intervention
n=7 Participants
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.
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 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.
|
|---|---|
|
Proportion of Days Covered With Medicine
|
0.69 Proportion of days covered with medicine
Interval 0.44 to 0.98
|
SECONDARY outcome
Timeframe: An average of 4 monthsProportion of intervention components completed relative to the components that were recommended by the portal based on adolescent/parent responses to the assessment battery.
Outcome measures
| Measure |
Intervention
n=16 Participants
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.
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 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.
|
|---|---|
|
Fidelity to Intended Use of Intervention Components
|
0 Proportion of intervention components
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 1 parent/adolescent dyad and 1 adolescent
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).
Outcome measures
| Measure |
Intervention
n=13 Participants
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.
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 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.
|
|---|---|
|
Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity
Adolescent
|
-0.19 score on a scale
Standard Deviation 0.27
|
|
Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity
Parent
|
-0.14 score on a scale
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 1 parent/adolescent dyad and 1 adolescent
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).
Outcome measures
| Measure |
Intervention
n=13 Participants
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.
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 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.
|
|---|---|
|
Change in Intention to Take/Give ADHD Medicine Regularly
Adolescent
|
-0.07 score on a scale
Standard Deviation 1.28
|
|
Change in Intention to Take/Give ADHD Medicine Regularly
Parent
|
0.03 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 2 adolescents
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).
Outcome measures
| Measure |
Intervention
n=6 Participants
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.
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 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.
|
|---|---|
|
Change in Adolescent Report of Medication Barriers
|
-0.44 score on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 1 parent
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).
Outcome measures
| Measure |
Intervention
n=7 Participants
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.
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 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.
|
|---|---|
|
Change in Parent Report of Medication Barriers
|
0.25 score on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 2 adolescents
Adolescent self-report of the number of occasions of giving away, trading, or selling ADHD medicine to someone for whom it was not prescribed.
Outcome measures
| Measure |
Intervention
n=6 Participants
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.
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 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.
|
|---|---|
|
Change in Medication Diversion
|
0 Events
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At baseline and 4 months laterPopulation: Missing data for 1 parent/adolescent dyad and 1 adolescent
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.
Outcome measures
| Measure |
Intervention
n=13 Participants
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.
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 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.
|
|---|---|
|
Change in Decision Making Involvement Scale
Adolescent: Child Seek
|
-0.39 score on a scale
Standard Deviation 0.49
|
|
Change in Decision Making Involvement Scale
Adolescent: Child Express
|
-0.22 score on a scale
Standard Deviation 0.69
|
|
Change in Decision Making Involvement Scale
Adolescent: Parent Seek
|
-0.08 score on a scale
Standard Deviation 0.68
|
|
Change in Decision Making Involvement Scale
Adolescent: Parent Express
|
-0.23 score on a scale
Standard Deviation 0.67
|
|
Change in Decision Making Involvement Scale
Adolescent: Joint/Options
|
0.07 score on a scale
Standard Deviation 0.86
|
|
Change in Decision Making Involvement Scale
Parent: Child Seek
|
-0.19 score on a scale
Standard Deviation 0.63
|
|
Change in Decision Making Involvement Scale
Parent: Child Express
|
0 score on a scale
Standard Deviation 1
|
|
Change in Decision Making Involvement Scale
Parent: Parent Seek
|
0.18 score on a scale
Standard Deviation 0.66
|
|
Change in Decision Making Involvement Scale
Parent: Parent Express
|
0.17 score on a scale
Standard Deviation 0.58
|
|
Change in Decision Making Involvement Scale
Parent: Joint/Options
|
-0.23 score on a scale
Standard Deviation 0.34
|
Adverse Events
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place