Web Based Tools to Improve Medication Continuity in Adolescents With ADHD

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT04386096
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder; Adherence, Medication	Other: Mehealth for ADHD software with medication continuity tools; Other: Mehealth for ADHD software with no medication continuity tools	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Randomized Controlled Trial of Web Based Tools to Improve Medication Continuity in Adolescents With ADHD
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Feb 16, 2021
• Actual Study Completion Date: May 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mehealth for ADHD software with medication continuity tools	Other: 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.
Active Comparator: Mehealth for ADHD software with no medication continuity tools	Other: 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.

Outcome Measures

Primary Outcome Measures

1. Proportion of Days Covered With Medicine [An average of 4 months]

   This will be calculated based pharmacy dispensing records

Secondary Outcome Measures

1. 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.

2. 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).

3. 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).

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).

5. 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).

6. 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.

7. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati
• National Institute of Mental Health (NIMH)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 12, 2021
• Statistical Analysis Plan - Dec 15, 2021
• Informed Consent Form - Apr 6, 2020

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT04386096
• Other Study ID Numbers: 2020-0236; R34MH112648
• First Posted: May 13, 2020
• Last Update Posted: Mar 21, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Adolescent	13.17 (1.28)	13.49 (1.14)	13.33 (1.20)
Parent	37.14 (6.58)	38.81 (7.07)	37.98 (6.79)
Sex: Female, Male (Count of Participants)
Female	6 30%	4 20%	10 25%
Male	14 70%	16 80%	30 75%
Female	20 100%	20 100%	40 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%	0 0%	2 5%
Not Hispanic or Latino	17 85%	20 100%	37 92.5%
Unknown or Not Reported	1 5%	0 0%	1 2.5%
Hispanic or Latino	1 5%	0 0%	1 2.5%
Not Hispanic or Latino	19 95%	20 100%	39 97.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 75%	17 85%	32 80%
White	2 10%	2 10%	4 10%
More than one race	3 15%	1 5%	4 10%
Unknown or Not Reported	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 75%	14 70%	29 72.5%
White	4 20%	2 10%	6 15%
More than one race	1 5%	3 15%	4 10%
Unknown or Not Reported	0 0%	1 5%	1 2.5%

Outcome Measures

1. Primary Outcome

Title	Proportion of Days Covered With Medicine
Description	This will be calculated based pharmacy dispensing records
Time Frame	An average of 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	20
Median (Full Range) [proportion of days covered with medicine]	0.24	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Fidelity to Intended Use of Intervention Components
Description	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

Outcome Measure Data

Analysis Population Description

Data were only collected for the "Mehealth for ADHD software with medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	0
Mean (Full Range) [Proportion of intervention components]	0.07

3. Secondary Outcome

Title	Change in Pre-intention Factors of Unified Theory of Behavior Change
Description	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

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in the "Mehealth for ADHD software with no medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Adolescent	-0.08 (0.55)	0.14 (0.72)
Parent	-0.24 (0.46)	-0.18 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent Pre-Intention Factors
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.30
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent Pre-Intention Factors
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Change in Intention to Take/Give ADHD Medicine Regularly
Description	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

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in the "Mehealth for ADHD software with no medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Adolescent	-0.51 (1.4)	-0.01 (1.43)
Parent	0.03 (1.19)	-0.42 (0.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent Intention to take/give ADHD medicine regularly
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.29
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent Intention to take/give ADHD medicine regularly
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Change in Adolescent-report of Medication Barriers
Description	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

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in the "Mehealth for ADHD software with no medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Mean (Standard Deviation) [score on a scale]	0.08 (0.76)	0.19 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Change in Parent-report of Medication Barriers
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Mean (Standard Deviation) [score on a scale]	-0.11 (0.5)	-0.07 (0.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Change in Medication Diversion
Description	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

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in the "Mehealth for ADHD software with no medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Mean (Standard Deviation) [Events]	0 (0)	0 (0)

8. Secondary Outcome

Title	Change in Decision Making Involvement Scale
Description	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

Outcome Measure Data

Analysis Population Description

Missing data for 2 participants in the "Mehealth for ADHD software with no medication continuity tools" group

Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools	Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.	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.
Measure Participants	20	18
Adolescent: Child Seek	-0.02 (1.02)	-0.02 (1.20)
Adolescent: Child Express	0 (1.12)	0.24 (1.12)
Adolescent: Parent Seek	0.16 (0.82)	0.10 (1.16)
Adolescent: Parent Express	0.13 (0.90)	0.10 (1.04)
Adolescent: Joint/Options	0.02 (0.91)	0.27 (1.01)
Parent: Child Seek	-0.05 (0.96)	-0.07 (0.85)
Parent: Child Express	-0.07 (1.02)	-0.15 (0.81)
Parent: Parent Seek	-0.10 (0.66)	-0.22 (0.79)
Parent: Parent Express	-0.11 (0.82)	-0.11 (0.71)
Parent: Joint/Options	-0.05 (0.88)	-0.04 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent: Child Seek
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent: Child Express
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent: Parent Seek
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent: Parent Express
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.93
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Adolescent: Joint/Options
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.43
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent: Child Seek
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent: Child Express
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent: Parent Seek
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent: Parent Express
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.10
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Mehealth for ADHD Software With Medication Continuity Tools, Mehealth for ADHD Software With no Medication Continuity Tools
	Comments	Change in Parent: Joint/Options
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.98
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	4 months
Arm/Group Title	Mehealth for ADHD Software With Medication Continuity Tools		Mehealth for ADHD Software With no Medication Continuity Tools
Arm/Group Description	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.		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.
All Cause Mortality
	Mehealth for ADHD Software With Medication Continuity Tools		Mehealth for ADHD Software With no Medication Continuity Tools
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Mehealth for ADHD Software With Medication Continuity Tools		Mehealth for ADHD Software With no Medication Continuity Tools
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Mehealth for ADHD Software With Medication Continuity Tools		Mehealth for ADHD Software With no Medication Continuity Tools
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.