NCT04173000

Tools to Improve Medication Continuity in Adolescents With ADHD

Completed NA Results posted Last updated 5 September 2024

What this trial tests

NA trial testing Mehealth for ADHD software with medication continuity tools in Attention Deficit Hyperactivity Disorder in 16 participants. Completed in 24 May 2021.

Timeline

2 July 2019

Primary endpoint
16 February 2021

24 May 2021

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	16
Start date	2 July 2019
Primary completion	16 February 2021
Estimated completion	24 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Mehealth for ADHD software with medication continuity tools
• Mehealth for ADHD software without medication continuity tools

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 11 to 15, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Days Covered With Medicine Primary · An average of 4 months

This will be calculated based pharmacy dispensing records

Group	Value	95% CI
Intervention	0.69	0.44 – 0.98

Fidelity to Intended Use of Intervention Components Secondary · 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.

Group	Value	95% CI
Intervention	0	0 – 0

Change in Pre-intention Factors of Unified Theory of Behavior Change Influencing Medication Continuity Secondary · At baseline and 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).

Adolescent

Group	Value	95% CI
Intervention	-0.19	± 0.27

Parent

Group	Value	95% CI
Intervention	-0.14	± 0.37

Change in Intention to Take/Give ADHD Medicine Regularly Secondary · At baseline and 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).

Adolescent

Group	Value	95% CI
Intervention	-0.07	± 1.28

Parent

Group	Value	95% CI
Intervention	0.03	± 0.55

Change in Adolescent Report of Medication Barriers Secondary · At baseline and 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).

Group	Value	95% CI
Intervention	-0.44	± 1.03

Change in Parent Report of Medication Barriers Secondary · At baseline and 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).

Group	Value	95% CI
Intervention	0.25	± 0.51

Change in Medication Diversion Secondary · At baseline and 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.

Group	Value	95% CI
Intervention	0	± 0

Change in Decision Making Involvement Scale Secondary · At baseline and 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.

Adolescent: Child Seek

Group	Value	95% CI
Intervention	-0.39	± 0.49

Adolescent: Child Express

Group	Value	95% CI
Intervention	-0.22	± 0.69

Adolescent: Parent Seek

Group	Value	95% CI
Intervention	-0.08	± 0.68

Adolescent: Parent Express

Group	Value	95% CI
Intervention	-0.23	± 0.67

Adolescent: Joint/Options

Group	Value	95% CI
Intervention	0.07	± 0.86

Parent: Child Seek

Group	Value	95% CI
Intervention	-0.19	± 0.63

Parent: Child Express

Group	Value	95% CI
Intervention	0	± 1

Parent: Parent Seek

Group	Value	95% CI
Intervention	0.18	± 0.66

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.