Improving Medication Adherence in ADHD Adolescents

Study Overview
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Brief Summary
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Investigates whether a family-based intervention for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in adolescents with history of medication nonadherence.

Detailed Description
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We will evaluate a dual component family-based intervention for adolescents with ADHD to improve medication adherence (Supporting Teen Adherence and Responsibility; STAR). STAR pairs Motivational Interviewing with parent-teen behavioral contracting. In the proposed study, adolescents with ADHD and a history of chronic nonadherence to their ADHD medication will be randomly assigned to medication alone (medication as usual: MAU) or MAU+STAR. They will be treated for 6 months with a 12 month maintenance period and 12 month followup. All interventions will occur at the offices of participants primary care physicians.

Official Title
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Improving Medication Adherence in ADHD Adolescents

Conditions
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ADHD

Intervention / Treatment
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* Other: Medication as usual
* Other: STAR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ADHD; currently prescribed an FDA-approved medication for ADHD, history of medication nonadherence (taking less than 60% of prescribed doses); full scale Intelligence Quotient >80, no current language delay and/or had no language delays before age 3. Exclusion Criteria: active medical conditions that could be worsened by stimulants (seizures, arrhythmias, hypertension) unless patient has clearance from primary specialist taking care of existing condition, pregnancy, Bipolar Disorder, schizophrenia, and/or other psychotic disorders, and diagnosis of current substance abuse or dependence (except nicotine), current psychotropic medication for conditions other than ADHD.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medication as usual<br>Medication as typically prescribed by physician. | Other: Medication as usual<br>* Physicians will prescribe medication as usual to the adolescent.<br>|
| Active Comparator: Medication as usual + STAR<br>Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence | Other: Medication as usual<br>* Physicians will prescribe medication as usual to the adolescent.<br>Other: STAR<br>* Adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence | Proportion of prescribed doses taken as measured by electronic monitoring devices. | Posttreatment (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention | Scores represent the total number of adolescent inattention symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed by parent on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of inattention. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive | Scores represent the total number of adolescent hyperactive-impulsive symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed by parent on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of hyperactivity-impulsivity. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms | Scores represent the total number of adolescent symptoms of oppositional defiant disorder (ODD) endorsed by parent on this rating scale. Possible scores range from 0 to 8 with higher scores representing the presence of more symptoms of ODD. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms | Scores represent the total number of adolescent symptoms of conduct disorder (CD) endorsed by parent on this rating scale. Possible scores range from 0 to 15 with higher scores representing the presence of more symptoms of conduct disorder. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Adolescent Report | Scores represent the total number of self-reported adolescent inattention symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of inattention. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms | Scores represent the total number of adolescent self-reported hyperactive-impulsive symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of hyperactivity-impulsivity. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms | Scores represent the total number of adolescent self-reported symptoms of oppositional defiant disorder (ODD) symptoms endorsed on this rating scale. Possible scores range from 0 to 8 with higher scores indicating the presence of more symptoms of ODD. | Posttreatment (6 months) | 
| Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms | Scores represent the total number of self-reported adolescent symptoms of conduct disorder (CD) endorsed on this rating scale. Scores range from 0 to 15 with higher scores indicating the presence of more symptoms of CD. | Posttreatment (6 months) | 
| Impairment Rating Scale - Parent Report | Scores represent the average parent rating of adolescent functional impairment across multiple domains of functioning (i.e., home, school, peer relationships). Possible scores range from 0 to 6 with higher scores indicating more severe impairment and need for treatment. | Posttreatment (6 months) | 
| Impairment Rating Scale - Adolescent Report | Scores represent the average adolescent self-report rating of adolescent functional impairment across multiple domains of functioning (i.e., home, school, peer relationships). Possible scores range from 0 to 6 with higher scores indicating more severe impairment and need for treatment. | Posttreatment (6 months) | 
| Maintenance of Medication Adherence | Continued monitoring of prescribed doses taken over 12-month monitoring period | 18 months | 
| Followup Medication Adherence | Continued monitoring of prescribed doses taken over 12-month followup period | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication nonadherence