Clinical trial NCT02271880: Improving Medication Adherence in ADHD Adolescents
Official title: Improving Medication Adherence in ADHD Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ADHD
Keywords: Medication nonadherence
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 7
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence
timeFrame: Posttreatment (6 months)
Secondary outcomes:
measure: Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Adolescent Report
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms
timeFrame: Posttreatment (6 months)
measure: Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms
timeFrame: Posttreatment (6 months)
measure: Impairment Rating Scale - Parent Report
timeFrame: Posttreatment (6 months)
measure: Impairment Rating Scale - Adolescent Report
timeFrame: Posttreatment (6 months)
measure: Maintenance of Medication Adherence
timeFrame: 18 months
measure: Followup Medication Adherence
timeFrame: 30 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
Study officials:
References: