Improving Medication Adherence in ADHD Adolescents

Not Applicable

Terminated

Conditions: ADHD

Interventions: Other: Medication as usual
Other: STAR

Registration Number: NCT02271880

Lead Sponsor: Florida International University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 7

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication as usual + STAR	STAR	Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence
Medication as usual	Medication as usual	Medication as typically prescribed by physician.
Medication as usual + STAR	Medication as usual	Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence

Primary Outcome Measures

Name	Time	Method
Medication Adherence	Posttreatment (6 months)	Proportion of prescribed doses taken as measured by electronic monitoring devices.

Secondary Outcome Measures

Name	Time	Method
Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms	Posttreatment (6 months)	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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms	Posttreatment (6 months)	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.
Impairment Rating Scale - Parent Report	Posttreatment (6 months)	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.
Impairment Rating Scale - Adolescent Report	Posttreatment (6 months)	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.
Maintenance of Medication Adherence	18 months	Continued monitoring of prescribed doses taken over 12-month monitoring period
Followup Medication Adherence	30 months	Continued monitoring of prescribed doses taken over 12-month followup period