Improving Medication Adherence in ADHD Adolescents

ADHD Clinical Trial

Official title:

Improving Medication Adherence in ADHD Adolescents

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02271880
• Other study ID #: MH097819
• Status: Terminated
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2019
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Other:
• Medication as usual
Physicians will prescribe medication as usual to the adolescent.
• STAR
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.

Locations

Country	Name	City	State
United States	Florida International University Center for Children and Families	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Proportion of prescribed doses taken as measured by electronic monitoring devices.	Posttreatment (6 months)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Maintenance of Medication Adherence	Continued monitoring of prescribed doses taken over 12-month monitoring period	18 months
Secondary	Followup Medication Adherence	Continued monitoring of prescribed doses taken over 12-month followup period	30 months