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Improving Medication Adherence in ADHD Adolescents

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ClinicalTrials.gov Identifier: NCT02271880
Recruitment Status : Terminated (This study was stopped prematurely due to low enrollment.)
First Posted : October 22, 2014
Results First Posted : February 19, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Florida International University

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Other: Medication as usual Other: STAR Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Medication Adherence in ADHD Adolescents
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Medication as usual
Medication as typically prescribed by physician.
 Other: Medication as usual
Physicians will prescribe medication as usual to the adolescent.
Active Comparator: Medication as usual + STAR
Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence
 Other: Medication as usual
Physicians will prescribe medication as usual to the adolescent.

Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Medication Adherence [ Time Frame: Posttreatment (6 months) ]
    Proportion of prescribed doses taken as measured by electronic monitoring devices.


Secondary Outcome Measures :
  1. Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention [ Time Frame: 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.

  2. Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive [ Time Frame: 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.

  3. Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms [ Time Frame: 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.

  4. Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms [ Time Frame: 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.

  5. Disruptive Behavior Disorder Rating Scale - Adolescent Report [ Time Frame: 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.

  6. Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms [ Time Frame: 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.

  7. Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms [ Time Frame: 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.

  8. Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms [ Time Frame: 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.

  9. Impairment Rating Scale - Parent Report [ Time Frame: 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.

  10. Impairment Rating Scale - Adolescent Report [ Time Frame: 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.

  11. Maintenance of Medication Adherence [ Time Frame: 18 months ]
    Continued monitoring of prescribed doses taken over 12-month monitoring period

  12. Followup Medication Adherence [ Time Frame: 30 months ]
    Continued monitoring of prescribed doses taken over 12-month followup period


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271880


Locations
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United States, Florida
Florida International University Center for Children and Families
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
More Information
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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT02271880    
Other Study ID Numbers: MH097819
First Posted: October 22, 2014    Key Record Dates
Results First Posted: February 19, 2018
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Florida International University:
Medication nonadherence