ADHD
Conditions
Keywords
Medication nonadherence
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.
Interventions
OTHERMedication as usual
Physicians will prescribe medication as usual to the adolescent.
OTHERSTAR
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.
Sponsors
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | Posttreatment (6 months) | Proportion of prescribed doses taken as measured by electronic monitoring devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
No enrolled participants were excluded from the study prior to assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Medication as Usual Medication as typically prescribed by physician.
Medication as usual: Physicians will prescribe medication as usual to the adolescent. | 3 |
| Medication as Usual + STAR Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence
Medication as usual + STAR: Physicians will prescribe medication and 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. | 4 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Premature discontinuation of study | 3 | 4 |
Baseline characteristics
| Characteristic | Medication as Usual | Total | Medication as Usual + STAR |
|---|---|---|---|
| Age, Continuous | 13.00 years STANDARD_DEVIATION 0 | 14.33 years STANDARD_DEVIATION 1.41 | 15.75 years STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 |
Outcome results
Primary
Medication Adherence
Proportion of prescribed doses taken as measured by electronic monitoring devices.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Medication Adherence | .667 Past 30 day proportion adherence | Standard Deviation 0.141 |
| Medication as Usual + STAR | Medication Adherence | 1.000 Past 30 day proportion adherence | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Adolescent Report | 1.00 score on a scale | Standard Deviation 1.41 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Adolescent Report | 0.00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms | 0 score on a scale |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms | 0 score on a scale |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms | .50 score on a scale | Standard Deviation 0.71 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms | 0.00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms | 0 score on a scale |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms | 0 score on a scale |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms | .50 score on a scale | Standard Deviation 0.71 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms | 0.00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive | 1.00 score on a scale | Standard Deviation 1.41 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive | 3.00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention | 3.50 score on a scale | Standard Deviation 4.95 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention | 7.00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms | .50 score on a scale | Standard Deviation 0.71 |
| Medication as Usual + STAR | Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms | 0.00 score on a scale | — |
Secondary
Followup Medication Adherence
Continued monitoring of prescribed doses taken over 12-month followup period
Time frame: 30 months
Population: Data were not collected.
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Impairment Rating Scale - Adolescent Report | 1.42 score on a scale | Standard Deviation 1.3 |
| Medication as Usual + STAR | Impairment Rating Scale - Adolescent Report | .00 score on a scale | — |
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.
Time frame: Posttreatment (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medication as Usual | Impairment Rating Scale - Parent Report | 2.58 score on a scale | Standard Deviation 0.82 |
| Medication as Usual + STAR | Impairment Rating Scale - Parent Report | 2.17 score on a scale | — |
Secondary
Maintenance of Medication Adherence
Continued monitoring of prescribed doses taken over 12-month monitoring period
Time frame: 18 months
Population: Data were not collected.