Not provided
Not provided
Not provided
Not provided
Not provided
This study was stopped prematurely due to low enrollment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication as usual | Active Comparator | Medication as typically prescribed by physician. |
|
| Medication as usual + STAR | Active Comparator | Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication as usual | Other | Physicians will prescribe medication as usual to the adolescent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | Proportion of prescribed doses taken as measured by electronic monitoring devices. | Posttreatment (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University Center for Children and Families | Miami | Florida | 33199 | United States |
No enrolled participants were excluded from the study prior to assignment to groups.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Medication as Usual | Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent. |
| FG001 | Medication as Usual + STAR | Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence Medication as usual + STAR (Supporting Teen Adherence and Responsibility): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Medication as Usual | Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent. |
| BG001 | Medication as Usual + STAR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Adherence | Proportion of prescribed doses taken as measured by electronic monitoring devices. | Posted | Mean | Standard Deviation | Past 30 day proportion adherence | Posttreatment (6 months) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication as Usual | Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent. |
Not provided
Not provided
Due to early termination of this study, only 3 participants (1 in the MAU+STAR arm and 2 in the MAU arm) reached the 6-month assessment. As a result, data should not be interpreted as indication of treatment effect due to the small sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Pelham | Florida International University | 305-348-0477 | wpelham@fiu.edu |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| STAR | Other | 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. |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Maintenance of Medication Adherence | Continued monitoring of prescribed doses taken over 12-month monitoring period | 18 months |
| Followup Medication Adherence | Continued monitoring of prescribed doses taken over 12-month followup period | 30 months |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Number | score on a scale | 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. | Posted | Number | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | Posttreatment (6 months) |
|
|
|
| Secondary | Maintenance of Medication Adherence | Continued monitoring of prescribed doses taken over 12-month monitoring period | Data were not collected. | Posted | 18 months |
|
|
| Secondary | Followup Medication Adherence | Continued monitoring of prescribed doses taken over 12-month followup period | Data were not collected. | Posted | 30 months |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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. | 0 | 4 | 0 | 4 |
Not provided
Not provided
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |