Trial Outcomes & Findings for Improving Medication Adherence in ADHD Adolescents (NCT NCT02271880)

NCT ID: NCT02271880

Last Updated: 2019-07-24

Results Overview

Proportion of prescribed doses taken as measured by electronic monitoring devices.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: Posttreatment (6 months)
• Results posted on: 2019-07-24

Participant Flow

No enrolled participants were excluded from the study prior to assignment to groups.

Participant milestones

Measure	Medication as Usual Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	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.
Overall Study STARTED	3	4
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Medication as Usual Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	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.
Overall Study Premature discontinuation of study	3	4

Baseline Characteristics

Improving Medication Adherence in ADHD Adolescents

Baseline characteristics by cohort

Measure	Medication as Usual n=3 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=4 Participants 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.	Total n=7 Participants Total of all reporting groups
Age, Continuous	13.00 years STANDARD_DEVIATION 0.00 • n=5 Participants	15.75 years STANDARD_DEVIATION 0.50 • n=7 Participants	14.33 years STANDARD_DEVIATION 1.41 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Posttreatment (6 months)

Proportion of prescribed doses taken as measured by electronic monitoring devices.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Medication Adherence	.667 Past 30 day proportion adherence Standard Deviation .141	1.000 Past 30 day proportion adherence Standard Deviation NA Only 1 participant was analyzed in this group. Thus, it is not possible to calculate a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention	3.50 score on a scale Standard Deviation 4.95	7.00 score on a scale Standard Deviation NA In this group, data are available for one participant only. Thus, it is not possible to calculate a standard deviation for this value.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive	1.00 score on a scale Standard Deviation 1.41	3.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms	.50 score on a scale Standard Deviation .71	0.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms	.50 score on a scale Standard Deviation .71	0.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report	1.00 score on a scale Standard Deviation 1.41	0.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms	.50 score on a scale Standard Deviation .71	0.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=1 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms	0 score on a scale	0 score on a scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=1 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms	0 score on a scale	0 score on a scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Impairment Rating Scale - Parent Report	2.58 score on a scale Standard Deviation .82	2.17 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Medication as Usual n=2 Participants Medication as typically prescribed by physician. Medication as usual: Physicians will prescribe medication as usual to the adolescent.	Medication as Usual + STAR n=1 Participants 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.
Impairment Rating Scale - Adolescent Report	1.42 score on a scale Standard Deviation 1.30	.00 score on a scale Standard Deviation NA In this group, data are available for 1 participant only. Thus, it is not possible to compute a standard deviation.

SECONDARY outcome

Timeframe: 18 months

Population: Data were not collected.

Continued monitoring of prescribed doses taken over 12-month monitoring period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Data were not collected.

Continued monitoring of prescribed doses taken over 12-month followup period

Outcome measures

Outcome data not reported

Adverse Events

Medication as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medication as Usual + STAR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Pelham

Florida International University

Phone: 305-348-0477

Email: wpelham@fiu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place