ADHDNCT02271880
Improving Medication Adherence in ADHD Adolescents
A study testing Medication as usual and STAR in people with ADHD, run by Florida International University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- ADHD
- What is being tested?
- Medication as usual and STAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University Center for Children and Families
Miami, Florida, 33199
About this study
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Medication as usual, STAR
- Keywords
- Medication nonadherence
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication as usualOther
Physicians will prescribe medication as usual to the adolescent.
STAROther
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication as usual | Active comparator | Medication as typically prescribed by physician. Receives: Other: Medication as usual |
| Medication as usual + STAR | Active comparator | Medication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence Receives: Other: Medication as usual; Other: STAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence
Proportion of prescribed doses taken as measured by electronic monitoring devices.
Measured: Posttreatment (6 months)
Secondary outcomes (12)
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.
Measured: Posttreatment (6 months)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Posttreatment (6 months)
Maintenance of Medication Adherence
Continued monitoring of prescribed doses taken over 12-month monitoring period
Measured: 18 months
Followup Medication Adherence
Continued monitoring of prescribed doses taken over 12-month followup period
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: This study was stopped prematurely due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271880
- Sponsor's protocol ID
- MH097819
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2014
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence in ADHD Adolescents
- ClinicalTrials.gov ID
- NCT02271880
- Acronym / sponsor ID
- MH097819
- Conditions
- ADHD
- Keywords
- Medication nonadherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped prematurely due to low enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication as usual | Active comparator | Other: Medication as usualMedication as typically prescribed by physician. |
| Medication as usual + STAR | Active comparator | Other: Medication as usual, Other: STARMedication as typically prescribed with the addition of the psychosocial intervention to improve medication adherence |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication as usualPhysicians will prescribe medication as usual to the adolescent. | Other | Medication as usual, Medication as usual + STAR |
| STARAdolescents 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. | Other | Medication as usual + STAR |
Primary outcome
Medication Adherence
Time frame: Posttreatment (6 months)
Proportion of prescribed doses taken as measured by electronic monitoring devices.
12 secondary outcomes
Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Adolescent Report
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms
Time frame: Posttreatment (6 months)
Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms
Time frame: Posttreatment (6 months)
Impairment Rating Scale - Parent Report
Time frame: Posttreatment (6 months)
Impairment Rating Scale - Adolescent Report
Time frame: Posttreatment (6 months)
Maintenance of Medication Adherence
Time frame: 18 months
Followup Medication Adherence
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication as usual and STAR in people with ADHD, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: Posttreatment (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.