Improving Medication Adherence in ADHD Adolescents

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adherence to Stimulant Treatment in Attention-Deficit Hyperactivity Disorder (ADHD) Patients (ASTA)

NCT00852059

ADHD

TERMINATED PHASE4

Parent-Provider Intervention for Improving Medication Adherence in Children With Attention Deficit Hyperactivity Disorder

NCT00429221

Attention Deficit Disorder With Hyperactivity

WITHDRAWN NA

Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

NCT01127607

ADHD

COMPLETED PHASE4

Examining Tolerance to CNS Stimulants in ADHD

NCT02039908

Attention-deficit/Hyperactivity Disorder

COMPLETED PHASE4

Increasing Academic Success in Middle School Students With ADHD

NCT02048579

Behavior Therapy + MI Intervention (Supporting Teens' Academic Needs Daily) Treatment as Usual

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medication as usual

Medication as typically prescribed by physician.

Group Type ACTIVE_COMPARATOR

Medication as usual

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Medication as usual

Intervention Type OTHER

Physicians will prescribe medication as usual to the adolescent.

STAR

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Medication as usual

Physicians will prescribe medication as usual to the adolescent.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No