NCT02271880

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

9 months

First QC Date

September 24, 2014

Results QC Date

August 8, 2017

Last Update Submit

July 10, 2019

Conditions

ADHD

Keywords

Medication nonadherence

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence

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

    Posttreatment (6 months)

Secondary Outcomes (12)

  • Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention

    Posttreatment (6 months)

  • Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive

    Posttreatment (6 months)

  • Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms

    Posttreatment (6 months)

  • Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms

    Posttreatment (6 months)

  • Disruptive Behavior Disorder Rating Scale - Adolescent Report

    Posttreatment (6 months)

  • +7 more secondary outcomes

Study Arms (2)

Medication as usual

ACTIVE COMPARATOR

Medication as typically prescribed by physician.

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

Other: Medication as usualOther: STAR

Interventions

Medication as usualOTHER

Physicians will prescribe medication as usual to the adolescent.

Medication as usualMedication as usual + STAR
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.

Medication as usual + STAR

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMedication Adherence

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. William Pelham
Organization
Florida International University
wpelham@fiu.edu
305-348-0477

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

October 22, 2014

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 24, 2019

Results First Posted

February 19, 2018

Record last verified: 2019-07

Locations

US(1)