Primary Care Prevention of Stimulant Diversion by High School Students With ADHD

June 13, 2022 updated by: Brooke S. G. Molina, Ph.D., University of Pittsburgh
The purpose of this study is to test clinical strategies that pediatric providers may use to prevent misuse and diversion of stimulants by their adolescent patients with ADHD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study addresses the increase in diversion (selling, sharing, loaning, or trading) of prescription stimulant medications by adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). In the absence of any standardized, empirically evaluated clinical strategies or interventions to prevent or decrease stimulant diversion, this project will test the effect of a brief provider-led intervention for stimulant diversion prevention among adolescents being prescribed stimulant medication in pediatric care. The investigators hypothesize that adolescents treated in pediatric practices randomized to the intervention will report decreased diversion, increased perceived risk of harm, and decreased intentions to divert compared to adolescents treated in pediatric practices randomized to treatment-as-usual. Secondary analyses will examine the effect of the intervention on additional contributing variables (e.g., patient, parent, and provider attitude and behavior change).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Youth and Family Research Program, WPIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of ADHD
  • Treatment with stimulant medication
  • Enrolled in or attending middle school or high school
  • Parent/guardian willing to participate
  • Receiving treatment at one of the 7 pediatric practices participating in the protocol

Exclusion Criteria:

  • Not diagnosed with ADHD
  • Not treated with stimulant medication
  • Not enrolled or attending middle school or high school
  • Parent/guardian unwilling to participate
  • Not receiving treatment at one of the 7 pediatric practices participating in the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Stimulant Diversion Prevention
Providers will be trained in methods to prevent or decrease the likelihood of stimulant diversion by their adolescent patients (education and counseling, strategies for use by patients and parents, and treatment adjustments).
Behavioral: Stimulant Diversion Prevention (SDP)
provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
No Intervention: Treatment As Usual
Standard clinical care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diversion Activity Questionnaire (Diversion); Change from baseline across follow-up assessments
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items indicating frequency (# of times) selling, sharing, trading, or loaning stimulant medication. Diversion frequency will increase less in the SDP group between baseline and follow-up assessments.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Perceived Risk of Harm Questionnaire; Change from baseline across follow-up assessments
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring the degree to which participants believe that people risk harming themselves if they take ADHD medication without a prescription (responses range from "no risk" to "great risk"). Mean perceived harm will increase more after baseline for the SDP vs control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Intentions to Divert Prescription Stimulants Questionnaire; Change from baseline across follow-up assessments
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring intention to share/sell/trade stimulant medication (responses range from "I definitely will" to "I definitely will not"). Intent to divert will increase less in the SDP vs control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring teen's report of the frequency of provider utilization of stimulant diversion prevention techniques (responses range from "no" to "yes, more than once" in the last 6 months). Number of techniques endorsed as occurring at least once will increase. Number will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Disclosure of Stimulant Treatment Questionnaire
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Number of people and/or groups who know about the teen's ADHD medication prescription (sum total across items). Total number will decrease after baseline in the SDP vs control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Diversion Activity Questionnaire (Approaches)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Number of times approached to sell or share ADHD prescription medication. Number will decrease after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Skills)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Increased likelihood (from "definitely not" to "definitely") of using diversion refusal skills. Score will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Increased ease (from "very difficult" to "very easy") in perceived use of diversion refusal skills. Score will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Frequency)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Increased frequency (from "never" to "almost always") of using diversion refusal skills. Frequency will increase more after baseline for the SDP vs control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Knowledge of Stimulant Diversion Consequences Questionnaire
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring knowledge of negative consequences of diversion; mean score will increase (responses for each consequence ranges from "very unlikely" to "likely"). Mean score will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Likelihood of Diversion Scale
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Assesses likelihood (response scale ranges from "I definitely would" to "I definitely would not") of diverting medication in specific situations. Mean response across items should increase toward "I definitely would not". Likelihood of diversion mean score will change after baseline toward "I definitely would not" more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Approval of Diversion by Proximal Social Contacts Questionnaire
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring approval of diversion by proximal social contacts; responses range from "strongly approve" to "strongly disapprove". Mean score will increase towards disapproval. Mean score will increase toward disapproval more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Attempted)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring attempted parental monitoring of stimulant medication (e.g., During the last 6 months, how much did either of your parents try to know.......). Mean score of responses across items. Mean score will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Actual)
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items measuring actual parental knowledge of teen's stimulant medication (e.g., During the last 6 months, how much did either of your parents really know.......). Mean score of responses across items. Mean score will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parent-Teen Communication about Alcohol, Drugs, Diversion
Time Frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Items assessing frequency of parent-teen discussion about diversion-related behavior (e.g., "Within the last 6 months, my parents talked with me about keeping my ADHD diagnosis and ADHD medication private"). Responses range from "never" to "three or more times". Number of items endorsed as occurring at least once or more often will increase after baseline more for the SDP than control group.
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brooke SG Molina, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U01DA040213 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will make de-identified data available to potential scientific collaborators upon request as allowed by local Institutional Review Board (IRB) regulations and after the main findings of the study have been accepted for publication. The investigators will honor requests to use data for research or teaching purposes only and that include a commitment to protect the privacy and confidentiality of the data per IRB requirements. Depending upon the size of the request, the investigators will charge, as needed, reasonable costs associated with preparation of datasets and assistance with dataset utilization.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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