- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080259
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
357
Phase
- 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
-
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Pennsylvania
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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
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 |
Intervention / Treatment |
---|---|
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).
|
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
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
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
Collaborators
Investigators
- 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
- Molina BSG, Joseph HM, Kipp HL, Lindstrom RA, Pedersen SL, Kolko DJ, Bauer DJ, Subramaniam GA. Adolescents Treated for Attention-Deficit/Hyperactivity Disorder in Pediatric Primary Care: Characterizing Risk for Stimulant Diversion. J Dev Behav Pediatr. 2021 Sep 1;42(7):540-552. doi: 10.1097/DBP.0000000000000923.
- McGuier EA, Kolko DJ, Joseph HM, Kipp HL, Lindstrom RA, Pedersen SL, Subramaniam GA, Molina BSG. Use of Stimulant Diversion Prevention Strategies in Pediatric Primary Care and Associations With Provider Characteristics. J Adolesc Health. 2021 Apr;68(4):808-815. doi: 10.1016/j.jadohealth.2020.12.006. Epub 2021 Jan 11.
- McGuier EA, Kolko DJ, Pedersen SL, Kipp HL, Joseph HM, Lindstrom RA, Bauer DJ, Subramaniam GA, Molina BSG. Effects of Training on Use of Stimulant Diversion Prevention Strategies by Pediatric Primary Care Providers: Results from a Cluster-Randomized Trial. Prev Sci. 2022 Oct;23(7):1299-1307. doi: 10.1007/s11121-022-01411-2. Epub 2022 Aug 11.
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)
October 13, 2016
Primary Completion (Actual)
September 18, 2019
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
June 17, 2016
First Submitted That Met QC Criteria
March 9, 2017
First Posted (Actual)
March 15, 2017
Study Record Updates
Last Update Posted (Actual)
June 16, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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