ADHDNCT03080259
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
A study testing Stimulant Diversion Prevention (SDP) in people with ADHD, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- Stimulant Diversion Prevention (SDP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2016to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Youth and Family Research Program, WPIC
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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).
- Conditions
- ADHD
- Being tested
- Stimulant Diversion Prevention (SDP)
- Keywords
- ADHD, Stimulant Misuse, Stimulant Diversion
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulant Diversion Prevention (SDP)Behavioural
provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
| Study group | Role | What they receive |
|---|---|---|
| Stimulant Diversion Prevention | Active comparator | 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). Receives: Behavioral: Stimulant Diversion Prevention (SDP) |
| Treatment As Usual | No intervention | Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversion Activity Questionnaire (Diversion); Change from baseline across follow-up assessments
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.
Measured: 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
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.
Measured: 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
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Secondary outcomes (12)
Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Disclosure of Stimulant Treatment Questionnaire
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Diversion Activity Questionnaire (Approaches)
Number of times approached to sell or share ADHD prescription medication. Number will decrease after baseline more for the SDP than control group.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Skills)
Increased likelihood (from "definitely not" to "definitely") of using diversion refusal skills. Score will increase after baseline more for the SDP than control group.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Management of Peer Requests Questionnaire (Diversion Refusal Frequency)
Increased frequency (from "never" to "almost always") of using diversion refusal skills. Frequency will increase more after baseline for the SDP vs control group.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Knowledge of Stimulant Diversion Consequences Questionnaire
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Likelihood of Diversion Scale
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Approval of Diversion by Proximal Social Contacts Questionnaire
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Attempted)
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Actual)
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Parent-Teen Communication about Alcohol, Drugs, Diversion
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.
Measured: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start13 Oct 2016
- Primary completion18 Sep 2019
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Brooke S. G. Molina, Ph.D., University of Pittsburgh
- Investigators
- Brooke SG Molina, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080259
- Sponsor's protocol ID
- U01DA040213
- Other IDs
- U01DA040213
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2016
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33908377McGuier 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.
PubMed 33446402Molina BSG, Kipp HL, Pedersen SL, Kolko DJ, Lindstrom RA, Bauer DJ, Howard AL, Joseph HM. Training Physicians to Prevent Diversion of Stimulant Medication for Attention-Deficit/Hyperactivity Disorder: A Cluster-Randomized Controlled Trial in Pediatric Primary Care. J Atten Disord. 2026 Oct 26:10870547261494970. doi: 10.1177/10870547261494970. Online ahead of print.
PubMed 42928699McGuier 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.
PubMed 35951253
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
- ClinicalTrials.gov ID
- NCT03080259
- Acronym / sponsor ID
- U01DA040213
- Conditions
- ADHD
- Keywords
- ADHD, Stimulant Misuse, Stimulant Diversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulant Diversion Prevention | Active comparator | Behavioral: Stimulant Diversion Prevention (SDP)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). |
| Treatment As Usual | No intervention | –Standard clinical care |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Stimulant Diversion Prevention (SDP)provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments | Behavioural | Stimulant Diversion Prevention |
Primary outcome
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.
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.
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.
12 secondary outcomes
Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire
Time frame: 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
Diversion Activity Questionnaire (Approaches)
Time frame: 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
Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)
Time frame: 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
Knowledge of Stimulant Diversion Consequences Questionnaire
Time frame: 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
Approval of Diversion by Proximal Social Contacts Questionnaire
Time frame: 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
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
Parent-Teen Communication about Alcohol, Drugs, Diversion
Time frame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Results publication: PubMed 33908377Molina 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.
- Results publication: PubMed 33446402McGuier 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.
- Derived from this study: PubMed 42928699Molina BSG, Kipp HL, Pedersen SL, Kolko DJ, Lindstrom RA, Bauer DJ, Howard AL, Joseph HM. Training Physicians to Prevent Diversion of Stimulant Medication for Attention-Deficit/Hyperactivity Disorder: A Cluster-Randomized Controlled Trial in Pediatric Primary Care. J Atten Disord. 2026 Oct 26:10870547261494970. doi: 10.1177/10870547261494970. Online ahead of print.
- Derived from this study: PubMed 35951253McGuier 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Brooke SG Molina, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulant Diversion Prevention (SDP) in people with ADHD, run by University of Pittsburgh 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jun 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080259, which also lists 4 linked publications.
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 16 Jun 2022.