Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
Primary Purpose
ADHD
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulant Diversion Prevention (SDP)
Sponsored by
About this trial
This is an interventional prevention trial for ADHD focused on measuring ADHD, Stimulant Misuse, Stimulant Diversion
Eligibility Criteria
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
Sites / Locations
- Youth and Family Research Program, WPIC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Stimulant Diversion Prevention
Treatment As Usual
Arm Description
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).
Standard clinical care
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03080259
First Posted
June 17, 2016
Last Updated
June 13, 2022
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03080259
Brief Title
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
Official Title
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2016 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Stimulant Misuse, Stimulant Diversion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stimulant Diversion Prevention
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Standard clinical care
Intervention Type
Behavioral
Intervention Name(s)
Stimulant Diversion Prevention (SDP)
Intervention Description
provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
Primary Outcome Measure Information:
Title
Diversion Activity Questionnaire (Diversion); Change from baseline across follow-up assessments
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Perceived Risk of Harm Questionnaire; Change from baseline across follow-up assessments
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Intentions to Divert Prescription Stimulants Questionnaire; Change from baseline across follow-up assessments
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Secondary Outcome Measure Information:
Title
Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Disclosure of Stimulant Treatment Questionnaire
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Diversion Activity Questionnaire (Approaches)
Description
Number of times approached to sell or share ADHD prescription medication. Number will decrease after baseline more for the SDP than control group.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Management of Peer Requests Questionnaire (Diversion Refusal Skills)
Description
Increased likelihood (from "definitely not" to "definitely") of using diversion refusal skills. Score will increase after baseline more for the SDP than control group.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Management of Peer Requests Questionnaire (Diversion Refusal Frequency)
Description
Increased frequency (from "never" to "almost always") of using diversion refusal skills. Frequency will increase more after baseline for the SDP vs control group.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Knowledge of Stimulant Diversion Consequences Questionnaire
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Likelihood of Diversion Scale
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Approval of Diversion by Proximal Social Contacts Questionnaire
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Attempted)
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Actual)
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Title
Parent-Teen Communication about Alcohol, Drugs, Diversion
Description
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.
Time Frame
baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooke SG Molina, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Youth and Family Research Program, WPIC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33908377
Citation
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.
Results Reference
result
PubMed Identifier
33446402
Citation
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.
Results Reference
result
PubMed Identifier
35951253
Citation
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.
Results Reference
derived
Learn more about this trial
Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
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