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

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: ADHD
• Intervention / Treatment: Behavioral: Stimulant Diversion Prevention (SDP)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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).	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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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	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)	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)	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)	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)	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	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	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	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)	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)	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	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

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Brooke SG Molina, PhD, University of Pittsburgh

Publications and helpful links

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

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: ADHD; Stimulant Misuse; Stimulant Diversion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Stimulants
• 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.