Primary Care Prevention of Stimulant Diversion by High School Students With ADHD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 357
- Locations
- 2
- Primary Endpoint
- Perceived Risk of Harm Questionnaire; Change from baseline across follow-up assessments
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- Knowledge of Stimulant Diversion Consequences Questionnaire(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Likelihood of Diversion Scale(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Parent-Teen Communication about Alcohol, Drugs, Diversion(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Diversion Activity Questionnaire (Approaches)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Attempted)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Disclosure of Stimulant Treatment Questionnaire(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Management of Peer Requests Questionnaire (Diversion Refusal Skills)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Actual)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Management of Peer Requests Questionnaire (Diversion Refusal Frequency)(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
- Approval of Diversion by Proximal Social Contacts Questionnaire(baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up)
Investigators
Brooke S. G. Molina, Ph.D.
Professor of Psychiatry and Psychology
University of Pittsburgh