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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Stimulant Diversion Prevention (SDP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stimulant Diversion Prevention<br>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)<br>* provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments<br>|
| No Intervention: Treatment As Usual<br>Standard clinical care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Stimulant Misuse, Stimulant Diversion