ADHD
Conditions
Keywords
ADHD, Stimulant Misuse, Stimulant Diversion
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).
Interventions
BEHAVIORALStimulant Diversion Prevention (SDP)
provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diversion Activity Questionnaire (Diversion); Change from baseline across follow-up assessments | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Management of Peer Requests Questionnaire (Diversion Refusal Skills) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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 | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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. |
| Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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. |
| Approval of Diversion by Proximal Social Contacts Questionnaire | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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 | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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. |
| Likelihood of Diversion Scale | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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. |
| Disclosure of Stimulant Treatment Questionnaire | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | 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) | baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up | Number of times approached to sell or share ADHD prescription medication. Number will decrease after baseline more for the SDP than control group. |
Countries
United States
Outcome results
None listed