Clinical trial NCT03080259: 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
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Stimulant Misuse
Stimulant Diversion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-03-15
Enrollment: 357
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Diversion Activity Questionnaire (Diversion); Change from baseline across follow-up assessments
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Perceived Risk of Harm Questionnaire; Change from baseline across follow-up assessments
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Intentions to Divert Prescription Stimulants Questionnaire; Change from baseline across follow-up assessments
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Secondary outcomes:
measure: Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Disclosure of Stimulant Treatment Questionnaire
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Diversion Activity Questionnaire (Approaches)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Management of Peer Requests Questionnaire (Diversion Refusal Skills)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Management of Peer Requests Questionnaire (Diversion Refusal Frequency)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Knowledge of Stimulant Diversion Consequences Questionnaire
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Likelihood of Diversion Scale
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Approval of Diversion by Proximal Social Contacts Questionnaire
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Attempted)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Parental Supervision and Monitoring Specific to ADHD Medication Questionnaire (Actual)
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
measure: Parent-Teen Communication about Alcohol, Drugs, Diversion
timeFrame: baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Youth and Family Research Program, WPIC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brooke SG Molina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.