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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080259
• Other study ID #: U01DA040213
• Secondary ID: U01DA040213
• Status: Completed
• Phase: N/A
• Start date: October 13, 2016
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: May 31, 2022
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Stimulant Diversion Prevention (SDP)
provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments

Locations

Country	Name	City	State
United States	Youth and Family Research Program, WPIC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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):80 — View 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. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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