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

NCT03080259 | Completed

• 1 other identifier: U01DA040213
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD; Stimulant Misuse; Stimulant Diversion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Utilization of Clinical Practice Strategies for Diversion Prevention Questionnaire

  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

• Diversion Activity Questionnaire (Approaches)

  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

• Management of Peer Requests Questionnaire (Diversion Refusal Self Efficacy)

  baseline, 6 month follow-up, 12 month follow-up, 18 month follow-up

Study Arms (2)

Stimulant Diversion Prevention

ACTIVE COMPARATOR

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)

Treatment As Usual

NO INTERVENTION

Standard clinical care

Interventions

Stimulant Diversion Prevention (SDP) BEHAVIORAL

provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments

Stimulant Diversion Prevention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Youth and Family Research Program, WPIC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• 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.

  PMID: 33908377 RESULT

• 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.

  PMID: 33446402 RESULT

• 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.

  PMID: 35951253 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Brooke SG Molina, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: March 15, 2017
• Study Start: October 13, 2016
• Primary Completion: September 18, 2019
• Study Completion: May 31, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)