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

NCT ID: NCT03080259

Last Updated: 2022-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-13

Study Completion Date

2022-05-31

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).

Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Stimulant Diversion Prevention

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).

Group Type ACTIVE_COMPARATOR

Stimulant Diversion Prevention (SDP)

Intervention Type BEHAVIORAL

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

Treatment As Usual

Standard clinical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stimulant Diversion Prevention (SDP)

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Brooke S. G. Molina, Ph.D.

Professor of Psychiatry and Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brooke SG Molina, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Youth and Family Research Program, WPIC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33908377 (View on PubMed)

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.

Reference Type RESULT
PMID: 33446402 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35951253 (View on PubMed)

Other Identifiers

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U01DA040213

Identifier Type: NIH

Identifier Source: secondary_id

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U01DA040213

Identifier Type: NIH

Identifier Source: org_study_id

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