CClinicalTrials.gg
Status unknownNCT03129334MSPDAUpdated Feb 25, 2020

Preventing Prescription Drug Abuse in Middle School Students

An interventional study of LST Middle School Online in Prescription Drug Abuse (Not Dependent), Substance Use and Substance Abuse, sponsored by National Health Promotion Associates, Inc.. Status unknown. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by National Health Promotion Associates, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Sep 2015, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
4,500
Allocation
Randomized
Ages
11 Years to 14 Years
Sex
All
01

Study summary

This project is designed to test a primary prevention approach to the problem of prescription drug misuse and abuse (PDA) among middle school students. The intervention uses both online e-learning and small group facilitator-led intervention modalities. Middle schools will be randomized to receive the intervention or serve as controls.

Read the detailed description

While there are a number of drug abuse prevention programs for middle school age youth, relatively few programs focus on preventing prescription drug abuse. Furthermore, due to growing constraints on classroom time, new evidence-based prevention programs are needed that flexibly incorporate the use of online digital technology and classroom/small-group components. The present study is developing and testing an adaptation of the evidence-based substance abuse and violence prevention approach called Life Skills Training (LST). The proposed preventive intervention for middle school PDA will (1) utilize both online digital and face-to-face intervention modalities to address PDA and concurrent ATOD use; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD use; (3) discourage diversion of prescription medications; and (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios. Middle schools will be randomized into either an intervention group that will receive the new intervention or a treatment-as-usual control group that will receive existing health education programming. At the end of the intervention period, and at a 12-month follow-up assessments, we will compare both groups with respect to changes in behaviors, norms, attitudes, and knowledge regarding PDA and substance use.

02

Conditions studied

  • Prescription Drug Abuse (Not Dependent)
  • Substance Use
  • Substance Abuse
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 4,500 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

National Health Promotion Associates, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Middle school aged-youth

Exclusion criteria

Exclusion Criteria:

  • Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4,500 participants (estimated)

Study arms

  • Experimental
    LST Middle School Online

    Students will participate in a series of e-learning modules plus classroom sessions related to drug abuse prevention, including prescription drug abuse

    Behavioral: LST Middle School Online

  • No intervention
    Treatment as Usual (Control)

    Students will not participate in the e-learning modules. They will receive any standard classroom instruction on drug abuse/health education.

Interventions

  • BehavioralLST Middle School Online

    The adapted intervention will (1) utilize both online e-learning module (self-guided) and classroom-based sessions (facilitator led) to address PDA and concurrent ATOD abuse; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD abuse; (3) discourage diversion of prescription medications; (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios; and (5) incorporate booster sessions.

06

What researchers measure

Primary outcomes

  1. Change in any prescription drug use in the past year

    The investigators will assess (via questionnaire) key study variables regarding prescription drug abuse and hypothesized risk and protective factors. These outcomes will be examined and compared in both the intervention group and the control group at a post-test assessment and 6- and 12-month follow-up assessments.

    Time frame: Post-test (within 2 weeks of completing final session/module of the intervention), 6-month followup, 12-month followup

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03129334
Lead sponsor
National Health Promotion Associates, Inc.
Responsible party
Kenneth W Griffin (Senior Research Scientiest, National Health Promotion Associates, Inc.) — Principal investigator
First posted
Apr 26, 2017
Start date
Sep 2015
Primary completion
Jun 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Feb 25, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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