Back to resultsA High School Program for Preventing Prescription Drug Abuse
Primary Purpose
Prescription Drug Abuse (Not Dependent), Substance Use, Substance Abuse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LST High School Online
Sponsored by
About this trial
This is an interventional prevention trial for Prescription Drug Abuse (Not Dependent)
Eligibility Criteria
Inclusion Criteria:
- High school aged-youth
Exclusion Criteria:
- Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Sites / Locations
- National Health Promotion Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LST High School Online
Treatment as Usual (Control)
Arm Description
Provided with the prevention program, consisting of e-learning modules and classroom sessions.
Standard health education
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03219190
First Posted
July 13, 2017
Last Updated
February 24, 2020
Sponsor
National Health Promotion Associates, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03219190
Brief Title
A High School Program for Preventing Prescription Drug Abuse
Official Title
A High School Program for Preventing Prescription Drug Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Promotion Associates, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project will develop and evaluate a program to prevent prescription drug abuse in high school students
Detailed Description
This Fast-Track SBIR project is designed to address the critical need for an effective primary prevention approach for prescription drug abuse (PDA), an urgent public health crisis in the United States. The project involves developing and testing an innovative new approach to the primary prevention of PDA among high school students utilizing e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the evidence-based substance abuse prevention approach called Life Skills Training (LST). The adapted intervention will address the relationship between PDA and alcohol, tobacco and other drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDA; discourage diversion of prescription medications; enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Drug Abuse (Not Dependent), Substance Use, Substance Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LST High School Online
Arm Type
Experimental
Arm Description
Provided with the prevention program, consisting of e-learning modules and classroom sessions.
Arm Title
Treatment as Usual (Control)
Arm Type
No Intervention
Arm Description
Standard health education
Intervention Type
Behavioral
Intervention Name(s)
LST High School Online
Intervention Description
The proposed preventive intervention for high school PDA will (1) utilize both online e-learning modules and interactive classroom sessions to address PDA and concurrent alcohol/drug abuse; (2) positively change social norms surrounding PDA and alcohol/drug abuse; (3) challenge positive expectancies about the benefits of PDA; (4) discourage diversion of prescription medication; (5) enhance protective factors by building social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios; and (6) include online booster sessions.
Primary Outcome Measure Information:
Title
Change in any prescription drug use in the past year
Description
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), 12-month follow-up, 24-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
High school aged-youth
Exclusion Criteria:
Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth W Griffin, PhD
Organizational Affiliation
National Health Promotion Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Promotion Associates
City
White Plains
State/Province
New York
ZIP/Postal Code
10604
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A High School Program for Preventing Prescription Drug Abuse
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