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NCT03219190 Clinical Trial

A High School Program for Preventing Prescription Drug Abuse

Substance Abuse Clinical Trial

Official title:
A High School Program for Preventing Prescription Drug Abuse

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03219190
Other study ID # 1R44DA04327301
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date April 2022

Study information
Verified date February 2020
Source National Health Promotion Associates, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project will develop and evaluate a program to prevent prescription drug abuse in high school students

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 3000
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility Inclusion Criteria:

- High school aged-youth

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• LST High School Online
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.

Locations
Country Name City State
United States National Health Promotion Associates White Plains New York

Sponsors (1)
Lead Sponsor Collaborator
National Health Promotion Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Post-test (within 2 weeks of completing final session/module of the intervention), 12-month follow-up, 24-month follow-up
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