NCT01755533

Brief Summary

The goals of this study are to develop a middle school substance use prevention curriculum for underserved rural youth and evaluate its efficacy compared to the existing, multicultural curriculum. In addition, we are studying how the curricula get taught by the teachers. Hypothesis 1: When compared to students in the control condition, students in the treatment conditions will report less substance use, more conservative norms, less positive expectations about substance use outcomes, and better life and communication skills. Hypothesis 2: When compared to students in the control condition, students in the researcher adaptation condition will report less substance use, more conservative norms, less positive expectations, and better life and communication skills. Hypothesis 3: When compared to students in the control condition, students in the teacher adaptation condition will report less substance use, more conservative norms, less positive expectations, and better life and communication skills. Hypothesis 4: Researcher adaptation will have a greater impact on substance use, norms, and expectations than teacher adaptation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,827

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

4.3 years

First QC Date

December 21, 2012

Last Update Submit

April 18, 2017

Conditions

Keywords

adolescent substance userural substance usemiddle school preventionimplementation processesimplementation qualityadaptation of prevention curriculadissemination

Outcome Measures

Primary Outcomes (1)

  • Change in substance use

    Self report measure

    Between the beginning of 7th grade and the end of 9th grade

Study Arms (3)

Rural curriculum

EXPERIMENTAL

Receive rural version of curriculum

Other: Rural curriculum

Classic curriculum

EXPERIMENTAL

Receive classic version of curriculum

Other: Classic curriculum

Control

NO INTERVENTION

Continue normal prevention activities

Interventions

Students in schools randomly assigned to this condition receive the rural version of the curriculum.

Rural curriculum

Students in schools randomly assigned to this condition receive the classic version of the curriculum.

Classic curriculum

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any student enrolled in treatment or control classes

You may not qualify if:

  • Students not enrolled in treatment or control classes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Communication Arts & Sciences, Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

  • Pettigrew J, Miller-Day M, Krieger J, Hecht ML. Alcohol and Other Drug Resistance Strategies Employed by Rural Adolescents. J Appl Commun Res. 2011;39(2):103-122. doi: 10.1080/00909882.2011.556139.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael L Hecht, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Communication Arts and Sciences

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 24, 2012

Study Start

February 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations