NCT02715206

Brief Summary

The purpose of this study is to determine if a new substance use prevention curriculum for rural middle schools is effective in reducing substance use and to study how prevention curriculum get implemented by teachers.

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 Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

7.5 years

First QC Date

February 25, 2016

Last Update Submit

April 18, 2017

Conditions

Substance Abuse Problem

Keywords

rural adolescents, substance use, prevention, adaptation

Outcome Measures

Primary Outcomes (3)

  • Recent use of alcohol

    Self report measure of recent use of alcohol

    30 days

  • Recent use of tobacco

    Self report measure

    30 days

  • Recent use of marijuana

    Self report

    30 days

Secondary Outcomes (2)

  • Perceptions of number of peers using drugs

    2 years

  • Perception of self efficacy resisting drug offers

    2 years

Study Arms (3)

Control

EXPERIMENTAL

middle schools not receiving keepin' it REAL; continue their own programs if any.

Behavioral: control

keepin' it REAL classic

EXPERIMENTAL

middle schools will implement keepin' it REAL classic drug prevention curriculum

Behavioral: keepin' it REAL classic

keepin' it REAL rural

EXPERIMENTAL

middle schools will implement the keepin' it REAL rural curriculum

Behavioral: keepin' it REAL rural

Interventions

keepin' it REAL classicBEHAVIORAL

keepin' it REAL consists of 10 classroom lessons implemented in 7th grade and 4 booster sessions implemented in 8th grade by the classroom teacher following training

keepin' it REAL classic
keepin' it REAL ruralBEHAVIORAL

keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.

keepin' it REAL rural
controlBEHAVIORAL

control group continues to teach whatever prevention curriculum they were using prior to study

Control

Eligibility Criteria

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

You may qualify if:

  • \- all 7th grade students in implementation middle

You may not qualify if:

  • lack of parental consent
  • lack of student assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (13)

  • Graham JW, Pettigrew J, Miller-Day M, Krieger JL, Zhou J, Hecht ML. Random assignment of schools to groups in the drug resistance strategies rural project: some new methodological twists. Prev Sci. 2014 Aug;15(4):516-25. doi: 10.1007/s11121-013-0403-9.

    PMID: 23722619BACKGROUND

  • Shin Y, Miller-Day M, Pettigrew J, Hecht ML, Krieger JL. Typology of delivery quality: latent profile analysis of teacher engagement and delivery techniques in a school-based prevention intervention, keepin' it REAL curriculum. Health Educ Res. 2014 Dec;29(6):897-905. doi: 10.1093/her/cyu061. Epub 2014 Sep 30.

    PMID: 25274721BACKGROUND

  • Choi HJ, Krieger JL, Hecht ML. Reconceptualizing efficacy in substance use prevention research: refusal response efficacy and drug resistance self-efficacy in adolescent substance use. Health Commun. 2013;28(1):40-52. doi: 10.1080/10410236.2012.720245.

    PMID: 23330857BACKGROUND

  • Krieger JL, Coveleski S, Hecht ML, Miller-Day M, Graham JW, Pettigrew J, Kootsikas A. From kids, through kids, to kids: examining the social influence strategies used by adolescents to promote prevention among peers. Health Commun. 2013;28(7):683-95. doi: 10.1080/10410236.2012.762827. Epub 2013 Aug 27.

    PMID: 23980520BACKGROUND

  • Colby M, Hecht ML, Miller-Day M, Krieger JL, Syvertsen AK, Graham JW, Pettigrew J. Adapting school-based substance use prevention curriculum through cultural grounding: a review and exemplar of adaptation processes for rural schools. Am J Community Psychol. 2013 Mar;51(1-2):190-205. doi: 10.1007/s10464-012-9524-8.

    PMID: 22961604BACKGROUND

  • Hopfer S, Hecht ML, Lanza ST, Tan X, Xu S. Preadolescent drug use resistance skill profiles, substance use, and substance use prevention. J Prim Prev. 2013 Dec;34(6):395-404. doi: 10.1007/s10935-013-0325-0.

    PMID: 23990398BACKGROUND

  • Miller-Day M, Pettigrew J, Hecht ML, Shin Y, Graham J, Krieger J. How prevention curricula are taught under real-world conditions: Types of and reasons for teacher curriculum adaptations. Health Educ (Lond). 2013;113(4):324-344. doi: 10.1108/09654281311329259.

    PMID: 26290626BACKGROUND

  • Moreland JJ, Raup-Krieger JL, Hecht ML, Miller-Day MM. The conceptualization and communication of risk among rural appalachian adolescents. J Health Commun. 2013;18(6):668-85. doi: 10.1080/10810730.2012.743620. Epub 2013 Feb 28.

    PMID: 23448190BACKGROUND

  • Pettigrew J, Miller-Day M, Shin Y, Hecht ML, Krieger JL, Graham JW. Describing teacher-student interactions: a qualitative assessment of teacher implementation of the 7th grade keepin' it REAL substance use intervention. Am J Community Psychol. 2013 Mar;51(1-2):43-56. doi: 10.1007/s10464-012-9539-1.

    PMID: 22739791BACKGROUND

  • Pettigrew J, Miller-Day M, Krieger J, Hecht ML. The Rural Context of Illicit Substance Offers: A Study of Appalachian Rural Adolescents. J Adolesc Res. 2012 Jul;27(4):523-550. doi: 10.1177/0743558411432639.

    PMID: 25620838BACKGROUND

  • 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.

    PMID: 21552345BACKGROUND

  • Miller-Day M, Hecht ML, Krieger JL, Pettigrew J, Shin Y, Graham J. Teacher Narratives and Student Engagement: Testing Narrative Engagement Theory in Drug Prevention Education. J Lang Soc Psychol. 2015 Dec 1;34(6):604-620. doi: 10.1177/0261927X15586429. Epub 2015 May 14.

    PMID: 26690668RESULT

  • Pettigrew J, Graham JW, Miller-Day M, Hecht ML, Krieger JL, Shin YJ. Erratum to: Adherence and Delivery: Implementation Quality and Program Outcomes for the Seventh-Grade keepin' it REAL Program. Prev Sci. 2015 Jan;16(1):100. doi: 10.1007/s11121-014-0506-y. No abstract available.

    PMID: 25274060RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael L Hecht, PhD

    The Pennsylvania 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

February 25, 2016

First Posted

March 22, 2016

Study Start

July 1, 2006

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(2)