Substance Abuse ProblemkiRNCT02715206
Adaptation Processes in School-based Substance Abuse Prevention
A study testing keepin' it REAL classic and keepin' it REAL rural in people with Substance Abuse Problem, run by Penn State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem
- What is being tested?
- keepin' it REAL classic and keepin' it REAL rural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,827 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all 7th grade students in implementation middle
Who cannot join
- lack of parental consent
- lack of student assent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University
Columbus, Ohio, 43210
The Pennsylvania State University
University Park, Pennsylvania, 16802
About this study
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.
Read the detailed description
The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL (refuse, explain, avoid, leave) middle school substance use prevention curriculum among a new target audience in rural Pennsylvania and Ohio, describe how teachers adapt the curriculum when they present it, and develop, implement, and evaluate a Pennsylvania/Ohio-version of the curriculum to test whether an evidence-based universal curriculum can be improved by adapting it to local cultures. keepin' it REAL is recognized as a "model program" by SAMHSA's (Substance Abuse and Mental Health Services Administration's) National Registry of Effective programs and is one of the few that are multicultural. The study will evaluate the effectiveness of the original curriculum, grounded in the cultures of the southwest and compare that to a new version, "re-grounded" in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA (National Institute on Drug Abuse) PA-05-118 (Program Announcement), Drug Abuse Prevention Intervention Research that calls for investigations addressing, "1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions." This proposal addresses all three points.
A randomized control trial will be conducted in middle schools to accomplish these goals. First, formative research will be conducted to develop a rural Pennsylvania/Ohio-version of the curriculum. Second, 39 rural schools will be randomly assigned to one of three conditions: teacher adaptation in which the original keepin' it REAL curriculum is implemented; researcher adaptation in which a new Pennsylvania-version of the curriculum is implemented, and a control group. We hypothesized the participation in either form of the curriculum will reduce drug use and that the researcher adaptation will produce better outcomes and less teacher adaptation than the teacher adaptation. A pretest will be administered followed by post-tests in 7-9th grades. Adaptation and fidelity will be measured in 3 ways: teachers completing a Program Quality and Adaptation online measure after each lesson, videotaped lessons, and attendance. The major hypothesis tests will be conducted using variants of the general linear model, taking into account the multilevel structure of the data, test of a mediation model, and growth modeling.
- Conditions
- Substance Abuse Problem
- Being tested
- keepin' it REAL classic, keepin' it REAL rural, control
- Keywords
- rural adolescents, substance use, prevention, adaptation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keepin' it REAL classicBehavioural
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 ruralBehavioural
keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.
controlBehavioural
control group continues to teach whatever prevention curriculum they were using prior to study
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | middle schools not receiving keepin' it REAL; continue their own programs if any. Receives: Behavioral: control |
| keepin' it REAL classic | Experimental | middle schools will implement keepin' it REAL classic drug prevention curriculum Receives: Behavioral: keepin' it REAL classic |
| keepin' it REAL rural | Experimental | middle schools will implement the keepin' it REAL rural curriculum Receives: Behavioral: keepin' it REAL rural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recent use of alcohol
Self report measure of recent use of alcohol
Measured: 30 days
Recent use of tobacco
Self report measure
Measured: 30 days
Recent use of marijuana
Self report
Measured: 30 days
Secondary outcomes (2)
Perceptions of number of peers using drugs
Self report
Measured: 2 years
Perception of self efficacy resisting drug offers
Self report measure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startJul 2006
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Substance Abuse ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael L. Hecht, Penn State University
- Investigators
- Michael L Hecht, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715206
- Sponsor's protocol ID
- R01DA021670
- Acronym
- kiR
- Status last verified
- Apr 2017
- First submitted
- 25 Feb 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23722619Shin 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.
PubMed 25274721Choi 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.
PubMed 23330857Krieger 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.
PubMed 23980520Colby 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.
PubMed 22961604Hopfer 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.
PubMed 23990398Miller-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.
PubMed 26290626Moreland 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.
PubMed 23448190Pettigrew 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.
PubMed 22739791Pettigrew 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.
PubMed 25620838Pettigrew 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.
PubMed 21552345Miller-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.
PubMed 26690668Pettigrew 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.
PubMed 25274060
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Processes in School-based Substance Abuse Prevention
- ClinicalTrials.gov ID
- NCT02715206
- Acronym / sponsor ID
- kiR / R01DA021670
- Conditions
- Substance Abuse Problem
- Keywords
- rural adolescents, substance use, prevention, adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,827 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goals of the proposed study are to conduct an effectiveness trial of the keepin' it REAL (refuse, explain, avoid, leave) middle school substance use prevention curriculum among a new target audience in rural Pennsylvania and Ohio, describe how teachers adapt the curriculum when they present it, and develop, implement, and evaluate a Pennsylvania/Ohio-version of the curriculum to test whether an evidence-based universal curriculum can be improved by adapting it to local cultures. keepin' it REAL is recognized as a "model program" by SAMHSA's (Substance Abuse and Mental Health Services Administration's) National Registry of Effective programs and is one of the few that are multicultural. The study will evaluate the effectiveness of the original curriculum, grounded in the cultures of the southwest and compare that to a new version, "re-grounded" in the rural culture of Pennsylvania and Ohio, while studying how teachers adapt both versions. This proposal responds to NIDA (National Institute on Drug Abuse) PA-05-118 (Program Announcement), Drug Abuse Prevention Intervention Research that calls for investigations addressing, "1) the development of novel drug abuse prevention approaches; 2) the efficacy and effectiveness of newly developed and/or modified prevention programs; 3) the processes associated with the selection, adoption, adaptation, implementation, sustainability, and financing of empirically validated interventions." This proposal addresses all three points.
A randomized control trial will be conducted in middle schools to accomplish these goals. First, formative research will be conducted to develop a rural Pennsylvania/Ohio-version of the curriculum. Second, 39 rural schools will be randomly assigned to one of three conditions: teacher adaptation in which the original keepin' it REAL curriculum is implemented; researcher adaptation in which a new Pennsylvania-version of the curriculum is implemented, and a control group. We hypothesized the participation in either form of the curriculum will reduce drug use and that the researcher adaptation will produce better outcomes and less teacher adaptation than the teacher adaptation. A pretest will be administered followed by post-tests in 7-9th grades. Adaptation and fidelity will be measured in 3 ways: teachers completing a Program Quality and Adaptation online measure after each lesson, videotaped lessons, and attendance. The major hypothesis tests will be conducted using variants of the general linear model, taking into account the multilevel structure of the data, test of a mediation model, and growth modeling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: controlmiddle schools not receiving keepin' it REAL; continue their own programs if any. |
| keepin' it REAL classic | Experimental | Behavioral: keepin' it REAL classicmiddle schools will implement keepin' it REAL classic drug prevention curriculum |
| keepin' it REAL rural | Experimental | Behavioral: keepin' it REAL ruralmiddle schools will implement the keepin' it REAL rural curriculum |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all 7th grade students in implementation middle
Key exclusion criteria (2 listed)
- lack of parental consent
- lack of student assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| keepin' it REAL classickeepin' 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 | Behavioural | keepin' it REAL classic |
| keepin' it REAL ruralkeepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade. | Behavioural | keepin' it REAL rural |
| controlcontrol group continues to teach whatever prevention curriculum they were using prior to study | Behavioural | Control |
Primary outcome
Recent use of alcohol
Time frame: 30 days
Self report measure of recent use of alcohol
Recent use of tobacco
Time frame: 30 days
Self report measure
Recent use of marijuana
Time frame: 30 days
Self report
2 secondary outcomes
Perceptions of number of peers using drugs
Time frame: 2 years
Perception of self efficacy resisting drug offers
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Background: PubMed 23722619Graham 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.
- Background: PubMed 25274721Shin 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.
- Background: PubMed 23330857Choi 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.
- Background: PubMed 23980520Krieger 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.
- Background: PubMed 22961604Colby 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.
- Background: PubMed 23990398Hopfer 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.
- Background: PubMed 26290626Miller-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.
- Background: PubMed 23448190Moreland 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.
- Background: PubMed 22739791Pettigrew 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.
- Background: PubMed 25620838Pettigrew 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.
- Background: PubMed 21552345Pettigrew 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.
- Results publication: PubMed 26690668Miller-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Hecht, PhD principal investigator
The Pennsylvania State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing keepin' it REAL classic and keepin' it REAL rural in people with Substance Abuse Problem, run by Penn State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent use of alcohol (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02715206, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.