The ICEC Cluster Trial: Integrated Community Engagement Collaborative for Youth Substance Use Prevention in Rural America

NCT07843576 | Not Yet Recruiting

• 2 other identifiers: STUDY00000478R01DA063662
• Study Type: interventional
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether the Integrated Community Engagement (ICE) Collaborative can help prevent alcohol, tobacco, and other drug use among youth living in rural communities. The study is coordinated through the West Virginia University Prevention Research Center and will be conducted in participating public schools and County Prevention Coalitions located in up to 36 rural counties in West Virginia. Students in grades 7 through 12 at participating public schools will complete confidential online surveys once each year for four years. The surveys will assess alcohol, tobacco, and other drug use, as well as family, peer, school, and community factors that may increase or decrease the risk of substance use. All participating counties will receive reports summarizing these survey results at the school and county levels. Counties will be randomly assigned to one of two groups. Counties in the intervention group will receive support from trained Network Coordinators who will work with local County Prevention Coalitions to review community data, engage local stakeholders, develop action plans, strengthen prevention efforts, and support implementation of community-selected prevention strategies. Counties in the comparison group will receive survey reports but will not receive this implementation support. The researchers will compare the two groups to determine whether the ICE Collaborative reduces youth alcohol, tobacco, and other drug use and improves community factors that support healthy youth development. The study will also evaluate whether the intervention strengthens community prevention coalitions, stakeholder engagement, resource development, and implementation of prevention programs and policies

Conditions

Adolescent Substance Use; Substance Use (Drugs, Alcohol); Tobacco Use

Keywords

Substance Use Prevention; Integrated Community Engagement Collaborative (ICEC); Icelandic Prevention Model; Rural Communities; Community Mobilization

Outcome Measures

Primary Outcomes (2)

• Change in Past 30-Day Alcohol, Tobacco, and Other Drug (ATOD) Use Prevalence

  Past 30-day prevalence of tobacco cigarette use, electronic cigarette use, alcohol use, drunkenness, and cannabis use among students in grades 7 through 12 will be assessed using annual school-based online surveys. Tobacco and e-cigarette use will be assessed on a 7-point scale ranging from 1=Never used, to 7=More than 20 times per day. Alcohol, drunkenness, and cannabis use will be assessed on a 7-point count scale ranging from 1=0 times, to 7=40 times+. Outcomes will be reported separately as the percentage of students reporting each substance use behavior during the previous 30 days. Higher percentages indicate greater substance use prevalence.

  Baseline and Annually through Year 5

• Change in Lifetime Alcohol, Tobacco, and Other Drug (ATOD) Use Prevalence

  Lifetime prevalence of tobacco cigarette use, electronic cigarette use, alcohol use, drunkenness, and cannabis use among students in grades 7 through 12 will be assessed using annual school-based online surveys. Outcomes will be reported separately as the percentage of students reporting lifetime use of each substance or behavior. Scoring for each of those variables will range from 1=0 times, to 7= 40 times+. Higher percentages indicate greater lifetime substance use prevalence.

  Baseline and Annually through Year 5

Secondary Outcomes (13)

• Change in Family Risk and Protective Factors

  Baseline and annually through Year 5

• Change in Peer Risk and Protective Factors

  Baseline and Annually through Year 5

• Change in School Risk and Protective Factors

  Baseline and Annually through Year 5

• Change in Leisure-Time Risk and Protective Factors

  Baseline and Annually through Year 5

• Change in Implementation Integrity and Consistency

  Baseline and Annually through Year 5

Study Arms (2)

ICE Collaborative With Network Coordinator Support

EXPERIMENTAL

Counties assigned to this arm will participate in the Integrated Community Engagement (ICE) Collaborative. Students in grades 7 through 12 will complete annual confidential surveys, and counties will receive school-level and county-level reports summarizing alcohol, tobacco, and other drug use and associated risk and protective factors. County Prevention Coalitions will receive implementation support from Network Coordinators, including coalition development, stakeholder engagement, dissemination and interpretation of local data, strategic planning, resource development, and support for implementation of locally selected prevention strategies through a structured community engagement process

Other: Integrated Community Engagement Collaborative

Survey Reporting Only

ACTIVE COMPARATOR

Counties assigned to this arm will participate in annual school-based surveys of students in grades 7 through 12 and will receive school-level and county-level reports describing alcohol, tobacco, and other drug use and associated risk and protective factors. Counties in this arm will not receive Network Coordinator support, coalition capacity-building activities, technical assistance, or implementation support provided through the Integrated Community Engagement Collaborative.

Other: School-Based Data Collection and Reporting without Network Coordinator Support

Interventions

Integrated Community Engagement Collaborative OTHER

The Integrated Community Engagement (ICE) Collaborative is a community capacity-building framework designed to strengthen local prevention systems and reduce youth alcohol, tobacco, and other drug use. The intervention includes annual collection and dissemination of youth survey data, coalition development, stakeholder engagement, data-driven decision making, strategic planning, technical assistance, resource development, and implementation support. Network Coordinators housed within Regional Prevention Lead Organizations provide ongoing support to County Prevention Coalitions to facilitate community-driven prevention planning and implementation. Counties participate in repeated annual implementation cycles throughout the study period.

Also known as: ICE Collaborative

ICE Collaborative With Network Coordinator Support

School-Based Data Collection and Reporting without Network Coordinator Support OTHER

Annual collection of confidential school-based survey data from students in grades 7 through 12 and dissemination of school-level and county-level reports describing alcohol, tobacco, and other drug use and associated risk and protective factors. Counties assigned to this condition receive data reports but do not receive implementation support, technical assistance, coalition development activities, or Network Coordinator assistance.

Survey Reporting Only

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Student Participants
• Enrolled in grades 7 through 12 at a participating public school in a participating West Virginia county.
• Able to complete a confidential online survey during school hours.
• Parent or guardian has not opted the student out of participation.
• Student provides assent to participate.
• Adult Coalition Participants
• Member of a participating County Prevention Coalition, implementation network, or stakeholder group.
• Participates in coalition planning, implementation, evaluation, or prevention activities.
• Able to complete coalition assessment questionnaires.
• Provides informed consent.

You may not qualify if:

• Student Participants
• Not enrolled in grades 7 through 12 at a participating public school.
• Attends a school in a non-participating county.
• Parent or guardian opts the student out of participation.
• Student declines assent or participation.
• Adult Coalition Participants
• Not affiliated with a participating coalition or implementation network.
• Declines informed consent.
• Unable to complete coalition assessment procedures.

Sponsors & Collaborators

• West Virginia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

WVU School of Public Health- West Virginia Prevention Research Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Tobacco Use

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Alfgeir L Kristjansson, PhD

  West Virgina University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfgeir L Kristjansson, PhD

CONTACT

304-293-3129; alkristjansson@hsc.wvu.edu

Jessica Coffman, MA

CONTACT

304-293-6283; jecoffman@hsc.wvu.edu

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: Professor

Model Details: Counties will be randomized in a 1:1 ratio to either the Integrated Community Engagement (ICE) Collaborative intervention or an active comparator condition. All participating counties will receive annual school-based youth surveys and school- and county-level data reports. Counties assigned to the intervention condition will additionally receive implementation support, technical assistance, coalition development support, and strategic planning assistance from Network Coordinators.

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)