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

Shifting the Landscape in Primary Substance Use Prevention for Rural America: The Integrated Community Engagement Collaborative (ICEC) Cluster Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Adolescent Substance Use; Substance Use (Drugs, Alcohol)
• Intervention / Treatment: Other: Integrated Community Engagement Collaborative; Other: School-Based Data Collection and Reporting without Network Coordinator Support

• Study Type: Interventional
• Enrollment (Estimated): 25000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alfgeir L Kristjansson, PhD; Phone Number: 304-293-3129; Email: alkristjansson@hsc.wvu.edu
• Study Contact Backup: Name: Jessica Coffman, MA; Phone Number: 304-293-6283; Email: jecoffman@hsc.wvu.edu

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU School of Public Health- West Virginia Prevention Research Center
      • Contact: Alfgeir L Kristjansson, PhD; Phone Number: 304-293-3129; Email: alkristjansson@hsc.wvu.edu
      • Contact: Jessica Coffman, MA; Phone Number: 304-293-6283; Email: jecoffman@hsc.wvu.edu
      • Principal Investigator: Alfgeir L Kristjansson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICE Collaborative With Network Coordinator Support; 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; 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.; Other Names: ICE Collaborative
Active Comparator: Survey Reporting Only; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Family Risk and Protective Factors	Family-domain scores will be assessed annually using student surveys measuring seven concepts: perceived parental support, family social support, time spent with parents, parental monitoring, social capital, parental reactions to substance use, and parental/sibling substance use. Composite scores will be calculated as follows: perceived parental support (5 items, 4-point Likert, range 4-20); family social support (3 items, 7-point Likert, range 3-21); time spent with parents (2 items, 5-point Likert, range 2-10); parental monitoring (2 items, 4-point Likert, range 2-8); social capital (2 items, 4-point Likert, range 2-8); parental reactions to substance use (5 items, 4-point Likert, range 4-16); and parental/sibling substance use (3 yes/no items). Higher scores on protective-factor measures indicate greater protection against youth substance use, while higher scores on risk-factor measures indicate greater exposure to substance use risk.	Baseline and annually through Year 5
Change in Peer Risk and Protective Factors	Peer-domain scores will be assessed annually using student surveys measuring five concepts: friend social support, peer substance use, peer delinquency, perceived peer respect for substance use, and perceived peer respect for delinquency. Composite scores will be calculated as follows: friend social support (3 items, 7-point Likert scale, range 3-21); peer substance use (5 items, 5-point Likert scale, range 5-25); peer delinquency (3 items, 5-point Likert scale, range 3-15); perceived peer respect for substance use (5 items, 5-point Likert scale, range 5-25); and perceived peer respect for delinquency (3 items, 5-point Likert scale, range 3-15). Higher scores on protective-factor measures indicate greater protection against youth substance use, while higher scores on risk-factor measures indicate greater exposure to substance use risk.	Baseline and Annually through Year 5
Change in School Risk and Protective Factors	School-domain scores will be assessed annually using student surveys measuring five concepts: supportive adults in school, supportive peers in school, motivation to learn and grow, school connectedness, and school absenteeism. Composite scores will be calculated as follows: supportive adults in school (5 items, 5-point Likert scale, range 5-25); supportive peers in school (4 items, 5-point Likert scale, range 4-20); motivation to learn and grow (5 items, 5-point Likert scale, range 5-25); school connectedness (composite score derived from survey items); and school absenteeism (2 items, 6-point count scale, range 2-12, with response options from none to 7 or more days). Higher scores on protective-factor measures indicate greater protection against youth substance use, while higher scores on risk-factor measures indicate greater exposure to substance use risk.	Baseline and Annually through Year 5
Change in Leisure-Time Risk and Protective Factors	Leisure-time domain scores will be assessed annually using student surveys measuring three concepts: late outside hours, structured recreational activities, and unstructured activities. Composite scores will be calculated as follows: late outside hours (2 items, 8-point count scale, range 2-16, with responses from never to 7 or more days); structured recreational activities (7 items, 9-point frequency scale, range 7-63, with responses from less than once per week to seven times per week); and unstructured activities (6 items, 5-point frequency scale, range 6-30, with responses from never to four or more times per week). Higher scores on protective-factor measures indicate greater protection against youth substance use, while higher scores on risk-factor measures indicate greater exposure to substance use risk.	Baseline and Annually through Year 5
Change in Implementation Integrity and Consistency	Implementation integrity and consistency will be assessed using the ICE Implementation Integrity and Consistency Assessment (ICE-IICA). Scores from 126 yes/no questions (scored 0/1) represent the percentage of required implementation activities completed across the ICE implementation process within each county. Higher scores indicate greater adherence to and consistency of implementation.	Baseline and Annually through Year 5
Change in Role Structure and Clarity- Efficient Practices	County Prevention Coalition Role structure and clarity will be assessed using the Efficient Practices subscale of the Internal Coalition Effectiveness Instrument (ICEI). Higher scores indicate more efficient coalition practices.	Baseline and Annually through Year 5
Change in Role Structure and Clarity- Coalition Efficiency Subscale	County Prevention Coalition Role structure and clarity will be assessed using the Coalition Efficiency subscale of the Communities That Care Coalition Functioning Survey (CFS). Higher scores indicate clearer coalition roles.	Baseline and Annually through Year 5
Change in Cohesion and Collaboration- Relationship and Participation	County Prevention Coalition Cohesion and collaboration will be assessed using 10 items from the Relationships and Participation subscales of the Internal Coalition Effectiveness Instrument (ICEI). Higher scores indicate greater levels of collaboration, teamwork, and coalition member relationships.	Baseline and Annually through Year 5
Change in Cohesion and Collaboration- CFS Cohesion and Participation Benefits	County Prevention Coalition Cohesion and collaboration will be assessed using the Cohesion and Participation Benefits subscales of the Communities That Care Coalition Functioning Survey (CFS) measured on a 5-point Likert scale with a total range from 10-50. Higher scores indicate greater cohesion and perceived benefits of participation.	Baseline and Annually through Year 5
Change in Relational Coordination	County Prevention Coalition Relational coordination will be assessed using 6 items the Relational Coordination Survey measured on a 5-point Likert scale with a total range from 6-30. Higher scores indicate stronger communication, shared goals, shared knowledge, and mutual respect among coalition members and partner organizations.	Baseline and Annually through Year 5
Change in Strategic Planning Capacity	County Prevention Coalition Relational coordination will be assessed using 6 items the Relational Coordination Survey measured on a 5-point Likert scale with a total range from 6-30. Higher scores indicate stronger communication, shared goals, shared knowledge, and mutual respect among coalition members and partner organizations.	Baseline and Annually through Year 5
Change in Stakeholder Engagement	County Prevention Coalition Stakeholder engagement will be assessed using the Community Impact Scale (CIS) and coalition records documenting stakeholder participation. The CIS assesses stakeholder satisfaction, perceived benefits, motivation, engagement, and knowledge gained measured on a 5-point Likert scale with a total range from 10-50. Higher scores indicate greater stakeholder involvement and engagement in coalition activities.	Baseline and Annually through Year 5
Change in Data-Driven Decision-Making Capacity	County Prevention Coalition Data-driven decision-making capacity will be assessed using an adapted version of the 3D-ME Inventory, the Data-Driven Decision-Making Questionnaire (DDDM-Q), and coalition records documenting dissemination and use of local survey data. In total 9 items will be applied and scored on a 5-point Likert scale with a range between 9 and 45. Higher scores indicate greater capacity to use data to guide coalition planning, resource allocation, and implementation decisions.	Baseline and Annually through Year 5

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Alfgeir L Kristjansson, PhD, West Virgina University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: September 13, 2026
• First Submitted That Met QC Criteria: September 24, 2026
• First Posted (Actual): September 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 28, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Community Mobilization; Rural Communities; Substance Use Prevention; Integrated Community Engagement Collaborative (ICEC); Icelandic Prevention Model
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Substance-Related Disorders; Tobacco Use
• Other Study ID Numbers: STUDY00000478; R01DA063662 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No