Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED) (I-ACTED)

February 25, 2026 updated by: Wake Forest University Health Sciences

The I-ACTED Study: Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth

The purpose of this research is to understand how participating or not participating in an action civics curriculum may affect the health and wellbeing of young people. Participants will be chosen from students who attend certain schools that choose to participate in the action civics curriculum. Participation in this research involves completing surveys during class time in the Spring and Fall 2021-2022 semesters and then completing online surveys outside of class in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Equal access to civic resources, such as opportunities for civic engagement and connections to one's community, are an important part of a culture of health. Meaningful experiences in civic engagement and community connectedness are transformative for young people - especially for youth from marginalized backgrounds, who often feel voiceless and excluded from decision-making in civic and social institutions. Theories and correlational evidence point to positive associations between civic engagement (e.g., volunteering, voting, and feelings of civic empowerment) and better mental, physical, and behavioral health and wellbeing. Meaningful civic engagement experiences may have an especially powerful effect on health and wellbeing for those from traditionally marginalized backgrounds. However, causal pathways between civic interventions, civic outcomes, and health and wellbeing outcomes among are not firmly established. Further, how civic engagement and sense of community affect health and wellbeing outcomes are unknown, and questions remain about for whom these effects may be especially beneficial. In this study, we ask whether an established civic intervention called Action Civics affects civic engagement and sense of community, and subsequently affects health and wellbeing among youth. To build on these observational findings, the study team will: (a) examine the causal links between youth civic engagement and sense of community and health, and (b) test whether an established school-based, civic engagement intervention can affect individual health and wellbeing and equity outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1659

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Currently enrolled Middle or High School student
  • Enrolled in a course with a teacher from a school participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Action Civics program
Students in this arm will take part in an Action Civics (AC) program. AC delivers action civics programming to young people from diverse backgrounds nationwide. AC offers a school-based action civics curriculum in which classes collectively choose a local issue, learn strategies and skills for taking civic action, develop an action plan, and take action on their selected local issue. Students, as a class, tackle topics ranging from health-related (e.g., health of school lunches) to safety-related (e.g. lack of crosswalks) to community social issues (e.g., community-police relations).
Behavioral: Participating in Action Civics program
Students in school classrooms participating in Action Civics program
No Intervention: No Action Civics program
Students in this arm will receive no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Time Frame: Baseline
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
Baseline
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Time Frame: 4-6 month following baseline
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
4-6 month following baseline
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Time Frame: 1 year following baseline
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
1 year following baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Community Connection Scale
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
Questionnaire measures sense of community using a Likert scale (1-5) with higher scores indicating higher sense of community. Based on from the California Healthy Kids Survey.
baseline, 4-6 month following baseline, 1 year following baseline
Questionnaire from the National Longitudinal Study of Adolescent to Adult Health
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
Questionnaire measures physical and mental health and wellbeing. Response options vary from 4-6 levels for the scales; higher numbers indicate better health.
baseline, 4-6 month following baseline, 1 year following baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies Depression (CES-D)
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
CES-D measures depressive symptoms using a 1-4 range (1=Rarely or none of the time, 2=Some or a little of the time, 3=Occasionally or a moderate amount of time, 4=All of the time). Higher scores CES-D suggest a greater presence of depressive symptoms.
baseline, 4-6 month following baseline, 1 year following baseline
Tobacco, Alcohol, Prescription medication, and other Substance use Tool part 2 (TAPS- 2)
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
Behavioral health symptoms will be measured using adapted items from part 2 of the TAPS questionnaire using a 1-4 range (1=never, 2=once or twice, 3=monthly, 4=weekly or more). Scores on these questions generate a risk level per substance endorsed, based on a range of possible scores per substance.
baseline, 4-6 month following baseline, 1 year following baseline
The World Health Organization- Five Well-Being Index (WHO-5)
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
WHO5 measures general wellbeing. Responses ranges from 0-25, with 25 representing best possible quality of life.
baseline, 4-6 month following baseline, 1 year following baseline
Social wellbeing-School Absences
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
Responses are counted as a continuous variable (number of class days missed) to generate a value.
baseline, 4-6 month following baseline, 1 year following baseline
Social wellbeing-Purpose tool
Time Frame: baseline, 4-6 month following baseline, 1 year following baseline
Items measure future aspirations/goals using a Likert scale (1-5) with higher composite scores indicating better social wellbeing.
baseline, 4-6 month following baseline, 1 year following baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Robert Wood Johnson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Parissa J Ballard, PhD, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00066103

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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