Mental Health Wellness 1I-ACTEDNCT04514133
Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED)
A study testing Participating in Action Civics program in people with Mental Health Wellness 1 and Social Interaction, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Mental Health Wellness 1, Social Interaction, Health Attitude
- What is being tested?
- Participating in Action Civics program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,659 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 15 Aug 2025
- 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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Currently enrolled Middle or High School student
- Enrolled in a course with a teacher from a school participating in the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Being tested
- Participating in Action Civics program
- Keywords
- civic engagement, health, social wellbeing, behavioral health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participating in Action Civics programBehavioural
Students in school classrooms participating in Action Civics program
| Study group | Role | What they receive |
|---|---|---|
| Action Civics program | Experimental | 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). Receives: Behavioral: Participating in Action Civics program |
| No Action Civics program | No intervention | Students in this arm will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
Measured: Baseline
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
Measured: 4-6 month following baseline
Youth Inventory of Involvement (activism, political engagement, and leadership items)
Questionnaire measures civic engagement using a Likert scale (1-5) with higher composite scores indicating more involvement in each domain
Measured: 1 year following baseline
Secondary outcomes (2)
Community Connection Scale
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.
Measured: baseline, 4-6 month following baseline, 1 year following baseline
Questionnaire from the National Longitudinal Study of Adolescent to Adult Health
Questionnaire measures physical and mental health and wellbeing. Response options vary from 4-6 levels for the scales; higher numbers indicate better health.
Measured: baseline, 4-6 month following baseline, 1 year following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start24 Jun 2021
- Primary completion15 Aug 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,659 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Parissa J Ballard, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514133
- Sponsor's protocol ID
- IRB00066103
- Acronym
- I-ACTED
- Status last verified
- Jul 2025
- First submitted
- 11 Aug 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ballard PJ, Cohen AK, Littenberg-Tobias J. Action Civics for Promoting Civic Development: Main Effects of Program Participation and Differences by Project Characteristics. Am J Community Psychol. 2016 Dec;58(3-4):377-390. doi: 10.1002/ajcp.12103.
PubMed 27982470Ballard PJ, Hoyt LT, Pachucki MC. Impacts of Adolescent and Young Adult Civic Engagement on Health and Socioeconomic Status in Adulthood. Child Dev. 2019 Jul;90(4):1138-1154. doi: 10.1111/cdev.12998. Epub 2018 Jan 23.
PubMed 29359473Cohen AK, Fitzgerald JC, Trejo G, Yalif IU, Wesson PD, Wolfson M, Ballard PJ. The I-ACTED study (investigating action civics training through an experimental design): a cluster randomized controlled trial of a school-based action civics education intervention on adolescent wellbeing. BMC Public Health. 2025 Oct 16;25(1):3513. doi: 10.1186/s12889-025-24838-y.
PubMed 41102741
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The I-ACTED Study: Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth
- ClinicalTrials.gov ID
- NCT04514133
- Acronym / sponsor ID
- I-ACTED / IRB00066103
- Keywords
- civic engagement, health, social wellbeing, behavioral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,659 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 14 Aug 2020 (actual)
- 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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action Civics program | Experimental | Behavioral: Participating in Action Civics programStudents 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). |
| No Action Civics program | No intervention | –Students in this arm will receive no intervention. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Currently enrolled Middle or High School student
- Enrolled in a course with a teacher from a school participating in the study
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Participating in Action Civics programStudents in school classrooms participating in Action Civics program | Behavioural | Action Civics program |
Primary outcome
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
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
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
2 secondary outcomes
Community Connection Scale
Time frame: 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
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 27 Feb 2026.
- Background: PubMed 27982470Ballard PJ, Cohen AK, Littenberg-Tobias J. Action Civics for Promoting Civic Development: Main Effects of Program Participation and Differences by Project Characteristics. Am J Community Psychol. 2016 Dec;58(3-4):377-390. doi: 10.1002/ajcp.12103.
- Background: PubMed 29359473Ballard PJ, Hoyt LT, Pachucki MC. Impacts of Adolescent and Young Adult Civic Engagement on Health and Socioeconomic Status in Adulthood. Child Dev. 2019 Jul;90(4):1138-1154. doi: 10.1111/cdev.12998. Epub 2018 Jan 23.
- Derived from this study: PubMed 41102741Cohen AK, Fitzgerald JC, Trejo G, Yalif IU, Wesson PD, Wolfson M, Ballard PJ. The I-ACTED study (investigating action civics training through an experimental design): a cluster randomized controlled trial of a school-based action civics education intervention on adolescent wellbeing. BMC Public Health. 2025 Oct 16;25(1):3513. doi: 10.1186/s12889-025-24838-y.
- Individual participant dataSharing planned: No
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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.
Parissa J Ballard, PhD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participating in Action Civics program in people with Mental Health Wellness 1 and Social Interaction, run by Wake Forest University Health Sciences at 1 site 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 2 inclusion and 0 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Youth Inventory of Involvement (activism, political engagement, and leadership items) (time frame: Baseline). 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 NCT04514133, which also lists 3 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 27 Feb 2026.