- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514133
Testing the Causal Effects of a Civic Engagement Intervention on Health and Wellbeing Among Youth (I-ACTED) (I-ACTED)
August 2, 2023 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
Recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
1500
Phase
- 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
- Name: Parissa J Ballard, PhD
- Phone Number: 336-716-0793
- Email: pballard@wakehealth.edu
Study Contact Backup
- Name: Grisel Trejo, MPH
- Phone Number: 336-716-2830
- Email: gtrejo@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest School of Medicine
-
Contact:
- Parissa J Ballard, PhD
- Phone Number: 336-716-0793
- Email: pballard@wakehealth.edu
-
Contact:
- Taylor J Arnold, MA
- Phone Number: 336-713-5019
- Email: tjarnold@wakehealth.edu
-
Principal Investigator:
- Parissa J. Ballard, PhD
-
-
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
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 |
Intervention / Treatment |
---|---|
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).
|
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
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
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
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.
Collaborators
Investigators
- 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
- 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.
- Ballard 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.
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)
June 24, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 3, 2023
Last Update Submitted That Met QC Criteria
August 2, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID 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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