Digital, Community-Advised, Social Action Cluster-Randomized Trial to Increase Civic Participation and Social Connection in the US
Phase: NA
Conditions: Social Connectedness, Community Engagement, Physical Wellbeing
Sponsor: University of Pennsylvania

Document: CONSORT Clinical Trials Supplement 
Official Study Title: Digital, Community-Advised, Social Action Cluster-Randomized Trial to 
Increase Civic Participation and Social Connection in the US 
NCT Number: NCT07013357 
Document Date: 03/23/2026 
 
 

Table of Contents 
Title and Structured Abstract ......................................................................................... 4 
Study Identification .................................................................................................... 4 
Study Description ....................................................................................................... 4 
Open Science ................................................................................................................. 4 
Trial Registration ........................................................................................................ 4 
Protocol and Statistical Analysis Plan ........................................................................... 4 
Data Sharing .............................................................................................................. 4 
Funding and Conflicts of Interest ................................................................................. 5 
Introduction .................................................................................................................. 6 
Background and Rationale .......................................................................................... 6 
Objectives ................................................................................................................... 6 
Methods ........................................................................................................................ 7 
Patient and Public Involvement ................................................................................... 7 
Trial Design ................................................................................................................ 8 
Changes to Trial Protocol ............................................................................................ 8 
Trial Setting ................................................................................................................ 9 
Eligibility Criteria ....................................................................................................... 9 
Intervention and Comparator ...................................................................................... 9 
Outcomes ................................................................................................................. 11 
Primary Outcomes (Prespecified) ................................................................................ 11 
Secondary Outcomes (Prespecified) ............................................................................. 12 
Exploratory Outcomes (Prespecified) ........................................................................... 12 
Additional Notes on Measurement ............................................................................... 13 
Sample Size .............................................................................................................. 14 
Randomization ............................................................................................................. 16 
Sequence Generation ................................................................................................ 16 
Allocation Concealment Mechanism .......................................................................... 16 
Implementation ........................................................................................................ 17 

Blinding ................................................................................................................... 17 
Statistical Analysis Plan – CDSP C-RCT ....................................................................... 18 
Table 2. .................................................................................................................. 20 
Sections 22-30 .............................................................................................................. 22 
References ................................................................................................................... 23 
 
 
 
 
 
 

Title and Structured Abstract 
Study Identification 
See ClinicalTrials.gov, NCT: 07013357. See “Official Title” 
 
Study Description 
See ClinicalTrials.gov, NCT: 07013357. See “Brief Summary” and “Detailed 
Description”. 
 
Open Science 
Trial Registration 
See ClinicalTrials.gov, NCT: 07013357. 
 
Protocol and Statistical Analysis Plan 
The IRB protocol, statistical analysis plan, along with all other referenced documents can 
be found in the following OSF repository: 
https://osf.io/we3k5/overview?view_only=79a840116e794605b7438adec16c5539 
 
Data Sharing 
De-identified individual participant data, including survey responses and coded 
qualitative indicators derived from discussion sessions and self-talk recordings (not the 
recordings themselves), will be made available after publication of the main trial findings. 
Shared materials will include the de-identified dataset, the data dictionary, and the statistical 
code used for the primary analyses. 

The facilitator and self-help session manuals, reading materials for the control group, 
facilitator training materials, as well as fidelity checklists, can be accessed in the OSF Repository 
(link in “Protocol and Statistical Analysis Plan”). 
Facilitator assessments, session transcripts, and GROV activity logs will only be shared 
in fully de-identified and aggregate form, as these materials may contain sensitive or potentially 
identifying information. Raw transcripts, facilitator notes containing personal details, 
audio/video files, and platform activity traces will not be shared due to confidentiality 
protections. 
Access to all shareable materials will require a data use agreement to ensure appropriate 
use. Requests should include a brief description of the proposed research and will be reviewed by 
the study team for scientific merit, feasibility, and alignment with ethical and privacy 
commitments. No personal identifiers will be released. Video and audio recordings are not 
shared due to privacy protections. 
 
Funding and Conflicts of Interest 
• Name of funder: Annenberg Endowment of the Division of Communication Science at 
Annenberg Public Policy Center. 
• Type of funding:  
o Direct monetary support 
o Indirect support: personnel, location, devices, and administrative support 
• Role of funder:  
o The funder plays no role in any aspect of the trial’s design, conduct, analysis, or 
reporting. 

• No financial and other conflicts of interest of the manuscript authors 
• No conflicts of interest. 
Introduction 
Background and Rationale 
N/A 
Objectives 
To evaluate whether participation in the Community Discussions and Social Participation 
intervention improves individual-level primary outcomes compared with a self-help control 
condition. 
Participants 
Adults (18+) residing in the United States, recruited online through a U.S. survey 
sampling company, with access to the internet, Zoom, and online GROV platform (intervention 
arm only). 
Intervention 
Three 90-minute virtual facilitated group sessions focused on (1) fostering social 
connections, (2) setting and achieving physical and mental well-being goals, and (3) pursuing 
shared community goals, supplemented by the GROV online platform for ongoing peer 
engagement. 
Comparator 
Three 90-minute virtual self-help sessions without facilitation or GROV access (given 
NIH reading materials instead), led by rotating peer discussion leaders using a structured self-
help manual. 
Primary Outcomes 

Physical well-being (continuous), civic participation (binary), new/re-established social 
connections (binary), and anxiety (continuous).  
Timepoint for Primary Outcome 
Measured directly after randomization (Baseline Questionnaire) and one-week post-
intervention (Immediate Follow-Up Questionnaire), and three months post-intervention (Three-
Month Follow-Up Questionnaire). 
Benefits 
Potential improvements in participants’ social connectedness, goal attainment, and 
community engagement; acquisition of self-help and discussion facilitation skills; and access to 
supportive social networks. 
Harms 
Minimal risk, limited to possible discomfort from sensitive group discussions or minor 
confidentiality concerns in virtual settings. Safeguards include trained facilitators/co-facilitators, 
breakout options for de-escalation, and post-session referrals when appropriate. 
Design Framework 
 
Although not framed within the formal estimands framework, the objective aligns with 
estimating the average causal effect of the intervention versus control. 
 
Methods 
Patient and Public Involvement 
Patients and members of the public were not involved in the design, conduct, analysis, or 
reporting of this trial. The intervention was developed by the research team and a Community 
Advisory Board (CAB) as part of a prior project for rural areas affected by the substance use 

epidemic and was adapted to a broader context and broader outcomes. The CAB also advised on 
this project. Other components of the study (including protocol development, outcome selection, 
and dissemination plans) were developed by the research team. No patients were involved. 
 
Trial Design 
This study is a two-arm, parallel-group randomized controlled trial with an allocation 
ratio of 1:1. Participants are individually randomized to either the facilitated community 
discussion intervention (experimental group) or the self-help discussion condition (control 
group). The trial follows a superiority framework, testing whether the facilitated intervention 
produces more favorable composite behavioral and well-being outcomes than the self-help 
condition. Randomization occurs at the individual participant level using a computer-generated 
allocation sequence. 
 
Changes to Trial Protocol 
  
This project will be registered at ClinicalTrials.gov, NCT: 07013357 and OSF 
[https://osf.io/we3k5/overview?view_only=79a840116e794605b7438adec16c5539] before the 
start of recruitment. Any amendments made during the course of the trial will be reflected in 
updated registry entries, with full disclosure in the registry history and in all reports and 
publications arising from the trial. Each amendment will be versioned with date-stamping. For 
each change, we will report in the final manuscript: what was changed, when (relative to 
recruitment, analysis, or unblinding), why (justification), whether the change was prespecified in 
the protocol or is post hoc, and its likely impact on trial validity (bias risk, power, 
interpretability). 

 
Trial Setting 
See ClinicalTrials.gov, NCT: 07013357, Contacts and Locations. 
 
Eligibility Criteria 
Inclusion Criteria 
Adults aged 18 years or older and currently residing in the United States. Participants 
should also be fluent in English and have access to a stable internet connection and a device 
capable of running Zoom. Participants must be available to attend three 90-minute virtual group 
sessions over approximately three weeks and complete baseline and follow-up surveys. 
Exclusion Criteria 
Individuals under 18 years of age or not residing in the United States will be excluded. 
Non-English speakers, those without access to Zoom-compatible technology or a private space to 
participate, and individuals currently enrolled in any other intervention projects conducted by 
this team will be removed. 
Recruitment Methods 
Participants are recruited through the online research platform Forthright, using 
advertisements through direct email or phone invitations. Recruitment materials describe the 
study as a voluntary opportunity to join virtual group sessions on well-being and community 
engagement. Eligible individuals sign the informed consent form before randomization. 
 
Intervention and Comparator 
Experimental Group (Facilitated Community Discussion Intervention) 

Participants assigned to the experimental condition attend three 90-minute virtual 
sessions via Zoom, scheduled one week apart. Sessions are led by a trained facilitator and co-
facilitator who guide participants through structured discussions based on the Community 
Discussion Manual. The intervention focuses on: 
• Setting and pursuing personal well-being and community engagement goals (e.g., 
physical and mental health, civic participation, social connection). 
• Encouraging mutual support and goal accountability through group reflection and 
discussion. 
• Strengthening participants’ sense of social connection, collective efficacy, and 
engagement. 
Between sessions, participants have access to the Grid for the Reduction of Vulnerability 
(GROV) digital platform, which provides opportunities for peer communication. Facilitators 
receive supervision and fidelity monitoring by senior project staff. 
 
Comparator Group (Self-Help Discussion Control) 
Participants assigned to the control condition attend three self-help 90-minute virtual 
sessions following the same schedule as the experimental group. Sessions are guided by a self-
help manual that includes structured prompts for goal setting and discussion, with no facilitator 
involvement. A research member moderates the session to address technical issues and providing 
referrals. One participant from each group is randomly designated as the discussion leader, 
responsible for following the self-help manual and maintaining the flow of the session. Control 
participants do not have access to the GROV platform. However, we will send them brief NIH 
reading materials on “Health Tips for Adults”. 

Materials 
All the intervention and self-help materials are available on the OSF repository: 
https://osf.io/we3k5/overview?view_only=79a840116e794605b7438adec16c5539 
Fidelity and Adherence 
Facilitators are trained using a standardized protocol and participate in ongoing 
supervision by a clinical psychologist to ensure fidelity. Session recordings are reviewed and 
scored on fidelity to confirm adherence to the manual and discussion procedures. Attendance and 
participation are tracked through session logs and platform data. 
Tailoring and Modification 
Experimental groups’ sessions follow fixed structures and overall topics for three 
sessions, but specific topics vary based on individuals’ personalized goal setting during the 
sessions. Controls sessions are self-run, so topics are fully decided by group members but the 
instructions by the research team remains the same across groups. 
 
Outcomes 
Primary Outcomes (Prespecified) 
• Physical well-being goal progress 
• Civic participation 
• Social connection 
• Anxiety 
Assessor: Participant self-report via Qualtrics surveys at baseline and immediate follow-up, and 
three-month follow-up. 

Secondary Outcomes (Prespecified) 
Prespecified secondary outcomes include: 
• Attitudes toward: 
o Health 
o Civic participation 
o Social connection 
o Problem-solving 
• Political participation 
• Political trust 
Assessor: Participant self-report via Qualtrics surveys at baseline and immediate follow-up, and 
three-month follow-up. 
Exploratory Outcomes (Prespecified) 
• Primary outcomes supplements 
• Social support 
• Well-being 
o Subjective well-being 
o Subjective health [3MFU only] 
o Self-care behaviors [3MFU only] 
• Goal progress toward  
o The Baseline goal [3MFU only] 
o The Immediate Follow-Up goal [3MFU only] 
o Goal mentioned in the discussion sessions [3MFU only] 
o Other goal [3MFU only] 

• Healthcare [3MFU only] 
• Language use [3MFU only] 
Assessor: Participant self-report via Qualtrics surveys at baseline and immediate follow-up, and 
three-month follow-up. 
Additional Notes on Measurement 
Session fidelity ratings are assessed separately from recordings and are not outcomes. 
Harms 
We defined adverse events using Penn IRB guidelines (Penn IRB Reportable Events, 
2025). Adverse events (AE) may occur within discussion sessions or surveys, and can include 
complaints of a participant indicating unexpected risks which cannot be resolved by the research 
team (e.g., reports harassment, etc.), or other event that may present economic or social harm to a 
subject or may adversely affect the subject’s well-being (e.g., private information leaking) that is 
directly related to the study. Serious Adverse Events (SAE) are defined as when the participant 
outcome results in death, is life threatening or requires admission to the hospital and warrants an 
early end to the trial (see Stopping Guidelines). 
Systematically Assessed Harm (active/targeted surveillance) 
We did not systematically assess harm since the study poses less than minimal risk. 
Non-systematically Assessed Harm (passive surveillance) 
Assessment of harms will take place throughout the study through non-systematic 
assessment. During discussion sessions, co-facilitators and facilitators monitor adverse events 
(AE) in real time according to the criteria defined above. While surveys do not ask about explicit 
AE behavior such as self-harm or drug use, we will screen participants survey comments and 

assess for AE (e.g., complaints, discomfort, etc.). Furthermore, we will screen for adverse events 
through direct messages on GROV (intervention-only) and email contacts. 
When any harm is reported through a discussion session, survey, or contact attempt, it 
will be reported to the PI and clinical supervisor. Research coordinators, who are not blind to the 
allocated trial group, will file AEs in the “Adverse Events Tracking Log” in an encrypted BOX 
folder. We will note participants CGC, Group, Condition, whether the IRB was contacted, and 
fill out all columns from the NIH Adverse Event template – event severity, relation to the study, 
classification as AE or SAE (NIH Adverse Event Report Form, 2025). We will use the NIH 
template to determine how to grade events based on the severity of harm, whether it is related to 
the study, and whether it classifies as an AE or SAE. The PI will review the sheet after all data 
collection is complete to ensure honest reporting. 
Sample Size 
We conducted power analyses assuming comparable effect sizes (i.e., a Cohen’s d 
ranging from 0.30 to 0.50) to those seen in a very similar two-arm C-RCT previously conducted 
by our research team (see Table 1). Based on these analyses, we determined that we would need 
to recruit, at most, 200 total participants to have adequate power to detect our anticipated 
intervention effect. If results are not statistically significant, we will consider doing sequential 
analyses and recruiting additional participants while adjusting the p-value. This will be 
considered based on practical limitations such as staffing and funding. 
 
Table 1.  
Sample Size Estimation Based on a Two-Arm C-RCT with 10 Cohorts 

Cohen’s d 
N per arm 
N total 
Min n per 
group 
Group 
design 
effect 
Recruit per 
group 
Total 
recruit 
0.3 
88 
176 
9 
1.24 
10 
200 
0.4 
50 
100 
5 
1.12 
6 
120 
0.5 
34 
68 
4 
1.09 
5 
80 
Note. N per arm = analyzable sample size that an individually-randomized trial would need (per 
arm / total); min n per group (m) = minimum number of analyzable participants that must be in 
every group (same in both arms); design effect = 1 + (m-1)ρ (the usual cluster design effect);  
recruit per group = participants to be recruited per group (assuming a 10% attrition rate at the 
individual level). The estimations are based on a power of ≥ 80%, an alpha level of .05 (two-
sided), two parallel arms with 1:1 allocation to 20 groups in total (10 per arm), and an ICC (ρ) = 
0.03. 
 
Explanation of any interim analyses and stopping guidelines  
Interim Analyses 
We will begin conducting interim analyses of the trial data on a weekly basis once the 
first two cohorts have completed the immediate follow-up assessment. We will use these 
analyses to assess whether any adjustments to the study protocol or sample size targets are 
warranted and monitor adverse events. 
 
Stopping Guidelines 
This study will be stopped before its completion if any of the following conditions is met: 

• The intervention is associated with serious adverse effects that call into question the safety of 
the intervention. 
• Difficulty in study recruitment or retention significantly impacts the ability to evaluate the 
study endpoints. 
• New information becomes available during the trial that necessitates stopping the trial. 
• Other situations occur that might warrant stopping the trial. 
 
Randomization 
Sequence Generation 
A blocked randomization (1:1) procedure will be used. Once twenty eligible participants 
with overlapping availabilities are identified, they will form a cohort. We will assign each 
participant a computer-generated-code (CGC) ranging from 0 to 2000 using the Excel 
RANDBETWEEN function. We will sort participants in ascending CGC order. From the top of 
the list downwards, we will first assign “Control” and then “Experimental” conditions in 
alternating order. If participants complete the baseline questionnaire but do not attend any 
sessions, we will re-randomize them to a future group. If they do not engage with this second 
group, we will drop them from analyses. 
 
Allocation Concealment Mechanism 
The randomization sequence and resulting assignment list will be stored in an encrypted, 
access-restricted PennBox folder available only to authorized study personnel. Assignment will 
occur only after cohort formation, and participants will be notified individually by email after 
group scheduling, ensuring concealment until allocation is finalized. 

Implementation 
Research coordinators will generate the allocation sequence, assign participants to 
groups, and distribute schedules and survey links. Facilitators and co-facilitators who conducted 
sessions do not have access to the randomization list prior to assignment.  
Blinding 
Trial participants are blinded to study conditions, whereas research personnel, including 
facilitators and co-facilitators, are not. In the informed consent form, all participants are 
informed of the same study process: they will partake in group discussion sessions designed to 
support U.S. adults who wish to become more involved in their communities and set goals. Study 
length, descriptions, and payment information are identical. Once all study materials are 
complete, we will send participants a full disclosure of conditions and study objectives.  
 
 
 

Statistical Analysis Plan – CDSP C-RCT 
 
The main statistical analyses will examine the intervention effect (i.e., experimental versus 
control) on the primary, secondary, and exploratory outcomes (see Table 2). These analyses, and 
all the following unless stated otherwise, will be conducted using the intention-to-treat (ITT) 
method. That is, all participants who complete at least one session will be included in the 
analyses in the group to which they were randomized after replacing missing data by using 
multivariate imputation by chained equations under the missing-at-random assumption. We will 
perform multi-level modeling with clustered cohorts and report the intra-class correlations (ICC) 
of the cohort. For each outcome, we will specify all possible random effects models (i.e., random 
intercept only, random slope only, random intercepts and slopes without their correlations, and 
random intercepts and slopes with their correlations) and select the best one based on model-fit 
indices (i.e., AIC, BIC, and the likelihood ratio test). Based on the selected model, we will report 
the unstandardized estimate (for continuous outcomes) or odds ratio (for binary outcomes) and 
95% confidence interval for the intervention effect on a given outcome. We will also use the 
mean and standard deviation of each condition to compute the effect size (i.e., Cohen's d) for 
each outcome. 
The primary outcomes include four targeted behaviors promoted in the intervention: (a) making 
progress toward a physical well-being goal (continuous), (b) engaging in civic participation 
(binary), (c) establishing new or old social connections (binary), and (d) decreasing anxiety 
(continuous). Please see the Outcomes and Measurement document on OSF for further details. 
The secondary outcomes consist of six potential mediators: attitudes toward civic participation, 
social connection, health, problem-solving, and political participation; finally, political trust. We 

will impose no alpha correction/adjustment for multiple outcome comparisons because we have 
no conjunction hypotheses, and these outcomes are not primary outcomes. 
For the exploratory outcomes, we will conduct the same mixed-effects model analysis and will 
re-estimate the model using ordinary least squares analysis if singular fits occur. All results will 
be interpreted in an exploratory manner, and no adjustments for multiple comparisons will be 
applied. 
The following exploratory outcomes are measured at the Three Month Follow-Up (3MFU) only: 
one item in social support indicating mental health support for others; self-care behaviors; 
subjective health; goal progress toward the baseline goal, the immediate follow-up goal, 
additional goals mentioned in the discussion sessions, and any other goal; healthcare behaviors; 
and frequency of refraining from hurtful language toward people with substance use disorder and 
other groups. We will use the same analytical procedures as for the mixed-effects model 
described above to analyze the 3MFU responses. For each 3MFU outcome with a corresponding 
baseline measurement, the primary analysis will adjust for the baseline value of that outcome as 
a covariate. This adjustment is prespecified and will be applied irrespective of the magnitude or 
statistical significance of any observed baseline differences between treatment groups. 
In addition to the main analyses, we will also conduct exploratory mediation analyses to test 
whether the effect of the intervention on the primary outcomes is mediated by effects on the 
secondary outcomes. We will test the significance of these mediation effects using bootstrapping 
with 10,000 iterations. Furthermore, we will carry out mediation analyses by using ChatGPT to 
conduct thematic coding of de-identified session transcripts, self-talk recordings, and GROV 
interactions to identify key themes and patterns. All large-language-model (LLM) analyses and 
model identification will use the research team's OpenAI Team API account, which excludes our 

data from any model-training or fine-tuning pipelines at OpenAI. Specifically, we will use the 
GPT-4o mini model or a later version. Models will be frozen at major version upgrades and re-
tested to ensure performance parity when other models are employed in the analyses. We will 
also double-code 5-10% of the qualitative data alongside the ChatGPT annotations to ensure 
satisfactory inter-rater reliability. 
Finally, we will use multi-level modeling to carry out the following sensitivity analyses and 
assess the robustness of our results: (a) modified ITT analyses (i.e., including those participants 
who only completed the baseline and did not attend any sessions); (b) per-protocol analyses (i.e., 
including only participants who completed all three Zoom sessions originally allocated); and (c) 
analyses including corresponding baseline measures, GROV activities, intervention process 
evaluation, and fidelity assessment as covariates. The sensitivity analyses described here are not 
exhaustive, and new analyses may be added based on the research team’s decision. We will also 
conduct process analyses by examining whether the number of sessions attended and GROV 
engagements correlate with the study outcomes in the intervention group. 
The thematic coding of qualitative data and LLM analyses will be conducted in Python and R. 
Other analyses will be conducted using the R statistical software, and we will test the 
significance of all results at the α = 0.05 level. 
Table 2.  
C-RCT Outcomes 
Tier 
Construct(s) & Example Items 
Primary 
• Physical well-being goal 
• Civic participation 

• Social connection 
• Anxiety 
Secondary 
• Attitudes toward: 
o Civic participation 
o Social connection 
o Health 
o Problem-solving 
• Political participation 
• Political trust 
Exploratory 
• Primary outcomes supplements 
• Goal progress toward  
o The Baseline goal [3MFU only] 
o The Immediate Follow-Up goal [3MFU only] 
o Goal mentioned in the discussion sessions [3MFU only] 
o Other goal [3MFU only] 
• Social support 
o Social support received 
o Social support offered [3MFU only] 
• Well-being 
o Subjective well-being 
o Subjective health [3MFU only] 
o Self-care behaviors [3MFU only] 
• Healthcare [3MFU only] 

• Language use [3MFU only] 
 
Sections 22-30 
Not applicable. 
 
 

References 
 
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Reaching Out, and Getting By: A Review of Self-reported Psychosocial Impacts of 
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5(CSCW1), 95:1-95:35. https://doi.org/10.1145/3449169 
NIH. (2025). Adverse Event (AE) Report Form. https://files.nccih.nih.gov/s3fs-public/CR-
Toolbox/Adverse_Event_Form_ver2_07-17-2015.pdf 
Penn IRB. (2025). Reportable Event Guidance. https://irb.upenn.edu/homepage/how-to-
submit/reportable-events/reportable-event-guidance/