Consent to Participate in Research

Basic Study Information
Title of the Project: Evaluating the Efficacy of Self-Help Tools for Adults Impacted by Childhood Sexual Violence using an On-line Community Learning Modality (2382580-3)

Principal Investigator: Dr. Felicia Green, Florida A & M University

Co PI: Angela Snyder, RN, MSN, MHA, Executive Director of Opus Peace


Invitation to be Part of a Research Study
You are invited to be part of a research study. This consent form will help you in choosing whether to participate in the study. Feel free to ask if anything is not clear in this consent document.


What is the study about and why are we doing it?
The purpose of this study is to better understand how an 8-week, trauma-informed online educational program may support adults who experienced sexual trauma during childhood. Many adults who were sexually traumatized as children do not have access to educational programs that help them understand the long-term emotional and relational effects of that trauma or provide practical self-help tools for healing outside of traditional therapy settings.

This study is based on the Soul Injury framework, which views trauma as an injury to a person’s inner life, sense of self, and meaning, rather than as a psychological disorder. The program focuses on education, self-awareness, and self-compassion to help participants better understand their experiences and strengthen their relationship with themselves.

The study will evaluate whether participation in the program is associated with:

· Increased awareness of the emotional and relational impacts of childhood sexual trauma

· Changes in participants’ sense of self

· Participants’ perceptions of how helpful the self-help tools are at the end of the course

Information will be collected through online surveys completed before and after the program, as well as a post-course evaluation of the self-help tools. The results will be used to improve trauma-informed educational programs and increase access to supportive, non-clinical healing resources for adults impacted by childhood sexual trauma.

Participation in this study is voluntary, and the program is educational and self-help in nature, not therapy or clinical treatment.

What will happen if you take part in this study?
If you agree to take part in this study, your participation will last approximately 8 weeks and will take place entirely online. Your participation is voluntary, and you may choose to stop at any time.

Before the program begins, you will be asked to complete an online pre-course survey, which will take about 10–15 minutes. This survey will ask questions about your awareness of how childhood sexual trauma may affect your emotional life and sense of self. Questions will use rating scales (for example, asking how strongly you agree or disagree with statements).

During the 8-week program, you will participate in weekly virtual group meetings. Each meeting will last approximately 90 minutes and will include:

A 20-minute prerecorded educational video
A facilitated small-group discussion with other participants
A grounding or closing exercise to help end the session in a supportive way
All meetings will take place online using a secure video-conferencing platform. You may choose how much you share during group discussions, and you may listen without speaking if you prefer.

Between weekly meetings, you will have access to self-paced educational and reflective activities, which will take approximately 90 minutes per week. These activities may include:

Additional short videos and reading materials
Self-help tools such as grounding exercises, reflective writin
You may complete them at your own pace and skip any activity that feels uncomfortable.

You will also have access to a moderated online community chat throughout the program, where participants can share reflections or encouragement. Participation in the chat is optional.

At the end of the 8-week program, you will be asked to complete an online post-course survey, which will take about 10–15 minutes. This survey will ask similar questions to the pre-course survey and will also ask you to rate how helpful you found the self-help tools used in the program.

Sensitive Topics

Some study activities and survey questions involve sensitive topics, including:

Childhood sexual trauma
Emotional responses such as shame, guilt, or distress
Self-reflection about identity, self-worth, and emotional well-being
You are not required to answer any question that makes you uncomfortable, and you may stop participating at any time. Support resources and contact information for the research team will be provided if you experience emotional discomfort.

Time Commitment

Your total time commitment will be approximately 3 hours per week for 8 weeks, plus about 20–30 minutes total to complete the pre- and post-course surveys.

How long will this study take and how many people will be in the study?
Your participation in this study will last approximately 8 weeks, plus the time needed to complete the pre-course and post-course surveys. The weekly time commitment is approximately 3 hours per week, which includes the weekly virtual meeting and self-paced activities between sessions. The pre-course and post-course surveys will each take about 10–15 minutes to complete.

Approximately 61 adults are expected to take part in this study.

What risks and discomforts might you experience from being in this study?
There are some risks and discomforts you might experience from taking part in this study. These risks are primarily emotional or psychological in nature, and there is also a small risk related to confidentiality.

Because this study focuses on childhood sexual trauma and its long-term emotional effects, some of the educational materials, discussions, and survey questions may bring up strong emotions. You may experience temporary feelings of sadness, anxiety, discomfort, distress, shame, or emotional overwhelm, particularly when:

· Watching educational videos related to childhood sexual trauma

· Participating in group discussions

· Completing reflective exercises

· Answering survey questions about your emotions, sense of self, or past experiences

Survey questions may ask about topics such as emotional responses to trauma, self-awareness, identity, or personal growth. These questions are intended to better understand participants’ experiences, but they may feel sensitive or upsetting for some individuals.

To help minimize emotional discomfort:

· Participation is voluntary, and you may skip any question or activity you do not wish to complete

· You may choose how much or how little you share during group discussions

· You may stop participating in the study at any time without penalty

· Contact information for the research team and mental health support resources will be provided if you experience distress

There is also a risk of loss of confidentiality, as personal information and responses are collected electronically, and some activities involve interaction with other participants in a group or online community setting. While this risk is considered low, it cannot be completely eliminated.

No physical risks are expected as part of this study.
How could you benefit from this study?
You may or may not receive direct benefit from participating in this study. However, possible benefits may include increased self-awareness, opportunities for reflection, and access to educational materials and self-help tools designed to support healing and understanding of the long-term impacts of childhood sexual trauma. These benefits cannot be guaranteed.

In addition, the information gained from this study may benefit society by increasing understanding of how trauma-informed, online educational programs can support adults impacted by childhood sexual trauma. Results from this study may help improve access to non-clinical, educational resources, inform the development of future support programs, and guide organizations and professionals working with survivors in creating more effective and accessible healing-oriented interventions.

What data will we collect from you?
As part of this study, we will collect self-reported information from you through online surveys and program participation activities.

The data collected will include:

· Responses to online pre-course and post-course surveys, which include rating-scale (Likert-style) questions about:

o Your awareness of the emotional and relational impacts of childhood sexual trauma

o Your sense of self and relationship with yourself

o Your perceptions of the helpfulness and effectiveness of the self-help tools used in the course

· Basic demographic information (such as age range gender). Basic sexual trauma history information (such as age the sexual trauma first occurred).

· Information related to program participation, such as completion of surveys and engagement with course materials

Survey questions may ask about sensitive topics, including emotional experiences, self-reflection, and the long-term effects of childhood sexual trauma. You may skip any question you do not wish to answer.

No medical records, therapy records, or biological samples will be collected as part of this study.

How will we protect your information?
We will protect your information by storing all survey responses and program participation data in secure, password-protected electronic files. Your name and any other information that could directly identify you will be stored separately from your survey and program data. Only the research team will have access to the information that links your identity to your responses.

Information about you may be reviewed by the following organizations for oversight purposes:

· Representatives of the FAMU Institutional Review Board

The data we collect will not be shared with other researchers outside of this study.

We plan to publish the results of this study to contribute to knowledge about trauma-informed educational programs. To protect your privacy, any published or presented results will not include any information that could directly identify you.

What will happen to the information we collect about you after the study is over?
After the study is complete, your name and any information that could directly identify you will be removed from the data collected during the study. The de-identified data will be stored on a secure, password-protected computer and/or secure cloud platform while the research team completes data analysis.

Once the analysis is finished, all de-identified data and any documents linking your identity to your responses will be securely deleted. Your information will not be used for any future research, and no individual participant will be identifiable in any reports, presentations, or publications.
How will we compensate you for being part of the study?
You will not receive any payment for participating in this study. However, as a participant, you will receive free access to the online Childhood Sexual Trauma course, which is valued at $49. This access includes all weekly educational videos, group discussions, and self-help materials for the duration of the 8-week program. You will retain access to the course materials even if you do not complete all program activities.

Your Participation in this Study is Voluntary
It is completely up to you to decide whether or not to take part in this research study. Participating is voluntary, and your decision will not affect your relationship with Opus Peace Corporation, Florida A&M University, or any of the community organizations assisting with recruitment. You will not lose any benefits or rights you already have if you decide not to participate.

Even if you agree to participate now, you may change your mind and withdraw at any time. You do not have to answer any questions you do not want to answer.

If you decide to withdraw before the study is completed, any survey responses or other data you have already provided will be removed from the study and securely deleted, and your access to the online course will not be affected

Contact Information for the Study Team and Questions about the Research


1. Contact information for the Study Team with any questions/concerns/or in case of emergency.

Angie Snyder

9894 54th Ave. N.

St. Petersburg, FL 33708

610-858-8740

Angie@OpusPeace.org



Contact Information for Questions about Your Rights as a Research Participant
If you have questions about your rights as a research participant, or wish to obtain information, ask questions, or discuss any concerns about this study with someone other than the researcher(s), please contact the following:



IRB Chairperson

Dr. Angela Thornton

Florida A&M University

Institutional Review Board

Room 308H SRC

Tallahassee, FL 32307-3800

850-412-5246

Please reference the protocol number found at the top of this document.

Your Consent

By acknowledging this document, you are agreeing to participate in this study. Please take time to ensure you understand the purpose of the study and what participation involves before providing your consent. You will be provided with a copy of this consent document for your records, and a copy will be maintained with the study records. If you have any questions about the study, you may contact the study team using the information provided above.

I understand the purpose of this study, and my questions to date have been answered to my satisfaction. By checking this box, I acknowledge that my participation is voluntary and that I agree to participate in this research study.

☐ I agree to participate

☐ I do not agree to participate



Participant Name (Printed): _____________________________



Participant Signature: ___________________________________
PLEASE READ THE ENTIRE INFORMED CONSENT ABOVE

Question Title

* 1. By acknowledging this document, you are agreeing to participate in this study. Please take time to ensure you understand the purpose of the study and what participation involves before providing your consent. You will be provided with a copy of this consent document for your records, and a copy will be maintained with the study records. If you have any questions about the study, you may contact the study team using the information provided above.

I understand the purpose of this study, and my questions to date have been answered to my satisfaction. By checking this box, I acknowledge that my participation is voluntary and that I agree to participate in this research study.

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* 2. Typing your name below indicates your informed consent to participate in this research study.

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* 3. Typing the date below indicates the date you have given informed consent to participate in this research study.

Date

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* 4. Enter your email below to recieve the pre-research survey questions

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