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Invitation to Participate in Research
The Teen Healthy Dating Study
An Invitation: We understand that you have legal custody of an adolescent female, aged 12-19. This teen is invited to participate in a study of prevention of dating violence. The research is being conducted by Anne DePrince, Ph.D., Cathryn Potter, Ph.D., and Stephen Shirk, Ph.D. of the Department of Psychology at the University of Denver. The project is funded by grants from the University of Denver and the National Institute of Justice.
Purpose: The purpose of this study is to understand factors that contribute to healthy dating relationships and the prevention of dating violence among teen girls in foster care. We are interested in testing whether two different types of programs are helpful to teens in creating healthy dating relationships. In addition, we are interested in whether these programs work better than not attending such a program. We do not work for the City or County of Denver or the Foster Care Clinic. We will be interviewing approximately 180 teens. Your teen is invited to participate in the study and she will be paid for her participation.
Description of the Study: Participation in the study involves two steps.
Step 1: First, we would like permission to conduct a screening interview with the teen to determine eligibility for this study. The interview will take about 3 hours and will focus on the teen's mood, social history (including responses to potentially traumatic experiences), teen’s past experiences, intellectual functioning, and attention. The teen will be paid $40 for participating, even if the teen is not eligible for the rest of the study.
The interview will help us know if the teen might benefit from the prevention programs. If eligible, the teen will be invited to participate in Step 2.
Step 2: The second part of the study involves research on two prevention programs designed to increase healthy relationships and decrease dating violence. If the teen is eligible and willing to participate, she will have an equal chance of being assigned to one of the prevention programs. No experimental medication is involved in the new treatment.
The prevention programs will involve the teen’s participation in 12-sessions of a prevention programs. She will receive $10 for each attended session to offset transportation costs. The prevention programs will be facilitated by two graduate-level co-leaders and a group of approximately 8 teens.
As part of the study, the teen will be asked to complete the same screening interview approximately 2 months after the program starts; then 2- and 6-months after the program ends. The teen will be compensated $40 for the 2nd interview; $40 for the third interview, and $40 for the fourth interview. During the course of the prevention program, she will be asked to complete questionnaires about her mood, things she is learning, and working with the therapist. The program sessions will be recorded so that the research team can make sure the prevention program is being delivered as planned.
Voluntary Participation and Right to Withdraw: Participation in the study is voluntary. If you do not want the teen to participate or she does not want to participate, it will not affect her opportunity to receive other services through the Department of Human Services. Further, you and the teen have the right to withdraw from the study at any time, including the right to stop attending the program. There is no penalty for withdrawal. If you or the teen decides to withdraw from the study, it will not affect your teen’s services with the Department of Human Services. If the teen decides to stop before the end of the 12-session program, she will have the opportunity to participate in post-treatment and follow-up interviews and receive payment for participating.
Confidentiality: Your teen’s responses during the study are kept strictly confidential by the researchers and will only be used for research purposes. Confidentiality of your teen’s responses is strictly maintained by the researchers unless she discloses an immediate threat to harm herself or others. Ground rules for teen group members regarding privacy of things discussed in the prevention group will be reviewed during the first group session. Data collected during this study are coded and stored by number, not by name, in order to maintain her confidentiality. Further, interviewers involved in this project have signed a confidentiality statement. If any publication results from this research, your teen will not be identified by name. Your teen will be assigned a number and her name will not appear on any test forms or other records. All audio-tapes of group sessions will be used for research purposes or for the purpose of quality assurance. The adolescent’s name will not appear on any of the tapes. A number code will be used for all recorded material. All test forms and records will be kept in a locked room in either a locked cabinet or on a secured computer. Original data will be kept for three years. The University of Denver Institutional Review Board and the National Institute of Justice can have access to data, but your teen will not be identified personally.
Potential Benefits: Participation in one of the prevention programs has the potential to improve coping skills and increase healthy relationships. However, we cannot guarantee such benefits. In addition, the teen will receive $40 for completion of first interview and $120 for the completion of the additional three interviews if she is eligible for the study. Finally, she will also receive up to $160 (or $10 per session) to offset transportation expenses to the interview and prevention program sessions.
Potential Risks: Because the screening interview focuses on the adolescent's moods, trauma history, and current functioning, she may experience some discomfort talking about these matters. However, the interviewers have been trained to follow a structured set of questions that have been used with many teenagers. In addition, she has the right to skip any question without penalty.
The prevention programs that are being offered have not been formally evaluated, however both programs are grounded in accepted principles of clinical practice. There is no guarantee that either prevention program will be effective for every participant. The primary risk for the teen involves dealing with emotional topics in the prevention program. She could experience some discomfort when emotional issues are addressed. However, the primary aim of the prevention program is to improve the adolescent’s coping abilities. Group leaders have been specifically trained to deliver the prevention programs, and are supervised by a licensed clinical psychologist.
Future Questions and Concerns : If you have any concerns or complaints about how you were treated during the research sessions, please contact Dr. Paul Olk, Chair, Institutional Review Board for the Protection of Human Subjects, at (303) 871-3454, or Sylk Sotto-Santiago, Office of Sponsored Programs at (303) 871-4052 or write to either at the University of Denver, Office of Sponsored Programs, 2199 S. University Blvd., Denver, CO 80208-2121.
Consent to Participate in Teen Healthy Dating Study
Authorization: I have read and understood the foregoing description of the Teen Healthy Dating Study. I understand that participation is completely voluntary.
I attest that the teen:
_____ is in the custody of the Department of Human Services pursuant to the order of the court.
_____ in my legal custody in my relation to her as ______.
I agree to have her participate in this research project. I understand that the study involves two steps; a screening interview to determine eligibility for the study; and participation in the larger study if eligible. I understand that the teen has an equal chance of being initially assigned to one of two prevention program groups. I understand that information gathered is for research purposes and is confidential. I have been informed of the limits of confidentiality. I understand that I may withdraw my consent at any time without penalty.
______
Adolescent’s Name
______
Legal Guardian Signature Date
______
Printed Name
______
Position with Department of Human Services / Juvenile Court, if applicable
ACKNOWLEDGEMENT AND AGREEMENT TO AUDIO RECORIDNG OF
ASSESSMENT NAD PREVENTION GROUP SESSIONS
For the purposes of data entry and analysis, we request permission to audiotape the assessment and prevention group sessions.
______I agree to have the adolescent’s assessment and prevention group sessions audio taped.
______I do not agree to have the adolescent’s assessment and prevention group sessions audio taped.
This project was approved by the University of Denver’s Institutional Review Board for the Protection of Human Subjects in Research on July 15, 2011.
ACKNOWLEDGEMENT AND AGREEMENT TO REPORTING OF
SUSPECTED ONGOING CHILD ABUSE
Explanation of State Mandated Reporting Requirement
You have been asked to consent for the teen in your legal custody to participate in the “Teen Healthy Dating Study”. The researchers of this study request your permission to report any reasonable suspicion of ongoing child abuse or neglect to the proper authorities. This means that they will break the confidentiality connected with this study if they think a child is being harmed and have your consent to do so. The chances that such a report will ever be made are very low, but you need to know about the possibility.
Explanation of Federal Research Confidentiality
Federal regulations require your approval for any information about your teen, as a research subject, to be released in an identifiable form. This law does not allow federally funded researchers to use any research information for purposes other than research without your permission. Therefore, we must have your written approval to break research confidentiality if it becomes necessary. You have the right to refuse to agree. If you refuse, the teen will not be enrolled in the study.
Your signature below indicates that you acknowledge and agree to allow the researchers of this study to comply with these reporting requirements about ongoing child abuse or neglect and fully understand the risks and consequences of such agreement.
______
Signature of Participant or Legal Representative Date
______
Signature of Witness Date
I have explained the reporting requirements and participant rights, and have answered all questions asked by the legal guardian. I have provided a copy of this form to the participant or legal representative.
______
Signature of Researcher Date
This project was approved by the University of Denver’s Institutional Review Board for the Protection of Human Subjects in Research on July 15, 2011.
Authorization to Release/Request Health Information for Research Purposes
I authorize the Department of Human Services and/or the Foster Care Clinic to release/request the following information contained in the medical records of:
______
Client Name Date of Birth
Please release information to/request information from:
Teen Healthy Dating Study, Principal Investigator: Anne P. DePrince, Ph.D.
University of Denver, Department of Psychology, Denver, CO 80208
I authorize Denver Department of Human Services and/or the Foster Care Clinic to the following release information to the research team: case information (for example, intake information), psychosocial history, and medication history.
I understand that this information is being collected for research purposes only. I am also aware that some of this information may be obtained by a researcher Review of Medical Record, and that no other information from that record will be photocopied, written, or used in any way.
This information has been disclosed from records protected by federal confidentiality rules (42 CFR P Part 2). The rules prohibit you from making any further disclosure of this information unless further exposure is expressly permitted through consent of the person to whom it pertains or as otherwise permitted by (42 CFR Part 2). A general authorization for the use of medical or other information is NOT sufficient for this purpose. The federal rules restrict any use of the information to criminally investigate or prosecute any alcohol or drug abuse patient.
This form expires one year from the date signed or upon revocation of consent, whichever comes first. A copy of this form is considered as valid as the original.
I hereby release the above parties from any liability which may result from furnishing this information.
______
Legal Guardian Signature Date