|
Institutional
Review Board for Baylor College of Medicine and Affiliated
Hospitals
|
|
Protocol
Number: H-25409
|
Status: Approved
|
Initial
Submit Date: 7/18/2009
|
Approval
Period: 10/13/2009 -
10/12/2010
|
|
|
Section
Aa: Title & PI
|
A1. Protocol
Title
|
|
|
CONTROLLED
EVALUATION OF EXPECT RESPECT SUPPORT GROUPS
|
|
|
A2. Principal
Investigator
|
|
|
Name:
|
AMY
CUELLAR
|
Phone:
|
713-791-1414
x6711
|
|
Id:
|
153538
|
Fax:
|
713-794-7844
|
|
Department:
|
PSYCHIATRY
& BEHAVIORAL SCIENCES
|
Email:
|
acuellar@bcm.tmc.edu
|
|
Center:
|
|
Mail
Stn:
|
BCM350
|
|
|
A3. Administrative
Contact
|
|
|
Name:
|
KRISTIN
HOLLAND
|
Phone:
|
770-488-3954
|
|
Id:
|
Non-Baylor
|
Fax:
|
770-488-1360
|
|
|
|
Email:
|
imh1@cdc.gov
|
|
|
|
Mail
Stn:
|
|
|
|
A3a. Financial
Conflict of Interest
|
Does
the investigator have a financial interest in any non-Baylor
sponsor or funding source for this research?
|
|
|
|
A3b. Cooperative
Agreement
|
Is
this a cooperative agreement protocol?
|
|
|
|
Which
institution is the IRB of record?
|
|
BCM:
Baylor College of Medicine
|
|
|
|
Section
Ab: General Information
|
A4. Co-Investigators
|
|
|
Name:
|
ANDRA
TETEN
|
Phone:
|
770-488-3936
|
|
Id:
|
157449
|
Fax:
|
770-488-1360
|
|
Department:
|
PSYCHIATRY
& BEHAVIORAL SCIENCES
|
Email:
|
teten@bcm.tmc.edu
|
|
Center:
|
|
Mail
Stn:
|
BCM350
|
|
|
|
Name:
|
BARBARA
BALL
|
Phone:
|
512-356-1623
|
|
Id:
|
Non-Baylor
|
Fax:
|
512-385-0662
|
|
Institution:
|
Safe
Place
|
Email:
|
bball@safeplace.org
|
|
Address:
|
PO
Box 19454 Austin, TX 78760
|
|
|
|
|
|
Name:
|
BARRI
ROSENBLUTH
|
Phone:
|
512-356-1628
|
|
Id:
|
Non-Baylor
|
Fax:
|
512-385-0662
|
|
Institution:
|
Safe
Place
|
Email:
|
brosenbluth@safeplace.org
|
|
Address:
|
PO
Box 19454 Austin, TX 78760
|
|
|
|
|
A5. Funding
Source:
|
|
|
Other: Centers
for Disease Control and Prevention
|
|
|
A6a. Institutions
where work will be performed:
|
|
|
CDC:
Centers for Disease Control - Georgia
|
|
|
A6b. Research
will be conducted outside of the United States:
|
|
|
Country:
Facility/Institution:
Contact/Investigator:
Phone
Number:
If documentation of
assurances has not been sent to the Office of Research,
please explain:
|
|
|
A7. Research
Category:
|
|
|
|
Section
B: Review Path Determination
|
B1. Full
Board or Expedited Review
|
Is
this an compassionate/emergency use situation?
|
|
|
|
If
this is a drug study, is an investigational new drug (IND)
application required?
|
|
|
|
If
this is a device study, is an investigational device exemption
(IDE) application required?
|
|
|
|
If
the research involves ONLY blood collection, are subjects
healthy, non-pregnant adults whose weight is at least 110
pounds, with amount drawn less than 550 ml in an 8 week period,
and with collection not occurring more frequently than 2 times
per week?
|
|
|
|
If
the research involves ONLY blood collection for other adults
and children, considering age, weight and health of subjects,
is the amount drawn in an 8 week period less than 50ml or 3 ml
per kg, and with collection not occurring more frequently than
2 times per week?
|
|
|
|
Does
the research involve ONLY the collection of biological
specimens for research purposes by noninvasive means? (e.g.
Hair; extracted teeth; excreta, sputum and external secretions;
placenta removed at delivery; mucosal and skin cells collected
by scraping or swab)
|
|
|
|
Does
the research involve ONLY the collection of data through
noninvasive procedures (not involving general anesthesia or
sedation) routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves? (e.g. EKG, ECHO,
EEG, Ultrasound, MRI)
|
|
|
|
Does
the research involve ONLY materials (data, documents, records,
or specimens) that have been collected, or will be collected
solely for non-research purposes (such as medical treatment or
diagnosis)?
|
|
|
|
Does
the research involve ONLY the collection of data from voice,
video, digital, or image recordings made for research purposes?
|
|
|
|
Does
the research involve ONLY individual or group characteristics
or behavior (including, but not limited to, research on
perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social
behavior) or research employing survey, interview, oral
history, focus group, program evaluation, human factors
evaluation, or quality assurance methodologies?
|
|
|
|
Does
the research involve pedigree studies, collection and/or
storage of specimens for DNA analysis or gene transfer?
|
|
|
|
B2. Exempt
From IRB Review
|
|
|
B3. Waiver
of Subject Authorization
|
|
|
Section
C: Background
|
|
|
The
prevalence and consequences of teen dating violence make it
a public health concern (Wolitzky-Taylor et al., 2008;
Eaton, Davis, Barrios, Brener, & Noonan, 2007) that
requires early and effective prevention. Despite recent
legislation in Texas and Rhode Island that requires schools
to provide teen dating violence education, to date, only
three prevention strategies—Safe Dates, the Youth
Relationships Project, and 4th R (Foshee et al., 1998; Wolfe
et al., 2003; Wolfe et al., in press) - have demonstrated
reductions in dating violence behaviors in rigorous,
controlled evaluations (Hickman, Jaycox, & Aronoff,
2004). In order to protect young people and build an
evidence-base of effective prevention strategies, evaluation
of additional programs is needed, including those programs
currently in the field (Teten, Ball, Valle, Noonan, &
Rosenbluth, 2009).
Teens are at risk for
experiencing dating abuse beginning with the initiation of
dating relationships during early adolescence. Nearly half
of 11– to 14-year olds report that they have been in a
dating relationship (Teen Research Unlimited, 2008). Among
those who experience dating violence victimization, 29%
report their first experience of abuse occurred at age
12-13, 40% at age 14-15, and 29% at age 16-17 (Burcky,
Reuterman, & Kopsky, 1988). Up to 45% of high school
students report experiencing some form of emotional,
physical, or sexual violence in their dating relationships
(Foshee, 1996; O’Keefe, 1997; Silverman, Rai, Mucci, &
Hathaway, 2001). Dating violence is associated with
subsequent adverse consequences, including substance abuse,
sexual risk behaviors, unintended pregnancy, sexually
transmitted diseases, unhealthy weight control behaviors,
depression, and suicidality (Teten et al., 2009).
Although
traditional conceptualizations of dating violence suggested
males were perpetrators and females were victims, surveys of
teen dating violence that assess both girls’ and boys’
violence perpetration consistently report a higher
percentage of girls than boys perpetrate physical violence
(Foshee, 1996; O’Keefe, 1997; Hickman et al., 2004;
Sears, Byers, & Price, 2006). Critics of these findings
suggest the effects of male and female-perpetrated
physically violent acts differ substantially in terms of
injury sustained and fear evoked (Dobash, Dobash, Wilson, &
Daly, 1992). Molidor, Tolman, and Kober (2000) found that
48% of girls in their sample and only 4% of boys reported
that a violent incident “hurt a lot.” Boys more
often (54%) responded that they “laughed” about
the violence compared to girls (10%). While the context,
meaning, and effect of violent behaviors may differ between
boys and girls, studies nevertheless point to the importance
of supporting both boys and girls in learning skills for
healthy relationships. As noted by O’Keefe (1997):
“every violent action creates a risk for a violent
response or future violent acts” (p. 6). Given the
prevalence and age of initiation reported for teen dating
and teen dating violence, prevention programs need to
involve boys and girls beginning with the middle school
years.
Multiple studies suggest that teens’
experiences with violence and violence-supportive or
accepting attitudes are linked with the perpetration of
dating violence (Wolfe, Wekerle, Reitzel-Jaffe, &
Lefebvre, 1998; Wolfe, Wekerle, Scott, & Pittman, 2001;
Wolfe, Wekerle, Scott, Straatman, & Grasley, 2004;
Malik, Sorenson, & Anehensel, 1997; O’Keefe, 1997,
1998). While the mechanism of these associations is unclear,
a history of child maltreatment has been associated with
boys threatening or carrying out dating violence, with boys
experiencing dating violence, and with girls being victims
of such violence (Wolfe, Wekerle, Scott, & Pittman,
2001). Witnessing parental violence (O’Keefe, 1997,
1998) has been associated with the perpetration of dating
violence among boys but not girls. Wolitzky-Taylor et al.
(2008) observed an association between experiencing serious
physical and sexual dating violence and having experienced a
previous traumatic event, such as sexual or physical assault
by someone other than a dating partner, having witnessed
community violence and parental violence, and experiencing
the loss of a loved one.
Prevention approaches
for dating violence may be applied universally to all
individuals in a population, regardless of the risk factors
described above, or they may have targeted application, such
that individuals at risk for experiencing or perpetrating
violence receive the prevention intervention. Universal
approaches are often didactic and classroom-based, aiming to
educate teens about healthy and abusive relationships (e.g.,
Avery-Leaf, Cascardi, O’Leary, & Cano, 1997;
Foshee et al., 1998; Jaffe, Suderman, Reitzel, & Kilip,
1992; Schewe, 2002), whereas targeted approaches may be
tailored to the particular needs of the at-risk group and
offered during the school day but outside of a classroom
curriculum. Experts have recommended intensive prevention
programs for youth who have experienced violence in the
family and in the community and who perpetrate or experience
abuse in their peer and early dating relationships (Wolfe et
al., 2003; Pepler et al., 2006; Williams et al., 2008). In
addition to countering risk factors, such as violence
supportive attitudes (Capaldi et al., 2001), targeted
prevention programs may also enhance potential protective
factors, such as establishing positive relationship norms in
the peer group (Williams et al., 2008). Teaching and
practicing positive behaviors is an important aspect of
building relationship competence. Cornelius and Resseguie
(2007) suggest that without a skill-building component to
improve proficiency of communication, negotiation, and
problem solving skills the likelihood of behavior change is
improbable. Teens themselves express the importance of
learning skills and ask for assistance to learn “how
to make relationships work” (Ball, Kerig, &
Rosenbluth, 2009; Sears, Byers, Whelan, & Saint-Pierre,
2006). Because some students may evidence higher risk for
dating violence, the intensity of a targeted approach in
addition to (or in place of) a universal strategy may be
needed for these students (e.g., Eaton et al., 2007;
Whitaker et al., 2006).
Thus far, the Youth
Relationships Project (YRP; Wolfe et al., 2003) is the only
published and rigorously evaluated dating violence
prevention program that targets at-risk adolescents. The YRP
is an 18-session program that provides coeducational groups
in community locations for youth with a history of
maltreatment. The controlled evaluation demonstrated
decreases in abuse perpetration and victimization and
emotional distress symptoms; however, participants did not
show expected growth in healthy relationship skills.
In
contrast to the Youth Relationship Project, Expect Respect
Support Groups (Ball, Rosenbluth, & Aoki, 2008) are
offered at middle and high schools - that is, in the social
environment where about 40% of the worst dating violence
incidents occur (Molidor, Tolman, & Kober, 2000).
School-based support groups are designed to reach a wide
range of at-risk students and to maximize accessibility.
Students are eligible for participation in Expect Respect
support groups (ERSG) if they have witnessed domestic
violence and/or experienced child abuse (emotional/mental,
physical, sexual, neglect) and/or are involved in abusive
peer and dating relationships. Boys and girls meet in
separate gender groups facilitated by same-gender group
leaders, which is intended to increase the sense of comfort
and safety for teens, to allow them to bond more quickly,
and to explore their expectations for relationships. The
primary goal of the 24-session program is to prevent at-risk
youth from becoming future victims and perpetrators in their
intimate relationships and to promote healthy, non-violent
relationship behaviors.
In a pilot evaluation of
26 ERSG (16 schools) significant increases in positive
dating behaviors and significant declines in emotional and
physical victimization and perpetration were found for
students who reported a history of peer and dating violence
(Ball, Teten, Noonan, Valle, Hamburger, & Rosenbluth, in
preparation). Perpetration of sexual violence increased over
time. We attribute the rise in this low base rate behavior
(M = 0.03 to M = 0.13) to its measurement (2 items),
increases in awareness due to intervention, and timing of
the final assessment (e.g., students completed final
assessments in session 23 of 24 and reported on their
behavior over the previous 3 months, so intervention effects
may not yet have been achieved). We addressed these
limitations by expanding the assessment of sexual violence
and in the current proposal will use a control group and
follow-up assessment to clarify change in sexual violence as
a result of the intervention.
Based on these
preliminary results, the current study proposes a controlled
evaluation of ERSG.
|
|
|
|
Section
D: Purpose and Objectives
|
|
|
In
the proposed study, BCM investigators (Drs. Cuellar and
Teten) and CDC staff (Dr. Teten and Ms. Holland) will not
participate in data collection and will not have access to
identifiable survey data. SafePlace staff (Dr. Ball, Ms.
Rosenbluth and their staff) will be responsible for
collection and management of identifiable data. Per guidance
from the Department of Health and Human Services, SafePlace,
as a function of its interaction with CDC, will obtain its
own Federal Wide Assurance number. BCM IRB will be the IRB
of record, as SafePlace and the Austin School District do
not have an alternative IRB. The details of these roles are
provided in Section F2.
Safe Place
(http://www.safeplace.org/site/PageServer) is the
organizational infrastructure through which Expect Respect
Support Groups (ERSG) were developed and is the mechanism
through which Expect Respect is implemented and disseminated
in schools. ERSG are a targeted group intervention for the
prevention of teen dating violence offered to at-risk
students. Promising results from preliminary pre-post
program evaluations suggest a controlled trial of ERSG is
warranted.
This protocol seeks approval to
collect students' survey response data for a controlled
evaluation. As targeted and universal prevention programs
are already implemented in Austin public schools and are
considered a standard practice in this district (per
legislative mandate), we are not seeking approval to conduct
the intervention, but rather to collect and analyze survey
data for research purposes.
The data will be
used to examine one primary and two exploratory aims:
Primary Aim: To evaluate the effectiveness of
ERSG to prevent and reduce teen dating violence perpetration
and victimization and increase healthy relationship skills
reported by at-risk male and female middle and high school
students compared to at-risk students in control schools who
do not provide ERSG.
Exploratory Aims: 1) To
evaluate whether or not the effectiveness of ERSG is
enhanced by the presence of a universal, school-wide
prevention program. 2) To examine moderators and mediators
of targeted and universal teen dating violence
interventions, such as biological sex, history of peer and
dating abuse at intake, and ability to identify
abuse.
Hypotheses: Primary Aim: We hypothesize
that ERSG participants will report less frequent dating
violence perpetration and victimization and more frequent
healthy relationship skills than students in the control
group.
Exploratory Hypotheses: 1) In order to
determine whether a universal prevention strategy produces
positive effects above and beyond a targeted prevention
strategy, we also seek to examine dating violence/healthy
relationship behaviors among participants who receive a
targeted prevention intervention only (ERSG) compared to
those who receive both the targeted (ERSG) and universal
(e.g., Safe Dates) prevention programs. We expect that
students who receive the universal prevention strategy in
addition to ERSG will not report significantly better
outcomes than those who only receive ERSG. 2) Based on
previous work, we hypothesize that students with recent peer
and dating violence victimization and perpetration will
evidence the greatest reduction in peer and dating violence
perpetration and victimization over the course of the
intervention. We will explore the effect of other variables
such as biological sex on outcome.
|
|
|
|
Section
E: Protocol Risks/Subjects
|
E1. Risk
Category
|
|
|
(45
CFR 46.404) Category 1: Research not involving greater than
minimum risk.
|
|
|
E2. Subjects
|
|
|
Age:
|
|
Adolescent
(13-17 yrs), Child (3-12 yrs)
|
|
|
|
|
|
|
Groups
to be recruited will include:
|
|
Healthy,
non-patient, normals
|
|
|
Vulnerable
populations to be recruited as subjects:
|
|
|
|
Vulnerable
populations require special protections. How will
you obtain informed consent, protect subject confidentiality,
and prevent undue coercion?
|
|
In
addition to the recruitment procedures outlined in Sections
F2 and J2, several steps will be taken to protect the
vulnerable population:
1) As the proposed study
seeks to recruit at-risk students, and as SafePlace is a
non-profit service organization, our recruitment procedures
will seek referrals for any student who may need assistance
with violence at home or in relationships. The intake
interview/screening will have two functions: 1) to provide
referrals to at-risk students and 2) to determine
eligibility for the study. Therefore, any student in
participating schools is eligible for an intake interview,
but only those students who meet the inclusion/exclusion
criteria will be given the option of participating in the
study. For example, an 18 year old may undergo an intake and
may be referred to community agencies for additional
services, but would not be eligible for study participation.
2) Students will be assured in the intake
session that the decision to participate in the study is
voluntary, and in no way affects his/her ability to
participate in other services.
3) Mandatory
reporting requirements will apply to the intake session. In
accordance with the Texas Family Code, facilitators will
make a report if students report experiencing child abuse
(mental/emotional injury, physical injury, sexual conduct
harmful to a child, or neglect). If students report during
the interview that they are perpetrating emotional, physical
or sexual abuse of another child, that information will be
reported by Safe Place personnel or AISD teachers to DPRS or
the appropriate law enforcement agency. The Expect Respect
policy for mandatory reporting is attached in Section S. As
the identity of the victim and perpetrator is not collected
on baseline, completion and follow up surveys that include
questions about peer and teen dating violence, mandatory
reporting will not apply to reports of violence made on the
surveys. (As BCM investigators will not be involved in data
collection or reporting, no Certificate of Confidentiality
will be sought for the proposed study).
4) All
students will receive educational materials about dating
violence, and local and online resources (attached in
Section S).
5) In the control schools, eligible
students who are not in crisis but in need of no or minimal
intervention will be eligible for the control condition.
Regardless of their decision to participate in the
evaluation, students from control schools in need of minimal
intervention will be offered short-term individual
psycho-education at school (1-3 sessions) by the Expect
Respect facilitators. We believe that this minimal
intervention represents an ethical "treatment as usual"
but we do not expect that the control intervention will
impede the possibility of detecting group differences.
6)
Parental notification: Although a waiver of parental consent
will be sought in the study (described in J1) participants
in both study groups also will be given a parental
information letter that they may choose to give to their
parents.
7) Participant confidentiality:
Participants will be assigned a code by Safe Place
co-investigators or their staff. No information that could
link a students' number to his/her data will be released to
anyone outside of SafePlace. The use of random codes will
also allow the PI, Dr. Amy Cueller, BCM volunteer
faculty/CDC science officer, Dr. Andra Teten, and CDC
project officer, Ms. Kristin Holland, to remain
"non-engaged" in the research. Neither BCM nor CDC
faculty will ever be able to link the participants' data to
their identity.
8) Payment of participant
incentives-retaining confidentiality: For survey completion,
study participants will receive payment in the form of a
mall gift card, so that no one could link the participant's
incentive to his/her participation in this study.
|
|
|
E3. Pregnant
woman/fetus
|
Will
pregnant women be enrolled in the research?
|
|
|
|
E4. Neonates
|
Will
neonates be enrolled in the research?
|
|
|
|
E5. Children
|
Will
children be enrolled in the research?
|
|
|
|
|
Section
F: Design/Procedure
|
F1. Design
|
Select
one category that most adequately describes your research:
|
|
d)
Questionnaire/survey/interview
|
|
|
Discuss
the research design including but not limited to such issues
as: probability of group assignment, potential for subject to
be randomized to placebo group, use of control subjects, etc.
|
|
The
proposed evaluation will use a
quasi-experimental/non-randomized design. To address the
primary aim, participants in middle and high schools
receiving targeted prevention services (ERSG) are compared
to students in control schools in which ERSG is not
available.
Intervention schools will be selected
from the Austin Independent School District (AISD), as ERSG
are already underway in 24 of the 31 AISD schools.
Approximately 10 control schools will be selected from three
neighboring districts (Del Valle ISD, Manor ISD, and/or
Pflugerville ISD) that have characteristics (e.g.,
demographics, socio-economic status and number of at-risk
students according to data published by the Texas Education
Agency) similar to the Austin ISD intervention schools.
|
|
|
Inclusion
Criteria:
|
|
Intervention
subjects will be students at middle and high schools
providing ERSG and control subjects will be students from
schools that do not offer ERSG. Only students from schools
that have agreed in writing to participate in the study will
be eligible. Within these schools, students in grades 6
through 12 ranging in age from 11 to 17 years will be
eligible to participate in this study.
Participants
who assent to the study must have a history of witnessing
domestic violence, and/or experiencing child abuse
(emotional/mental, physical, sexual, neglect) and/or being
involved in abusive peer and dating relationships. Inclusion
criteria for the proposed study will be assessed during the
intake session.
|
|
|
Exclusion
Criteria:
|
|
Exclusion
criteria for the evaluation are having never experienced
(i.e., been a victim, perpetrator, or witness of ) any form
of violence or requiring a higher level of care than the
ERSG can provide. In other words, students in crisis (e.g.,
acute emotional upset, suicidal or homicidal ideations) will
not be eligible. Students in crisis (at either intervention
or control schools) will be referred for mental health,
social and/or legal services.
Students younger
than 11 or 18+ years old will be excluded. Our past work
suggests very few 18 year olds participate in ERSG or are
referred by teachers, so we expect that our exlusion of 18
year olds will effect very few students. Also, based on
public records, very few 10 year olds are in middle school.
Therefore our criteria should allow for most of the eligible
middle and high school students to meet the age requirement.
|
|
|
F2. Procedure
|
|
|
INVESTIGATOR
ROLES: Dr. Amy Cuellar, a faculty member at BCM, will serve
as the PI of this study and point of contact for BCM IRB
purposes. She will also serve as a no-cost psychological
consultant for the study. Dr. Cuellar is a licensed clinical
psychologist and has expertise in the development and
treatment of mental illness, with emphasis in trauma-related
sequelae. As at-risk students participating in the
evaluation may have experienced trauma in the home or dating
relationships, Dr. Cuellar will provide consultation to Safe
Place personnel/ERSG facilitators, but not to students
participating in the study, as needed, to address these
issues. Dr. Cuellar has provided professional feedback on
survey development, and she will provide input on proper
survey administration and training tactics for Safe Place
personnel. Dr. Cuellar will not participate in the
collection or analysis of data. To protect the
confidentiality of the participants, Dr. Cuellar will not
have access to individually identifiable data or direct
contact with study participants.
Dr. Barbara
Ball and Ms. Barri Rosenbluth are staff members at Safe
Place and will coordinate the Expect Respect evaluation. All
Expect Respect facilitators will be Safe Place employees and
will be responsible for administering surveys and collecting
and coding data obtained from the surveys. In addition, Safe
Place employees and teachers/staff at participating schools
will be responsible for reporting child abuse. These
reporting procedures are required by state and local
agencies and have been included in this protocol only to
emphasize measures that will be taken to ensure the safety
of students participating in this study (see intake protocol
in Section S).
Dr. Andra Teten, a co-investigator
on this study is volunteer faculty at BCM and a science
officer at the Centers for Disease Control and Prevention
(CDC). She has provided professional insight on the
development of surveys to be administered in this study. Dr.
Teten will help to analyze deidentified data from the
pre-test, post-test, 12 month, and 18 month surveys, which
will be sent to her by Safe Place personnel. Ms. Kristin
Holland (project officer) is an employee at the CDC, the
funding agency. Per CDC policy for non-engagement, Dr. Teten
and Ms. Holland will maintain oversight of the project and
offer technical assistance, but will have no access to
identifiable data and will have no contact with study
participants. Deidentified data will be sent to Drs. Cuellar
and Teten and Ms. Holland by Safe Place personnel.
NOTE:
Data collection will not take place at BCM. The study is
being conducted by Safe Place personnel in school districts
in and around Austin, Texas. Safe Place has requested their
own Federal Wide Assurance (FWA) number as a non-profit
organization, per federal regulations for human subject
research and will request approval to conduct this
evaluation from AISD, which will require IRB approval before
approval is granted. However, AISD is not associated with an
IRB; therefore, BCM is to be the IRB of record, but
SafePlace will have its own FWA
number.
RECRUITMENT/REFERRAL: Expect Respect
facilitators will provide orientation sessions for school
staff to raise awareness about risk factors and warning
signs of teen dating violence and to obtain referrals.
In
intervention schools, ERSG will be advertised through
posters and the school newsletter. Students will primarily
be referred by school counselors and teachers, although
self-referrals may occur as well. Groups will be voluntary
and meet in a location that will afford participants
privacy.
In control schools, the study will also
be advertised in the school through posters and the school
newsletter. Students will primarily be referred by school
counselors and teachers, although self-referrals may occur
as well.
INTAKE/SCREENING: An intake session will
be conducted by ERSG facilitators in intervention and
control schools to assess students’ eligibility
(intake protocol included in Section S). During the intake
interview, facilitators explain the confidentiality policy
and mandatory reporting requirements. Students who are
eligible for the study (per screening form in Section S)
will be given an opportunity to participate and assent to
study participation.
At the conclusion of the
intake session, all students will receive a packet of
educational materials about dating violence, and local and
online resources (attached in Section S).
SURVEY
COMPLETION/COLLECTION OF EVALUATION DATA: Following intake
sessions, students participating in the ERSGs and control
groups will complete a baseline survey (attached in Section
S) to assess recent peer and dating violence, healthy
relationships behaviors, and demographic and attitudinal
variables which may mediate/moderate intervention response.
Surveys will be administered by ERSG faciliators trained and
employed by SafePlace, and SafePlace ERSG facilitators will
be responsible for collecting and coding the survey data.
Intervention: Students in the ERSG schools will
then attend 24 support group sessions weekly over the next
24 weeks.
Control Group/"Treatment as
Usual": Students in the control group will go about
their schedule as normal, not attending support group
sessions, but may also receive short-term services
(individual psycho-education at school [1-3 sessions] by the
Expect Respect facilitators), if needed.
In
addition to the baseline survey, surveys will be conducted
at approximately 8 months following baseline (i.e., at
completion of the ERSG), and at two follow-up times (12
months and 18 months after baseline).
FOLLOW-UP:
ERSG facilitators will collect follow-up data using one of
three methods: 1) Contacting ERSG participant through a
school official; 2) Contacting ERSG participant in person
during school hours; or 3) for students who will be
graduating, moving, or transitioning to high school from
middle school, contacting the students via phone (if the
student grants permission to do so).
Data
collected from the four surveys will allow us to assess
statistically significant differences between the treatment
and control groups and will help us to evaluate the
program's effectiveness.
INSTRUMENTS: We have
attached the survey instrument to be used in the evaluation.
Survey items collect information about emotional, physical,
and sexual peer and dating violence victimization and
perpetration, use of healthy relationship skills,
relationships characteristics, peer relationships,
demographics, use of other teen dating violence prevention
services, social desirability, and attitudes toward dating
violence. These measures were developed in collaboration
with scientists at the Centers for Disease Control and
Prevention and 1) are adapted from validated measures of
teen dating violence, and 2) reflect the behaviors of
interest and theory of change of Expect Respect. The
Reactive Proactive Questionnaire (Raine et al., 2006) has
also been included in the instrument packet and will be used
to determine if subtype of aggression moderates response to
intervention.
|
|
|
|
Section
G: Sample Size/Data Analysis
|
G1. Sample
Size
|
How
many subjects (or specimens, or charts) will be used in this
study?
|
|
|
|
Please
indicate why you chose the sample size proposed:
|
|
Based
on a past, uncontrolled program evaluation of Expect Respect
Support groups, we anticipate that in the Austin ISD, 400
students will undergo an intake session, of whom 300 will be
eligible for Expect Respect Support Groups, of whom 200 will
complete the baseline and completion assessments.
Therefore during each year of data collection
(2010-2011, 2011-2012, and 2012-2013 school years), we will
aim to recruit 300 eligible students (could require 400
intakes) from the intervention schools and 300 (also
potentially 400 intakes) students from the control schools
for a total of 900 intervention and 900 control
students.
Our power analysis is based on the
following assumptions: 1) The unit of analysis for the study
will be the school. We anticipate 24 AISD schools will
participate in the intervention and 10 schools from
neighboring districts will participate in the control group.
2) Based on the preliminary evaluation we expect
approximately 10 participants in each intervention school
each year and we expect 10-20 participants in each control
school each year. 3) We anticipate that the frequency of
dating violence between intervention and control schools
will differ by 10% at the end of the intervention. 4) We
anticipate that the intra-class correlation coefficient will
be .01. Based on these assumptions our power is at least 83%
with complete data from approximately 1000-1300
students.
Estimated power would be higher if
differences between proportions were bigger, cluster size
increased, or ICC were smaller. Although steps will be taken
to retain students in the control and intervention groups,
we expect some attrition based on the preliminary evaluation
and conservatively anticipate complete data from 1200 of
these students, which is consistent with our power analysis.
|
|
|
G2. Data
Analysis
|
Provide
a description of your plan for data analysis. State the types
of comparisons you plan (e.g. comparison of means, comparison
of proportions, regressions, analysis of variance). Which is
the PRIMARY comparison/analysis? How will the analyses proposed
relate to the primary purposes of your study?
|
|
Data
analysis for our primary aim (examine group differences
between control and intervention students) will involve: 1)
descriptive analyses of group characteristics to examine
prevalence and incidence of dating violence and chi-squared
tests of independence with odds ratios to examine
differences in prevalance of dating violence for control and
intervention students. Study hypotheses will be examined in
several ways depending on the unit of analysis (e.g.,
student, school, school district): 1) Parametric tests such
as logistic regression will be used to examine group
differences over time, 2) Nonparametric tests such as
Wilcoxon rank sum test will be used to examine group
differences on non-normal outcomes (e.g., sexual violence),
and 3) structural equation modeling (panel and growth curve
models) will be used to test for differences between
intervention and control groups over time.
For
logistic regressions and structural equation models we will
take into account baseline differences on demographic
characteristics, mediators, and dating violence outcomes for
students who are lost to follow-up between baseline and
follow-up. Variables found to differ between follow-up
survey responders and nonresponders will be included as
covariate in multivariate analyses of program effectiveness.
|
|
|
|
Section
H: Potential Risks/Discomforts
|
H1. Potential
Risks/Discomforts
|
Describe
and assess any potential risks/discomforts and assess the
likelihood and seriousness of such risks:
|
|
The
risk of losing confidentiality is minimal and will be
managed by assigning a random code to students (by Safe
Place co-investigators or their staff), by SafePlace
personnel not releasing any information that could link a
students' number to his/her data, by storing personally
identifying information in a locked cabinet, by using random
subject numbers and not personally identifiable information
in databases, and by emailing only de-identified
datasets.
Subjects may experience slight
emotional upset (i.e., anger, shame, embarrassment)
associated with responding to questions about current or
past victimization or perpetration. Expect Respect
counselors will be available during the survey completion
times to attend to emotional upset that, while possible, is
unlikely.
|
|
|
H2. Data
and safety monitoring plan
|
Do
the study activities impart greater than minimal risk to
subjects?
|
|
|
|
H3. Coordination
of information among sites for multi-site research
|
Is
the BCM Principal Investigator acting as the
SPONSOR-INVESTIGATOR for this multi-site research?
|
|
|
|
Is
BCM the COORDINATING CENTER for this multi-site research?
|
|
|
|
|
Section
I: Potential Benefits
|
Describe
potential benefits to be gained by the individual subject as a
result of participating in the planned work.
|
|
Five
potential benefits exist for the students' participation.
First, the participant will gain the experience of
participating in a research protocol, which may be a
valuable educational experience. Second, responding to the
questionnaires in the proposed study may provide the
participant insights into him/herself and may provide the
impetus to seek help or other positive changes. Third,
students will receive a list of prevention, family violence,
dating violence, and mental health resources available in
their area, should they choose to seek help for any of the
issues assessed in the study (see Section S). Individual
psycho-education (1 – 3 sessions) is available if a
minimal intervention is indicated. Fourth, very few teen
dating violence prevention strategies have been developed
and implemented. Expanding the evidence base of effective
teen dating violence efforts will lead to the development
and implementation of effective intervention and prevention
programs. Fifth, increased awareness of warning signs and
risk factors of teen dating violence among school personnel
will benefit students. However, the participant may obtain
no benefit from participating.
|
|
|
Describe
potential benefits to society of the planned work.
|
|
The
assessment, treatment, and prevention of interpersonal
violence are perhaps the most important and most difficult
tasks facing students, parents, and teachers. The legal,
interpersonal, social, physical health, and psychological
consequences of violence are far-reaching and are a constant
strain on individuals and society. Expanding the
understanding of effective teen dating violence prevention
programs builds the evidence base, a goal which will benefit
youth who are at risk or who are already perpetrating or
experiencing dating violence. The data collected from
subjects will allow us to evaluate the ERSG program, which
could provide strong support for the implementation of
similar programs in schools with at risk student
populations.
|
|
|
Do
anticipated benefits outweigh potential risks? Discuss the
risk-to-benefit ratio.
|
|
This
proposed work has a favorable risk-to-benefit ratio because
(1) surveys may provide the participant with a deeper
self-understanding, (2) students will receive a list of
resources for violence prevention and mental health
treatment, (3) participation in research may be a valuable
learning experience, (4) results of the study have the
potential to influence assessment, intervention, and
prevention programs in clinical and community settings, and
(5) the possible risks are minimal and typically transient.
|
|
|
|
Section
J: Consent Procedures
|
J1. Waiver
of Consent
|
Will
this research require a waiver of consent and authorization?
|
|
|
|
Will
additional pertinent information be provided to subjects after
participation?
|
|
|
|
Explain
why providing subjects additional pertinent information after
participation is not appropriate.
|
|
Data
collected will be used strictly for the purpose of
evaluating the ERSG program as a whole. We do not anticipate
any information after participation in the study to be
pertinent to participants. However, all participants will
have the opportunity to discuss questions arising from the
surveys with the Expect Respect facilitators and they will
all receive information and local resources for shelters,
counseling and violence prevention programs.
|
|
|
J1a. Waiver
of requirement for written documentation of Consent
|
Is
this research subject to FDA regulations?
|
|
|
|
Explain
how the research involves no more than minimal risk to the
participants, and the specifics demonstrating that the research
does not involve procedures for which written consent is
normally required outside of the research context.
|
|
|
|
Explain
how the only record linking the participant and the research
would be the consent document, and how the principal risk would
be potential harm resulting from a breach of confidentiality,
and how each participant will be asked whether he or she wants
documentation linking the participant with the research and
their wishes will govern.
|
|
|
|
J2. Consent
Procedures
|
Who
will recruit subjects for this study?
|
|
Third
Party: Expect Respect facilitators and School staff
|
|
|
Describe
how research population will be identified, recruitment
procedures, and consent procedures in detail.
|
|
Only
students age 11-17 at participating middle and high schools
will be recruited.
At both control and
intervention schools, Expect Respect facilitators will
provide orientation sessions for school staff to raise
awareness about risk factors and warning signs of teen
dating violence, and to obtain referrals. Students will be
primarily referred by school counselors and teachers,
although self-referrals may occur as well.
In
intervention schools, ERSG will be advertised in the school
through posters, and the school newsletter.
In
control schools, students will have the opportunity to talk
to an Expect Respect facilitator about peer and dating
violence and healthy relationships and to participate in a
study. The study also will be advertised in the school
through posters and the school newsletter.
In
intervention schools: When a student is referred to Expect
Respect facilitators, an intake session will be completed
during which the counselor determines the student's
eligibility for support group participation (see
inclusion/exclusion criteria in F1 and section S for intake
protocol and screening form). At the end of the intake
session eligible students will be given information about
ERSG and asked if they are interested in participating.
Participation in ERSG is voluntary. If the student gives
his/her assent to participate in the program, he/she will
then be told about the evaluation. It will be explained that
the decision to release their de-identified survey responses
for this research is voluntary, and that the decision to
assent to the evaluation in no way affects his/her ability
to participate in ERSG or other prevention services.
Following this discussion the facilitator will obtain
informed assent from the students. Students will also be
informed that they may rescind their assent to release their
data for any reason at any time.
In control
schools: When a student is referred to Expect Respect
facilitators and intake session will be completed during
which the facilitator determines the student’s
eligibility for participation in the study (see inclusion/
exclusion criteria in F1 and section S for intake protocol
and screening form). At the end of the intake, students
eligible for the control condition will be given information
about the evaluation and asked if they are interested in
completing surveys as part of the control condition. If the
student is interested, it will be explained that the
decision to complete the surveys and release their data is
voluntary, and that the decision to consent to the
evaluation in no way affects his/her ability to participate
in community-based prevention or other services (e.g. 1 –
3 psycho-educational sessions or referrals for more
intensive services). Following this discussion the Expect
Respect facilitator will obtain informed assent. Students
will also be informed that they may rescind their assent to
release their data for any reason at any time.
All
students will receive a packet of educational materials
about dating violence, local and online resources (see
Section S).
Although, waiver of parental consent
will be sought in the study to protect the welfare of the
at-risk students (described attachment J4) participants in
both intervention and control schools will be given a
parental information letter (in Section S) that they may
choose to give to their parents.
In Section S,
please find a completed "Section J - Privacy and
Intrusiveness" form and a "Section J –
Children: Waiver of Permission of Parents or Guardians"
form
|
|
|
Are
foreign language consent forms required for this protocol?
|
|
|
|
J3. Privacy
and Intrusiveness
|
Will
the research involve observation or intrusion in situations
where the subjects would normally have an expectation of
privacy?
|
|
|
|
J4. Children
|
Will
children be enrolled in the research?
|
|
|
|
J5. Neonates
|
Will
non-viable neonates or neonates of uncertain viability be
involved in research?
|
|
|
|
J6. Consent
Capacity - Adults who lack capacity
|
Will
Adult subjects who lack the capacity to give informed consent
be enrolled in the research?
|
|
|
|
J7. Prisoners
|
Will
Prisoners be enrolled in the research?
|
|
|
|
|
Section
K: Confidentiality
|
Will
research data include health information by which subjects can
be identified?
|
|
|
|
Where
will research data be kept? How will such data be secured?
|
|
Data
will be stored at the Resource Center at SafePlace (1515A
Grove Blvd., Austin, TX 78741). Data will be double locked
in a file cabinet with a locking mechanism and in an office
with a locked door.
De-identified datasets may
be emailed to the investigators for the purpose of data
analysis, but no information that could be used to identify
the subjects will be included in these data.
|
|
|
Who,
besides the PI, the study staff, the IRB and the sponsor, will
have access to identifiable research data?
|
|
Access
to identifiable research data will be restricted to Expect
Respect/SafePlace staff or IRB.
BCM PI, Amy
Cueller; CDC science officer, Andra Teten; and CDC project
officer, Kristin Holland (IRB Administrative Contact), will
remain "non-engaged" in the research, meaning that
they will never be able to link the participants' data to
their identity. The only people who will have access to
identifiable research data are Expect Respect staff.
|
|
|
Will
you obtain a Certificate of Confidentiality for this study?
|
|
|
|
Please
further discuss any potential confidentiality issues related to
this study.
|
|
|
|
|
Section
L: Cost/Payment
|
Delineate
clinical procedures from research procedures. Will subject's
insurance (or subject) be responsible for research related
costs? If so state for which items subject's insurance (or
subject) will be responsible (surgery, device, drugs, etc). If
appropriate, discuss the availability of financial counseling.
|
|
There
will be no cost to the participant.
|
|
|
If
subjects will be paid (money, gift certificates, coupons, etc.)
to participate in this research project, please note the total
dollar amount (or dollar value amount) and distribution plan
(one payment, pro-rated payment, paid upon completion, etc) of
the payment.
|
|
|
|
Distribution
Plan:
|
|
Both
control and intervention group participants will receive the
first $10 mall gift card upon completion of the baseline
survey, another $10 mall gift card for the 8-month/program
completion survey, and a $10 mall gift card for each
follow-up survey.
All incentives will be
distributed in the form of gift cards to protect the
confidentiality of the students.
To ensure
equitable resources/services are being provided to both
intervention and control schools, and to offset the
administrative burden placed on the control schools, an
incentive (one-time payment of $1000) will be offered to
control schools to participate in this study. Past work
suggests that offering incentives to control schools
facilitates the schools likelihood of participating in
research.
Intervention schools will not be
offered the incentive, because they will receive prevention
services from SafePlace and will benefit from the
implementation and evaluation of the ERSG program.
|
|
|
|
Section
M: Genetics
|
How
would you classify your genetic study?
|
|
|
|
Discuss
the potential for psychological, social, and/or physical harm
subsequent to participation in this research. Please discuss,
considering the following areas: risks to privacy,
confidentiality, insurability, employability, immigration
status, paternity status, educational opportunities, or social
stigma.
|
|
|
|
Will
subjects be offered any type of genetic education or
counseling, and if so, who will provide the education or
counseling and under what conditions will it be provided? If
there is the possibility that a family's pedigree will be
presented or published, please describe how you will protect
family member's confidentiality?
|
|
|
|
|
Section
N: Sample Collection
|
|
|
|
Section
O: Drug Studies
|
Is
this study placebo-controlled?
|
|
|
|
Does
the research involve a drug or biologic (including radioactive
drugs) that is not approved by the FDA?
|
|
|
|
Will
the research involve a radioactive drug that is not approved by
the FDA?
|
|
|
|
|
|
|
Section
P: Device Studies
|
Does
this research study involve the use of ANY device?
|
|
|
|
|
Section
Q. Consent Form(s)
|
|
|
|
Section
R: Advertisements
|
ADVERTISEMENT: Other:
flyer and newsletter
|
Exact
language of Advertisement:
|
|
All
flyers are attached in Section S. The language below (and
the flyers) would be posted in the schools or would appear
in the student newsletter.
#1 for Intervention
schools:
CONFUSED ABOUT YOUR RELATIONSHIP? Do you
have questions about love? Do you get jealous easily? Do you
have a hot temper? Have you hurt someone you cared about? Is
there violence in your home? Check out the Expect Respect
groups. Ask your counselor for information.
#2
for Intervention schools:
Have you ever been with
someone who… Tried to control you? Told you what to
wear? Scared you at times? Pushed or hit you? Was very
jealous? Called you names? Check out the Expect Respect
groups. Ask your counselor for information.
#1
for Control schools:
CONFUSED ABOUT YOUR
RELATIONSHIP? Do you have questions about love? Do you get
jealous easily? Do you have a hot temper? Have you hurt
someone you cared about? Is there violence in your home? Ask
your counselor for information.
#2 for Control
schools:
Have you ever been with someone who…
Tried to control you? Told you what to wear? Scared you at
times? Pushed or hit you? Was very jealous? Called you
names? Ask your counselor for information.
|
|
|
|
emorandum