IPV and Fatherhood Intervention in Residential Substance Abuse Treatment
Phase: NA
Conditions: Intimate Partner Violence, Substance Abuse/Addiction, Child Maltreatment
Sponsor: University of South Florida

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Official Study Title: 
Intimate Partner Violence and Fatherhood Intervention in Residential Substance 
Abuse Treatment 
 
NCT Number:  NCT02979262 
 
Date Last Modified:  8/14/2017   
 
 IRB approval:  8/27/2018  
 
 
 

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Project Title 
Intimate Partner Violence and Fatherhood Intervention in Residential Substance 
Abuse Treatment  
 
Study Rationale and Background Information 
Substance use and intimate partner violence (IPV) are two severe problems that 
often co-occur (Centers for Disease Control & Prevention, 2013; Centers for Disease 
Control, 2012; Shorey, Stuart, & Cornelius, 2011) and can lead to poor parenting 
behaviors (Gustaffson & Cox, 2012; McMahon, Winkel, & Rounsaville, 2008).  
Current treatments for co-occurring substance abuse and IPV are lacking (Stover, 
2013).  This study will test initial efficacy of a novel intervention for IPV and 
substance use among fathers in residential substance abuse treatment: Fathers for 
Change compared to a standard parenting intervention.   
 
Research Hypotheses 
This initial pilot will assess the feasibility, acceptability, and intervention signal of 
Fathers for Change compared to a Parent Education Condition within a residential 
treatment center for substance dependent men.  We will test the following specific 
hypotheses: 
 
1. Fathers in the Fathers For Change (FFC) group will have comparatively greater 
completion rates in both the residential and aftercare components of the program 
compared to fathers in the Dads ‘n’ Kids (parenting education-PE) program. 
2. Fathers in the FFC group will exhibit greater improvement in hostile cognitions, 
emotion regulation and physiological arousal at the time of residential treatment 
discharge (12 weeks) and following aftercare sessions (16 weeks) than fathers in 
the Dads ‘n’ Kids group. 
3. Men in the FFC group will experience comparatively less substance abuse relapse 
at the 3 month-follow-up than in the Dads ‘n’ Kids group. 
4.  Men in the FFC group will report fewer intimate partner violence (IPV) incidents 
and CM risk behaviors at 24 week follow-up than fathers in the Dads ‘n’ Kids group. 
5.  Exploratory Hypothesis: The relationship of Intervention (FFC versus PE) to 
substance abuse relapse, IPV, and child maltreatment risk behavior (at 24 week 
follow-up) will be mediated by reductions in hostile cognitions and emotion 
regulation (measured at 16 weeks). 
 
Study Design 
Sixty fathers, their female co-parent and youngest child will be recruited to 
participate in the study. At the time of intake at Westcare’s Emerge Program and 
Salvation Army’s Residential Substance Abuse Rehabilitation Program, fathers will 
be provided flyers about the study. Men who express an interest in participating in a 
parenting program as part of their treatment will fill out an initial interest form with 
their counselors (including their name, arrival and discharge date, information 
about how often they're in contact with their children) and have their counselors 
submit this form to the Project Coordinator. The Project Coordinator will schedule a 
screening with the potential participant and will be asked to sign a consent form, 

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and to sign a release of information to review their SA treatment and criminal 
history. Men will be told that his questionnaire and records will be reviewed and 
will be contacted further if considered eligible by the PI based on the study’s 
requirements.  
 
This will provide the opportunity to contact the mother to conduct a phone 
screening in regards to IPV history and willingness to participate. If the mother 
indicates an IPV history that involved hospitalization or strangulation or a current 
full no contact protective order, he will be notified that based on the demographic 
screening, he is not eligible for the study. If the father is eligible and agrees to 
participate in the study, the research assistant will contact the father to set up a 
baseline assessment and the co-parent will be contacted to set up a baseline 
interview by phone or in-person if she wants to participate. If the father is not 
eligible for the program we will remove the bottom portion of his screening form 
that includes personal information (name, arrival and discharge date, and WestCare 
or Salvation Army counselor information) and shred it. The top portion including 
de-identified information (IPV history and contact with children) will be kept to 
keep track of the number of referrals compared to the number of participants in the 
program. 
 
Mothers of the father’s youngest child will be recruited in several ways: 
1.  When she visits the facility she will be approached by study staff in person. 
2. She will be mailed study flyers asking her to contact the research office. 
3. Westcare or Salvation Army staff will call mothers and ask permission for 
study staff to contact them to tell them about the study.   
 
Following completion of baseline assessments, subjects will be randomly assigned 
to the FFC intervention or the Parenting Education (Dads ‘n’ Kids) condition. To 
increase the likelihood that treatment groups are balanced with respect to 
demographic variables, and moderators, subjects will be assigned to treatment 
conditions through urn randomization using a Microsoft Access-based program. In 
urn randomization, an algorithm modifies ongoing randomization probabilities 
based on prior composition of treatment groups and maximizes multivariate 
equivalence of groups 
 
Fathers in each treatment group will meet individually with their assigned therapist 
once per week for 50-60 minutes of treatment.  The Fathers for Change Intervention 
has three phases:  individual focused, co-parent relationship focused and restorative 
parenting focused.  Beginning with motivational interviewing, the clinician and 
father will discuss child development, the impact of SA and violence on parenting, 
and the father’s own childhood experiences of SA and violence and how he would 
like things to be different for his own children. The clinician will also provide skills 
training to reduce hostile cognitions and increase emotion regulation skills. In co-
parenting focused sessions the clinician will teach communication and problem 
solving skills, these topics will be addressed with or without the co-parents 
participation. In family sessions the clinician focuses on restorative parenting to 

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rebuild the father-child relationship.   These phases can be delivered either 
individually to the father or together with his children present.  The decision 
whether family members are invited to participate will be made on a case by case 
basis dependent on safety of the co-parent and child, their wish to participate and 
their ability to come to the treatment facility.   
 
The Dads n’ Kids (Parenting Education-PE) Program will provide individual sessions 
only. PE was developed to provide parent education and support that is typically 
available to SA parents at risk for child maltreatment. This program was selected as 
the comparison condition because PE and FFC are equivalent in terms of treatment 
dose, duration, client expectation for a parenting intervention, and formation of a 
helping alliance with a caring professional. The clinician will provide assistance in 
solving problems related to family basic needs (e.g. health care, child care, housing 
and education). The clinician will also provide topic pamphlets that will focus on 
creating routines and rituals, ages and milestones to be aware of, alternative to 
spanking, and nutrition/fitness.   The intervention is a behaviorally focused 
intervention to build parenting skills. 
 
Participants in both groups will be asked to complete a baseline interview once they 
have been enrolled in one of our programs. Short, monthly interviews will take 
place to assess the client’s motivation to change and working alliance with their 
assigned clinician. The research assistant will also conduct three post-assessment 
interviews: 1. Post-residential interview at 12 weeks; 2. Post-intervention interview 
at 16 weeks; and 3. A 3-month follow-up interview at 24 weeks from baseline. Co-
parents will be asked to complete a baseline assessment and a 3-month follow-up 
assessment.  
 
A complete list of study measures are outlined in Table 1.  Fathers will meet in a 
confidential office to complete study measures that will be administered in 
interview format.  Following administration of paper and pencil measures, fathers 
will complete the Articulated Thoughts in Simulated Situations Task.  They will 
listen to audio recorded scenarios and vocally speak their thoughts into an audio 
recorder.  Their statements are transcribed for coding by trained, blind coders. 
Upon completion of hearing these potentially stressful scenarios, research assistants 
will guide participants through a debriefing relaxation exercise of guided imagery 
and deep breathing to ensure men are calm prior to leaving the assessment session.  
We have successfully used all the included measures in prior studies with the target 
population without any adverse events.   
Fathers will meet the following Inclusion criteria:  (1) current DSM-5 criteria for 
substance use disorder of alcohol, cocaine, marijuana, amphetamines, or opiates at 
the time of admission to Westcare or Salvation Army; (2) report physical or 
psychological violence in an intimate relationship within 12 months of admission to 
the program (based on court/police records or self- report); and (3) be expecting 
his first biological child in the next 6 months (current or former partner is 
pregnant), have at least one biological child under the age of 15  with whom they 

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lived or had at least once per month contact prior to admission to Westcare or 
Salvation Army.   Each will agree to have their female co-parents contacted for 
participation as collateral informants and will provide the contact information.  If a 
participant has more than one child in the age range, the youngest child will be the 
target of assessment. Female co-parents (the target children’s mothers) will be 
invited to participate as collateral informants on research assessments and to 
participate in a portion (2 -4) of the intervention sessions.  If a female co-parent 
does not consent to participate, a male participant will still be allowed to enroll in 
the study if he meets eligibility criteria. 
Individuals will be excluded who: 1) Have histories of severe physical violence 
against a female partner (e.g. strangulation, causing hospitalization) based on police 
records, self or partner reports; 2) Men who have an active FULL/NO CONTACT 
protective order pertaining to their partner or child (Westcare and Salvation Army 
have access to criminal record/court information for all of its residential clients.  
Participants will sign releases of information during informed consent to allow the 
study team to access this information to determine eligibility); 3) Have cognitive 
impairment (a mini mental state score <25); 4) Have major medical complications 
such as a head injury or HIV dementia that may also be a confound in the study 
interventions; 5) Have current untreated psychotic or bipolar disorder (reported by 
history, as part of the Westcare or Salvation Army record, or self-report); or 6) Are 
currently suicidal or homicidal.    If potential participants have a prior diagnosis of 
bipolar or psychotic disorder that is currently treated and symptoms are well 
managed based on initial study interview and after collateral contact with the 
Westcare or Salvation Army treatment teams, they may participate in the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 1. Standardized Measures and administration for Randomized Trial 
 
 
Instrument 
 
Rater 
 
Reliability 
 
Base
-line 
 
Monthly 
During 
Intervention 
Post 
Residential 
Intervention 
12 weeks 
 
Post 
Intervention 
16 weeks 
 
3 month 
follow-up 
24weeks 
SA Outcomes 
 
 
 
 
 
 
 
Timeline follow-back 
for SA  
Father and 
Mother 
.91 
 
X 
X 
X 
X 
Urinalysis Drug Panel 
Father 
NA 
X 
X 
 
X 
X 
IPV Outcomes 
 
 
 
 
 
 
 
Conflict Tactics Scale 
Revised (CTS2) 
Father and 
Mother 
.79 to .95 
X 
 
 
 
X 
Timeline follow-back 
for IPV 
Father and 
Mother 
.91 
 
X 
X 
X 
X 
Court and Arrest 
Records 
N/A 
N/A 
X 
 
 
 
X 
CM Risk Outcomes 
 
 
 
 
 
 
 
Parental Reflective 
Functioning 
Questionnaire (PRFQ) 
Father  
.82 
X 
 
 
X 
X 
Adult Adolescent 
Parenting Inventory 
(AAPI)  
Father and 
Mother 
.74 to .98 
X 
 
 
X 
X 
Father-Child Free Play 
coded using (CIB)+ 
Blind 
Coders 
 
 
 
 
 
X 
Quality of Co-Parental 
Relationship Scale 
Father and 
Mother 
F: .66 - .88 
M: .80 - .83 
X 
 
 
X 
X 
Satisfaction Outcomes 
 
 
 
 
 
 
 
Client Satisfaction 
Questionnaire 8 
Father 
N/A 
 
 
 
X 
 
Mediators 
 
 
 
 
 
 
 
Articulated Thoughts in 
Stimulated Situations 
(ATSS) and HR/SC 
Blind 
Coders 
N/A 
X 
 
X 
 
 
Difficulties in Emotion 
Regulation Scale 
(DERS) 
Father 
.93 
X 
 
X 
X 
X 
State-Trait Anger 
Inventory (Staxi) 
Father 
.84 - .93 
X 
 
X 
X 
X 
Rumination-Reflection 
Scale (ARQ) 
Father 
.88 - .91 
X 
 
X 
X 
 

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Working Alliance 
Inventory 
Father and 
Clinician 
.79 - .97 
 
X 
 
 
 
Motivation to Change 
(URICA-DV) 
Father 
.85 - .87 
 
X 
 
 
 
Moderators 
 
 
 
 
 
 
 
Childhood Trauma 
Questionnaire  
Father 
.80 - .97 
X 
 
 
 
 
Self-Report 
Psychopathy Scale 3 
Father 
.60 
X 
 
 
 
 
Life Change Index Scale 
Father 
N/A 
X 
 
 
 
X 
Brief Symptom 
Inventory (BSI) 
Father 
.74 - .89 
X 
 
 
X 
X 
Addiction Severity 
Index 
Father 
.89 
X 
 
 
 
 
Father Interview 
RA 
N/A 
X 
 
 
X 
X 
Treatment Services 
Review 
Father 
N/A 
 
 
 
X 
X 
PhenX Measure: Self-
Report HIV Testing 
Father 
N/A 
X 
 
 
 
 
FRPN FATHER 
ENGAGEMENT 
SCALE_v1 
Father 
N/A 
 
 
 
X 
X 
FRPN FATHER 
ENGAGEMENT 
SCALE_v2 
Father 
N/A 
 
 
 
X 
X 
FRPN FATHER 
ENGAGEMENT 
SCALE_v3 
Father 
N/A 
 
 
 
X 
X 
Measure of Contact-
Fatherhood Research 
and Practice Network 
Father 
N/A 
 
 
 
X 
X 
Domestic Violence Quiz 
Father 
N/A 
X 
 
X 
 
Co-Parenting Quiz 
Father 
N/A 
X 
 
X 
 
 
 
At the 3 month follow-up, fathers will be asked to attend a play assessment with 
their child.  This will be a 30 minute appointment in which they will play with toys 
or games with their child for 15 minutes, clean up and then complete several 
puzzles with their child. These session will be audio recorded and coded using the 
Child Interactive Behavior Rating Scale by trained blind coders. 
 
The PI, co-investigator Stover, and study coordinator will be the only ones who have 
access to the data, and data will be stored in locked file cabinets and on password 
protected computers.  Data will be analyzed in aggregate to investigate study 
hypothesis (stated above). 

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Urinalysis Data Collection 
 
To ensure urine screening data is available for all participants, including those who 
are no longer receiving services and providing urine samples at Westcare, Inc., or 
Salvation Army,  any participants who have not given urine drug screens at 
Westcare Inc. or Salvation Army within a week of the post-treatment and 3 month 
follow-up assessments, Integrated iCups from Instant Technologies will be used for 
urine drug screening at the time of their assessment interviews.  RAs will provide 
clean test cups taken from the packaging just prior to collection.  Participants will be 
asked to provide the urine sample at the end of the assessment session.  They will go 
into a private bathroom at the location of the interview.  They will be instructed to 
place the sample in the cup and close it.  RAs will wear rubber gloves when handling 
test samples.  They will immediately read the urine test results by peeling the test 
panel on the side of the cup and reading the results.  They will document the results 
on the Urine Screening Form.  The urine sample and rubber gloves will be 
immediately disposed of in the waste bin at the location. 
 
 
Sample Size 
 
The study will be recruiting 60 male participants that are in a 6 month 
residential treatment, their female co-parents (youngest child’s mother) and their 
youngest child for a total sample of 180. 
 
Study Population  
Sixty male participants of the WestCare Community Involvement Center or 
the Salvation Army Adult Rehabilitation Center who are residents.  
Inclusion criteria:  1. Is the father (biological or adoptive) of a child under 15 
years old (including an unborn fetus expected in the next 6 months); 2. Reports 
some verbal or physical aggression in his current or former co-parenting 
relationship; 3. Is diagnosed with substance use of alcohol, cocaine, amphetamines, 
opiates, marijuana at the time of intake at Westcare or Salvation Army. 
Exclusion criteria: 1. Participants with significant cognitive delays will be 
excluded as study questionnaires are not intended for those with a reading level 
below grade 8; 2. Participants with active psychotic or suicidal symptoms will be 
excluded due to the severity of those issues. 3. Participants will be excluded if there 
is an active no-contact protective order pertaining to the child or the co-parent; 4. 
Individuals who cannot speak English because study measures have not been 
translated into other languages; 5. Have cognitive impairment (a mini mental state 
score <25); 6. Have major medical complications such as a head injury or HIV 
dementia that may also be a confound in the study interventions; 
Female co-parents of the father’s youngest child and his youngest child will 
also be recruited into the study. 
 
Equipment: 

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During the Articulated Thoughts in Stimulated Situations (ATSS) we will be 
assessing heart rate and skin conductance with a BioLog device. Participants will be 
asked to wear three (3) receptors that will be placed on their chest by the client to 
measure heart rate. They will also be asked to wear two skin conductance sensors 
that they will place on two of their fingers. These receptors and sensors are attached 
to a small device that will allow the research team to assess heart rate and skin 
conductance throughout the 30 minute audio recording. This device is being used to 
measure their stress level and biological reactions to each scenario that they’ll be 
listening to. Although there is minimal risk if they choose to participate in this task, 
they will have the option of completing the ATSS recording with or without wearing 
the BioLog device. Participants will not be forced to use the device if they do not 
want to.  
 
 
Expected Results  
We expect that: 
1. Men in the FFC group will have significantly higher completion rates than PE 
fathers. 
2. Men in the FFC group will have significantly lower scores on the STAXI, 
DERS, ATSS and lower physiological arousal during stress tasks than PE 
fathers post intervention and at 24 week follow-up. 
3. Men in the FFC group will have a significantly greater understanding of co-
parenting and the impact of violence on their children compared to the PE 
group post-intervention. 
5.  Men and co-parents in the FFC group will report higher treatment satisfaction 
than the PE group.  
 
Principal Investigator 
Kathleen Moore, Ph.D. 
Associate Research Professor 
Louis de la Parte Florida Mental Health Institute 
Department of Mental Health Law and Policy 
 
Risks 
 
The risks of this study are minimal.  Participants may find it difficult to talk 
about stressful events that have happened to them and their families.  They may 
experience some discomfort answering questions or talking about these things.  
Participants will be allowed to withdrawal from the study at any time.  Participants 
may request a short break or discontinue any questionnaire at any time. If the child 
seems distressed or does not want to participate during play sessions, they will be 
discontinued. Additionally, male participants will be receiving residential treatment 
at WestCare or Salvation Army and have an individual therapist at the facility in 
addition to individual sessions as part of the research program.  The support of the 
residential program and their individual therapist will provide them with support if 
discomfort arises at any time during the study.   

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Risk to female collateral informants is also minimal.  Men are enrolled in 
residential substance abuse treatment so are not in the community or living with 
their families at the time of enrollment and the bulk of the study.  Female co-parents 
will be contacted individually and safety of her participation will be assessed.  If she 
feels her participation will put her at any risk for retaliation or violence by the 
father, she will not be enrolled.  Prior to initiating co-parent treatment sessions with 
both partners for those in the FFC group, the clinician will assess the safety of the 
co-parent and ensure both want to participate.  If significant symptoms or 
difficulties of female co-parents are revealed, this information will be reviewed with 
the study co-investigator, Dr. Stover, and appropriate referrals will be provided to 
mothers who participate in the study.  Mothers will be interviewed individually and 
confidentially on different dates and locations from the fathers in the study.   
 
 
A.  Behavioral therapies 
 
Psychological risks are minimal and not different from those of equivalent non-study 
psychotherapeutic interventions.  For the treatment condition, frequent monitoring (at least 
weekly) of the participants’ clinical status by the therapist and research staff will ensure 
identification and withdrawal from the study of participants who show significant 
psychological or symptomatic deterioration. If a participant shows significant symptomatic 
deterioration such that they are a danger to themselves or others or are in need of crisis 
intervention, the study clinical consultant, Ms. Kisha Miller, a licensed clinical social worker 
and certified addiction counselor, will assess the client in consultation with the participants 
primary counselor or clinical director at Westcare or Salvation Army.  A determination will 
be made about whether a higher level of care is needed beyond what is provided in the 
residential treatment setting.  If significant symptoms or difficulties of female co-
parents are revealed, this information will be reviewed with the study PI, Dr. Moore 
and co-investigator Stover, and appropriate referrals will be provided to mothers 
who participate in the study. 
 
B.  Rating Scale and Questionnaires and ATSS Task. 
 
 
To participate in this study, subjects are asked to complete various forms and 
questionnaires during their initial enrollment and post-treatment. All of the questionnaires are 
non-invasive and standardized and should add no risk to the subjects. They have been used in 
previous research with this population. The major disadvantage is the time taken to complete 
them.  The ATSS paradigm has been used with the study population by the PI in her 
previous pilot studies and by others doing IPV research without adverse events.  We 
will follow practices typically used with laboratory anger and distress tasks to debrief 
participants.  As stated above, research assistants will guide participants in a 
relaxation session including guided imagery and deep breathing to ensure men are 
calm and not leaving the sessions aroused, distressed or angry.  In the event that a 
participant remains agitated following the implementation of diaphragmatic breathing 
and a guided imagery scenario, the RA will contact the study clinical consultant, Ms. 
Miller, Westcare, or Salvation Army clinical director to assess risk and next steps. 
 

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Our past experience with these measures indicates that they are acceptable to patients. The 
initial baseline assessments for the study will take approximately 2 hours for completion for 
men and 1 hour for women. Post-treatment assessments will take approximately 1 hour for 
completion. A research assistant will meet with the patients independent of their clinician and 
conduct all assessments.  Only patients’ code numbers will be recorded on the forms 
themselves to protect confidentiality.   
 
Benefits 
 
Participants will receive an individual intervention to address parenting and 
co-parenting.  As such, their mental health, physical health, and familial functioning 
may improve as a consequence of participation.  Furthermore, this research will 
inform interventions for fathers with substance abuse and violence histories in 
residential treatment, enabling us to better treat these problems.   
 
Compensation 
 
Male participants in both the FFC Program and the Dads ‘n’ Kids Program will 
receive $35.00 for their post-intervention interview at week 16 and will be paid 
$50.00 for completing the 3 month follow-up interview with the research assistant. 
Female co-parents will receive $25.00 for completing a baseline assessment and 
$50.00 for completing a 3 month follow-up interview with the research assistant.  
 
Human Subjects Considerations 
Informed Consent 
 
 The P.I. and study coordinator will give flyers to the WestCare and Salvation 
Army staff, who will distribute them to male residents at intake into the facilities.  
They will be provided a screening sheet to complete and turn in if they are 
interested in participating.  Volunteers who meet the study criteria will be taken on 
a first come - first serve basis.  The study coordinator will then set up confidential 
meetings with volunteers individually to obtain informed consent.  Consent forms 
will be given to participants and reviewed verbally by the study coordinator.  
Consents will clearly outline confidentiality and the limits that apply (see below).  
Potential participants will be allowed to ask questions at this time and take as long 
as necessary to give consent.   
 
Female co-parents will receive flyers mailed from the facility.  They will be 
asked to call the research team to learn about the study. They will also be 
approached by study staff in-person when they visit the facility to ask if they would 
like to learn about the study.  Either in person or on the phone, participants will talk 
privately with a study staff member to learn about the study and to complete 
informed consent. 
 
Safeguards for Vulnerable Subjects 
It will be made clear to all potential volunteers that participation in this study will in 
no way affect participants’ legal standing or the services they receive at WestCare or 
Salvation Army.  Additionally, limits to confidentiality will be clearly outlined to 
participants as noted below.   
Suicidal or Homicidal Ideation or Intent: 

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Upon report of suicidal intentions or the threat of harm to others, the PI and clinical 
consultant Ms. Miller will be notified immediately. Ms. Miller, a licensed clinical 
social worker, in conjunction with the residential treatment staff at Westcare or 
Salvation Army will determine what steps are need to protect the safety of the 
participant and any others in the community.  The PI, co-investigator Stover and 
clinical consultant Ms. Miller have extensive experience in dealing with high-risk 
behaviors and abides by all state and federal regulations.               
 
Additional Safety and Comfort.  All research staff will receive substantial training and 
supervision to ensure that their interactions with all male participants and female collateral 
informants are not only professional, but also warm, friendly, non-confrontational, and 
respectful to all participants. 
 
Privacy and Confidentiality 
The limits to confidentiality will be clearly explained to participants.  These limits 
include any report of previously unreported child or elder abuse or any indication 
that the participant is a harm to themselves or someone else.  In these instances, Dr. 
Moore, will assess the situation in collaboration with the treatment team at 
Westcare or Salvation Army and notify the appropriate authorities (e.g. Child Abuse 
Reporting careline).  Participants will also be informed of the limits of 
confidentiality with regard to disclosure of substance use while in the program.  
Westcare and Salvation Army policy will require that this information be shared 
with the participants’ primary therapists so this can be addressed in the context of 
the clients’ ongoing residential treatment at Westcare or Salvation Army.   
 
All data will be kept private and confidential.  All participants will be given a unique 
ID number, such that their data cannot be tied back to them in any way.  The PI, co-
investigator Stover and study coordinator will be the only ones who have access to 
the data, and data will be stored in locked file cabinets and on password protected 
computers.  Data will be analyzed in aggregate to investigate study hypothesis 
(stated above), with identifying information withheld. 
 
To assure the confidentiality and protection of participants with respect to 
videotaping, the following steps will be taken: 
 
• Participants have the right to refuse videotaping.  Participants who consent 
to videotaping will be informed that they have the right to stop taping at any 
time during any session. 
• Each therapist or RA will conduct the taping him/herself. All taping will take 
place in a confidential treatment room at Westcare or Salvation Army.   
• Each video file will be labeled with the participant’s study identification 
number and a coded session date. 
• The therapist or RA will be log and store the tapes in locked files in secure 
research offices at USF.   
• Access to the video files will be limited to specially trained research raters 
who will rate the files according to established process rating systems.  All 

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ratings will be done in our research offices. Upon completion of these ratings, 
the files will be erased unless participants agreed to have them used for 
training purposes.   
 
Certificate of Confidentiality 
 
To help us protect the participants’ privacy, we have attained a Certificate of 
Confidentiality from the National Institutes of Health. We can use this Certificate to 
legally refuse to disclose information that may identify the participant in any federal, 
state, or local civil, criminal, administrative, legislative, or other proceedings, for 
example, if there is a court subpoena. The researchers will use the Certificate to resist 
any demands for information that would identify the participant, except as explained 
below.  
 
The Certificate cannot be used to resist a demand for information from personnel of 
the United States Government that is used for auditing or evaluation of federally 
funded projects or for information that must be disclosed in order to meet the 
requirements of the federal Food and Drug Administration (FDA). 
 
The Certificate of Confidentiality does not prevent the participant or a member of 
the participants’ family from voluntarily releasing information about the participant 
or the participants’ involvement in this research. If an insurer, employer, or other 
person obtains the participants’ written consent to receive research information, 
the researchers may not use the Certificate to withhold that information