: Developing a Brief Family-Involved Treatment for Alcohol Use Disorders
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: University of New Mexico

 
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UNM IRB PROTOCOL 
 
TITLE: Developing a Brief Family-Involved Treatment for Alcohol 
Use Disorders: Phase II 
VERSION DATE: February 12, 2017 
INVESTIGATOR/RESPONSIBLE 
FACULTY: 
Barbara McCrady, Ph.D. 
STUDENT INVESTIGATOR:  
FUNDING AGENCY: National Institute on Alcohol Abuse and Alcoholism 
 
BACKGROUND/SCIENTIFIC RATIONALE 
The overall aim of this treatment development study is to develop an efficacious, brief, family-
involved treatment that can be used flexibly in on-going alcohol treatment settings to advance the 
dissemination of evidence-based treatment.  The PI and her colleagues have been developing a 
couple-based alcohol treatment, Alcohol Behavioral Couple Therapy (ABCT), and conducting research 
on this treatment since the late 1970s.  The proposed research builds on our earlier NIAAA-supported 
efficacy trials and studies of mechanisms of change in ABCT.  
 Significant advances have been made in the treatment of Alcohol Use Disorders (AUDs), and 
several psychosocial and pharmacological approaches have good evidence for their efficacy.  Despite 
these advances, only about 35-40% of patients complete a pre-defined length of treatment (e.g., Anton 
et al., 2006; Project MATCH Research Group, 1997), and only about 30% of patients sustain 
abstinence and 30-35% reduce their drinking to nonharmful levels over a year of follow-up (Miller, 
Walters, & Bennett, 2001).  Sadly, then, between 30 and 35% of patients are consuming alcohol at 
pretreatment levels one-year after treatment.  These figures suggest that there is considerable room to 
improve existing treatments to enhance adherence and improve outcomes.  The goal of the proposed 
study is to develop an intervention to involve families in treatment to improve retention, adherence, and, 
ultimately, treatment outcomes.   
Family involvement leads to better treatment outcomes for individuals with alcohol and other 
substance use disorders (Carr, 2014; McCrady, Epstein, Cook, Jensen, & Hildebrandt, 2009; McCrady 
et al., 1986; O’Farrell, Choquette, & Cutter, 1998; Powers, Vedel, & Emmelkamp, 2008).  Unfortunately, 
although national surveys suggest that 80% of substance abuse treatment programs provide some 
family-involved treatment (Forcehimes et al., 2010), very little of this treatment is evidence-based. 
Possible barriers to the use of evidence-based, family-involved alcohol treatment include: (a) the length 
and complexity of empirically supported family therapies (Haug, Shopshire, Tajima, Gruber, & Guydish, 
2008); (b) patient and family factors such as patient reluctance to have their families involved, family 
concerns about feeling blamed or responsible for the patient’s treatment, and pragmatic issues related 
to scheduling (McCrady, Epstein, Cook, Jensen, & Ladd, 2011); (c) clinician barriers such as 
disagreements with the models underlying evidence-based approaches, lack of appropriate training, 
and the perceived complexity of couple and family therapies (e.g. Haug et al., 2008); and (d) 
institutional barriers such as difficulties with third-party reimbursement for family treatment sessions. 
In the past decade the alcohol field has moved towards briefer manual-guided interventions that 
can be learned and implemented fairly easily by healthcare providers.  We believe there are several 
reasons to expand the brief intervention literature by developing a brief family-involved treatment 

 
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model.  First, there is consistent evidence that family involvement helps to engage treatment-resistant 
alcohol and drug abusers into therapy (Manuel et al., 2012; Miller, Meyers, & Tonigan, 1999), enhances 
the probability that adults in detoxification units later enter formal treatment (Ino & Hayasida, 2000; 
O’Farrell, Murphy, Alter, & Fals-Stewart, 2008), and improves outcomes across a range of populations 
(McCrady et al., 2009; McCrady et al., 1986; O’Farrell et al., 1998; Powers et al., 2008).  Second, 
although these findings are promising, few efforts have focused on the integration of efficacious 
elements of family-involved interventions within on-going community-based treatment.   
The proposed study takes this next step.  Specifically, the treatment to be developed and tested in 
this grant, “B-FIT” (Brief Family-Involved Treatment), is designed as an add-on to community-based 
substance abuse treatment-as-usual (TAU).  B-FIT uses family involvement to enhance patient 
treatment adherence and outcomes by improving family functioning and increasing family-provided 
incentives for treatment adherence and abstinence.  Study aims are carefully sequenced to develop the 
B-FIT treatment and judge its merits. 
Figure 1.  Proposed relations among B-FIT active ingredients, mediators, and outcomes  
 
 
OBJECTIVES/AIMS/HYPOTHESES 
The overall study has three specific aims: 
Aim 1.  To modify our existing ABCT model to make it (a) appropriate for any concerned family 
member, (b) shorter, (c) focused on key mechanisms of change identified in prior research, (d) 
appropriate for use as part of an on-going alcohol treatment program, and (e) more efficacious by 
incorporating behavioral contracting procedures  (O’Farrell & Fals-Stewart, 2000; Smith & Meyers, 
2004).   
Aim 2. To conduct a small-scale clinical trial of B-FIT to: Aim 2a. Obtain preliminary effect-size 
estimates of the impact of B-FIT on (a) patient treatment adherence; (b) drinking outcomes; (c) family 
functioning; and (d) functioning of the concerned family member. Aim 2b.  Obtain estimates of the 
disseminability of the protocol by assessing: (a) clinicians’ ability to learn and implement the 
Commit-
ment to 
abstinence 
Treatment 
Conditions 
Active 
Ingredients 
Candidate 
Mediators 
Secondary 
Outcomes 
Primary 
Outcomes 
Teaching 
skills to 
reinforce 
change 
More 
positive 
shared time 
Family 
relationship 
satisfaction 
Abstinence 
CFM 
individual 
functioning 
DSM-V AUD 
symptoms; 
Drinking 
conse-
quences 
TAU 
TAU + 
B-FIT 
Figure Key.  
Solid line = positive 
relationship.  
Dotted line=negative 
relationship. 
Communica-
tion training 
More 
positive 
communica-
tion 
Teach skills 
to increase 
positive 
exchanges 
Treatment 
adherence 
Perceived 
family 
support 

 
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intervention; (b) clinician evaluations of the ease of protocol implementation; (c) patient and family 
member feedback about B-FIT; and (d) the proportion of patients and concerned family members 
willing to participate in the intervention. Aim 2c.  Develop and conduct a preliminary test of a 
methodology to study the active ingredients in the B-FIT treatment and purported mechanisms by which 
it works. Aim 2d. Test major moderators of the treatment effect: (a) demographic variables and severity 
of AUD; (b) individual psychological variables; and (c) familial distress/support.  
Aim 3.  Finalize materials for a larger-scale RCT, including: (a) treatment manual; (b) patient and 
family manuals; (c) clinician training materials; (d) a treatment integrity rating system; (e) all measures. 
 
The focus of this IRB application is the pilot study and randomized clinical trial.  We were 
previously approved for the focus group portion of the study in IRB application 01815.   
 
STUDY DESIGN AND PROCEDURES 
I. 
Study Design 
  
Feedback from the initial focus groups (IRB application 01815) will be used to modify the therapist 
and patient materials prior to implementation of the B-FIT protocol.  After materials are ready, therapists 
will receive a short, intensive training that will include didactic material and role-play rehearsal of each 
intervention.  Following this training, six patients with alcohol use disorders (AUDs) and their concerned 
family members (CFMs) will be recruited to pilot test the treatment.  A short debriefing questionnaire will 
be administered to the therapist, patient, and CFM after each session that will query several aspects of 
the session:  (a) length and timing; (b) ease or difficulty in delivering or understanding material; (c) 
relevance to the patient and family member; and (d) open-ended comments about the intervention.  
Based on the experience with the first six patients and family members, additional adjustments will be 
made to the therapist manual and handouts.  A second set of focus groups will be used to obtain 
feedback on the revised materials using the same procedures detailed in IRB application 01815.  
Adjustments to the materials will be completed in response to this feedback.  These revised materials 
will then be used for a small clinical trial to evaluate the B-FIT intervention compared to treatment-as-
usual (TAU). 
II. 
Study Procedures 
 
Table 1.  Study Measures for Patients (PT) and Concerned Family Members (CFM) 
PURPOSE 
MEASURE 
TYPE OF 
MEASURE 
TIME TO 
ADMINISTER 
(MINUTES) 
WHEN ADMINISTERED? 
Screening 
Baseline 
Within-
Treatment 
Follow-
Up 
PT 
CFM 
PT 
CFM 
PT 
CFM 
PT 
CFM 
Patient and Concerned Family Member measures 
Patient 
Eligibility 
B-FIT Screening Interview 
- Patient.  Includes: 
 
 
 
 
 
 
 
 
 
 
 
• 
Important People 
Interview (importance 
item only) 
Self-report 
2 
X 
 
 
 
 
 
 
 
 
• 
AUDIT  
Interview 
10 
X 
 
 
 
 
 
 
 
 
• 
Drug Abuse Screening 
Test (DAST-10) 
Interview 
5 
X 
 
 
 
 
 
 
 
 
• 
SCID Psychotic 
screener  
Interview 
5 
X 
 
 
 
 
 
 
 
 
• 
Partner Violence 
Screen  
Interview 
2 
X 
 
 
 
 
 
 
 

 
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SCID-Substance Abuse 
Module  
Self-report 
15 
X 
 
 
 
 
 
 
X 
CFM 
Eligibility 
B-FIT Screening Interview 
– Family.  Includes: 
 
 
 
 
 
 
 
 
 
 
 
• 
AUDIT  
Interview 
10 
 
X 
 
 
 
 
 
 
 
• 
Drug Abuse Screening 
Test (DAST-10) 
Interview 
5 
 
X 
 
 
 
 
 
 
 
• 
SCID Psychotic 
screener 
Interview 
5 
 
X 
 
 
 
 
 
 
 
• 
Partner Violence 
Screen 
Interview 
2 
 
X 
 
 
 
 
 
 
Descriptive 
and 
Moderators 
B-FIT Demographic 
Interview 
Self-report 
12 
 
 
X 
X 
 
 
 
 
 
Confidential Information 
Form (CASAA locator 
form) 
Self-report 
10 
 
 
X 
X 
 
 
 
 
 
SCID-5 screener with PCL-
5 
Interview 
10 
 
 
X 
 
 
 
X 
 
Pre-post 
patient 
substance 
use 
measures 
Form-90 
Interview 
45 
 
 
X 
 
 
 
 
 
 
Form-90 follow-up 
Interview 
25 
 
 
 
 
 
 
X 
 
 
Drinker Inventory of 
Consequences (DrINC) 
Self-report 
10 
 
 
X 
 
 
 
 
 
 
Short Inventory of 
Problems (SIP) 
 
5 
 
 
 
 
 
 
X 
 
 
Inventory of Drug Use 
Consequences (INDUC) 
 
10 
 
 
X 
 
 
 
X 
 
CFM 
functioning 
measures 
Beck Depression Inventory 
Self-report 
8 
 
 
 
X 
 
 
 
X 
 
Beck Anxiety Inventory 
Self-report 
8 
 
 
 
X 
 
 
 
X 
Biological 
measures 
Breathalyzer  
 
Self-report 
5 
 
 
X 
 
 
 
X 
 
Mediators 
Treatment Services 
Review (TSR: treatment 
attendance, use of 
medication, self-help group 
involvement) 
Self-report  
5 
 
 
 
 
X 
 
X 
 
 
Commitment to Sobriety 
Scale  
Self-report 
5 
 
 
X 
 
X 
 
X 
 
 
Perceived Social Support – 
Family  
Self-report 
15 
 
 
X 
 
 
 
X 
 
 
Family Environment Scale  
Self-report 
15 
 
 
X 
X 
 
 
X 
X 
 
Pleasant Events Schedule 
- adapted 
Self-report 
15 
 
 
X 
X 
X 
X 
X 
X 
 
FACES-IV 
Self-report 
5 
 
 
X 
X 
X 
X 
X 
X 
B-FIT 
evaluation 
Helping Alliance 
Questionnaire 
 
Self-report 
8 
 
 
 
 
X 
X 
 
 
 
Client Satisfaction 
Questionnaire 
Self-report 
8 
 
 
 
 
X 
X 
X 
X 
Therapist measures (all within treatment) 

 
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Active 
ingredients 
Clinician use of each B-FIT 
interventions 
Self-report 
5 
 
 
Brief C-TIRS 
Coders 
60 
Mediators 
B-FIT Session attendance 
Self-report 
2 
 
Patient homework 
compliance 
Self-report 
2 
 
CFM homework 
compliance 
Self-report 
2 
B-FIT 
evaluation 
Helping Alliance 
Questionnaire 
 
Self-report 
8 
 
Clinician feedback on B-
FIT 
Self-report 
5 
 
Initial screening.  Patients will be screened in person or over the phone by study personnel.  A 
simple checklist will be used to determine eligibility criteria related to date of treatment entry, age, and 
methadone maintenance status.  AUD diagnosis will be assessed using the substance abuse module of 
the SCID interview (First et al., 2002).  Psychotic symptoms will be assessed using the psychotic 
screening questions from the SCID (http://www.scid4.org).  Presence of domestic violence will be 
assessed using the Partner Violence Screen (Feldhaus et al., 1997).  These measures are all included 
in the B-FIT Screening interview.  If eligible, the patient will be provided with a brief description of the 
study, will be asked to provide the name of an eligible CFM and verify frequency of contact and 
perceived importance (using one item from the Important People Interview, Longabaugh & Zywiak 
(1999), and will sign a release of information to allow study personnel to contact the family member and 
will be asked to mention study participation to the family member.   
CFMs will be screened in person or over the phone by study personnel.  A simple checklist will be 
used to assess family member age, frequency of contact with the patient, and current help-seeking 
status.  Presence of domestic violence will be assessed using the Partner Violence Screen (Feldhaus 
et al., 1997).  Psychotic symptoms will be assessed using the psychotic screening questions from the 
SCID (http://www.scid4.org).  Severity of alcohol use will be assessed with the AUDIT (Saunders, 
Aasland, Babor, de la Fuente, & Grant, 1993); a score of 8 or greater will exclude the CFM from the 
study.  Severity of drug dependence will be assessed with the DAST-10 (Skinner, 1982); a score of 3 or 
greater will exclude the CFM.  If eligible, the family member will be provided with a brief description of 
the study, and asked about willingness to participate.   
Baseline assessment. Baseline assessments with patients and CFMs will be conducted by staff 
from the CASAA Program Evaluation Service (PES).  Screening and baseline measures assess 
inclusion/exclusion criteria; locator and tracking information, sociodemographic descriptors, potential 
moderator variables; alcohol and other drug use, consequences, and diagnosis; CFM functioning and 
baseline measurement of hypothesized mediators of response to treatment (see Table 1).   Each 
individual will be interviewed separately, and the patient and CFM may be scheduled at different or the 
same times for their baseline interviews.  Patient baseline data collection will take approximately 2.5 
hours; CFM baseline data collection will take approximately 1.25 hours.  Patients will be compensated 
$50; CFMs will be paid $30.  
Randomization. After the baseline interview, couples will be randomly assigned to TAU or 
TAU+B-FIT using urn randomization (Stout, Wirtz, Carbonari, & Del Boca, 1994) to balance groups on 
patient gender, severity of alcohol dependence, and type of CFM (parent versus partner versus other).   
Treatment Conditions 

 
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Treatment as usual (TAU).  Turquoise Lodge Hospital (TLH) provides detoxification services and 
residential treatment to adults with substance use disorders.  The average residential stay is 18-21 
days.  TLH is currently developing an intensive outpatient program from which we also plan to recruit.  
TAU at TLH consists of mainly group and some individual therapy.  Families do not typically participate 
in treatment but are allowed to visit patients during designated weekend hours.   
TAU + B-FIT.  Patients randomized to the TAU + B-FIT condition will receive standard TAU at TLH, 
a combination of individual and group CBT.  In addition, the patient and CFM will participate together in 
three B-FIT sessions of 60 minutes duration.  The sessions typically will be scheduled at weekly 
intervals.  The B-FIT protocol is designed to be manual-guided.  Session 1 includes:  (a) rationale for 
CFM involvement and psychoeducation about alcohol problems; (b) interventions to identify ways that 
the patient and CFM can be supportive to each other; (c) interventions to identify a shared positive 
activity for the patient and CFM; (c) introduction to effective communication, and a communication 
handout.  Session 2 includes:  (a) brief review of the results of the supportive behaviors and shared 
positive activity and discussion of problems encountered; (b) selection of a second activity with 
implementation plans that address any problems encountered in implementing the first activity; (c) 
review of the communication handout; (d) therapist coaching of the patient and CFM to try out one 
effective communication skill and then therapist helping the patient and CFM to use better 
communication skills for the balance of the session; (e) introduction to the recovery contract, including 
identification of specific patient behavior for the CFM to reinforce (treatment attendance or medication), 
and what CFM behavior will be used as the reinforcer; (f) development of a written recovery contract 
and discussion of potential problems in implementation of the contract.  Session 3 includes:  (a) review 
of the supportive behaviors, shared positive activity, and recovery contract; (b) review of the second 
communication handout; and (c) role play rehearsal to apply communication skills to discussion of a 
specific topic. The three sessions will follow a similar structure, regardless of the relationship status of 
the CFM and whether or not the patient and CFM live together.  The content of the sessions will be 
tailored to the specific relationship.  For example, an intimate other might provide a backrub to a patient 
as a reinforcer; a sibling might take the patient out for dinner as a reinforcer.  Consistent with a 
behavioral approach, the therapist will help the patient and CFM develop a concrete plan for the 
implementation of each intervention that is tailored to their relationship and living situation.  Each 
implementation plan will specify the day(s) and time(s) that skills will be practiced, and also identify 
barriers to implementation.   
Treatment fidelity. To measure treatment fidelity to ABCT, the PI and colleagues developed the 
37-item Couples Treatment Integrity Rating Scale (C-TIRS (Hallgren et al., under review).  Because 
ABCT includes interventions not relevant to B-FIT, the C-TIRS will be shortened to eliminate CBT 
items; other items will be reworded to assess interventions with family member rather than just an 
intimate partner.  Sessions will be digitally recorded and rated for fidelity by graduate students trained 
to use the modified C-TIRS, using training and reliability procedures used previously in our lab.   
Therapist selection, training, and supervision. B-FIT therapy sessions will be provided by a 
TLH clinician.  Clinician training will include four elements:  (a) didactic material on the rationale for B-
FIT and each B-FIT intervention as well as a detailed description of each intervention; (b) role play 
rehearsal of each intervention; (c) supervised practice with the B-FIT manual with the first six 
patients/CFMs in which each audio-taped session will be reviewed by Dr. McCrady Fink, or Epstein and 
feedback provided to the clinician; (d) additional didactic training and role play rehearsal with the 
modified B-FIT protocol after the pilot testing and second round of focus groups.  Treatment delivery 
will be monitored throughout the small clinical trial and Drs. McCrady, Fink, and Epstein will continue to 
listen to session tapes and give feedback to study clinicians.  

 
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Within treatment data collection. At TLH, patients and CFMs will complete measures of patient 
drinking since the last session, CFM level of distress, patient and CFM use of B-FIT interventions, and 
satisfaction with the treatment session (see Table 1).  Patients and CFMs will each be compensated 
$10 for completing within-treatment forms after each session.   
Follow-up. Patients and CFMs in the randomized clinical trial will be re-assessed at CASAA four 
months after baseline data collection (approximately 3 months after the last B-FIT session if all three 
sessions are completed).  Persons with alcohol and other substance use disorders often have unstable 
lives, inconsistent living arrangements, and telephones that are turned off at times.  To assist in 
keeping track of participants, a study locator form (Confidential Information Form) will be used.  This is 
standard procedure in substance abuse research, and has been used in clinical trials at CASAA and 
elsewhere for 20 years.  The form asks participants to provide personal contact information as well as 
contact information for relatives or friends who could assist the researchers in finding participants who 
cannot be located through their initial contact information.  Participants give signed consent on the 
locator form for research staff to use the contact information (see bottom of pages 1 & 3).  Specifically, 
on page 1, the consent reads, “I hereby grant my permission for the above information to be used to 
locate me if I cannot be found, for the purpose of completing a research interview.  I understand that I 
may withdraw this permission at any time.”  At the bottom of page 3, participants give separate consent 
for the research team to contact individuals listed on the form:  “I hereby grant my permission for the 
people I have named above to be contacted in the event that I cannot be found.  I understand that the 
only purpose of such contact would be to locate me, and that the individuals need not be given any 
information about the nature of the research in which I am participating, unless I grant permission.  I 
may at any time change these names or withdraw my permission for one of more of them to be 
contacted.”  This form is used only for participants who are continuing in the research but difficult to 
locate; it is not used for participants who have formally withdrawn from the study. 
Patients and CFMs in the pilot study will not provide follow-up assessments.  Patients and CFMs in 
the clinical trial each will be compensated $40 for completion of follow-up data collection.  See Table 1 
for list of assessments.  Some patients may still be receiving treatment services at the time of research 
follow-up; this information will be tracked on the Treatment Services Review (McLellan, Alterman, 
Cacciloa, Metzger, & O’Brien, 1992). 
III. Consent Procedures 
 
PES staff will obtain full informed consent at TLH in a one-on-one, private meeting.  Prospective 
research participants will be apprised of all requirements of the study, including the sessions, the type 
of therapy, who will provide that therapy, the nature of the assessments, follow-up requirements, official 
records that will be reviewed, who is responsible for the study, and to whom the subject should go if 
they need information or help. The Consent Form also states that participating in the study will neither 
help nor hurt the participant’s standing in any legal matters.   Standard Consent form assurances are 
included, for example that the subject may withdraw from the study at any time with no harm to them or 
loss of services to which they are otherwise entitled.  Consent forms will be signed by the prospective 
research participants (patients and CFM), and a research staff person and dated.  In addition, a Federal 
Certificate of Confidentiality (FCC) has been obtained to ensure a higher level of protection for 
participant research data.  Participants will be provided a copy of the consent form (see appended 
patient and CFM consent forms for both the pilot and RCT). 
It is possible that patients or family members could be under the influence of alcohol or drugs during 
the consent process and therefore at diminished decisional capacity.  Research staff obtaining consent 
will have the discretion to terminate the consent procedure if they have clear reason to believe the 

 
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person is intoxicated, either through positive breathalyzer results or overt behavior, as reliable 
biological assessment of acute non-alcohol drug intoxication is unavailable.   
 
As an additional safeguard to ensure understanding during the consent process, the patient and 
family member consent forms will end with a brief quiz containing the following True/False questions: 
(1) I will be in 3 therapy sessions that include a family member and myself (True); (2) I will not be paid 
for my participation (False); and (3) My conversations during the therapy sessions will be recorded 
(True).  The person obtaining consent will verbally address any incorrect responses with the participant 
and re-verify if the person understands the consent and wishes to participate. 
HIPAA identifiers being collected will include name, date of birth, physical address, phone number, 
appointment dates, and e-mail address.  This information will be necessary for tracking and scheduling 
participants from baseline through treatment and follow-up.  We will also be collecting date of birth in 
order to describe the age of the sample.  We will be using a HIPAA form (see appended).  
 
IV. Study Timelines 
 
Clinicians will be trained in the B-FIT intervention during September 2015 in preparation for the 
pilot study.  The six pilot participants will be recruited, treated, and debriefed October through 
December, 2015.  From January to March 2016, treatment manuals will be modified based on pilot 
outcomes.  The new manuals will be distributed to focus groups of patients, CFMs, and clinicians in 
April and the focus group data will be analyzed in May.  The manuals will be modified in June and July, 
and all materialized finalized in August, 2016.  Clinicians will be trained in the revised B-FIT intervention 
in September 2016.  RCT participants will be recruited starting in October 2016 and ending in June 
2017, with the final participants completing the study intervention in July 2017.  Follow-up assessments 
will take place between January and November 2017.  Finally, data will be analyzed and interpreted 
between December 2017 and March 2018. 
 
V. Study Location(s) 
 
The study will be conducted through the Center on Alcoholism, Substance Abuse, and Addictions 
(CASAA), a UNM research center with a 25-year history of conducting clinical trials of innovative 
treatments for alcohol and other substance use disorders.  Participants will be recruited and treated at 
Turquoise Lodge Hospital (TLH), which is run by the New Mexico Department of Health and located in 
Albuquerque.  TLH offers a range of substance use disorder treatment services including psychosocial 
and medical interventions.  CASAA researchers have conducted multiple clinical studies at TLH and the 
CASAA Program Evaluation Service (PES) staff, who will assist in recruitment and data collection, has 
established procedures for recruiting and assessing research participants at TLH. 
 
VI. Participant Compensation 
 
Participants will be compensated for providing research data at a rate of approximately $20/hour.  
Patient baseline data collection will take approximately 2.5 hours; CFM baseline data collection will take 
approximately 1.25 hours.  Patients will be compensated $50; CFMs will be paid $30.  During 
treatment, patients and CFMs will complete measures of patient drinking since the last session, CFM 
level of distress, patient and CFM use of B-FIT interventions, and satisfaction with the treatment 

 
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session.  Patients and CFMs will each be compensated $10 for completing within-treatment forms after 
each session.  Finally, patients and CFMs in the clinical trial each will be compensated $40 for 
completion of follow-up data collection.  Patients and CFMs in the pilot study will not provide follow-up 
assessments.  All payments will be in the form of Walmart gift cards.  During inpatient treatment, gift 
cards will be securely stored with patients’ personal belongings and available for retrieval upon the 
patient’s discharge. 
VII. Study Resources 
 
Most patients with AUDs seeking treatment have at least one family member (Copello et al., 2010); 
analyses of the Project MATCH outpatient sample recruited in Albuquerque, NM (conducted for this 
proposal) reveal that 85.8% of patients in the sample named a family member or significant other as a 
collateral who would be willing to provide data.  It should be noted that only 7% of New Mexico 
Hispanics are not English-speaking, so few potential patients will be excluded because of language 
barriers.  In Project COMBINE 26.9% of clients had a concerned family member attend at least one 
treatment session (Hunter-Reel et al., 2012), so even if our recruitment rate for families is similar to 
COMBINE we will should have sufficient patient flow.  Recruitment, intervention and data collection will 
take place at TLH and CASAA (for follow-up). 
Three PES staff will be available for recruitment, data collection, and data entry.  Four psychology 
doctoral students will be available to assist with recruitment, data collection, and data entry as needed.  
PES has provided participant recruitment, assessment, tracking, and follow-up services to investigators 
at CASAA for the past 20 years, and for approximately 75 different clinical trials.  PES has collected 
data for studies of vulnerable populations including incarcerated juveniles and adults, opiate dependent 
adolescents, homeless and pregnant women, and persons receiving substance abuse treatment in 
residential and ambulatory treatment settings.  PES has worked regularly with TLH staff for several 
previous studies.  Thus they are knowledgeable about the data collection process and understand how 
to work with patients and also how to identify difficulties requiring intervention.   
In addition to the availability of on-site Master’s-level clinicians and medical staff at TLH, the 
CASAA research team includes licensed clinical psychologists who will provide backup consultation.  
There will be no need to utilize outside emergency resources, as our sites will fully cover these needs.   
Clinicians will utilize CASAA’s existing digital audio recorders to record in-session interactions.  
Hard copy data will transported daily from TLH to CASAA and stored in locked filing cabinets, and 
consent forms will be securely stored in a separate locked cabinet.  All computerized data (including 
audio recordings) will be backed up on the CASAA server, which is firewall protected and accessible 
only through individual authorization and passwords.  Data will be analyzed and integrated into B-FIT 
materials by core research staff including the PI. 
VIII. Unanticipated Problems 
 
The ongoing interaction between TLH clinicians and medical staff, patients and their families, and 
CASAA research staff will help to ensure that if there are any adverse clinical events they will be 
identified and dealt with swiftly.  It will be made clear during training that any adverse events need to be 
dealt with locally and quickly and that the PI (a licensed clinical psychologist) should be notified during 
the event if need be, or the same day if it is not an emergency.  Any unanticipated adverse events will 
be recorded, and an adverse event form will be completed and submitted to the UNM IRB within seven 
days.   

 
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EXPECTED RISKS/BENEFITS 
I. 
Risks  
 
We believe the risks in this research are minimal.  We foresee no physical risks as a result of 
participating in the research project.  Similarly we foresee no direct financial or legal risks as a result of 
participating in the research study.  Clients may be involved with the criminal justice system, but that 
involvement is overseen by other entities and is not a part of the research project. If we find the 
participant is intoxicated at baseline or follow-up assessment they will be voluntarily retained at the site 
until they are legally sober. There are three potential areas of risk:  (1) perceived coercion to participate 
in the study; (2) a risk of some psychological harm in carrying out treatment studies. Participants may 
find answering some of the questions causes discomfort, or that participating in treatment with a family 
member contributes to relationship distress; (3) potential breaches of confidentiality.  Methods for 
managing these potential risks are outlined below. 
Perceived coercion:  We are working with clients who may have been convicted of DWI or 
otherwise are involved in the criminal justice system.  However, the treatment they receive as part of 
this research study has no bearing on the requirements they need to fulfill obligations with the court.  
We will make it clear both verbally and in the Informed Consent form that participation in the treatment 
study will neither help nor hinder their standing with the courts.  Further, only clients who have 
voluntarily admitted themselves (i.e., are not court-mandated) to treatment at TLH will be eligible for 
study participation.  
Although participants in this study are not prisoners, they may be involved in the criminal justice 
system insofar as they have been convicted for an alcohol related offense.  We will make it very plain 
that data collected as part of the research study will not be available to the courts and will have no 
bearing on their status with the courts.  Because they are not prisoners they will not require special 
protections, but we still need to be mindful that simply being involved in the criminal justice system 
makes them more vulnerable than a group not involved in the criminal justice system.   
More generally, it is possible that patients may believe they should participate to maintain good 
standing with their treatment providers.  The recruitment and informed consent processes will clearly 
state that participation in the study intervention or subsequent withdrawal will have no impact 
whatsoever on their course of treatment. 
Potential psychological harm:  There is always a risk of some psychological harm in carrying out 
treatment studies.  First, some of the questions in the assessment instruments may cause discomfort in 
some people.  We have administered these measures in previous research studies and have found that 
they cause minimal distress to most people. If time needs to be taken so the person can compose 
themselves the interviewers will allow them to do so.  In the unlikely case that a question causes severe 
discomfort, senior clinical staff from TLH will be called in and the PI will be contacted by phone.  All 
data collection will be completed by experienced interviewers from the CASAA Program Evaluation 
Services (PES), who have had training in how to deal with crises, such as giving respite time, calling a 
clinician, and when to call a crisis center.  The second potential source of psychological harm is that the 
provision of family-involved treatment could increase conflict in the family.  Families in which there is 
domestic violence will be screened out of the study, so the risk of actual physical violence will be 
decreased substantially.  One of the most consistent findings for family-involved treatment for alcohol 
and other substance use disorders is an increase in couples or family satisfaction and a decrease in 
domestic violence, and the B-FIT treatment protocol is designed to teach better communication skills, 

 
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thus mitigating the chance of increased conflict. The therapy will be given by licensed and trained 
counselors who have experience working with people with substance use disorders, and they will 
receive formal training and on-going supervision in the B-FIT protocol.  If a participant (patient or CFM) 
finds some of the issues difficult the counselor can help them work through those issues.  Furthermore, 
the research staff includes licensed clinical psychologists who will provide backup consultation to the 
therapists.   
Potential breaches of confidentiality:  The third risk is the possibility of a breach of confidentiality. 
Several steps will be taken to minimize the risk of breaches of confidentiality:   
 
(1) Data will be labeled only with participant identification number.  Participant names and study 
identification numbers will be recorded and stored separately from the research data files.   
 
(2) All research data collected by a research assistant on site at will be transported from TLH to 
the CASAA research offices in a briefcase or similar closed storage medium - loose papers or papers in 
open folders will not be allowed.  After returning to the research office, assessment instruments and 
audio recordings will be logged in on our firewall-protected network and the hard copy data stored in a 
locked file cabinet.   
 
(3) Data collected from this project will be available only to selected research staff.  Data will be 
collected by research staff and shared with treatment staff only if there is a need in order to protect 
client or CFM safety.  For example, if during the baseline measures research staff find out that a 
participant has current suicidal ideation we would share this with the therapist because this could have 
material effect on the participant’s well being.  CASAA has a standard procedure for following up on 
reports of suicidal ideation (see CASAA Participant Emergency Procedure in the Appendices).  During 
the assessment, research personnel review the self-report Beck Depression Inventory (BDI), which 
includes a suicidal ideation item, and implement the CASAA Participant Emergency Procedure if the 
participant has endorsed suicidal ideation on this form or has reported suicidal ideation at any point 
during the research interview.   
If a participant reports possible child abuse or neglect, study personnel will inform the Principal 
Investigator or Dr. Fink if Dr. McCrady is unavailable.  Dr. McCrady or Dr. Fink will make a 
determination of whether there is a possibility of child abuse or neglect and, if so, will make a report to 
the New Mexico Children, Youth and Families Department (CYFD) within one business day.  Other 
than those contingencies only the research staff composed of the PI, research assistants who will be 
administering the measures, and co-investigators will have continuing access to identified client data.  
Other research staff will also have access on an as-needed basis.  For example, if the data analyst 
needs to access a particular client record he would have that access.  
 
(4) We have applied for and received a Federal Confidentiality Certificate from the Office of 
Research Protection. 
(5) For screening, we will create separate Excel spreadsheet logs of screens for patients and 
CFMs.  All screens will be logged into the spreadsheets with a yes/no for whether the individual meets 
each inclusion/exclusion criterion.  Individuals will be identified on the spreadsheet by screen 
participant number.  The screening spreadsheet will not contain names or contact information.  Screens 
for ineligible individuals will be filed in a locked file cabinet in a locked room without names or other 
identifying information on the forms.  If both the patient and CFM meet initial eligibility criteria and are 
interested in the study they will be assigned a study number, a file will be created for them, and their 
screens will be filed in their study file.  A second spreadsheet with study ID numbers and participant 
names for individuals who meet initial screening criteria and are interested in the study will include a 
field for screen participant number.  Because the screens and spreadsheet for ineligible potential 

 
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participants will never have identifying information we plan to retain these data on the same schedule 
as other data (five years post publication).  The data from the screens will be used to report the number 
of individuals screened, and reasons for ineligibility. 
 
Benefits  
We expect that participation in the B-FIT and Treatment as Usual (TAU) conditions will offer 
substantial help to both the client and their CFM in helping them reduce alcohol consumption and 
subsequent risky behaviors.  We anticipate that the advice that CFMs receive in the B-FIT program will 
give them new knowledge and tools to work with family members who have had an alcohol use 
disorder.  B-FIT is an add-on to a community based substance abuse treatment program and will use 
family involvement to enhance patient treatment adherence and outcomes by improving family function 
and increasing family-provided incentives for treatment adherence and abstinence.  By beginning to 
improve their family interactions during their inpatient stay, patients may be more likely to enter a social 
environment that promotes sobriety following discharge.  There also is research evidence suggesting 
that participating in research evaluations as part of alcohol treatment studies has positive benefits, so 
even those in the TAU condition may receive additional benefit by completing the research measures.  
As stated above, we believe the risks of being involved in this research as very minimal.  Therefore, we 
believe that the benefits will outweigh the risks. 
We believe that the enhanced therapy we propose in this application will add substantial original 
knowledge to the addictions field.  As mentioned in the beginning of this proposal, substance use 
disorders are a continuing and relatively intransigent problem.  AUD treatment outcomes are 
suboptimal; we hope to improve outcomes by focusing on ways to support adherence and reinforce 
change outside of therapeutic settings.  If the enhanced therapy proves to be efficacious, we think that 
the minimal risks to clients are outweighed by the knowledge to be gained. 
 
Human Subjects Interactions 
I. 
Target Population 
 
Participants will be:  (a) patients with AUDs receiving services at TLH, and (c) family members of 
patients with AUDs who are receiving services at TLH.   
 
Given that our target population is substance abuse treatment patients and their family members, 
it is likely that many participants will be ethnic minorities, economically or educationally disadvantaged, 
or with trauma histories.  Because we want our sample to be representative, it is justified that we 
include participants who may come from these groups, although such characteristics will not affect 
study inclusion or exclusion.  There is the potential that pregnant women could participate in the 
intervention, although this will not be a concern given the non-invasive, low-risk nature of the study. 
   
As previously stated, TLH patients may be involved in the criminal justice system insofar as they 
have been convicted for an alcohol related offense.  We will make it very plain during informed consent 
that data collected as part of the research study will not be available to the courts and will have no 
bearing on their status with the courts.  Because they are not prisoners they will not require special 
protections, but we still need to be mindful that simply being involved in the criminal justice system 
makes them more vulnerable than a group not involved in the criminal justice system.  Further, only 
clients who have voluntarily admitted themselves (i.e., are not court-mandated) to treatment at TLH will 
be eligible for study participation.  

 
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Individuals receiving inpatient services may perceive decreased autonomy in their decision to 
participate in the study.  As a precaution against this, we will recruit only patients who admitted 
themselves voluntarily to TLH’s inpatient unit.  More generally, it is possible that patients may believe 
they should participate to maintain good standing with their treatment providers.  The recruitment and 
informed consent processes will clearly state that participation in the study intervention or subsequent 
withdrawal will have no impact whatsoever on their access to or course of treatment. 
There is also a risk that patients or family members could be under the influence of alcohol or drugs 
and therefore at diminished decision-making capacity.  It will be at the discretion of staff obtaining 
consent or collecting assessments to use a breathalyzer on a patient or family member showing signs 
of intoxication; as there is no reliable method for assessing acute drug intoxication, staff will have the 
discretion to preclude participation based on visible impairment regardless of breathalyzer results.  
Clinicians conducting therapy sessions will use the same discretion.  This information will be made 
clear in the informed consent forms.  The informed consent forms will also include a short quiz to help 
ensure that patients and family members fully understand the nature of study participation (see 
appended).     
 
II. 
Inclusion and Exclusion Criteria 
 
Participants will include patients receiving services at TLH and a CFM who is willing to participate 
in the treatment and research.  To be included, patients must: (a) have voluntarily initiated treatment 
(not been court-mandated) and had at least one alcohol treatment session in the last 30 days; (b) meet 
DSM-5 criteria for an AUD; (c) have an adult family member who is willing to participate; (d) be at least 
18 years of age; (e) able to speak and read English at a 6th grade level; (f) not show current psychotic 
symptoms; and (g) not meet criteria for a severe non-alcohol substance use disorder.  Family members 
will be included if they: (a) are at least 18 years of age; (b) able to speak and read English at a 6th 
grade level;  (c) have in-person and/or telephone/text/email contact with the patient at least 4 days per 
week; (d) are rated as “important” by the patient on the Important People Interview (Longabaugh & 
Zywiak, 1999); (e) are willing to participate in treatment by coming to family visiting hours; (f) are not 
seeking treatment for an alcohol or drug problem of their own; (g) do not show current psychotic 
symptoms; and (h) do not meet screening criteria for a current alcohol or other drug problem. Patients 
and family members also will be excluded from the clinical trial if either partner reports domestic 
violence in the past 12 months serious enough to warrant medical attention, or if either reports 
concerns about participating in treatment with the patient/family member.   
 
III. Participant Enrollment 
 
Our goal is to enroll 12 pilot participants (6 patients, 6 CFMs) who complete the three session 
treatment and 120 RCT participants (60 patients, 60 CFMs) who complete the three session treatment.  
We anticipate that approximately 20% of patient-family member dyads will not complete the full three 
sessions, so it may be necessary to recruit up to 16 pilot participants and 150 RCT participants to 
achieve the final targeted sample sizes. 
 
IV. Recruitment and Screening Procedures 
 
At study initiation, the PI and members of the research team will meet with TLH clinicians to 
describe study goals and procedures, inclusion/exclusion criteria, and study incentives.  A simple 

 
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checklist of study inclusion/exclusion criteria and referral cards will be provided to TLH clinicians.  The 
clinician will complete the card and obtain patient consent for CASAA PES staff to contact potentially 
eligible patients.  The study recruitment specialist will collect referral cards from TLH staff to identify 
potential study participants and track patients who refuse participation.   
Patients will be screened in person or over the phone by research staff for eligibility and interest 
in study participation.  At the beginning of the screening, the staff member will clarify, “Now I am going 
to ask you a few short questions about your alcohol and drug use, your relationship to your family 
member, and your own psychological state to see if you and your family member are eligible for this 
study.  If you do not want to answer a question that is fine and we can end our conversation at that 
point."  A simple checklist will be used to determine eligibility criteria related to date of treatment entry, 
age, and methadone maintenance status.  AUD diagnosis will be assessed using the substance abuse 
module of the CIDI interview (Robins et al., 1988).  Psychotic symptoms will be assessed using the 
psychotic screening questions from the SCID (http://www.scid4.org).  Presence of domestic violence 
will be assessed using the physical violence items from the Partner Violence Screen (Feldhaus et al., 
1997).  If eligible, the patient will be provided with a brief description of the study, will be asked to 
provide the name of an eligible CFM and verify frequency of contact and perceived importance (using 
one item from the Important People Interview, Longabaugh & Zywiak (1999), and will sign a release of 
information to allow study personnel to contact the family member and will be asked to mention study 
participation to the family member.   
 
Research staff will obtain study informed consent and consent to contact the CFM.  After informed 
consent, research staff will contact the CFM to describe the study and conduct an initial screening.   
CFMs will be screened in person or over the phone by study personnel.  At the beginning of the 
screening, the staff member will clarify, “Now I am going to ask you a few short questions about your 
alcohol and drug use, your relationship to your family member, and your own psychological state to see 
if you and your family member are eligible for this study.  If you do not want to answer a question that is 
fine and we can end our conversation at that point."  A simple checklist will be used to assess family 
member age, frequency of contact with the patient, and current help-seeking status.  Presence of 
domestic violence will be assessed using the Partner Violence Screen (Feldhaus et al., 1997).  
Psychotic symptoms will be assessed using the psychotic screening questions from the SCID 
(http://www.scid4.org).  Severity of alcohol use will be assessed with the AUDIT (Saunders, Aasland, 
Babor, de la Fuente, & Grant, 1993); a score of 8 or greater will exclude the CFM from the study.  
Severity of drug dependence will be assessed with the DAST-10 (Skinner, 1982); a score of 3 or 
greater will exclude the CFM.  If eligible, the family member will be provided with a brief description of 
the study, and asked about willingness to participate.  If ineligible, the family member will be offered 
referrals for other treatment programs (we will only do this with family, as the patients will already be in 
treatment). 
If the family member is willing to participate and meets all screening criteria, the research staff 
member will meet with the family member, complete the informed consent, and collect baseline study 
data.  After the CFM has provided informed consent, the research staff member will collect baseline 
data from the patient.  
We will create separate Excel spreadsheet logs of screens for patients and CFMs.  All screens 
will be logged into the spreadsheets with a yes/no for whether the individual meets each 
inclusion/exclusion criterion.  Individuals will be identified on the spreadsheet by screen participant 
number.  The screening spreadsheet will not contain names or contact information.  Screens for 
ineligible individuals will be filed in a locked file cabinet in a locked room without names or other 
identifying information on the forms.  If both the patient and CFM meet initial eligibility criteria and are 
interested in the study they will be assigned a study number, a file will be created for them, and their 
screens will be filed in their study file.  A second spreadsheet with study ID numbers and participant 
names for individuals who meet initial screening criteria and are interested in the study will include a 

 
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field for screen participant number.  Because the screens and spreadsheet for ineligible potential 
participants will never have identifying information we plan to retain these data on the same schedule 
as other data (five years post publication).  The data from the screens will be used to report the number 
of individuals screened, and reasons for ineligibility. 
 
V. Privacy of Participants 
 
Eligibility screening and informed consent will occur one-on-one between research staff and 
potential participants in a discrete environment.  Treatment sessions will take place in closed offices at 
TLH.  Because patients and family members will already be familiar with the treatment setting, we 
expect that they will feel comfortable and unconcerned with potential stigma associated with 
participating in an on-site study.  As detailed elsewhere, session audio recordings and all hard copy 
data will be stored securely and accessible only to the research team.  Audio recordings will be 
reviewed in closed rooms at the lowest reasonable volume or with headphones.  
HIPAA identifiers being collected will include name, physical address, phone number, appointment 
dates, and e-mail address.  This information will be necessary for tracking and scheduling participants 
from baseline through treatment and follow-up.  We will also be collecting date of birth in order to 
describe the age of the sample.  We will be using a HIPAA form (see appended).  
 
STUDY DATA 
I. 
Data Management Procedures 
 
All data collected by a research assistant on site will be transported from TLH to the CASAA 
research offices in a briefcase or similar closed storage medium—loose papers or papers in open 
folders will not be allowed.  After returning to the research office, all hard copy data will be stored in a 
locked file cabinet.  Audio recordings will immediately be transferred onto a computer and deleted from 
the digital recorder.  All computerized data (including audio recordings) will be stored on the CASAA 
server, which is firewall protected, and accessible only through individual authorization and passwords.  
Audio recordings will be reviewed in closed rooms at the lowest reasonable volume or with 
headphones.  Data will be retained for publication purposes for five years following the last study 
publication, per usual data retention standards.   
Data collected from this project will be available only to selected research staff.  Data will be 
collected by research staff and shared with treatment staff only if there is a need in order to protect 
patient or family member safety.  For example, if during the baseline assessment a research staff 
member finds out that a participant has current suicidal ideation, we would share this with a clinician 
because this could have material effect on the participant’s well being.  Other than those contingencies 
only the research staff composed of the research assistants, co-investigators and the PI will have 
continuing access to participant data. Similarly, disclosures of child abuse or neglect will, by law, be 
reported to the CYFD. 
 
II. 
Data Analysis/Statistical Considerations 
 
Statistical power.  The R34 mechanism is developmental in nature and for this reason 
substantial emphasis in this application is placed upon both inferential testing and the estimation and 
evaluation of effect sizes.  Our test of the efficacy of the B-FIT intervention after anticipated attrition 
(15%; Aim 2a) will include 34 participants in the B-FIT group and 17 in TAU and test outcomes both for 

 
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percentage of days abstinent (PDA) and percentage of days of heavy drinking (PDH). We believe that 
this is a conservative estimate given the method in which the planned HLM handles missing data.   In a 
two-tailed test adjusted for conducting correlated tests of drinking behavior over time (α = .05/2 = .025), 
the baseline dependent measure entered as a fixed covariate and 1 df for the between-group term, we 
estimate that we will have .703 power to reject the null hypothesis of no difference between TAU and 
TAU + B-FIT with 51 participants and an effect size of .20 (d = .25 to achieve power of .80).  
Statistical analyses. An extensive set of analyses is proposed that includes the assessment of 
treatment fidelity, document CFM and patient satisfaction with the B-FIT intervention, and examine 
outcomes in general, mechanisms of change, and potential moderators of treatment response.  Initial 
attention will be directed to investigating overall and between-group attrition rates and distributions of 
key measures prior to conducting primary analyses. Although quantitative support will be provided in 
the achievement of all study Aims, the described statistical analyses will focus on the stated objectives 
in study Aim 2a, 2c, and 2d, which are central to the proposed model (Figure 1).  
Aim 2a. Obtain estimates of the relative impact of B-FIT on patient treatment adherence, 
drinking outcomes, family functioning, and functioning of the CFM. Treatment adherence will be 
defined as the total number of TAU sessions attended between randomization and the 4-month follow-
up interview (measured by the TSR and Form-90).  Two primary alcohol use measures will be 
considered and aggregated into four monthly values: proportion abstinent days from alcohol (PDA: 
days abstinent/ 30 days) and percentage of days of heavy drinking (PDH). Family functioning will be 
assessed using the Cohesion and Conflict subscales of the Family Environment scale, and the Family 
Communication scale total score. CFM functioning will be defined as total scores on the Beck 
Depression Inventory (BDI) and Beck Anxiety Inventory (BAI).    
Generalized linear models (GLM) will assess the relative benefit of the B-FIT intervention to 
TAU alone on treatment adherence, family, and CFM functioning. Parameter estimates will be derived 
using maximum likelihood with robust estimators.  In the treatment adherence GLM, two covariates are 
planned: number of TAU sessions attended prior to randomization and baseline PDA.  The dependent 
measure will be the total number of TAU sessions attended from randomization to the 4-month follow-
up and treatment assignment will be entered as a between-subject factor. A two-tailed test will be done 
with Type I error set at α = .05. Four GLMs will be used to assess the relative benefit of B-FIT on family 
functioning; two using the patient 4-month report of family Cohesion and Conflict and two based upon 
CFM 4-month report of family Cohesion and Conflict.  Baseline values of the two scales will be used as 
covariates. Treatment group will be entered into the model as a between-subject factor and Type I error 
will be adjusted to α = .05/2 = .025 in the two-tailed tests. The relative benefit of B-FIT on CFM 
functioning will be determined using two GLMs.  The first GLM will use 4-month BDI scores as the 
dependent measure and baseline values of the BDI will be entered as a covariate. Baseline values of 
PDA for the CFM also will be entered as a covariate to negate any influence of drinking on self-reported 
depression. Treatment assignment will be entered as a between-subject factor.  A second GLM 
following the same strategy then will use the 4-month BAI score as the dependent measure. These 
tests of CFM functioning will be adjusted by α = .05/2 = .025 to control for inflated Type I error.  
The relative benefit of adding the B-FIT sessions to TAU on drinking over four months will be 
determined using two longitudinal hierarchical linear models, one for PDA and a second for PDH 
(Raudenbush & Bryk, 2002). Modeling of change in alcohol use will be restricted to the linear effect 
given the limited number of time points. The random intercept in the unconditional models will be 
examined first, followed by fitting the conditional models, which will introduce baseline value of the 
respective drinking measure (PDA or PDH) as a fixed covariate and the random linear time term. 
Treatment group will then be entered in level two of the model and will be tested via the t-statistic. 

 
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Cross-level interactions will be tested via the t-statistic to identify potential time by group interactions in 
changes in alcohol use. Type I error will be adjusted to α = .05/2 = .025 to account for the correlation 
between PDA and PDH. 
Aim 2c. This aim will investigate whether the relative benefit of B-FIT occurred for the 
presumed reasons. As such, this aim will focus only on participants assigned to the B-FIT group (n = 
40 at baseline).  Tests of mediation will use a product-of-coefficients approach with a bootstrapping 
procedure (Hayes, 2009). This choice provides the most powerful test of mediation with smaller 
samples and does not assume normality in the distribution of (a’b’) product terms (Preacher and Hayes, 
2008; Hayes, 2009). Three active ingredients of B-FIT will be investigated separately: (1) teaching skills 
to reinforce change, (2) teaching skills to increase positive exchanges, and (3) teaching skills to 
improve communication, all of which are measured within treatment by the modified C-TIRS.  Baseline 
values of mediators will be entered into all planned analyses as covariates. Overall, we will conduct six 
meditational tests.  First, we will conduct 3 mediational tests to evaluate our prediction that teaching 
skills to reinforce change will increase 4-month abstinence (PDA) by mobilizing three mediators during 
the treatment phase of the study (TAU treatment adherence, commitment to abstinence, and perceived 
family support). The fourth test will examine if teaching skills to reinforce change increases family 
satisfaction (month 4) through enhanced impressions of perceived family support (within treatment). 
Our fifth test will examine if teaching skills to enhance positive family exchanges produces increased 
family satisfaction (month 4) by increasing positive shared time (within treatment).  Finally, we will 
assess if teaching skills to improve communication increases 4-month family relationship satisfaction by 
mobilizing more positive partner communications within treatment. No adjustment for inflated Type I 
error is planned for these six tests.  
Two post hoc strategies will be used to assess the confidence we can place on the results of 
our unprotected tests.  First, we will employ a multiple meditational model (Hayes, 2009) to examine the 
actions of one B-FIT active ingredient, teaching skills to reinforce change.  Here, if two or more of the 
mediators linked with this active ingredient are found to be significant in the primary analyses we will 
enter those mediators into a single multiple meditation model. Although this approach lacks the 
precision of the primary analyses, it does address the concern of potential mediator multicolinearity and 
the likely erroneous rejections of null hypotheses. Second, we will descriptively asses the magnitude 
and consistency of a and b path estimates generated in our primary meditational analyses. Using meta-
analytic techniques, for example, we will determine if the a (n= 5) and b (n=6) path parameter estimate 
distributions are homogeneous or not using the Q statistic (Borenstein, Hedges, Higgins, & Rothstein, 
2009).  We believe that the rejection of the assumption of homogeneity will provide important 
descriptive information in the identification of “key signals” or actions among the active ingredients and 
presumed mediators. 
Aim 2d. Moderators of B-FIT Response. Three classes of moderators will be collected at the 
intake interview and examined in these exploratory analyses: (1) demographic variables, (2) 
psychological variables, and (3) familial distress/support, such as perceived social support from family.  
Primary interest will focus on the moderating effect of these variables on monthly PDA and PDH while 
secondary analyses will assess the extent to which these moderators influence family relationship 
satisfaction.  All moderators will be binary, and we will use median splits on continuous moderator 
variables to generate groups with equal number of patients, e.g., patient age.  Two longitudinal HLM 
growth models will assess potential moderating effects of patient characteristics on treatment 
effectiveness using PDA and PDH.  Baseline value of the dependent measure will be entered as a 
covariate and monthly PDA and PDH will be the dependent measure in the hierarchical linear model.  
The time effect will be restricted to the linear term and a given moderator variable will be entered in 
level two of the model. Additional terms entered in level 2 of these models will include a dummy coded 

 
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variable representing treatment assignment and a product term reflecting the group assignment by 
moderator interaction. We acknowledge that the exploratory analyses in Aim 2d are statistically 
underpowered and involve substantial inflated Type I error.  In this light we are especially interested in 
the “pattern” of statistically significant findings in our moderator analyses rather than in a single 
inferential test.  
 
III. Quality Control and Quality Assurance 
 
Treatment fidelity. To measure treatment fidelity to ABCT, the PI and colleagues developed the 
37-item Couples Treatment Integrity Rating Scale (C-TIRS (Hallgren et al., under review).  Because 
ABCT includes interventions not relevant to B-FIT, the C-TIRS will be shortened to eliminate CBT 
items; other items will be reworded to assess interventions with family member rather than just an 
intimate partner.  Sessions will be digitally recorded and rated for fidelity by graduate students trained 
to use the modified C-TIRS, using training and reliability procedures used previously in our lab.   
Therapist selection, training, and supervision. B-FIT therapy sessions will be provided by a 
TLH clinician.  Clinician training will include four elements:  (a) didactic material on the rationale for B-
FIT and each B-FIT intervention as well as a detailed description of each intervention; (b) role play 
rehearsal of each intervention; (c) supervised practice with the B-FIT manual with the first six 
patients/CFMs in which each audio-taped session will be reviewed by Dr. McCrady Fink, or Epstein and 
feedback provided to the clinician; (d) additional didactic training and role play rehearsal with the 
modified B-FIT protocol after the pilot testing and second round of focus groups.  Treatment delivery 
will be monitored throughout the small clinical trial and Drs. McCrady, Fink, and Epstein will continue to 
listen to session tapes and give feedback to study clinicians. 
Data quality assurance. PES has established standards for tracking data collection and quality.  
PES staff will review a checklist for each participant, verifying that they have completed all appropriate 
assessments and procedures.  Regulatory binders will be created as a reference and updated on an 
ongoing basis to reflect any revised measures and consent forms.  Assessments will be entered into 
the database twice by separate individuals, and the PES director will do monthly checks to identify and 
resolve any discrepancies in data entry. 
 
IV. Participant Confidentiality 
 
Several steps will be taken to minimize the risk of breaches of confidentiality:   
(1) All research data collected by a research assistant on site at TLH will be logged in and taken 
back to the CASAA research offices in a briefcase or similar closed storage medium for transport - 
loose papers or papers in open folders will not be allowed.  After returning to the research office, the 
assessment instruments will be logged in and the hard copy data stored in a locked file cabinet.  Audio 
recordings will immediately be transferred onto a computer and deleted from the digital recorder.  
Consent forms will be stored separately from the research data files in a locked file cabinet.  All 
computerized data (including audio recordings) will be stored on the CASAA server, which is firewall 
protected, and accessible only through individual authorization and passwords.  Audio recordings will 
be reviewed in closed rooms at the lowest reasonable volume.   
 
(2) Data collected from this project will be available only to selected research staff.  Data will be 
collected by research staff and shared with treatment staff only if there is a need in order to protect 

 
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client or CFM safety or the safety of a child.  Other than those contingencies only the research staff 
composed of the PI, research assistants who will be administering the measures, and co-investigators 
will have continuing access to identified client data.  Other research staff will also have access on an 
as-needed basis.  For example, if the data analyst needs to access a particular client record he would 
have that access.  Data will be retained for publication purposes for five years following the last study 
publication, per usual data retention standards. 
 
(3) We have applied for and received a Federal Confidentiality Certificate from the Office of 
Research Protection. 
(4) We will create separate Excel spreadsheet logs of screens for patients and CFMs.  All 
screens will be logged into the spreadsheets with a yes/no for whether the individual meets each 
inclusion/exclusion criterion.  Individuals will be identified on the spreadsheet by screen participant 
number.  The screening spreadsheet will not contain names or contact information.  Screens for 
ineligible individuals will be filed in a locked file cabinet in a locked room without names or other 
identifying information on the forms.  If both the patient and CFM meet initial eligibility criteria and are 
interested in the study they will be assigned a study number, a file will be created for them, and their 
screens will be filed in their study file.  A second spreadsheet with study ID numbers and participant 
names for individuals who meet initial screening criteria and are interested in the study will include a 
field for screen participant number.  Because the screens and spreadsheet for ineligible potential 
participants will never have identifying information we plan to retain these data on the same schedule 
as other data (five years post publication).  The data from the screens will be used to report the number 
of individuals screened, and reasons for ineligibility. 
 
V. Participant Withdrawal 
 
Consent forms (see appended) will clearly state that participants may withdraw from the study 
intervention at any time for any reason and that this will not affect their course of treatment or standing 
in the criminal justice system (if applicable).  The research team will withdraw participants in the event 
that evidence of domestic violence or severe psychopathology is detected after the initial screening, as 
these factors could interfere with treatment.  Participants who withdraw from treatment will continue to 
be tracked for follow-up data collection.  Participants who withdraw completely from the study will no 
longer be tracked, although their data will be retained unless they request otherwise. 
 
 
PRIOR APPROVALS/REVIEWED AT OTHER IRBS 
This project will not be reviewed at another IRB. 
 
 
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APPENDICES 
 
1) Consent Form(s) 
2) Assessment(s) 
3) Other Documents: 
o Therapy manual 
o CASAA Emergency Procedures