A Culturally Sensitive Intervention for TBI Caregivers in Latin America
Phase: NA
Conditions: Traumatic Brain Injury
Sponsor: Virginia Commonwealth University

NCT00207803 
A Culturally Sensitive Intervention for TBI Caregivers in Latin America 
 
PI: Paul Perrin, PhD 
 
NCT #: 02207803 
 
Virginia Commonwealth University Internal Review Board (IRB): HM20001660 
 
Document approval date: 5/6/2014 
 
Document Type: Protocol 
 

NCT00207803 
Research Strategy 
Recruitment and 
Retention. Clinicians 
working on the rehabilitation 
units will inform TBI patients 
of the study. If the patient is 
interested, the site-PI will 
discuss the study and obtain 
informed consent, which will 
include their permission for 
the caregiver to participate. The site-PI will then invite the caregiver to participate and obtain informed consent. 
We selected a 12-month enrollment period because, based on TBI admissions data and previous studies 
conducted at the 3 sites, this window is necessary to enroll 110 dyads. Dyads will be randomly assigned to the 
treatment or control group, and each patient and caregiver will be paid the local currency equivalent of $10 per 
data collection. Demographic and baseline data will be collected prior to discharge, as well as outcome data at 
2 and 4 months post-discharge (Figure 2). A 4-month follow-up period was selected instead of a longer follow 
up because our research60 has suggested that the inpatient stay on an acute unit and the first 3 months post-
discharge are the most stressful time periods for family TBI caregivers, and that their mental health and health 
related quality of life only increase marginally between 3 months and 1 year post-discharge. Therefore, the first 
several months after discharge are a critical time frame for intervention and follow up, as these variables 
remain fairly constant after initiating a particular trajectory.  
TBI Patient Inclusion Criteria. All patients treated for TBI and discharged home will be invited to participate 
if they meet the following criteria: (1) give permission for their caregiver to participate; (2) sign an informed 
consent giving permission to obtain demographic and health information; (3) have the ability to communicate 
over the phone for data collection; and (4) are between 18-60 years of age. If a patient is aphasic (estimated 
10%), arrangements will be made to collect data with self-administered paper-pencil reports via postal mail. 
Caregiver Inclusion Criteria. TBI caregivers are eligible to participate who meet the following criteria: (1) 
have a telephone in the home or cellular phone and are able to talk on the phone; (2) sign an informed 
consent; (3) score at least a 13 on a health literacy screening tool; and (4) are between 18-85 years of age. 
Caregivers with scores below 13 will identify a family member or friend to review the guidebook with the 
caregiver. If no one is identified, the TAP clinician will review the materials with the caregiver.  
Sample Estimation and Power. We anticipate that during a 12-month enrollment period, we will enroll 
approximately 110 caregiver-patient dyads (n = 220), of which 55 will be in the treatment group and 55 will be 
in the control group. Of the 110 dyads, 20 will be in Cali, Colombia; 20 in Neiva, Colombia; and 70 in Mexico 
City, Mexico. Allowing for a 25% attrition rate based on our previous data collection1 with the TAP, over the 4-
month data collection period, we estimate complete data on 84 dyads.  
In order to determine the effect size that a final n of 84 dyads would be able to uncover, we performed a 
power analysis using G*Power 3 software for a repeated measures multivariate analysis of variance 
(RMANOVA) with three time points and two groups. This RMANOVA would uncover all large and medium-size 
effects, as well as many small-size effects. Our prior pilot study on the TAP generally showed medium-size 
effects on caregiver strain and depression, so our estimated sample size should be sufficient. Additionally, in 
the proposed study, the intervention will include in-home interventions of 60-minute duration, as opposed to the 
30-minute duration in our previous pilot study. We are therefore expecting a larger effect size in the proposed 
study. If the TAP is found to be effective based on these analyses, at the end of the study, caregivers in the 
control group will receive the caregiving guidebook that had been provided to the intervention group as well as 
a written summary of the problem solving techniques and skills addressed in the intervention. 
Transition Assistance Program Intervention. Dr. Perrin, Dr. Arango, and the site-PI will train a clinical 
psychologist at each rehabilitation facility to provide the TAP. Only clinical psychologists will serve as clinicians 
in order to reduce possible confounds from differing professional specialties of clinicians. The TAP involves 
three components to improve caregiver mental health and informal care: (1) skill development, (2) education, 
and (3) supportive problem solving. The TAP includes one face-to-face meeting between the clinician and 
caregiver prior to discharge, as well as an in-home visit to the caregiver in weeks 1, 2, 4, and 6.  
Guidebook Development. Our research team will develop a guidebook entitled “A Guidebook for TBI 
Caregivers” based heavily on our research examining the needs of TBI caregivers in Latin America, as well as 
on other published studies on TBI. Our research25 has shown, for example, that the top reported needs of TBI 

NCT00207803 
caregivers in this region include “To have a professional to turn to for advice,” “To have my questions 
answered honestly,” “To have enough resources for the patient,” and “To have explanations from professionals 
given in terms I can understand.” This guidebook will be created to target these needs directly and therefore 
likely include chapters addressing (1) basic medical information about TBI, (2) common caregiver experiences, 
(3) TBI recovery issues such as disability, disruption in sense of self, social isolation, and depression, and (4) 
resources to assist TBI caregivers. An extensive formative evaluation of the guidebook will include focus 
groups with TBI clinicians at the rehabilitation facilities in Mexico and Colombia, as well as with TBI clinicians 
and researchers at Virginia Commonwealth University. The guidebook will be translated into Spanish and 
piloted with TBI clinicians and caregivers at the rehabilitation sites in Colombia and Mexico who will provide 
quantitative and qualitative feedback on the guidebook’s appropriateness for Latino TBI caregivers. After the 
feedback is incorporated into the guidebook, it will be ready for further evaluation in this study. In the TAP for 
stroke caregivers which we implemented in Puerto Rico and Texas1, we developed and piloted the guidebook 
in the first 2 months of that study’s timeline. For the current proposal, we doubled the estimated time for this 
deliverable in order to account for possible challenges in piloting the guidebook at 3—instead of 2—sites. 
Session 1. In preparation for Session 1 with the caregiver, the rehabilitation clinician delivering the TAP will 
meet with the facility’s rehabilitation team to identify the primary difficulties anticipated for the TBI patient after 
discharge. The clinician will take notes on the particular needs of the patient and bring these notes to Session 
1 with the caregiver. Before discharge, the clinician will implement Session 1, a 1-hour meeting with each 
caregiver in the intervention group only. The primary focus of Session 1 is to orient the caregiver to the TAP 
and prepare the caregiver for discharge home. The clinician will provide the caregiver a guidebook and 
orientation to it, encouraging the caregiver to use it as a resource. 
The clinician will also administer the health literacy screening tool, and with caregivers who score below a 
13, the clinician will help identify a family member or friend to review the guidebook with the caregiver. The 
clinician will then ask what concerns the caregiver has about taking care of the TBI patient after discharge, 
taking notes on the caregiver’s responses. The clinician will also share with the caregiver the primary 
difficulties that the rehabilitation team had anticipated the TBI patient experiencing after discharge. The 
clinician will provide support and help the caregiver problem-solve caregiving related to these issues. 
Sessions 2-5. The clinician will make four 1-hour in-home visits to the TBI caregiver at 1, 2, 4, and 6 weeks 
after hospital discharge. The TBI patient may or may not be present during these visits, depending on the 
needs and wishes of the caregiver. These visits will involve the same general format. The clinician will bring his 
or her notes from the previous sessions and from the rehabilitation team’s input. The clinician will review the 
content of these notes with the caregiver, checking in to see whether the problems are still present and to what 
extent. The clinician will engage in supportive problem-solving and will refer the caregiver to the guidebook 
sections relevant to the issues, walking the caregiver through those sections. Because of this format, the TAP 
is specifically designed for clinicians to tailor its use not only according to possible cross-site differences in 
what may be necessary for the intervention, but also for differences in caregiver care responsibilities and 
needs within a single site. The entire structure of the TAP is centered around the caregiver’s most pressing 
needs. The clinician will take notes on the continued problems and the strategies for resolving them. 
Data Collection 1. After enrollment and immediately before discharge (as well as before Session 1 for the 
treatment group), demographic and baseline data will be collected from the TBI patient and caregiver. The site-
PI will meet with the patient and caregiver separately. The site-PI will read items aloud from an assessment 
packet to the patient and caregiver, circling participants’ responses. The caregiver packet will include validated 
measures of caregivers’ health status, health care utilization/cost, burden, depression, sense of coherence, 
quality of informal care provided, and relationship satisfaction. The patient packet will include validated 
measures of patients’ functional and health status, health care utilization/cost, self-perceived burden, 
depression, quality of informal care received, and relationship satisfaction. 
Data Collection 2-3. At 2 and 4 months after hospital discharge, the site-PI will collect follow-up data from 
the TBI patient and caregiver over the phone using the same validated measures and in the same format as 
during Data Collection 1. For the treatment group only in Data Collection 2, the site-PI will also collect 
qualitative information from the  
Outcome Measures. The majority of outcome measures have previously been translated and validated 
among Spanish speakers. For the four that have not (Exemplary Care Scale, Relationship Assessment Survey, 
Self-Perceived Burden Scale, and Brief Health Literacy Screening Tool), we will use Chapman and Carter’s31 
methodology to translate and back-translate the measures, whereby a bilingual and bicultural researcher will 
translate the original measure into Spanish, and a separate bilingual and bicultural researcher blinded to the 

NCT00207803 
original measure will then back-translate it into English. Any discrepancies between the original English and 
back-translated English will be resolved mutually. We will pilot the four translated measures with rehabilitation 
teams at each site and amend the instruments to improve their face validity in the three local cultures54 while 
ensuring the standardization of each instrument across the three sites. We will then administer the instruments 
over the course of our study, and after collecting outcome data, we will run exploratory factor analyses to 
establish each measure’s factor structure, as we have done and advocated for in our own research 
investigating measure psychometrics among individuals after acute TBI54 and across various global regions55. 
Based on these analyses, we will remove items that do not accurately measure the constructs under scrutiny57. 
Functional Independence Measure (FIM; patient functional status). The FIM is the most widely used 
method of assessing function and assistance needs in individuals with a disability. The FIM has a total score 
and six subscales: self-care, sphincter control, transfer capability, locomotion, communication, and social 
cognition. The FIM32 consists of 18 items, and responses use a 7-point ordinal scale. The reliability of the FIM 
is well established: in a meta-analysis33 the median inter-rater reliability for the total FIM was 0.95 and the 
median test-retest and equivalence reliability values of 0.95 and .92 respectively.  
Exemplary Care Scale (ECS; patient and caregiver rating of quality of informal care). The ECS is an 11-
item self-report questionnaire that assesses the extent to which caregivers engage or do not engage in 
activities that help care recipients maintain dignity and respect.34 Response choices are on a Likert scale (1 = 
never; 2 = sometimes; 3 = often; 4 = always), and higher scores indicate higher exemplary care. Parallel 
caregiver and care recipient versions are available, with equivalent measurement properties. The ECS has 
been shown to be a valid measure of the quality of informal care for individuals with disabilities.34  
Patient Health Questionnaire-9 (PHQ-9; patient and caregiver depression). The PHQ-935 is the depression-
specific module of the Patient Health Questionnaire. The 9-item instrument directs the respondent to indicate 
how often he/she has been bothered by each item using a response from 0 (not at all) to 3 (nearly every day). 
Total score range from 0 to 27, and higher scores represent high depression. The Spanish version used for 
this study36 is reliable and valid in assessing depression in Spanish speakers.37,38  
Relationship Assessment Survey (RAS; patient and caregiver relationship satisfaction). The RAS39 is a 7-
item scale originally developed to assess quality of marital relationships but was later adapted to apply for 
multiple types of interpersonal relationships (RAS-G40). Item responses are on a 5-point Likert scale (1 = not 
satisfied and 5 = very satisfied), and higher scores represent higher satisfaction. 
Self-Perceived Burden Scale (SPBS; patient self-perceived burden). The SPBS assesses care recipients’ 
feelings of dependence and guilt over responsibility for their caregiver’s difficulties.41 The SPBS contains 10 
items which respondents rate with a 5-point Likert scale (1 = none of the time and 5 = all of the time), with 
higher scores indicating higher self-perception of a being a burden. 
Sense of Coherence Scale (SOC; patient and caregiver sense of coherence). The SOC42 is a 13-item self-
report questionnaire that assesses a person’s tendency to perceive life events as meaningful, understandable, 
and manageable.43 Item responses range from 1 (never) to 7 (very often), and higher scores reflect a stronger 
sense of coherence.44 The Spanish SOC has good internal reliability and validity.43  
Zarit Burden Interview (ZBI; caregiver burden). The ZBI45 is one of the most widely used scales measuring 
subjective caregiver burden. It is a 22-item, self-report questionnaire with items referring to the 
caregiver/patient relationship and evaluating the caregiver’s health condition, psychological well-being, 
finances, and social life. Responses can range from ‘never’ to ‘nearly always,’ and higher scores indicate 
greater levels of caregiver distress.46 The Spanish version of the ZBI has good internal reliability.47  
36-Item Short Form (SF-36; patient and caregiver health status). The SF-36 is one of the most widely used 
instruments to assess self-reported Health-Related Quality of Life (HRQoL) in individuals with TBI.48 The items 
address eight dimensions of health: physical function, role-physical, bodily pain, general health, energy/vitality, 
social function, role-emotional, and mental health. Scores range from 0-100, with higher scores indicating 
better health. It has been translated Spanish, and has well-established reliability and validity in Spanish-
speaking populations.49  
Brief Health Literacy Screening Tool (BRIEF; caregiver health literacy). The BRIEF50 is a 4-item measure of 
health literacy level. In its initial construction, a factor analysis indicated that the BRIEF measures one distinct 
construct: “health literacy” (Eigenvalue = 2.4) accounting for 60% of score variance. The BRIEF has good 
convergent validity with other longer measures of health literacy. 

NCT00207803 
Overall Study Timeline. An activity and milestone timeline for the 2-year grant cycle appears in Table 1.