Intervention Pilot With Parents of Technology-Dependent Children
Phase: NA
Conditions: Depressive Symptoms, Multiple Chronic Conditions, Family Caregivers
Sponsor: University Hospitals Cleveland Medical Center

 
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[USE THIS BIOMEDICAL PROTOCOL TEMPLATE IF YOUR PROJECT INVOLVES ANY 
PHYSICAL CONTACT OR MEDICAL INTERVENTIONS WITH PARTICIPANTS]   
 
INSTRUCTIONS: 
 Use this template to prepare a document with the information from the following 
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when making changes.  
 
PROTOCOL TITLE: 
 
Intervention Pilot with Parents of Technology-Dependent Children  
(Modified 6/1/18 and approved by UHCMC IRB) 
 
PRINCIPAL INVESTIGATOR: 
 
Name- Valerie Toly, PhD, RN, CPNP 
 
Primary Department- CWRU FPB School of Nursing 
 
Telephone Number- 216-368-3082 
 
Email Address- vab@case.edu 
 
UH FACULTY ADVISOR: 
If the principal investigator’s primary role at UH is resident, fellow or student, identify a faculty 
advisor. 
 
Name N/A 
 
Primary Department 
 
Telephone Number  
 
Email Address 
 
OTHER DEPARTMENTS INVOLVED IN THIS STUDY (IF APPLICABLE): 
Pulmonology- Dr. Kristie Ross is the UH Sponsor 
 
VERSION NUMBER: 
 
Include the version number of this protocol if assigned by an outside entity.  
I am not sure of the version number.  
 
DATE:  
 
Include the date of submission or revision.  
It is the current version as of May 21, 2018 
 
 
 
 
 
 

 
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Objectives 
 
1. Describe the purpose, specific aims, or objectives. 
2. State the hypotheses to be tested.   
Purpose: The purpose of this randomized clinical trial (RCT) is to test the efficacy of a 
Resourcefulness Training intervention designed for 94 parent (male and female) 
caregivers of technology-dependent children on the parents’ psychological and physical 
outcomes and on family outcomes at 6 weeks, 3 months, and 6 months post-intervention. 
Theoretical underpinnings of Resourcefulness Training posit that caregivers with greater 
resourcefulness will experience less stress and, as a result, will augment their caregiving 
capacity. This intervention involves the following components: 1) a face-to-face session for 
teaching social (help-seeking) and personal (self-help) resourcefulness skills using a 32 minute 
video, 2) ongoing access to video vignettes of parents of technology-dependent children 
describing the application of resourcefulness skills in daily life, 3) 4 weeks of skills’ 
reinforcement using daily journal writing by the parents, and 4) weekly phone calls from the 
intervention nurse over 4 weeks after face-to-face intervention training. Booster sessions for the 
intervention group at 2 and 4 months post-intervention consist of a phone call and one week of 
journal writing. The Attention Control group will receive weekly phone calls for the first four 
weeks plus any usual care. In this exploratory stage of intervention work, we will evaluate the 
impact of the intervention on psychological and physical outcomes and family outcomes (family 
functioning) over time and whether changes in resourcefulness skills mediate these outcomes.  
 
The specific aims of the study are to: Aim 1: Determine whether Resourcefulness 
Training versus Attention Control improves psychological (general mental health, 
depressive cognitions, depressive symptoms, appraised stress, burden) and physical 
outcomes (general physical health, chronic stress [hair cortisol]) and family outcomes 
(family functioning) over 6 months in parents of technology dependent children, after 
controlling for the parents’ race/ethnicity, sex, family income, and children’s functional 
status. Aim 2: Determine whether changes in psychological and physical outcomes 
andfamily outcomes are mediated by changes in parents’ levels of resourcefulness 
(personal and social). 
   
 
Background 
1. Describe the relevant prior experience and gaps in current knowledge describing how it 
will add to existing knowledge.      
2. Describe any relevant preliminary data.      
 
Please add relevant references at the end of the protocol, not at the end of this section. 
Introduction/Background 
Caring for a child at home who is dependent on medical technologies such as mechanical 
ventilation, intravenous nutrition, feeding tubes or tracheostomies, can be a daunting task. 
Mothers, often the primary caregivers of technology-dependent children, not only manage the 
demanding care regimens and coordinate the frequent health care and therapy appointments, but 
must handle many other household responsibilities and perhaps outside employment. Past 

 
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research indicates that maintaining the mental health of caregivers and positive family 
functioning affect the chronically ill child’s growth and development.1 Toly2 found that 39.2% of 
mothers caring for a technology-dependent child at home (n=103) scored ≥ 16 on the Center for 
Epidemiological Studies- Depression Scale (CES-D) indicating high risk for clinical depression. 
Furthermore, 34.9% of the variance in family functioning was explained primarily by level of 
depressive symptoms, underscoring the impact of such symptoms.2 Empirical evidence indicates 
that resourcefulness training (RT) is an effective cognitive-behavioral intervention that directly 
contributes to a decrease in negative emotions and depressive cognitions and improved 
functioning and health3-5and it can be implemented on an individual basis in a variety of locales.  
This pilot study will provide valuable experience in the development and testing of a RT 
intervention with mothers of technology-dependent children as well as provide necessary 
preliminary data regarding effect size for a larger, subsequent intervention study. The study 
results will also aid in any necessary intervention modifications based upon the feasibility, 
acceptability, and fidelity information gleaned from participants and interventionists. 
Justification/Rationale/Significance of the Study 
In controlled, experimental trials, RT was found to significantly improve resourcefulness,3-5 
adaptive functioning and life satisfaction15 in elders. RT also improved negative emotions, 
functioning and depressive cognitions up to 12 weeks post intervention.6 While past studies of 
RT have used a group teaching format/videoconferencing,4 two current studies are examining the 
efficacy of RT using an in-person individual format including grandmothers raising 
grandchildren.16  This format is based on research indicating stronger effects for individualized 
interventions16. Additionally, this study includes an opportunity to practice and reinforce RT 
skills taught using expressive writing (EW); personal journaling about specific events. EW has 
been found to significantly improve physical and psychological health and reduce negative 
emotions as well as health care visits.17 While RT has not been tested in young caregivers, 
equivocal effectiveness is anticipated.  
Although children with special health care needs comprise only 16.2% of all children under 
18 years, they accounted for 45.5% of the medical expenditures in 2000 due to significantly 
more out-patient visits, hospitalization, and medications than other children.18 Children who are 
technology dependent, while small in number, consume a large proportion of the health care 
dollars, yet little research has been done to examine how to help promote positive family 
functioning that will assist in better care for their child. 
The study model is based on resourcefulness theory.19-20 Major constructs in the model 
represent contextual factors, process regulators, resourcefulness (personal, social), and quality of 
life outcomes. RT is proposed to directly affect all model constructs except contextual factors as 
indicated by dashed lines. Contextual factors include mother’s variables (age, race, income, 
education), child’s variables (age, level of technology dependence, functional status) and 
caregiving situation (duration of care, amount of home health care nursing). Process regulators 
(depressive cognitions, depressive cognitions, burden, stress) include variables that mediate 
effects of contextual factors on resourcefulness. Depressive cognitions are thought patterns that 

 
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may lead to depression.22 Assertions that cognitions influence resourcefulness has been validated 
in women caregivers.19 
Resourcefulness is an “acquired repertoire of skills and behaviors necessary for the 
successful execution of self-control behavior.”19 p.26 These skills are learned throughout life by 
informal training or may be taught in cognitive behavioral programs and include the belief that 
one is able to cope effectively despite adversity.19 Skills of self-instruction, problem-solving, 
belief in coping effectiveness are used to control the effects of disturbing feelings, thoughts and 
sensations on performance of daily tasks.19 Zauszniewski’s20 model includes personal 
resourcefulness (self-help) and social resourcefulness (help-seeking) that are beneficial for 
maintaining healthy physical and psychological functioning across the lifespan. Resourcefulness 
training (RT) includes teaching positive self-talk, problem-solving and priority setting.15 
Empirical evidence indicates that resourcefulness is a significant predictor of quality of life 
for non-caregivers/caregivers.19, 23 Parent outcomes are conceptualized as absence of depressive 
symptoms, positive family functioning, better self-assessed health. Depressive symptoms 
include depressed mood and feelings of helplessness and hopelessness.10 Greater resourcefulness 
is a significant predictor of a decreased level of depressive symptoms.25 Conversely, less 
resourcefulness contributed to perceptions of worse family functioning in grandmothers raising 
grandchildren.17 Family functioning is a parent’s perception and level of satisfaction with 
relationships between the family and individuals as well as subsystems and the community. Self-
assessed health is the mother’s perception of her health and includes both physical and 
psychological well-being.27 Based on the theoretical and empirical literature, the study model 
proposes that contextual factors, process regulators, and resourcefulness all directly affect quality 
of life outcomes.  
 
Inclusion and Exclusion Criteria 
1. Describe how individuals will be screened for eligibility.  
2. Describe the criteria that define who will be included in your final study sample.  
 
Inclusion 
1. 
Parents who are at least 18 years of age 
2. 
Parents caring for a child age 16 years and younger at home who is technology-
dependent (Group 1 mechanical ventilators; Group 2 intravenous 
nutrition/medication; Group 3 respiratory or nutritional support); 
3. 
Able to speak, write and understand English. 
4. 
 
 
3. Describe the criteria that define who will be excluded in your final study sample. 
 
Exclusion 
1. 
Parents of children with cancer. 
2. 
 
3. 
 
4. 
 
 

 
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Number of Research Participants 
1. Indicate the target number of research participants to be accrued locally.  
2. If this is a multi-site study, indicate the total number of research participants to be 
accrued across all sites. 
For this study, 123 subjects are expected to be enrolled.  
Vulnerable Populations 
1. Indicate specifically if you will include each of the following special populations by 
checking the appropriate box:  
☐ 
Adults unable to consent 
 
☒ 
Minors (infants, children, teenagers)  
 
☐ 
Wards of the state 
 
 
☐ 
Foster Children 
 
☒ 
Pregnant Women  
 
☐ 
Neonates 
☐ 
Neonates of Uncertain Viability 
 
☐ 
Employees of CWRU or UHHS 
 
☐ 
Prisoners 
 
☐ 
Illiterate Individuals 
 
☐ 
Non-English Speaking 
 
☐ 
University Students 
 
2. If the research involves individuals that are included in a vulnerable population, describe 
the additional safeguards included to protect the rights and welfare of the individuals for 
each population indicated. 
 
We will include pregnant women or women who become pregnant while enrolled in the 
study because many mothers of technology-dependent children are in the child-bearing 
years. They will be told that they are volunteers and can leave the study at any time. 
While we will not be directly asking the children any questions we will be asking their 
parent to describe things such as what type of technological equipment they use and 
questions about their eating and sleeping. Therefore, we have a procedure for asking 
about the child’s assent if they are 7 years or older. 
 
3. If excluding pregnant women, illiterate or non-English speaking individuals, provide a 
scientific rationale for the exclusion.  Inconvenience or cost is not an acceptable 
rationale. 
We will exclude illiterate or non-English speaking individuals due to the amount of 
reading, writing that must be done as part of the intervention and follow up data 
collection. Also, our instruments have not been translated into another language. 
 
Recruitment Methods 
1. Describe the source of the research participants.  
2. Describe the methods that will be used to identify potential research participants.  

 
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3. Justify the feasibility of recruiting the required number of suitable research participants 
within the agreed recruitment period. For example, how many potential research 
participants do you have access to?  
4. Describe when, where, and how potential research participants will be recruited.  
5. Describe materials that will be used to recruit research participants. 
 
Participant recruitment and enrollment: RB&C Specialty Clinics (Pulmonary, 
Gastroenterology, Trach/Vent, Comprehensive Care) and Family Learning Center who are 
associated with this study will distribute the IRB approved study flyer or brochure that 
contains study staff contact information to potential participants. Potential participants can 
then call the study staff with questions or to volunteer.  
 
We will also check EMR (All Scripts, Soarian, Whiteboard) and do prescreening for 
potential participants by checking pulmonology outpatient clinic schedules. We will come to 
clinic to meet those who meet eligibility to invite them to hear more about the study. If they 
are interested the study team member will ask about a date/time for appointment. If they are 
unsure of their schedule we will ask for the best way to contact them to set up appointment at 
a time/place of their choosing like their home or a library.  
 
Another recruitment strategy will be to post IRB approved study flyers in RB&C/UH 
Common areas, Family Learning Center and Family Resource Center as well as the RB&C 
inpatient units that admit technology-dependent children and their corresponding family 
lounge bulletin boards or posting areas as well as clinic rooms. This will help to gain 
visibility of our study to enhance recruitment efforts. 
 
We will also distribute our brochures and flyers at family health fairs, specialty 
organization meetings, support groups, parenting events and gatherings that are frequented 
by parents of technology-dependent children in Northeast Ohio community to promote 
awareness of the study by community. In addition, they will be distributed to organizations 
such as United Cerebral Palsy, Achievement Center of Cleveland, Health Departments that 
provide services for technology-dependent children and their families. We will also place ads 
in regional Parenting Magazines and Facebook to help promote recruitment.  
 
Discharge coordinators from RB&C 3, 5, and 6 who typically admit children who are 
discharged home dependent on technology will identify potential participants who meet 
eligibility criteria and ask if a study team member can speak with them about the study. If 
they agree, a study team member will talk with the parent and ask the best way to contact 
after the child is discharged home. Data collection would be completed following the child's 
discharge.  
 
The RB&C Specialty Clinics (Pulmonary, Gastroenterology, Trach/Vent, Comprehensive 
Care) will identify names and contact information of patients meeting inclusion criteria. A 
letter describing the study and a request for the parent to contact the researcher will be sent 
by study staff to mothers. The letter also informs the parent that study staff will follow-up 
with him/her by telephone in about 1 week. This method of recruitment has been successful 
in the Principal Investigator’s previous studies. An assent information letter for the child will 

 
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also be included with the letter sent to the mother. The parent is to give this letter to the child 
to read if he/she is over age 7 years and able to read it independently. If the child is over 7 
years of age and is unable to read the letter independently, the mother will be asked to read it 
to the child. The parent will then obtain verbal assent from the child that he/she is in 
agreement to have the mother participate in the study. Potential participants will be contacted 
by telephone to assess eligibility and to determine if she is willing to participate in the study. 
During the telephone pre-screening interview, the nature of the study and the fact that the 
interview is part of a pre-screening process and does not represent enrollment in the study 
will be clearly explained to the subject.  The questions asked during the interview do not 
present more than minimal risk or harm to the participants and the interview does not contain 
any procedures for which written consent is normally required outside of the research context 
according to 45 CFR 46.117 (c ) 2. See attached document for pre-screening question. This 
question will determine if the child remains dependent on medical technology and thus 
determines the parent's eligibility for participation in the study. 
 
We will also recruit potential participants using Facebook and Twitter. This includes 
development of a Facebook page that includes contact information for study staff and the 
IRB approved recruitment flyer. “Friend” requests will be made to parent caregiver 
organizations who have members likely to meet eligibility requirements that includes an 
introductory letter. We will also recruit using Facebook ads that target users that have 
connections with technological equipment, technology-dependence and children. Twitter will 
also be used for recruitment. An image of the IRB approved study flyer will be attached with 
the tweets. 
 
Participants who meet the inclusion criteria will be identified by the RB&C pulmonary, gastroenterology, 
trach/vent and comprehensive care clinics and invited to participate.  A letter describing the study and a 
request for the parent to contact the researcher will be sent by study staff to these mothers. The letter 
also informs the parents that study staff will follow-up with him/her by telephone in about 1 week. This 
method of recruitment has been successful in the Principal Investigator’s previous studies. An assent 
information letter for the child will also be included with the letter sent to the parent. The parent 
is to give this letter to the child to read if he/she is over age 7 years and able to read it 
independently. If the child is over 7 years of age and is unable to read the letter independently, 
the parent will be asked to read it to the child. The parent will then obtain verbal assent from the 
child that he/she is in agreement to have the mother participate in the study. Potential participants 
will be contacted by telephone to assess eligibility and to determine if she is willing to participate 
in the study. Following this assessment and affirmation of the parent’s willingness to participate 
they will be queried as to the child’s receipt of the assent letter and confirm the child’s assent to 
have the mother participate in the study. With the above confirmed, the parent will be asked to 
set up an appointment with the research staff at a mutually convenient time and location. If the 
potential participant does not contact the research team in 1 week a phone call will be made to invite 
them to volunteer for the study. 
  
In addition to the informational letter that will be sent to potential participants identified by study sites, 
clinic providers will hand out a flyer that gives the study contact information. It will be up to the parent 
to then contact the study staff to ask questions or to volunteer to participate. The flyer will help to 
advertise the study. 

 
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Potential participants will also be recruited using a Facebook page and Twitter. Both forms of social 
media will assist in the distribution of the IRB approved study flyer to enhance recruitment efforts. We 
will include limits of Northeast Ohio since data collection is done face-to-face. 
  
1. A Facebook page will be developed to post the flyer and increase awareness regarding the study. A 
"Friend" request will be sent to other parent caregiver organizations with Facebook sites likely to include 
eligible participants  asking for permission to post the IRB approved study flyer on their Facebook page 
and let their members know about the study. The informational letter to be sent with the "Friend" 
request is attached. 
  
2. Tweets are limited to 140 characters or less. Tweets will be used and an 
image of the study flyer will be attached with the tweets.  As we find more 
followers and parent caregiver organizations, we will tag them in our tweets to 
increase our visibility. “@” will be used to tag or mention an organization  and 
“#” will be used to categorize the tweets. Here are examples of tweets: 
  
@resourceTD needs your help to test a way to reduce stress in #parent 
#caregivers of technology-dependent children in Northeast Ohio! 
@resourceTD Are you a #parent #caregiver of a child who uses #oxygen 
#ventilator or #gtube medical technology in Northeast Ohio? 
@fpbnursing researching how to reduce stress in #parent #caregivers of 
children on medical technology in Northeast Ohio. Please contact us to help! 
 
Following this assessment and affirmation of the mother’s willingness to participate the 
parent will be queried as to the child’s receipt of the assent letter and confirm the child’s 
assent to have the mother participate in the study. With the above confirmed, the parent will 
be asked to set up an appointment with the research staff at a mutually convenient time and 
location. If the potential participant does not contact the research team in 1 week, a phone 
call will be made to invite them to volunteer for the study.  
An appointment will be made to meet with the potential participant at the time and place 
of their choosing (their home, public library, their place of employment, child's therapy 
center such as United Cerebral Palsy Center, Dahm's Clinical Research Unit) to obtain 
informed consent. Study personnel will obtain informed consent and explain to the potential 
participant that he/she is being asked to provide consent for participation in a research study. 
It will be explained that participation is totally voluntary and their choice regarding 
participation will not affect their child's care in any way. Additionally, parents will be given a 
description of the study, procedures, risks and benefits, confidentiality and voluntary nature 
of the study including the option to withdraw at any time. Following this discussion, parents 
will be given the consent form to review. Parents will be given the opportunity to take a few 
minutes alone to review the written consent form and to make a decision regarding 
participation. No data collector that has clinic contact with the potential participant will 
engage in their recruitment so there is no undue influence to participate. Parents will be 

 
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assured that none of the data obtained will be communicated to any healthcare personnel at 
the outpatient clinic or hospital site. A study brochure will be given to participants. 
 
Setting 
1. Describe the sites or locations where your research team will conduct the research.  
We will conduct the research data collection at a private place of the parent’s choosing 
such as their home, library. Our study office is located in the FPB School of Nursing, 
CWRU. 
 
2. Identify where your research team will identify and recruit potential research 
participants. As described in the above section we will recruit our participants from a 
number of RB&C Specialty Clinics (Pulmonary, Gastroenterology, Trach/Vent, 
Comprehensive Care) and Family Learning Center. We will also distribute our brochures 
and flyers at family health fairs, specialty organization meetings, support groups, 
parenting events and gatherings that are frequented by parents of technology-dependent 
children in Northeast Ohio community to promote awareness of the study by community. 
In addition, they will be distributed to organizations such as United Cerebral Palsy, 
Achievement Center of Cleveland, Health Departments that provide services for 
technology-dependent children and their families. We will also use social media such as 
Facebook and Twitter as well as place Facebook ads to advertise the study. The RB&C 
specialty clinics will provide lists of eligible participants so that an introductory letter can 
be sent out to potential participants asking them to contact the study office or in 2 weeks 
we will contact them to see if they are interested in participating. We will also be using 
UH EMR (Physician Portal, Sorian) to screen RB&C specialty clinics described above 
for potential participants and go to the clinic to invite them to hear more about the study 
 
3. Identify the physical location where research procedures will be performed.  
See above comments. Data collection- private place of the parent’s choosing. 
 
Consent Process 
Indicate whether you will be obtaining consent: 
☒ Yes  
☐ No 
 
If yes describe: 
 Where the consent process will take place 
 Any waiting period available between informing the prospective subject and 
obtaining the consent 
 Any process to ensure ongoing consent 
 The role of the individuals listed in the application as being involved in the 
consent process 
 The time that will be devoted to the consent discussion 
 Steps that will be taken to minimize the possibility of coercion or undue influence 
 Steps that will be taken to ensure the research participants’ understanding 
Where consent take place: Private place of the parent’s choosing. 

 
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Waiting period: The potential participant will have time between when they schedule the 
appointment and arriving at the appointment. 
Process to ensure ongoing consent: The participant ensures ongoing consent if they schedule and 
show up for data collection appointments. 
Role of individuals listed on application involved in consent process: All listed on the application 
as obtaining consent will ask the potential participant if they would prefer to read the or to if 
they’d like the team member to go through the consent form with the participant. The team 
member would then answer any questions they may have about the study.   
Time devoted to the consent process: Typically, it takes 5-10 minutes depending on how long it 
takes the participant to read the consent and the number and type of questions.  
Steps to minimize coercion or undue influence: No team member performing consent process 
will be provider of care for the parent, child. Team members obtaining consent will be certain to 
mention that they are volunteers and their care won’t be affected in any way by decision to 
participate or not participate in the study.  
Steps to ensure participants’ understanding: To ascertain that potential participants fully 
understand the study, what is required of them, risks and benefits and their rights as a participant 
they will be asked to indicate understanding with a "yes" or "no" response. They will also be 
given an opportunity to ask any questions they have regarding the study. 
 
Waiver or Alteration of Consent Process or Documentation (consent will not be obtained, 
written consent will not be documented) 
Indicate which part of the consent process you are requesting be waived or altered: 
☐ 
I will obtain consent, but not participant’s signature 
☒ 
I will obtain consent, but request a waiver for pre-screening purposes 
 
☐ 
 I will obtain consent, but request a waiver of some of the elements of consent  
                      (e.g. use of deception) 
 
☐ 
 I will not obtain consent, and I am requesting a full waiver of consent 
 
1. Give the rationale for the request of a waiver or alteration of the consent process or 
documentation.  
We need to have a waiver due to prescreening to verify if the individual is eligible for the 
study.  
 
2. If you will obtain consent, but not document consent in writing (e.g. over the phone, 
verbally, electronic survey, etc.), please describe and provide a rationale. N/A 
Describe how you will be documenting that a research participant has consented 
 
Be sure to upload a consent script or information sheet with your study protocol 
 
Additional Considerations for Consent Process with Adults 
Non English Speakers 
 If research participants who do not speak English will be enrolled, describe the 
process to ensure that the oral and written information provided to those research 
participants will be in that language during initial consent as well as throughout 
the study. Indicate the language that will be used by those obtaining consent.  

 
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 List the language(s) other than English that will be included. 
 Above is Not Applicable 
 
Adults Unable to Consent 
 Describe the process to determine whether an individual is capable of consent. 
 List the individuals from whom permission will be obtained in order of priority 
(e.g. durable power of attorney for health care, court appointed guardian for 
health care decisions, spouse, and adult child).  
o For research conducted outside of the state, provide information that 
describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
procedure(s) involved in the research. 
Above is Not Applicable 
 
 Describe the process for assent of the research participants. Indicate whether: 
o Which subjects that are unable to consent will be required to give assent? 
If not all, explain why.  
o Describe whether assent of the research participants will be documented 
and the process to document assent.  
Above is Not Applicable 
 
Research Participants Who Are Not Yet Adults (infants, children, teenagers) 
1. Will parental permission be obtained from: 
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child or 
☐  Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the care 
and custody of the child 
☐  Waiver of parental permission 
Above is Not Applicable 
 
2. Describe whether permission will be obtained from individuals other than parents, 
and if so, who will be allowed to provide permission. Describe the process used to 
determine these individuals’ authority to consent to each child’s participation in 
research.  
Above is Not Applicable 
 
3. Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required to 
assent. Children who are 7 years of age or older. An assent information letter for 
the child will also be included with the letter sent to the parent. The parent is to 
give this letter to the child to read if he/she is over age 7 years and able to read it 
independently. If the child is over 7 years of age and is unable to read the letter 
independently, the parent will be asked to read it to the child. The parent will 

 
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then obtain verbal assent from the child that he/she is in agreement to have the 
mother participate in the study 
 
4. When assent of children is obtained describe how it will be documented. 
Assent will be documented during the time scheduling takes place. Document along 
with scheduling notes in Project Manager’s log.  
 
 
 
Sharing of Results with Research Participants 
Describe whether results (study results or individual subject results such as results of 
investigational diagnostic tests, genetic tests, or incidental findings) will be shared with the 
research participants or others (e.g. the subject’s primary care physicians) and if so, describe 
how the results will be shared.  
 
 
☒  Results will not be shared with research participants 
Results will be shared after the study and the study analysis are complete by request only. 
 
 
Study Design, Procedures and Timeline 
1. Describe and explain the study design.  
 
 
Research Design. A quasi-experimental RCT design with random assignment 
will be used to test the efficacy of a Resourcefulness Training (RT) intervention 
compared with an attention control group in mothers and fathers of technology-
dependent children. All participants will receive a face-to-face visit from study 
staff for the T1 data collection. In addition, the intervention group will receive 
individually tailored RT web based instruction via an approximately 30 minute 
video that provides details on each of the 8 resourcefulness skills with short 
examples of application, instruction on journal writing to practice and reinforce 
use of resourcefulness skills, access to video tapes of parents describing 
application of resourcefulness skills in the care of their technology-dependent 
child. Parents will be asked to provide their email address so that we may send 
them invitation for access to the website that they may visit at any time to 
access the video tapes. Data will also be collected face-to-face at 3 months (T3) 
and 6 months (T4) post-intervention. At 6 weeks parents will be emailed a link 
to the REDCap survey for Time 2 data collection and contacted by phone for SF-
12 survey with email reminders. Open-ended questions following their final data 
collection appointment will allow mothers/fathers to discuss feasibility, 
acceptability, and fidelity of this intervention and suggestions for potential 
modification of the intervention and follow up procedures. 
For this study, 99 female participants and 24 male participants are expected to 
be enrolled that takes into account 10% attrition. 
Measures/Instruments. 

 
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The Depressive Cognition Scale an 8-item scale (α =.75), will measure 
depressive thought patterns that may lead to depression.8 Reponses on a 6-
point scale range from strongly agree (5) to strongly disagree (0) with a score 
range 0-40. Items include depressive cognitions such as hopelessness and 
worthlessness; higher scores indicate more depressive cognitions. 
The Resourcefulness Scale, a 28-item scale (α =.85), will assess both 
personal (16 items) and social (12 items) resourcefulness.9 Responses on a 6-
point scale range from extremely descriptive (5) to not descriptive (0) with a 
score range 0-140; higher scores indicate greater resourcefulness. Construct 
validity was assessed using confirmatory factor analysis. 
The CES-D Scale will measure depressive symptoms.10 The 20-item interval 
scale (α =.85), with responses ranging from rarely (0) to most or all of the time 
(3) is summed; higher scores indicate more depressive symptoms. A cut-off of 
16 is used to identify those at high risk for clinical depression. 
Medical Outcomes Short Form Health Survey (SF-12 v.2) is a 12-item 
scale that is a measure of perceived physical health status and mental health. It 
measures the following eight concepts: physical function, general health, bodily 
pain, role limitation due to physical health, bodily pain, vitality, social function, 
role limitation due to emotional problems and mental health. Two distinct 
component scores (physical, mental) are then derived. Median α for the two 
subscales is >.76.27 
The Feetham Family Functioning Survey (FFFS), a 25-item scale (α =.85), 
will assess family functioning.12Reponses on a 7-point likert scale range from 
little (1) to much (7) that asks (a) how much is there now? (b) how much 
should there be? This provides a discrepancy score; higher scores reflect 
greater the dissatisfaction with family functioning.12 
The Demographic Characteristics Questionnaire includes questions about 
the child’s age, mother’s/father's age, education and race. Questions regarding 
additional covariates such as caregiving duration (years), home health care 
nursing hours per week and family income are also included. Mothers/fathers 
will also be asked if they are willing to be contacted in at a later date should 
future studies be conducted. If yes, mothers/fathers will complete the section of 
the demographic questionnaire with address, zip codes and names and contact 
information of 2 persons who might know there whereabouts should they move. 
The Functional Status II-Revised (FSII-R) will assess the child’s functional 
status.13 The 14-item tool (α=.86) is administered in two parts. Part 1 asks 
parents about performance of the activity or behavior in the past two weeks 
with responses ranging from never/rarely (0) to almost always (2); Part 2 
probes responses indicating poor function to determine if responses were due to 
illness. Higher scores indicate higher function.13 
Level of Technology Dependency Questionnaire will be used to determine 
group assignment (Group 1 mechanical ventilators; Group 2 intravenous 
administration of nutritional substances/drugs; Group 3 respiratory/nutritional 
support equipment). Past studies of this population have used this rubric.14 

 
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Resourcefulness Skills Scale is an 8-item questionnaire (α=.78) that will 
assess the fidelity of the Resourcefulness Training (RT) 
intervention.30 Participants are asked the frequency of use for each of the items 
taught in the RT intervention from never (0) to always (3). Higher scores 
indicate greater use of resourcefulness skills.30 
Parent Inventory for Parents (PIP) is a 42-item scale (α=.80-.96) that 
assesses parenting stress (frequency, difficulty) of caring for a chronically ill 
child; higher scores indicates greater stress Construct validity was established 
by significant coreelations with state anxiety and general measures of parenting 
stress. 
Chronic Stress will be measured by a hair cortisol sample. 
Caregiver Burden will be measured using the Zarit Burden Interview-12 
(α=.85-.89), a 12-item tool that assesses the burden people feel when taking 
care of another person; higher scores indicates higher burden. 
Qualitative Assessment of Feasibility, Acceptability, and Fidelity of RT 
will be assessed by audio-recording participant’s responses to: “Tell me what 
it was like for you to (a) do expressive writing and (b) apply RT?”, “What parts 
were easiest/most challenging?”, “What part of RT was most/least interesting?”, 
“Did you learn all parts of RT?”, “How can we enhance RT teaching/learning in 
the future?” "Any parts of the intervention (ie. teaching or intervention 
materials) or follow up you think we can modify to appeal more to male 
caregivers?" The research team responses will be assessed by analysis of 
journal entry responses to the following questions on at least a bimonthly basis: 
“What parts of teaching RT were easiest/most challenging?,” Was any portion of 
the intervention omitted?,” “Is the timing of data collection appropriate?,” 
“What portion (if any) of the intervention needs to be modified?,” “What 
challenges (if any) have there been with study recruitment?,” “Has any group 
contamination been noted?,” “Describe rate of and reasons for attrition.” “What 
challenges have occurred with the follow-up data collection?” 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table 1: Study Tools and Measures 
Variable 
Measure 
(Appendix A) 
Time of measure 
Reliability in previous 
studies 
Outcome Variables: Parent 
 
Enroll  6 Wk 
3M   6M      
 
Psychological and Physical 
Health 
Medical Outcomes 
Short Form Health 
Survey (SF-12 
version 2) 
 X       X       X       X     α=.85-.93 
Depressive Cognitions 
Depressive 
Cognition Scale 
 X       X       X       X     α=.75-.93 
Depressive Symptoms 
Center of 
Epidemiological 
Studies- Depression 
Scale (CES-D) 
 X       X       X       X     α=.84-.93 
Stress 
Pediatric Inventory 
for Parents (PIP)- 
subjective 
Hair Cortisol- 
objective 
 X       X       X       X     
 
 X                X       X 
α=.80-.96 
 
Sensitivity/Specificity=100% 
Burden 
Zarit Burden 
Interview-12 
 X       X       X       X     α=.85-.89 
Outcome Variable: Family 
 
Enroll  6 Wk 
3M   6M      
 
Family Functioning 
Feetham Family 
Functioning Survey 
 X       X       X       X     α=.73-.83 
Mediating Variable 
 
Enroll  6 Wk 3M   6M 
 
Resourcefulness:  Personal 
Resourcefulness 
Scale (Personal 
Resourcefulness 
Subscale) 
 X       X       X       X   α=.83 
Resourcefulness:  Social 
Resourcefulness 
Scale 
(Social 
Resourcefulness 
Subscale) 
 X       X       X       X   α=.79 
Covariates 
 
Enroll  6 Wk 3M   6M 
 
Parent: 
·         Race/Ethnicity, Gender, 
Family Income 
 
Enrollment form 
 
 X 
 
IRR=1.0 
Technology-Dependent Child: 
·         Functional Status 
 
Functional Status II-
Revised 
 
 X       X       X       X   
 
α=.76-.80 
Sample Characteristics 
 
Enroll  6 Wk 3M   6M 
 
Parent: 
·         Age, Marital Status, 
Duration of Tech. Dependent 
Child Caregiver Role 
·         Education, Amount of 
Home Nursing Support Services, 
Lay Caregiving Assistance 
·         Interpersonal Support 
 
Enrollment form 
 
 
Enrollment form 
 
 
Interpersonal 
Support Evaluation 
List 
 
 X 
 
 
 X       X       X       X  
 
 
 X       X       X       X   
 
IRR=1.0 
 
 
IRR=1.0 
 
 
α=.88-.90 
Technology-Dependent Child: 
 
 
 

 
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After confirming the child's assent and obtaining the participant's written 
informed consent, the participant will be assigned a code number. 
Mothers/fathers  will be randomly assigned to one of two treatment conditions- 
Resourcefulness Training intervention or Attention Control using the Minim 
computerized method of random assignment based on parent gender, child's 
type of technology (mechanical ventilation or intravenous medication/nutrition, 
all others), race ethnicity (White non-Hispanic, all others). Data collection will 
take place in a private place of the mother’s/father's choosing such as her/his 
home. The instruments should take about 50 minutes to complete at initial 
enrollment but thereafter it should take about 30 minutes (Table 1). After the 
participant has completed the self administered questionnaires, the interviewer 
will score the CES-D. If the total score of the CES-D exceeds the cutoff of 16 for 
depressive symptoms the participant will be notified and the 
information  regarding mental health resources will be given-(see additional 
files). Following T1 data collection, mothers/fathers will receive either 
intervention or attention control protocol according to their random assignment. 
The RT intervention which includes instruction on maintaining a 28 day journal 
will take about 45-50 minutes to review with participants.   At T4, one 
additional questionnaire, Resourcefulness Skills Scale, will be given to the 
Resourcefulness Training intervention group only to assess for intervention 
fidelity. Reminder post cards will be sent as needed. A $25 gift card will be 
given following completion of questionnaires at each of four time points. 
Following completion and submission of all questionnaires and the RT journals, 
participants will be interviewed via speaker phone to determine the  feasibility, 
acceptability and fidelity of the intervention. Telephone interviews will take 
place at a time convenient for the participant and will be audio-recorded. 
In order to aid in retention, participants will be mailed birthday cards on the 
parent's and child's birthdays as well as monthly postcards with an inspirational 
message and contact information for the study office. 
The RT intervention group will be taught RT skills and mnemonic strategies 
(acronyms, practice) to facilitate recall of RT skills using a web based program 
that includes a video approximately 32 minutes long. The 8 letters in the 
acronym RESOURCE will be used to prompt recall: Rely on 
family/friends; Exchange ideas with others; Seek professionals or 
experts; Organize daily activities; Use positive self-talk; Reframe the situation 
positively; Change from usual reaction; Explore new ideas. Practice of RT will 
occur through using a personal semi-structured journal (example in other study 
documents) to daily record which resourcefulness skills were used that day as 
well as one’s thoughts and feelings related to specific situations in which the 
resourcefulness skills were used. As intervention reminder tools mothers/fathers 
will be given a laminated card to keep in their journal as well as a magnet to 
·         Age 
·         Type of Medical 
Technology Used 
Enrollment form 
Technology 
Dependency 
Questionnaire 
 X   
 X       X       X       X   
 
IRR=1.0 
NA 
 

 
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place on their refrigerator with the above 8 letter acronym RESOURCE and 
reminder phrases as well as the PI's name, research study office email and 
telephone number (See Attachment).  They will also be given a brochure with a 
summary of the intervention. The intervention nurse will also obtain the 
participant's email so that an invitation can be sent to access the study RT 
videos on Box.com. The RT intervention group will be asked to review their RT 
laminated card with the RESOURCE acronym each day prior to journaling and 
write about any RT skills used. To assist with adherence to daily journaling, the 
intervention nurse will make weekly calls for 4 weeks to query for questions; 
reminding them to write in their journals. Mothers/fathers will be encouraged to 
summarize the events for any days missed. Journals will be mailed back by 
participants in the self-addressed, stamped envelopes provided at 4 weeks after 
RT to monitor adherence and review for content. The intervention nurse will 
also describe the use of the RTvideo and the video tape vignettes (2-3 minutes 
each) as examples of resourcefulness skill application during care of their 
technology-dependent child. 
  
Booster sessions of Resourcefulness Training will be delivered at 2 and 
4 months post-enrollment to refresh the subject’s memory of 
resourcefulness skills and prevent decline in skill usage. The sessions will 
be conducted in 8 to 10-minute telephone calls. The intervention nurse will 
record the parent’s memory of skills learned, review skills that have been 
forgotten, determine whether he/she still has and uses the RESOURCE reminder 
card and magnet, ask for examples of skill application since the last study 
contact and which skills were used most often and were the most helpful, and 
collaboratively plan approaches to promote continued skill application. Parents 
who are unable to locate the RESOURCE card and/or magnet will be mailed a 
new one. Because practice is an important component of this intervention, we 
will ask them to begin 1 week of daily journaling as they did for the initial 
Resourcefulness Training intervention, using journal pages given in advance. We 
will phone them one week after each booster session (2-3 minutes) to inquire 
about their journaling and answer questions about application of 
resourcefulness skills. They will be asked to return their journals in a study-
provided self-addressed, stamped envelope. To keep contact equitable control 
group participants will receive phone calls (about 5-10 minutes) from the study 
team at 2 and 4 months post-enrollment to ask how the participant and child 
have been doing since last contact and to remind them of upcoming 
appointments. 
  
 
 
2. Provide a description of all study-related research procedures being performed 
including procedures being performed to monitor research participants for safety or 
minimize risks.  
Minimal risk is involved with participation in this study. Physical discomforts 
might involve fatigue due to the length of time (about 50 minutes) needed to 

 
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answer the interview and study questions. Parents will be told that they may 
choose to take a break at any point during the interview. The amount of time 
required for participation in the study may also be viewed as an inconvenience. 
A potential emotional risk during the interview is that recalling information 
regarding their child’s course of illness and home management difficulties may 
make some parents uncomfortable. Participants will be told that they may 
withdraw from the study at any time. The interviewer will be vigilant to assess 
the participant’s discomfort. Participants experiencing considerable discomfort 
will be asked if they wish to stop the interview and will be given supportive 
assistance by the interviewer. The mother/father will then be given the number 
of United Way First Call (211) to access on call mental health professional 
services in their local area or Cuyahoga County 24-Hour Mental Health Crisis 
Information and Referral Hotline (216-623-6888). If any participant is noted to 
have a level of depressive symptoms above the recognized cutoff of 16 on the 
Center for Epidemiological Studies (CES-D) measure she/he will be told of the 
findings and given an information sheet regarding accessing mental health care 
resources such as United Way First Help (phone 211) or the Cuyahoga County 
24-Hour Mental Health Crisis Information and Referral Hotline (216-623-6888). 
Any participant noted to have a score of 23 or above on the CES-D will be 
assessed for imminent risk of suicide by asking if they have had any thoughts of 
harming themselves in any way or perhaps killing themselves. If the answer to 
any portion of the question is “yes” the participant will be told of a concern for 
their safety and the necessity for the interviewer to contact the Mobile Crisis 
Team from the Cuyahoga County 24-Hour Mental Health Crisis, Information and 
Referral Hotline immediately. The risks and discomforts involved are reasonable 
because the risks are temporary and can be minimized by the above 
procedures. In addition, the discomfort is no more than what the participant 
might experience in her/his daily life. 
 
3. Describe: Procedures to decrease risk- See above 
Drugs/Devices; Source Records- Not Applicable 
☐  Procedures performed to lessen the probability or magnitude of risks 
☐  List all drugs and devices used in the research and the purpose of their use and 
their regulatory approval status (more detailed information is requested in the 
section on Drugs and Devices at the end of this document.) 
☐  The source records, including medical or educational records, which will be 
used to collect data about subjects 
4. Describe when research procedures will take place and the duration of an individual 
subject’s participation in the study. Use of the descriptive table listing the study 
procedures that indicates the visit/week of the interventions below is encouraged. See 
above table and description. 
 
 
 
 

 
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Radiation and Radioactive Substances 
1. Does the research involve the use of radiation or radioactive substances? 
 
☐  Yes     ☒  No – leave rest of the section blank 
 
If yes, answer the following questions. 
Please note that you must receive Radiation Safety Committee (RSC) prior to IRB 
submission. 
2. Is the radiation use only for the purposes of the research study (e.g. over and above 
standard of care) 
☐  Yes     ☐  No 
 
3. Does the protocol use radionuclides? 
☐  Yes     ☐  No 
 
4. Provide justification for the additional risk associated with the research radiation use. 
 
ClinicalTrials.gov Information 
Has this study been registered on ClinicalTrials.gov?  
☒  Yes. Provide the following:  
 
i. The ClinicalTrials.gov identifier: NCT03301831 
ii. Investigator/sponsor responsible for registering: Valerie Toly 
 
☐  No. Explain if there are plans to register or why registration is not required  
(i.e., the study is not NIH funded, registration is in process, or does not meet the 
definition of a clinical trial) 
 
List of Data to be Collected 
1. Indicate what identifiers you will collect 
☒ 
Name 
☒ 
Address 
☒ 
Dates related to an individual (e.g., Date of admission, birth, surgery, etc.) 
☒ 
Telephone number 
☐ 
Fax number 
☒ 
Email address 
☐ 
Social security number 
☒ 
Medical record number 
☐ 
Health plan beneficiary number 
☐ 
Account number 
☐ 
Certificate/license number 

 
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☐ 
Any vehicle or other device serial 
☐ 
Device identifiers or serial numbers 
☐ 
Web URL 
☐ 
Internet protocol (IP) address 
☐ 
Finger or voice prints 
☐ 
Photographic images 
☐ 
Other: Any characteristic that would uniquely identify the individual 
 
2. List all other data to be collected for the research study (e.g. laboratory values, physician 
notes, length of stay, etc.).  
Hair sample for cortisol level, audio recording with only subject ID number for exit interview 
regarding intervention for intervention group only. Questionnaires will be administered as well.  
 
Data Analysis Plan 
1. Describe the data analysis plan, including any statistical procedures. Provide a power 
analysis if applicable.   
2. If applicable, describe the primary and secondary study endpoints including safety 
endpoints.   
 
ANALYSIS. All data will be entered into UH REDCap and cleaned.We hypothesize 
that parents receiving the Resourcefulness Training intervention will have 
significant improvement in parental outcomes (psychological and physical) and 
family outcomes (family functioning) compared with parents in the Attention 
Control arm. We also hypothesize that resourcefulness will mediate the effect of 
the intervention on all study outcomes. 
  
Preliminary Analyses. Exploratory data techniques will be used to examine 
univariate characteristics (central tendency, dispersion, and distribution) of 
demographics and covariates measured upon randomization 
in each arm. These exploratory techniques will be based on proportions (in the 
case of dichotomous variables) and medians and/or means (in the case of 
variables measured on an interval scale). Due to randomization, no 
formal tests of these variables will be performed because any imbalance 
between arms is known to be due to chance. Profile plots will also be used to 
describe the participant-specific (parent) and arm-specific trends for 
each outcome over the four time points. 
  
Primary Analyses. 
Aims 1 & 2: Analysis of the monthly rate of change in each of the parent 
outcomes in each arm will be estimated via linear mixed models and fit using 
SAS PROC MIXED.108,109 Each model will include a random 
intercept and slope (possibly modeled using a polynomial spline) to account for 
between-subject variance in each outcome over time. Conditional on these 
random effects, we will also explore within-subject variance in 

 
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each outcome over time using different residual covariance structures and 
select the most appropriate structure using likelihood-based criteria. Fixed 
effects will include a continuous variable to represent time since 
randomization, an indicator variable to represent the intervention, and 
stratification factors used during randomization (facility, OTA technology group, 
sex and race/ethnicity). Assuming a linear rate of change over time, the 
regression coefficient of the terms representing interactions between time and 
the intervention indicator variable will be used to estimate the difference in the 
monthly rate of change in each outcome between the two arms. 
  
To determine if resourcefulness mediates the effect of the resourcefulness 
intervention on parent outcomes, a model-based causal mediation 
model110,111 will be fit using separate generalized linear models of 
parent outcomes at 3 months after randomization that adjust for the 
intervention indicator variable, stratification factors, and the mediator at 6 
weeks after randomization. This model will allow us to decompose the total 
effect of the resourcefulness intervention on maternal outcomes at 3 months 
into direct and indirect (or mediated) effects and will allow us to estimate the 
proportion of the total effect that is mediated. Variance estimates, and 
consequently 95% confidence intervals, will be estimated using a bootstrapping 
procedure based on 1000 bootstrap samples. To more fully explore the 
temporal pattern of mediated effects, we will use similar models to also 
estimate the mediated effect using measurements of the mediator and maternal 
outcome taken at other time points as well (e.g., total effect of resourcefulness 
intervention on parent outcomes at 6 months that are mediated by personal or 
social resourcefulness at 3 months). 
  
To account for any multiple comparisons, a Bonferroni-corrected two-sided 
significance level will be applied to all analyses for all aims. Additionally, as with 
any study, we expect some level of missing data at each time point. To adjust 
for the missing data in all mixed-models analyses, we will use pattern-mixture 
models. This modeling approach will be applied to each model to ensure that 
missing data is adequately accounted for in each analysis. In contrast to a 
“completers only” approach, pattern-mixture models will provide a consistent 
and asymptotically efficient estimate of the effect of intervention on the monthly 
rate of change in parent and family outcomes when data is missing not at 
random. 
 
Secondary Analyses. To obtain more precise estimates of the intervention effect 
on the time point interval rate of change in each parent or family outcome, 
additional multivariable analyses will characterize and estimate the relationship 
between potential covariates at baseline and each outcome. For continuous 
variables that do not have a linear relationship with the outcome, appropriate 
transformations or categorization will be considered. For nominal and ordinal 
variables, the number and type of categories will be considered to obtain 

 
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the optimum relationship, if any, with the outcome. Based on a two-sided 
significance level of 0.15, any baseline covariate found to be associated with the 
outcome will be included in the model described for the Primary Analyses. 
  
Modification of the intervention effect on the monthly rate of change in each 
parent outcome will also be tested in each model by including an interaction 
between a pre-specified effect modifier measured at baseline, the intervention 
indicator variables, and the variable representing time since randomization. 
Should an interaction be detected based on a two-sided significance level of 
0.05, the monthly rate of change in each outcome will be estimated in each of 
the arms for each level of a categorical effect modifier or at the 25th, 50th, 
and 75th percentiles of a modifier that is measured on an interval scale. 
  
Sensitivity analyses will also be applied to all mediation models described for 
the Primary Analysis to evaluate the assumption of sequential ignorability (e.g., 
no unmeasured confounders of the association between the mediator and each 
maternal outcome). As described by Imai et al,111 this analysis will assess how 
large an effect an unobserved confounder must have on both models to cause a 
non-significant mediated effect. 
 
Confidentiality of Specimens and Banking 
☐  
 I am not storing specimens in this research project – please leave the rest of this section 
blank 
 
 
Describe: 
☒  The source of the specimens  Hair samples for cortisol level     
☒  Where the specimens will be stored  Locked file cabinet in study office    
☒  How long the specimens will be stored  Until final data collection then 
shipped together in one batch to lab for analysis    
☒  How the specimens will be labeled   Each hair sample will be labeled with 
participant ID number and time point sample taken   
☒  How the specimens will be accessed  Going into locked file cabinet     
☒  Who will have access to the specimens  Members of the research team who 
have IRB approval.     
☒  When and how will the specimens be destroyed   The specimens will be 
autoclaved and destroyed following processing by the lab.    
☒  How will the specimens be transported (Please note if transporting specimens, 
a Material Transfer Agreement (MTA) is required).  The hair samples are 
wrapped in foil and enclosed in an envelope. All samples will be shipped next 
day air FedEx to the lab in a box.     
Describe: 
☐  The procedures to release specimens including: 
i. The process to request a release      

 
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ii. Approvals required for a release      
iii. Who can obtain specimens      
iv. The data to be provided with specimens, including if the data will be 
identifiable to others    No data other than ID number and time point. 
☐  For genomic data, please include an attestation of no master list and no attempt will 
be made to re-identify the specimens.      
 
Are you storing the specimen for future use for other research projects? 
☐   
Yes 
☒   
No 
 
Confidentiality of Data 
1. To maintain the confidentiality of the data: 
☒ 
I will use a unique study identifier (not derived from the participants personal 
            identifiers) to code individuals’ data  and I will store this ID log separate from  
            study data. 
☐ 
Other (please explain) 
 
2. How are you storing your electronic data? 
☐ 
UH Redcap 
☒ 
CWRU Redcap  
☒ 
Secure Research Environment (SRE) 
☒ 
CWRU Box 
☐ 
OnCore 
☐ 
UH Secure Network Drive 
☒ 
CWRU Secure Network Drive 
☐ 
Other - List storage method and provide justification: 
 
3. ☒ 
I acknowledge that paper research data and documents will be stored in a double- 
            locked secure environment in the following location:  
            Location: FPB School of Nursing- Study Office 
 
4. If sharing data, describe: Not Applicable.  
 The exact data elements that will be shared      
 How data will be sent      
(Please note if sharing data, a Data Use Agreement (DUA) is required. 
 
HIPAA Authorization  
If you are going to be accessing PHI (Protected Health Information), indicate how HIPAA 
authorization will be obtained (check all that apply): 
☒   
HIPAA authorization is in the consent form 
☒   
Requesting a full or partial waiver of HIPAA for prescreening 
☐   
Requesting a full or partial waiver of HIPAA 

 
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1. Describe why the study cannot be completed without the specified identifiable 
information. We would not be able to contact the participants for initial enrollment or 
follow up data collection. 
2. If the identifiable information will be used or disclosed by anyone other than the research 
team, please state who those individuals/entities are and provide justification for the 
disclosure. Not applicable. 
3. Describe how long identifiers will be kept for in relation to study length and data 
collection and analysis. They will be kept until data collection and analysis is completed 
and manuscript writing is finished.  
 
☒  I assure that protected health information collected for purposes of this research study 
will not be reused or disclosed to any other person or entity, except as required by law, 
for authorized oversight of the research study, or for other research for which the use of 
disclosure of protected health information for which an authorization or opportunity to 
agree or object is not required by 45 CFR 164.512 
 
Risks to Research Participants 
1. List the reasonably foreseeable risks such as breach of confidentiality, discomforts, 
hazards, or inconveniences to the research participants related to their participation in 
the research. Include a description of the probability, magnitude, duration, and 
reversibility of the risks. Include the physical psychological, social, legal, and economic 
risks.  
Minimal risk is involved with participation in this study. Physical 
discomforts might involve fatigue due to the length of time (about 50 
minutes) needed to answer the interview and study questions. Parents 
will be told that they may choose to take a break at any point during the 
interview. The amount of time required for participation in the study may 
also be viewed as an inconvenience. A potential emotional risk during the 
interview is that recalling information regarding their child’s course of 
illness and home management difficulties may make some parents 
uncomfortable. Participants will be told that they may withdraw from the 
study at any time. The interviewer will be vigilant to assess the 
participant’s discomfort. Participants experiencing considerable discomfort 
will be asked if they wish to stop the interview and will be given 
supportive assistance by the interviewer. The mother/father will then be 
given the number of United Way First Call (211) to access on call mental 
health professional services in their local area or Cuyahoga County 24-
Hour Mental Health Crisis Information and Referral Hotline (216-623-
6888). If any participant is noted to have a level of depressive symptoms 
above the recognized cutoff of 16 on the Center for Epidemiological 
Studies (CES-D) measure she/he will be told of the findings and given an 
information sheet regarding accessing mental health care resources such 
as United Way First Help (phone 211) or the Cuyahoga County 24-Hour 
Mental Health Crisis Information and Referral Hotline (216-623-6888). 

 
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Any participant noted to have a score of 23 or above on the CES-D will be 
assessed for imminent risk of suicide by asking if they have had any 
thoughts of harming themselves in any way or perhaps killing 
themselves. If the answer to any portion of the question is “yes” the 
participant will be told of a concern for their safety and the necessity for 
the interviewer to contact the Mobile Crisis Team from the Cuyahoga 
County 24-Hour Mental Health Crisis, Information and Referral Hotline 
immediately. The risks and discomforts involved are reasonable because 
the risks are temporary and can be minimized by the above procedures. 
In addition, the discomfort is no more than what the participant might 
experience in her/his daily life. 
2. If applicable, indicate which experimental procedures may have risks to the research 
participants that are currently unforeseeable.  
3. If applicable, indicate which procedures may have risks to an embryo or fetus should the 
research participant or their partner be or become pregnant. Not applicable. 
4. If applicable, describe the risks to others who are not research participants. Not 
applicable. 
5. Describe the availability of medical or psychological resources that research 
participants might need. See above. 
 
Provisions to Protect the Privacy Interests of Research Participants 
Describe the steps that will be taken to protect research participants’ privacy interests.  
(consider issues such as physical space, proximity to other, and participant preferences)  
 
To maintain participant privacy, all interviews will be conducted in a private 
area in a place of the mother’s/father's choosing such as her/his home, public 
library, place of employment or the Dahms Clinical Research Center. Privacy will 
be maintained as well in the procedures for identifying participants as described 
above. Participants will be mailed an introductory letter prior to study staff 
making telephone contact. 
Facebook and Twitter will be used to post the IRB flyer about the study. A 
"Friend" request will be sent to parent caregiver organizations who have 
members likely to meet inclusion criteria along with an introductory letter about 
our study and the request to post our recruitment flyer. The organization can 
make a decision to accept or reject the request to post our study flyer. Potential 
participants reached through either Facebook or Twitter would then self-identify 
and voluntarily contact us to hear more about the study and decide on 
participation. When they contact the study staff they will be screened for 
eligibility including residence within Northeast Ohio for face-to-face data 
collection. 
           A digital audio recording device will be used during parent interviews 
that might be regarded as an invasion of privacy. The reason for use of the 
audio recording device is to allow the data collector to focus on the interview 
and probes without the encumbrance of taking notes and risk missing essential 
portions of the parent’s response. Using the recording device will therefore add 

 
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to the richness of the interview data for analysis. The participant’s name will not 
be mentioned on the digital recording. The recording device and any memory 
cards will be kept in a locked filing cabinet when not in use. 
 
 
Potential Benefit to Research Participants 
1. Describe the potential benefits that individual research participants may experience from 
taking part in the research. Include the probability, magnitude, and duration of the 
potential benefits. Indicate if there is no direct benefit.  
2. If no direct benefit, state the potential benefit to society or others. Do not list 
compensation.  
 
Participants may receive some benefit from the stress reducing methods used in 
this study (Resourcefulness Training, journal writing). The potential risk for 
emotional distress is minimal and reasonable given the potential benefit for 
reducing stress and improving quality of life. This study will benefit other 
families by aiding in our understanding of what methods help mothers/fathers 
reduce stress and promote optimal family functioning when they are caring for a 
technology-dependent child. 
 
Withdrawal of Research Participants 
1. Describe the anticipated circumstances under which research participants will be 
withdrawn from the research without their consent.  
2. Describe the procedures that will be followed when research participants withdraw or 
are withdrawn from the research, including partial withdrawal from procedures with 
continued data collection.  
 
Possible causes for the participant to be withdrawn from the study include that 
the child with special medical technology has become too ill or has died. The 
participant may decide to withdraw from the study due to lack of interest to 
complete the remaining questionnaires at T2, T3, T4 or that she/he is not 
interested in continuing to complete the journal writing. If the participant 
indicates an intent to withdraw from the study, she/he will be invited to 
complete the final phone interview that describes challenges of the intervention, 
suggestions for modifications in the intervention and/or data collection 
procedures, and reasons for desire to withdraw from the intervention study. 
Participants will not be followed after they have voluntarily withdrawn from the 
study unless they indicate that they wish to be contacted in the future for any 
follow-up studies.  
 
 
 
 
 
 

 
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Alternatives to Participation 
1. Please list other available clinical treatments.  
2. Please state if a subject could continue on standard of care therapy and what that might 
include.  
3. If not a clinical trial you may state that the alternative is not to participate. If there is a 
viable alternative you must list it in the consent.  
 
The only alternative to participation is to choose not to participate. Potential 
participants will be told that choosing not to participate would not affect their 
child’s health care in any way. 
 
Costs to Research Participants 
☒   There are no costs to research participants or their insurance companies – please leave the 
rest of this section blank 
 
1. If applicable, describe what costs the research participants will be responsible for 
because of participation in the research including but not limited to: transportation to 
study visits, parking for study visits, costs of procedures, lost, broken or stolen devices, 
costs of drugs or therapy, etc.  
2. You must clearly state if insurance will be charged and who will be responsible if 
insurance does not pay.  
3. List what research procedures and research interventions will be covered by this study.  
 
Research Participant Compensation 
☐   There is no compensation for research participants – please leave rest of this section blank 
  
1. Describe the schedule, payment method and payment total of any incentives or 
compensation that research participants will receive for participation in the research 
(e.g., gift cards or cash with amounts, t-shirts, devices, bags, swag, etc.)        
2. Describe the schedule, payment method and payment total of any reimbursements that 
research participants will receive for participation in research (e.g., parking, mileage, 
meals, etc.)      
There is no reimbursement for parking and meals but an incentive will be given 
to participants for their time and inconvenience. Participants will be given a $25 
Amazon gift card at each of 4 time points following completion and return of the 
questionnaires. The total payment will be $100 over the study time if they 
complete all portions (4 data collection points) of the study. 
 
Compensation for Research Related Injury 
Describe who will pay for the costs of medical treatment and/or compensation in the event of a 
research related injury: 
☐   
Funding agency is providing some/all payment for injury 
☐   
Funding agency is providing no payment for injury 
☒   
Not applicable 

 
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Provisions to Monitor the Data to Ensure the Safety of Research Participants 
1. Describe the Data and Safety Monitoring Plan for the proposed study. Describe how 
often the data will be monitored for completeness, accuracy and adherence to the 
protocol. 
2. Is there a formal Data and Safety Monitoring Board/Committee? If yes, provide 
information about the DSMB/C including the contact information of the committee 
member(s) (as applicable); whether it is independent from the study sponsor; how often it 
meets; the type of data that will be used; written reports, etc.  
 
Data and safety monitoring will be conducted to determine if data collection 
should be altered or stopped. Every 6 months the DSM Committee will assess 
the risks and benefits of the study by reviewing individual adverse events and 
unanticipated problems that have occurred during the study. Data monitoring 
will include a review of the accuracy, validity, reliability and completeness of 
data collection. Dr. Toly, the principal investigator will make the decision related 
to altering the study in collaboration with the committee if more than two 
mothers/fathers experience significant discomfort or distress that required a 
referral to United Way First Call. 
 
Data and Safety Monitoring 
a.     Monitoring Entity 
A Safety Monitoring Committee (SMC) team will be comprised of “non-research 
team” members from the university community, including a bioethicist who is 
also a nurse (Dr. Barb Daly bjd4@case.edu), a statistician not involved with the 
project (Dr. Chris Burant cxb43@case.edu), and a doctorally prepared RN (Dr. 
Sara Douglas sld4@case.edu) with a specialty in caregiver research. Study team 
members will include Dr. Valerie Toly, PI, and Dr. Carol Musil, Co-I. Dr. Daly will 
chair the committee and be responsible to submit reports to the NINR within 2 
weeks of the meeting. The committee members who are outside the study team 
will review data on the study as provided by Drs. Toly and Musil and conduct 
random auditing of the research records to assess study safety and regulatory 
compliance. 
  
b.    Data Safety Monitoring Committee 
Twice annually throughout the project, this committee will review data on this 
study regarding 1) study safety, including auditing selected cases for 
compliance with IRB requirements, conformance with informed consent 
requirements, verification of source documents, and investigator compliance; 2) 
minimizing research-associated risk; and 3) protecting the confidentiality of 
participant data. In addition, it will review (1) all causes of mortality and (2) 
issues with participation. The rate of recruitment refusal (percent and reasons) 
and subject attrition (percent and reasons) will be tracked and reported at these 
reviews. Differential attrition from the intervention and control arms also will be 
monitored. If concerns or problems are identified by the SMC, they will be 

 
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reported to the IRB and NINR/NIH via email by Dr. Toly and Dr. Daly, 
respectively, within 3 business days after they are identified. If there are 
recommendations made by the SMC, the action plan for response or notice of 
any actions taken by the IRB regarding the research and any responses to those 
actions will be provided to NINR Officials within 2 weeks. 
  
c.     Adverse and Unanticipated Events 
At the onset and across the duration of the study, all staff and Investigators will 
have instructional review of the nature and types of unanticipated and adverse 
events as described by the NINR and the CWRU IRB. As they occur, all 
unanticipated events and adverse events will immediately be reported to the PI 
who will report them to the IRB according the IRB protocol reporting procedures 
for both serious and non-serious adverse event  and unanticipated problem 
reporting. These will be summarized in the twice annual reports to the SMC. 
Annual progress reports to the IRB and NINR/NIH will include a summary of the 
SMC’s activities and findings as well as any adverse events regarding human 
subjects. Program Officials at NINR will be informed in a timely manner (3 
business days) of unanticipated problems (e.g., a data breach) or unexpected 
serious adverse events that may be related to the study protocol or IRB-
approved revisions to the study protocol that indicate a change in risk for 
participants. 
  
Although this study is deemed as having minimal risk, we recognize that some 
unanticipated or adverse events may occur, which may vary in seriousness. As 
an example of a less serious event, if a participant learns the nature of the 
experimental condition (Resourcefulness Training) and calls to express 
disappointment, we will inform him/her before he/she completes the study that 
all participants who are in the comparison group will be given the opportunity to 
receive the Resourcefulness Training after completing the study. These 
situations will be noted and reported at the next SMC meeting. 
  
Some participants may have personal situations that may cause them to contact 
our project staff for assistance. If parents contact us requiring assistance of any 
kind, we will note that and give them United Way’s First Call for Help telephone 
number. The First Call service provides resources on various issues such as 
legal matters, housing, etc. We also will have a list of statewide and national 
agencies for making necessary referrals and can provide more specific resources 
if necessary. Experienced project staff, including the Investigators, will be 
available to talk with participants usually within 24 hours should they express 
distress, concern or request help for problems. These situations will be 
documented and reported to the IRB and to the SMC and reviewed as necessary 
for protocol implications. If parents have questions regarding the care of their 
children they will be referred to their child’s healthcare provider. 
  

 
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For serious adverse events, the PI or Project Manager will report to the IRB, as 
per CWRU reporting requirements, within 3 business days, any serious adverse 
event that occurs, such as the death of a research subject, even if presumed to 
be unrelated to the study protocol. 
  
d.    Multi-site Study Compliance 
This is not a multi-site study, however, all investigators and study staff will be 
instructed in the components of the data and safety and monitoring plan and 
reporting requirements. 
  
e.     Assessment of External Factors or Relevant Information 
Annual assessments of new literature in the field that may have an impact on 
the safety of participants or on the ethics for the research study will be 
conducted by the graduate student research assistant under the oversight of 
the PI and Co-Is. The PI and Co-Is will evaluate this new information for its 
bearing on all aspects of this research project. This information and the team’s 
analysis will be disseminated to the SMC at least annually, or sooner if 
important external factors or relevant information is identified that impacts 
subject safety or raises ethical concerns. In addition, at each committee 
meeting, SMC members also will be queried about new studies or ethical issues 
that they think should be discussed or reviewed, and these items put on the 
SMC meeting agenda.    
  
f.      Advanced Plans for Interim or Futility Analysis 
This research project compares the psychological and physical outcomes of 
Resourcefulness Training against Attention Control in parents caring for 
technology-dependent children at home. The study investigators anticipate a 
medium effect size for these interventions; given this expectation and the low 
risk nature of the study, no formal “futility analysis” will be conducted. 
However, data summaries will be reviewed by the SMC every six months and 
interim analyses will be conducted as recommended by the SMC. 
 
 
 
Drugs or Devices 
☒   There are no drugs or devices being utilized in this research project – please leave rest of this 
section blank 
 
1. If the research involves drugs or device(s), describe your plans to store, handle, and 
administer those drugs or device(s) so that they will be used only on research 
participants and be used only by authorized investigators.  
2. How will the drug(s) be dispensed (i.e., indicate the pharmacy that will be used)? 
3. If the drug is investigational (has an IND) or the device has an IDE or a claim of 
abbreviated IDE (non-significant risk device), identify the holder of the 
IND/IDE/Abbreviated IDE        

 
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Additional Information 
If you have any additional information regarding your study not covered in the template, please 
include it here. 
 
Community-Based Participatory Research 
☒   
This is not a community-based participatory research project – please leave rest of this 
section blank 
 
If applicable, describe the involvement of the community in the design and conduct of the 
research.  
Note: Community based research is research that is conducted as an equal partnership between 
academic investigators and members of a community. In Community Based Participatory 
Research (CBPR) protects, the community participates fully in all aspects of the research 
process.   
 
International information 
☒   
This is not an international study – please leave rest of the section blank 
☐   
We will be conducting this research at the following international sites: 
1.  
☐   
We are recruiting participants outside of the US from the following locations: 
1.  
☐   
We are sending data outside of the US to the following locations: 
1.  
☐   
We are receiving data from outside of the US from the following locations: 
1.  
 
MULTI-SITE RESEARCH (when UH or CWRU is the IRB of Record) 
Does this project have multiple sites? 
☒   
Yes 
☐   
No 
 
The Cleveland Clinic Children’s Hospital (Pulmonary, Gastroenterology, Neurology 
sections) are only inviting their patient’s parents to participate in the study. If the parent is 
interested they complete a form giving their contact information that the CC team sends to 
us via secure email. 
 
Non-Local Site Information for Multi-Site Studies 
If this is a multi-site study where you are the lead investigator, list the following information for 
each relying site: 
1. Name of site:  

 
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2. PI of relying site:  
3. Name of IRB contact:  
4. Phone number of IRB contact:  
5. Email address of IRB contact:  
 
Non-Local Recruitment Methods for Multi-Site Studies 
If this is a multi-site study and research participants will be recruited by methods not under the 
control of the local site (e.g. call centers, national advertisements) describe those methods. 
Local recruitment methods are described above.  
1. Describe when, where, and how potential research participants will be recruited.  
2. Describe the methods that will be used to identify potential research participants.  
3. Describe the materials that will be used to recruit research participants.  
 
Above Not Applicable. 
 
Multi-Site Research Communication Plan (when you are the lead investigator)  
Not applicable 
 
If this is a multi-site study where you are the lead investigator, describe the processes to ensure 
communication among sites including: 
 All sites will have the most current version of the protocol, consent document, and 
HIPAA authorization      
 All required approvals (initial, continuing review and modifications) have been obtained 
at each site (including approval by the site’s IRB of record)      
 All modifications have been communicated to sites, and approved (including approval of 
the site’s IRB of record) before the modification is implemented      
 All engaged participating sites will safeguard data, including secure transmission of 
data, as required by local information security policies      
 All local site investigators conduct the study in accordance with applicable federal 
regulations and local laws      
 All non-compliance with the study protocol or applicable requirements will be reported 
in accordance with local policy      
If this is a multi-site study where you are the lead investigator, describe the method for 
communicating to engaged participant sites:  
 Problems      
 Interim results      
 The closure of the study      
 
 
 
 
 
 
 
 
 

 
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References    
  
1.   Miles, M. S., Holditch-Davis, D., Burchinal, P., & Nelson, D. (1999). Distress 
and growth outcomes in mothers of medically fragile infants. Nursing Research, 
48(3), 129-140. 
2    Toly, V. (2009). Normalization and family functioning in families with a child 
who is technology dependent.Doctoral dissertation, Case Western Reserve 
University, Cleveland, OH. 
3.   Braden, C. (1991). Patterns of change over time in learned response to 
chronic illness among participants in systemic lupus erythmatosus self-help 
course. Arthritis Care Research, 4, 158-167. 
4.   Rosswurm, M.A., Larrabee, J.H. et al. (2002). Training family caregivers of 
dependent elderly adults through on-site and telecommunication 
programs. Journal of Gerontological Nursing, 28, 27-38. 
5.   Zauszniewski, J.A., Eggenschwiler, K., Preechawong, S., Roberts, B.L., & 
Morris, D.L. (2006). Effects of teaching resourcefulness skills in elders. Aging 
and Mental Health, 10(4), 1-9. 
6.   Zauszniewski, J., Bekhet, A., et al. (2007). Effects of teaching 
resourcefulness and acceptance on affect, behavior, and cognition of chronically 
ill elders. Issues in Mental Health Nursing, 28, 575-592. 
7.   Zauszniewski, J.A., Krafcik, K., et al. (2004). Focused 
reflection: Reminiscence for elders using specific themes and visual 
images. Journal of the Applied Gerontology, 23(4), 429-442. 
8.   Zauszniewski, J.A. (1995). Development and testing of a measure of 
depressive cognitions in older adults. Journal of Nursing Measurement, 3(1), 
31-41. 
9.   Zauszniewski, J., Lai, C., et al., (2006). Development and testing of the 
resourcefulness scale for older adults. Journal of Nursing Measurement, 14, 57-
68. 
10. Radloff, L. S. (1977). The ces-d scale: A self-report depression scale for 
research in the general population. Applied Psychological Measurement, 1, 385-
401. 
11. Murphy, F. (1994). Relationship between family use of normalization and 
psychosocial adjustment in children with chronic physical disorders. Unpublished 
Masters Thesis, McGill Univ, Montreal, Quebec. 
12. Roberts, C. S., & Feetham, S. L. (1982). Assessing family functioning across 
three areas of relationships. Nursing Research, 31(4), 231-235. 
13. Stein, R. E., & Jessop, D. J. (1990). Functional status ii(r): A measure of 
child health status. Medical Care, 28(11), 1041-1055. 
14. Office of Technology Assessment. (1987).Technology-dependent children: 
Hospital care vs. home care: A technical memorandum, Congress of the United 
States. 
15. Zauszniewski, J. (1997). Teaching resourcefulness skills to older 
adults. Journal of Gerontological Nursing, 23, 14-20. 

 
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16. Richards, K., Enderlin, C., et al. (2007). Tailored bio-behavioral 
interventions: A literature review and synthesis. Research and Theory for 
Nursing Practice, 21, 271-285. 
17. Pennebaker, J. (1997). Writing about emotional experiences as a 
therapeutic process. Psychological Science, 8(3), 162-166. 
18. Newacheck, P., & Kim, S. (2005). A national profile of health care utilization 
& expenditures for children with special health care needs. Archives in Pediatric 
& Adol. Medicine, 159(1), 10-17. 
19. Rosenbaum, M. (1990). Learned resourcefulness: On coping skills, self-
control, and adaptive behavior. New York: Springer Publishing. 
20. Zauszniewski, J.A. (2006). Resourcefulness. In J.J. Fitzpatrick & M. Wallace 
(Eds.), Encyclopedia of Nursing Research (pp.256-258). New York: Springer 
Publishing. 
21. Zauszniewski, J., Morris, D., Preechawong, S., & Chang, H. (2004). Reports 
of depressive symptoms in elders with chronic conditions. Research and Theory 
for Nursing Practice, 18(2/3), 185-196. 
22. Zauszniewski, J.A. (1995). Development and testing of a measure of 
depressive cognitions in older adults. Journal of Nursing Measurement, 3(1), 
31-41. 
23. Zauszniewski, J., Picot, S., Roberts, B., et al. (2005). Predictors of 
resourcefulness in African American women. Journal of Aging and Health, 7, 
609-633. 
24. Musil, C., Warner, C., Zauszniewski, J., Wykle, M., & Standing, T. (in press). 
Grandmother caregiving, family stress and strain, and depressive 
symptoms, Western Journal of Nursing Research. 
25. Musil, C., Warner, C., Zausniewski, J., Jeanblanc, A., & Kercher, K. (2006). 
Grandmothers, caregiving, and family functioning. Journal of Gerontology, 61B, 
S89-S98. 
26. Deatrick, J. et al. (2006). Family management style framework: a new tool 
with potential to assess families who have children with brain tumors. J. of 
Pediatric Oncology Nursing, 23(1), 19-27. 
 
27. Ware, J., Kosinski, M., & Keller, S. (1996). A 12-item short-form health 
survey. Medical Care, 34, 220-233. 
 
28. Lee, K. A., Hicks, G., & Nino-Murcia, G. (1991). Validity and reliability of a 
scale to assess fatigue. Psychiatry Research, 36, 291-298. 
 
29. Buyssee, D., Reynolds, C., Monk, T., Berman, S., & Kupfer, D. 
(1989). Psychiatry Research, 28, 193-213. 
 
30. Zauszniewski, J. A., & Bekhet, A. K. (2011, in review). Measuring use of 
resourcefulness skills: Psychometric testing of a new scale. Nursing Research 
and Practice. 
 
 

 
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Please reference the Investigator Manual for local institutional requirements.