Coaching in Context for Caregivers of Children With Spinal Cord Injury
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: Thomas Jefferson University

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
1 
 
Coaching Caregivers of Children with Spinal Cord Injury 
NCT# 03898700 
April 2021 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
2 
 
  
Background and Rationale: 
 
Parents of young children serve as caregivers, providing a variety of assistance until youth are able to do 
tasks and care for themselves on their own.  When a child has a chronic health condition, such as a SCI, 
parents often become lifelong caregivers.  A majority of caregivers of youth with SCI are mothers.  This 
caregiving role is associated with poor outcomes in health related quality of life, for example caregivers 
are at high risk for emotional stress, fatigue, social isolation and frequent episodes of ill health.  
Interventions for caregivers of youth with chronic conditions and special needs have been investigated 
previously, but none for caregivers of youth with SCI.   
 
Occupational Performance Coaching (OPC) is an intervention that provides a framework where 
professionals specifically coach caregivers to identify and solve issues that are barriers to their 
performance in their parenting and caregiving roles.  Currently there are no studies on OPC in pediatric 
SCI but it has potential to fill the gap in interventions for caregivers of youth with SCI.   OPC may be the 
intervention to fill this void because it employs problem solving, it focuses on identifying solutions to 
participation challenges that are associated with the social and physical environments which have been 
identified as problematic and lastly the evidence on OPC with caregivers of youth with other conditions 
shows positive outcomes on parent self-efficacy, stress and competency. 
 
Specific Aims: 
 
The specific aim of this study is twofold. First, to establish the feasibility of the OPC for caregivers of 
youth with SCI, and second to establish standardized methodological procedures for a future multi-
center study on the effectiveness of OPC as an intervention for caregivers of youth with SCI.   
 
Within this twofold aim, there are seven study objectives: 
1. To determine the degree to which caregivers of youth with SCI believe in their ability to 
create and achieve meaningful participation goals. 
2. To determine the degree to which therapists implement OPC, with fidelity.  
3. To determine caregiver and therapist satisfaction and acceptance with OPC. 
4. To establish the reliability of the OPC fidelity measure. 
5. To determine the degree to which outcome instruments are completed in their entirety, and 
with accuracy and validity. 
6. To establish parameters for a future randomized-controlled trial (RCT) on OPC including 
dosage and delivery specifications for OPC intervention; sample size estimation; and cost 
and time requirements for OPC study implementation.  
7. To determine the feasibility of randomizing caregivers of youth with SCI into a treatment 
groups. 
Risks and Benefits:  
 
1. The risks involved in this research are minimal.  Participants may become bored or tired during 
the coaching sessions or they may become upset or frustrated.  Additionally, there may be a loss 
of confidentiality.  In order to protect against risk, coaches are trained clinicians with experience 
working with parents of children with SCI.  In order to minimize the risk of loss of confidentiality, 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
3 
 
an identification number will be assigned to all participants.  Identification number and 
corresponding name will be kept in a secure location separate from any participant data. 
2. Potential benefits include an intervention developed specifically to meet the needs of female 
primary caregivers of children with SCI including but not limited to mothers, grandmothers and 
aunts surrounding caregiving of a child with a chronic condition.  This intervention employs 
problem solving, which is an approach that has been identified as highly relevant for caregivers 
with SCI, and one that has shown to be highly effective for caregivers of children with other 
chronic conditions. Secondly, it explicitly focuses on identifying solutions to participation 
challenges that are associated with the social and physical environments which are areas 
identified by children with SCI and their caregivers as being problematic.  
 
 
Research Strategy 
 
Significance: This study addresses the unmet needs of female primary caregivers of youth with SCI.  This 
is significant in that if these needs are not addressed through interventions that are explicitly designed 
to empower caregivers in their caregiving and parenting roles, both caregivers of youth with SCI and 
youth with SCI will remain vulnerable to the well-established adverse implications of information 
caregiving.  This is the first study to establish the feasibility of an intervention explicitly for female 
primary caregivers of youth with SCI, and it will inform the development of standardized methodological 
procedures for the use of OPC as an intervention for caregivers of youth with SCI as well as a future RCT 
that will assess the efficacy of OPC for caregivers of youth with SCI.   
 
Design: A sample of convenience will be used.  Following consent and baseline data collection, 
participants will  be assigned to one of two  coaching methods, face to face format or phone.  
Participants who receive coaching over the phone will follow the exact procedures as face to face except 
coaching will be provided over the phone.  The OPC intervention will last up to 10 weeks.  Participants 
will be involved in the study for up to 18 months including baseline data collection, the intervention, and 
follow up data collection. 
 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
4 
 
  
 
 
 
Sample: A convenience sample of up to 20  female primary caregivers, including but not limited to 
mothers, grandmothers and aunts of children with SCI will be recruited from three facilities specializing 
in pediatric SCI care and rehabilitation using the following inclusion and exclusion criteria: 
 
Inclusion Criteria  
1. 
Female primary caregivers of children with traumatic or acquired, non-progressive SCI 
between 6 and 13 years of age 
2. 
Female primary caregivers will have legal guardianship of their child with SCI;  
3. 
Speak, read and comprehend English 
4. 
be available for face-to-face visits at a location in close proximity to the coach who will 
be providing coaching 
5. 
have a cell phone with text messaging capabilities; be willing to utilize cell phone or land 
line for coaching 
6. 
be able to verbalize challenges in their own participation or their child’s participation 
during initial screening 
7. 
Provide written consent 
 
Exclusion Criteria 
1. 
Severe mental health condition (female primary caregiver) as documented in the child’s 
     medical record or reported to research staff by child’s treating physician or medical team  
 
 
member 
a. If potential participants experience emotional distress, a qualified mental health 
professional will be available to provide appropriate resources or referrals if 
needed.  
b. This would be documented in the child’s medical record as standard procedure by 
the qualified mental health professional 
2. 
Abuses or addictions (female primary caregiver) to illicit or prescribed substances or  
alcohol at the time of  screening as documented in the child’s medical record or reported 
to research staff by the child’s treating physician or medical team member 
3. 
Have a child with a diagnosis of suspected conversion syndrome at the time of screening  
 
as documented in the child’s medical record or reported to research staff by the child’s  
 
treating physician or medical team member 
4. 
Have a child who is suicidal at the time of screening as documented in the child’s medical  
 
or reported to research staff by the child’s treating physician or medical team member 
a. If suicidal ideation (including intent and/or plan) is communicated at any point 
research staff will connect the participant with the qualified mental health 
professional who will conduct a suicide risk assessment and if needed, break 
confidentiality to call emergency personnel.  
b. This would be documented in the child’s medical record as standard procedure by 
the qualified mental health professional  

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
5 
 
 
 
Facilities:  Three facilities specializing in pediatric SCI care and rehabilitation will recruit for and enroll 
participants in the study 1) Shriners Hospitals for Children- Chicago 2) Shriners Hospitals for Children –
Philadelphia and 3) TIRR Memorial Hermann- Houston.  Thomas Jefferson University is the regulatory 
and lead site, however no participants will be enrolled at this site.  Each enrolling site will have 1-2 
trained coaches who will each recruit, enroll, and complete the study procedures for data collection 
with up to 5 participants. 
 
Data Collection and Study Procedures: 
1. Following consent, screening, and enrollment, baseline data collection will occur including 
baseline demographics of caregiver and child characteristics, the Beck Anxiety Inventory, the 
International Spinal Cord Injury Basic Data Set for Primary Caregivers, and the International 
Spinal Cord Injury Pediatric Activities and Participation Basic Data Set. 
2. Each coach will provide the intervention to up to 5 participants.  Participants will be 
assigned to coaching method based on their order of enrollment. Depending on the coach, 
the first 1-2 participants enrolled will have face to face coaching.  The next 1-3 participants 
will have phone coaching.  Seven female primary caregivers will receive the face to face and 
9 will receive the phone coaching, for a total of 16 participants to receive the intervention.  
3. In the event that face to face is not feasible, participants will have coaching via phone.    
4. Caregivers who are have face to face coaching will receive up to 10 coaching sessions at a 
location that is mutually convenient for the caregiver and coach. 
a. The caregiver and coach will decide on how the sessions will be distributed over a 
10 week period 
b. All 10 sessions must be completed within a 10 week period 
c. Each session will not exceed 90 minutes 
d. If goals are accomplished before 10 sessions, coaching  will cease 
e. The general content, format and purpose of each coaching session is outlined in 
Table 1 below. 
f. All coaching sessions will be audio-recorded for assessment of treatment fidelity  
5. Caregivers who are enrolled but who have not started coaching will receive monthly text 
messages from the project coordinator starting 1 month after enrollment. This is for 
retaining the participant. 
6. The start and stop time of each OPC session will be documented on a study specific CRF that 
will also include information on caregiver attendance.   
7. If coaching sessions are cancelled, rescheduled and/or missed coaches will document the 
occurrence and the caregivers’ reasons for missing the session will be documented. 
8. Caregivers who received and finished face to face coaching will be contacted on a monthly 
basis by the project coordinator via phone and asked about how goal focused problem 
solving skills have been generalized to other participation challenges and goals.  This will be 
done to keep the caregivers engaged while assessing generalization of skills gained through 
coaching.  
9. Assessments (primary). 
a. Canadian Occupational Performance Measure: This outcome will evaluate 
performance of and satisfaction with performance in self-identified goals. 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
6 
 
Performance and satisfaction will be rated on a scale between 1-10, where 1 is 
“cannot perform” “not satisfied” and 10 is “performs without a problem” and “very 
satisfied”. Goals will be rated by the caregivers before and after coaching.  
10. Secondary (exploratory)  
a. Parenting Sense of Competence Scale (PSOC): most widely used measure of parental 
self-efficacy, it contains 17 items rated on a 6 point scale and evaluates satisfaction 
with parenting 
b. Parenting Stress Index Short Form-4 (PSI-SF-4):  one of the most widely used 
measures of parental stress, it provides a method to evaluate parent stress with few 
items.  It is comprised of 3 subscales including Parental Distress, Parent-Child 
Dysfunctional Interaction and Difficult Child as well as a Total Stress Scale.   
c. Pediatric Measure of Participation Short Form (PMoP SF) Parent Report: used to 
measure a caregiver’s perception of their child’s participation 
11. Satisfaction – following completion of coaching, caregivers will participate in a semi-
structured interview to explore satisfaction (Table 2)  
 
 
Table 1: General Content and Sequence of Coaching Session 
 
 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
7 
 
Table 2: Example of Questions for Final Caregiver Satisfaction Interviews 
 
 
Recruitment: Primary female caregivers, including but not limited to mothers, grandmothers and aunts 
of children with SCI will be identified and recruited from the SCI practices at each facility.  A member of 
the research team at each facility will make personal contact with the potential participant either 1) 
during their child’s scheduled appointment or 2) via phone.  Both methods will introduce the study and 
inquire about interest.  If there is interest a contact form will be completed and a future appointment 
will be scheduled.   
Informed Consent Process:  Informed consent will be obtained from participants who have the capacity 
to give informed consent by a member of the research team who is authorized to consent for this study.  
The process will include a thorough discussion of all the elements outlined in the informed consent 
document, including but not limited to what is expected to happen during the study, risks and benefits 
of the planned intervention, and any possible alternatives.  Potential participants will be given sufficient 
time to consider consenting to the study.  The participant will be given a copy of the signed consent 
form.  The original consent will be maintained in the participant’s study binder/folder and kept in a 
locked storage cabinet. 
 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
8 
 
Data Storage and Transmission 
1.    Original Site Data: Data will be recorded on standardized or study-specific case report forms.  
Participants will be assigned a confidential study identifier.  The original data and subject 
identifiers from each site will be kept in a locked file cabinet, accessible only to the key research 
staff working on the study.  
2.    Data Transmission from Participating sites to the Lead Site: All data transmitted from the 
participating site will be de-identified, and coded with a unique subject identifier. Copies of all 
de-identified measures, CRFs, and audio recordings will be sent to the lead site via secure 
upload to a study specific Sharefile Account. The PI and/or project coordinator at the lead site 
will retrieve all data from the Sharefile account and save it to the designated file on the research 
drive. Once the data of participating sites are saved, they will be permanently removed from the 
Sharefile account.    
 
Data Handling and Analysis: All data will be recorded on study specific CRFs and standardized measures 
and assessments.  It will be sent to the lead site following the procedure above and will be entered into 
a study specific database.   
Primary Outcome 
1. Canadian Occupational Performance Measure:  A 2-point change on the COPM indicates a 
clinically meaningful change, and 0.9 and 1.9 were found to be optimal cut-off points for 
performance and satisfaction, respectively.  We will examine changes in COPM performance 
and satisfaction scores using non-parametrics.  
Secondary Exploratory 
2. BIGSS: We will calculate Spearman rank correlation coefficients (rs) and create a correlation 
matrix to examine the relationships among caregivers’ confidence in achieving goals, goal 
attainment (COPM), parent competency, stress, anxiety and participation, parent 
perceptions of child’s participation, and caregiver and child characteristics. We will use 
these associations to better define inclusion and exclusion criteria for a future RCT on OPC, 
and to define primary and secondary endpoints for a future RCT.  
3. Fidelity:  Descriptive and summary statistics will be used to identify the number (mean, 
mode and range) of coaching sessions conducted for the face-to-face OPC group and the 
phone OPC group, and the average number and range of sessions required for goal 
attainment. We will also identify the average time per OPC session for both groups. The 
number of missed sessions and reasons for missing sessions will be identified. We will 
examine variability among the four coaches, and will determine if significant differences in 
these variables exist between OPC face-to-face and phone OPC. These data will be used to 
define the dosing parameters of OPC for a future RCT.      
4. The audio-recordings of each OPC session will be transcribed verbatim. The transcriptions 
will be read and evaluated on treatment fidelity. Inter-rater reliability on treatment fidelity 
between the two graduate assistants will be evaluated by calculating intraclass correlation 
coefficients (ICC, Model 2,1) with 95% confidence intervals (CI). The PI will randomly select 
10 transcribed face-to-face OPC sessions and 10 phone OPC sessions, and will also assess 

Coaching Informal Caregivers  
 
Version: Abbreviated Protocol 2018 
 
 
9 
 
treatment fidelity. Agreement between the assessments of fidelity will serve as an internal 
quality control, but will also further assess reliability using ICC (2,1) with 95% CI.