Spinal Cord Injuries
Conditions
Brief summary
This pilot study has two aims. The first aim is to establish the feasibility of coaching for caregivers of youth with spinal cord injury, and the second aim is to establish methodological procedures for a future multi-center study on the effectiveness of coaching as an intervention for caregivers of youth with spinal cord injury.
Detailed description
This study addresses the unmet needs of female primary informal caregivers of youth with spinal cord injury. A one-group pre-post treatment design will be used. Consented caregivers will receive coaching via face-to-face or via the phone. Each caregiver will participate in up to 10 coaching sessions. Each coaching session will last up to 90 minutes. Coaching sessions will be audiorecorded and transcribed verbatim. Outcomes of coaching on caregivers' self-identified goals will be assessed using the Canadian Occupational Performance Measure.
Interventions
BEHAVIORALstrength based coaching
strength based and solution focused coaching
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pre-post coaching intervention
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* female primary caregiver of youth between 6-13 years of age with traumatic spinal cord injury * female primary caregivers have legal guardianship of their child with spinal cord injury * speak, read and comprehend English * be available for face-to-face coaching * have a cell phone with text messaging capabilities, and willing to utilize cell or land line for coaching and data collection * able to verbalize changes in their own participation or their child's participation during initial screen * written consent
Exclusion criteria
* severe mental health condition of female caregiver, as documented in child's medical record or reported to research staff by child's treating MD or medical team member * abuses illicit or prescribed substances or alcohol at time of initial screen as documented in child's medical record or reported to research staff by child's treating MD or medical team member
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Canadian Occupational Performance Measure (COPM) | Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline) | Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coaching in Context 10, 1 hour sessions of strength based coaching sessions
strength based coaching: strength based and solution focused coaching | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Coaching in Context |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 37.14 years STANDARD_DEVIATION 5.15 |
| Canadian Occupational Performance Measure Performance Score | 4.23 units on a scale |
| Canadian Occupational Performance Measure Satisfaction Score | 3.97 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Change in Canadian Occupational Performance Measure (COPM)
Rates self perceived performance and satisfaction with self-identified goals on a 10 point likert scale (1 cannot do, not satisfied; 10 can do without a problem, very satisfied). A 2-point change is considered clinically meaningful.
Time frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coaching in Context | Change in Canadian Occupational Performance Measure (COPM) | COPM Performance | 2.48 score on a scale | Standard Deviation 2.01 |
| Coaching in Context | Change in Canadian Occupational Performance Measure (COPM) | COPM Satisfaction | 2.80 score on a scale | Standard Deviation 1.33 |
Comparison: This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Performance scores from 31 coaching goals across 7 informal caregivers were used for analysis.p-value: <0.001Wilcoxon (Mann-Whitney)
Comparison: This one-group feasibility study examined outcomes of coaching using descriptive statistics (changed score) and the Wilcoxon signed-rank test. A changed score of 2 points reflects clinical significance. The Wilcoxon was used to determine statistical significance. Satisfaction scores from 31 coaching goals across 7 informal caregivers were used for analysis.p-value: <0.001Wilcoxon (Mann-Whitney)