Spinal Cord InjuriesNCT03898700
Coaching for Caregivers of Children With Spinal Cord Injury
A study testing strength based coaching in people with Spinal Cord Injuries, run by Thomas Jefferson University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- strength based coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Sep 2018to 16 Nov 2019
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Shriners Hospitals for Children
Chicago, Illinois, 60612
TIRR Memorial Hermann Rehabilitation Hospital
Houston, Texas, 77030
Shriners Hospitals for Children
Philadelphia, Pennsylvania, 19438
About this study
Official title: Coaching in Context for Caregivers of Children With Spinal Cord Injury
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- strength based coaching
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strength based coachingBehavioural
strength based and solution focused coaching
| Study group | Role | What they receive |
|---|---|---|
| coaching in context | Other | 10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone. Receives: Behavioral: strength based coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start28 Sep 2018
- Primary completion16 Nov 2019
- Study completion16 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post coaching intervention
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MJ Mulcahey, PhD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898700
- Sponsor's protocol ID
- 533863
- Status last verified
- Apr 2023
- First submitted
- 22 Jan 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No