Coaching for Caregivers of Children With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

Coaching in Context for Caregivers of Children With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898700
• Other study ID #: 533863
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: November 16, 2019

Study information

• Verified date: April 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cord injury.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 16, 2019
• Est. primary completion date: November 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• strength based coaching
strength based and solution focused coaching

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Chicago	Illinois
United States	TIRR Memorial Hermann Rehabilitation Hospital	Houston	Texas
United States	Shriners Hospitals for Children	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)