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Coaching for Caregivers of Children With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
strength based coaching
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Shriners Hospitals for Children
  • Shriners Hospitals for Children
  • TIRR Memorial Hermann Rehabilitation Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

coaching in context

Arm Description

10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2019
Last Updated
April 17, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03898700
Brief Title
Coaching for Caregivers of Children With Spinal Cord Injury
Official Title
Coaching in Context for Caregivers of Children With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
November 16, 2019 (Actual)
Study Completion Date
November 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-post coaching intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
coaching in context
Arm Type
Other
Arm Description
10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone.
Intervention Type
Behavioral
Intervention Name(s)
strength based coaching
Intervention Description
strength based and solution focused coaching
Primary Outcome Measure Information:
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is focused on primary female informal caregivers
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MJ Mulcahey, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Shriners Hospitals for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
TIRR Memorial Hermann Rehabilitation Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Coaching for Caregivers of Children With Spinal Cord Injury

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