Coaching for Caregivers of Children With Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: strength based coaching

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Shriners Hospitals for Children
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19438
      • Shriners Hospitals for Children
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: coaching in context; 10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone.	Behavioral: strength based coaching; strength based and solution focused coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: MJ Mulcahey, PhD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2018
• Primary Completion (Actual): November 16, 2019
• Study Completion (Actual): November 16, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 533863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No