Coaching for Caregivers of Children With Spinal Cord Injury

NCT03898700 | Completed Results

• 1 other identifier: 533863
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

coaching in context

OTHER

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

Behavioral: strength based coaching

Interventions

strength based coaching BEHAVIORAL

strength based and solution focused coaching

coaching in context

Eligibility Criteria

• Gender Eligibility Details: This study is focused on primary female informal caregivers
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (3)

Shriners Hospitals for Children

Chicago, Illinois, 60612, United States

Location

Shriners Hospitals for Children

Philadelphia, Pennsylvania, 19438, United States

Location

TIRR Memorial Hermann Rehabilitation Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

We did not achieve our desired sample size of 16. We originally planned to have an equal number of caregivers in each group, however caregivers did not want to be coached in person due to logistical challenges. The study is limited by the small sample size, and COPM scores were generated from more than one goal from each caregiver (there were 31 COPM goals across the 7 participants, with each participant contributing between 3-5 goals).

Results Point of Contact

• Title: Dr. MJ Mulcahey
• Organization: Thomas Jefferson University

maryjane.mulcahey@jefferson.edu

215-503-2888

Study Officials

• MJ Mulcahey, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post coaching intervention

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: April 2, 2019
• Study Start: September 28, 2018
• Primary Completion: November 16, 2019
• Study Completion: November 16, 2019
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)