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Completed

NCT Number: NCT03898700

Coaching 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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospitals for Children, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

strength based coaching

Behavioral

strength based and solution focused coaching

Primary outcomes

  1. Change in Canadian Occupational Performance Measure (COPM)

    Time frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)

    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.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Coaching in Context for Caregivers of Children With Spinal Cord Injury

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2019
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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