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Coaching for Caregivers of Children With Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03898700
Recruitment Status : Unknown
Verified March 2019 by Thomas Jefferson University.
Recruitment status was:  Enrolling by invitation
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Study Description
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Brief Summary:
This pilot study has two aims. The first aim is to establish the feasibility of occupational performance 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: strength based coaching Not Applicable

Detailed Description:
This study addresses the unmet needs of female primary caregivers of youth with spinal cord injury. A randomized crossover delayed treatment design will be used. Consented caregivers will be assigned to one of two groups: coaching via face-to-face and delayed coaching via 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 for assessment of treatment fidelity.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Two group delayed treatment cross over design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Occupational Performance Coaching for Caregivers of Children With Spinal Cord Injury
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: coaching face to face
10, 1 hour sessions of face to face strength based coaching sessions
 Behavioral: strength based coaching
strength based and solution focused coaching
Active Comparator: phone coaching
10, 1 hour sessions of strength based coaching via phone.
 Behavioral: strength based coaching
strength based and solution focused coaching


Outcome Measures
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Primary Outcome Measures :
  1. Change in Canadian Occupational Performance Measure [ 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. We will also use participant anchors to determine success.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study is focused on primary female caregivers
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898700


Locations
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United States, Illinois
Shriners Hospitals for Children
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Shriners Hospitals for Children
Philadelphia, Pennsylvania, United States, 19438
United States, Texas
TIRR Memorial Hermann Rehabilitation Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: MJ Mulcahey, PhD Thomas Jefferson University
More Information
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Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03898700    
Other Study ID Numbers: 533863
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System