Coaching for Caregivers of Children With Spinal Cord Injury

NCT ID: NCT03898700

Last Updated: 2023-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2019-11-16

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-post coaching intervention
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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coaching in context

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

Group Type OTHER

strength based coaching

Intervention Type BEHAVIORAL

strength based and solution focused coaching

Interventions

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strength based coaching

strength based and solution focused coaching

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MJ Mulcahey, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Shriners Hospitals for Children

Chicago, Illinois, United States

Site Status

Shriners Hospitals for Children

Philadelphia, Pennsylvania, United States

Site Status

TIRR Memorial Hermann Rehabilitation Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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533863

Identifier Type: -

Identifier Source: org_study_id

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