Spinal Cord InjuriesNCT03898700

Coaching for Caregivers of Children With Spinal Cord Injury

A study testing strength based coaching in people with Spinal Cord Injuries, run by Thomas Jefferson University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Spinal Cord Injuries
What is being tested?: strength based coaching
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 3 sitesUnited States
Study dates: 28 Sep 2018to 16 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

Official title: Coaching in Context for Caregivers of Children With Spinal Cord Injury

Read the 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.

Conditions: Spinal Cord Injuries
Being tested: strength based coaching
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

strength based coachingBehavioural
strength based and solution focused coaching

Study groups in NCT03898700
Study group	Role	What they receive
coaching in context	Other	10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone. Receives: Behavioral: strength based coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 201816 Nov 2019

First posted2 Apr 2019
Study start28 Sep 2018
Primary completion16 Nov 2019
Study completion16 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Pre-post coaching intervention
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03898700
Sponsor's protocol ID: 533863
Status last verified: Apr 2023
First submitted: 22 Jan 2019
Last updated: 18 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
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All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coaching in Context for Caregivers of Children With Spinal Cord Injury
ClinicalTrials.gov ID: NCT03898700
Acronym / sponsor ID: 533863
Conditions: Spinal Cord Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Thomas Jefferson UniversityUniversity, hospital or other
Study start: 28 Sep 2018 (actual)
Primary completion: 16 Nov 2019 (actual)
Study completion: 16 Nov 2019 (actual)
First posted: 2 Apr 2019 (actual)
Results: Posted 18 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Pre-post coaching intervention

Arm	Type	Receives
coaching in context	Other	Behavioral: strength based coaching10, 1 hour sessions of face to face strength based coaching sessions provided face to face or over the phone.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
strength based coachingstrength based and solution focused coaching	Behavioural	coaching in context

Primary outcome

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.

Results and safety

Results posted to the registry on 18 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coaching in Context	9	7

Primary outcome: Change in Canadian Occupational Performance Measure (COPM)

Time frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	Coaching in Context n = 7
COPM Performance	2.48 (2.01)
COPM Satisfaction	2.80 (1.33)

Coaching in Context: Median Difference (Final Values): 2, p <0.001, Wilcoxon (Mann-Whitney)
Coaching in Context: Median Difference (Net): 2, p <0.001, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: up to 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coaching in Context	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injuries

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MJ Mulcahey, PhD principal investigator

Thomas Jefferson University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing strength based coaching in people with Spinal Cord Injuries, run by Thomas Jefferson University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Canadian Occupational Performance Measure (COPM) (time frame: Baseline - before coaching and repeated at end of 10 coaching sessions (12 weeks from baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03898700.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.