StudentsNCT07083713
Group Coaching Study for Life Goals
A study testing Group Coaching in people with Students and Spinal Cord Injury, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study plans to implement's group coaching with neurodivergent STEM undergraduate students, individuals with spinal cord injuries and their caregivers, and individuals with Ehler's Danlos Syndrome. A trained coach will facilitate the 10 group coaching sessions using the project created coaching protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Students, Spinal Cord Injury, Ehlers Danlos Syndrome
- What is being tested?
- Group Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with four types of chronic conditions are included.
- Neurodivergent students:
- Jefferson neurodivergent undergraduate STEM students Jefferson students who major in Chemistry, Biochemistry, Biology, Pre-Medical Studies, Psychology/biopsychology, Textiles production science, Industrial design, Engineering, Health Sciences, or Exercise science
- Ehler's Danlos Syndrome:
- Have been diagnosed by a physician with any form of Ehlers-Danlos Syndromes
- understand and speak English fluently
Show all 21Show fewer
- Be a resident of the United States.
- be 18 years of age and older
- has the ability to join the group coaching session by phone or video conferencing.
- 3 Person with SCI:
- Self-report as having a spinal cord injury or disease
- Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing. 4 Care partner of a Person with SCI:
- Provides part or full-time care for a family member/significant other with SCI, need not live in the same household Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing.
Who cannot join
- Less than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Group Coaching for Life Goals in People With Neurological Conditions: A Feasibility Study
This study plans to implement's group coaching with neurodivergent STEM undergraduate students, individuals with spinal cord injuries and their caregivers, and individuals with Ehler's Danlos Syndrome. A trained coach will facilitate the 10 group coaching sessions using the project created coaching protocol. Assessments at pretest and posttest will include two measures addressing the concept of self-efficacy and two others addressing belonging, as well as a battery of tools estimating feasibility.
Read the detailed description
Background Individuals who have chronic conditions which impact their participation in daily activities generally experience reduced self-efficacy and belonging, which are known to affect their quality of life. Building capacity in these areas is possible as evidenced by the group peer mentoring literature, the individual coaching literature, and the outcomes of Jefferson's GOALS2 program. Group coaching combines the key features of these two approaches but has yet to be used to build capacity in these groups.
Objective To examine group coaching's feasibility and utility for building self-efficacy and belonging.
Hypothesis Group Coaching will increase self-efficacy and belonging by a change effect of 20% as per the General Self-Efficacy Scale, Relationship Closeness Scale, and the Sense of Belonging Scale.
Inclusion criteria People with four types of chronic conditions are included.
- Neurodivergent students: Jefferson neurodivergent undergraduate STEM students Jefferson students who major in Chemistry, Biochemistry, Biology, Pre-Medical Studies, Psychology/biopsychology, Textiles production science, Industrial design, Engineering, Health Sciences, or Exercise science
- Ehler's Danlos Syndrome:
- Have been diagnosed by a physician with any form of Ehlers-Danlos Syndromes
- understand and speak English fluently
- Be a resident of the United States.
- be 18 years of age and older
- has the ability to join the group coaching session by phone or video conferencing. 3 Person with SCI:
- Self-report as having a spinal cord injury or disease
- Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing. 4 Care partner of a Person with SCI:
- Provides part or full-time care for a family member/significant other with SCI, need not live in the same household Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing.
Procedures Recruitment will involve flyers online on websites, social media, newsletters, patient portals, support groups, clinics, and hospitals. Research staff will then reach out to the participant to schedule the COPM over zoom. The zoom meeting will start with the OHR-8H form to confirm the participants willingness to participate. After consenting, the participant will provide information for the COPM, which will be recorded by the research staff member. After completion of the COPM, the participant is provided with a Jefferson Qualtrics link to the following surveys: Social demographic questionnaire General Self-Efficacy Scale, Relationship Closeness Scale, and the Sense of Belonging Scale. The surveys are completed during the zoom call with the research staff member present to answer any questions the participant may have while completing the surveys. After survey completion, participants will be asked to provide their avalability for the group coaching session. After research staff have selected a date for the coaching session, participants will be sent an email informing them of the time and the topic of the coaching session. A reminder email will be sent 24 hours before the session. A total of 10 group coaching sessions will occur for each participant. These will occur in two groups of up to six participants each. The coaching sessions will include conversations regarding specific topics with the goal of facilitating participant in gaining insight and strategies towards set goal. The goals are based on the earlier COPM interview. The coaching sessions will be facilitated by two trained coaches who are study staff members. These coaching sessions will be audio recorded over zoom. Research staff will later fill out surveys including the AIM, IAM, \& FIM based on their experiences will the coaching sessions. After the completion of the 10 coaching sessions, participants are scheduled for a second COPM over zoom. The participant will assess their progress based on their earlier COPM, and the interview will be recorded by the research staff member. After completion of the COPM, the participant is provided with a Jefferson Qualtrics link to the following surveys: General Self-Efficacy Scale, Relationship Closeness Scale, the Sense of Belonging Scale, and to determine feasibility through the Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM). The surveys are completed during the zoom call with the research staff member present to answer any questions the participant may have while completing the surveys. After survey completion, the participant will be thanked for their time and a time will be scheduled for picking up their ClinCard payment.
Analysis Demographic data will be summarized descriptively, mean, and standard deviation scores for the intervention feasibility and percentage of completion for the assessment will be determined for assessment of feasibility. Assessment of the outcome measures will be done to calculate how many participants reached the change effect of 20%. Satisfaction will also be assessed using descriptive statistics. Qualitative analysis will be conducted on the session transcripts. Feasibility will be assessed using the AIM, IAM, \& FIM.
- Conditions
- Students, Spinal Cord Injury, Ehlers Danlos Syndrome, Care Givers
- Being tested
- Group Coaching
- Medical subject headings
- Spinal Cord Injuries, Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CoachingBehavioural
Group coaching using a protocol developed with Coaching in Context model
| Study group | Role | What they receive |
|---|---|---|
| Group coaching | Experimental | Group coaching 10 sessions Receives: Behavioral: Group Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Performance and Satisfaction is scored for 9 items using a 1 to 10 scoring system, and higher scores indicate better performance and satisfaction.
Measured: Week 1 and 10
Acceptability measure
Acceptability of Intervention Measure is scored from 1 to 5, higher scores are better
Measured: Week 10
Feasibility of Intervention measure
Feasibility of intervention is scored from 1 to 5, higher scores are better
Measured: Week 10
Intervention Appropriateness Measure
The appropriateness of the intervention is assessed using this measure. The scoring is from 1 to 5, higher scores are better.
Measured: Week 10
Secondary outcomes (3)
General Self Efficacy
A measure of self-efficacy has 10 items. The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Measured: Week 1 and 10
Relationship Closeness Scale
Peers in group and with others are measured on this scale from 1 to 7, and higher scores are better.
Measured: Week 1 and 10
Sense of Belonging
A measure that assesses the sense of belonging in a group, higher scores are better. Each item is scored from 1 to 4, mean scores calculated.
Measured: Week 1 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jul 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StudentsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083713
- Sponsor's protocol ID
- IRIS-ID-2024-1010
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cadematori C, Alpajora B, Sivori T, Betz S, Gerhardt N, Dunn W, Mulcahey MJ. Preliminary examination of Coaching in Context with clients with spinal cord injury. Spinal Cord Ser Cases. 2021 Apr 13;7(1):27. doi: 10.1038/s41394-021-00391-9.
PubMed 33850100Mulcahey MJ, Gerhardt N, Alpajora B, Thielen CC, Dunn W. Coaching-in-Context With Informal Maternal Care Partners of Children With Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2022 Winter;28(1):99-113. doi: 10.46292/sci21-00045. Epub 2022 Jan 19.
PubMed 35145338Potvin MC, West EK, Morales AN, Sailor KS, Coronado N. "I Could Really Use This": Occupational Therapy Students' Perceptions of Learning to Coach. Occup Ther Int. 2022 Oct 13;2022:2266326. doi: 10.1155/2022/2266326. eCollection 2022.
PubMed 36312841
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Coaching for Life Goals in People With Neurological Conditions: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07083713
- Acronym / sponsor ID
- IRIS-ID-2024-1010
- Conditions
- Students, Spinal Cord Injury, Ehlers Danlos Syndrome, Care Givers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to implement's group coaching with neurodivergent STEM undergraduate students, individuals with spinal cord injuries and their caregivers, and individuals with Ehler's Danlos Syndrome. A trained coach will facilitate the 10 group coaching sessions using the project created coaching protocol. Assessments at pretest and posttest will include two measures addressing the concept of self-efficacy and two others addressing belonging, as well as a battery of tools estimating feasibility.
Detailed description
Background Individuals who have chronic conditions which impact their participation in daily activities generally experience reduced self-efficacy and belonging, which are known to affect their quality of life. Building capacity in these areas is possible as evidenced by the group peer mentoring literature, the individual coaching literature, and the outcomes of Jefferson's GOALS2 program. Group coaching combines the key features of these two approaches but has yet to be used to build capacity in these groups.
Objective To examine group coaching's feasibility and utility for building self-efficacy and belonging.
Hypothesis Group Coaching will increase self-efficacy and belonging by a change effect of 20% as per the General Self-Efficacy Scale, Relationship Closeness Scale, and the Sense of Belonging Scale.
Inclusion criteria People with four types of chronic conditions are included.
- Neurodivergent students: Jefferson neurodivergent undergraduate STEM students Jefferson students who major in Chemistry, Biochemistry, Biology, Pre-Medical Studies, Psychology/biopsychology, Textiles production science, Industrial design, Engineering, Health Sciences, or Exercise science
- Ehler's Danlos Syndrome:
- Have been diagnosed by a physician with any form of Ehlers-Danlos Syndromes
- understand and speak English fluently
- Be a resident of the United States.
- be 18 years of age and older
- has the ability to join the group coaching session by phone or video conferencing. 3 Person with SCI:
- Self-report as having a spinal cord injury or disease
- Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing. 4 Care partner of a Person with SCI:
- Provides part or full-time care for a family member/significant other with SCI, need not live in the same household Understand and speak English fluently
- Be a resident of the United States.
- Be 18 years of age and older
- Stable health condition
- Have the ability to join the group coaching session by phone or video conferencing.
Procedures Recruitment will involve flyers online on websites, social media, newsletters, patient portals, support groups, clinics, and hospitals. Research staff will then reach out to the participant to schedule the COPM over zoom. The zoom meeting will start with the OHR-8H form to confirm the participants willingness to participate. After consenting, the participant will provide information for the COPM, which will be recorded by the research staff member. After completion of the COPM, the participant is provided with a Jefferson Qualtrics link to the following surveys: Social demographic questionnaire General Self-Efficacy Scale, Relationship Closeness Scale, and the Sense of Belonging Scale. The surveys are completed during the zoom call with the research staff member present to answer any questions the participant may have while completing the surveys. After survey completion, participants will be asked to provide their avalability for the group coaching session. After research staff have selected a date for the coaching session, participants will be sent an email informing them of the time and the topic of the coaching session. A reminder email will be sent 24 hours before the session. A total of 10 group coaching sessions will occur for each participant. These will occur in two groups of up to six participants each. The coaching sessions will include conversations regarding specific topics with the goal of facilitating participant in gaining insight and strategies towards set goal. The goals are based on the earlier COPM interview. The coaching sessions will be facilitated by two trained coaches who are study staff members. These coaching sessions will be audio recorded over zoom. Research staff will later fill out surveys including the AIM, IAM, \& FIM based on their experiences will the coaching sessions. After the completion of the 10 coaching sessions, participants are scheduled for a second COPM over zoom. The participant will assess their progress based on their earlier COPM, and the interview will be recorded by the research staff member. After completion of the COPM, the participant is provided with a Jefferson Qualtrics link to the following surveys: General Self-Efficacy Scale, Relationship Closeness Scale, the Sense of Belonging Scale, and to determine feasibility through the Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Intervention Appropriateness Measure (IAM). The surveys are completed during the zoom call with the research staff member present to answer any questions the participant may have while completing the surveys. After survey completion, the participant will be thanked for their time and a time will be scheduled for picking up their ClinCard payment.
Analysis Demographic data will be summarized descriptively, mean, and standard deviation scores for the intervention feasibility and percentage of completion for the assessment will be determined for assessment of feasibility. Assessment of the outcome measures will be done to calculate how many participants reached the change effect of 20%. Satisfaction will also be assessed using descriptive statistics. Qualitative analysis will be conducted on the session transcripts. Feasibility will be assessed using the AIM, IAM, \& FIM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility
| Arm | Type | Receives |
|---|---|---|
| Group coaching | Experimental | Behavioral: Group CoachingGroup coaching 10 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- People with four types of chronic conditions are included.
- Jefferson neurodivergent undergraduate STEM students Jefferson students who major in Chemistry, Biochemistry, Biology, Pre-Medical Studies, Psychology/biopsychology, Textiles production science, Industrial design, Engineering, Health Sciences, or Exercise science
Key exclusion criteria (1 listed)
- Less than 18 years
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 |
|---|---|---|
| Group CoachingGroup coaching using a protocol developed with Coaching in Context model | Behavioural | Group coaching |
Primary outcome
Canadian Occupational Performance Measure
Time frame: Week 1 and 10
Performance and Satisfaction is scored for 9 items using a 1 to 10 scoring system, and higher scores indicate better performance and satisfaction.
Acceptability measure
Time frame: Week 10
Acceptability of Intervention Measure is scored from 1 to 5, higher scores are better
Feasibility of Intervention measure
Time frame: Week 10
Feasibility of intervention is scored from 1 to 5, higher scores are better
Intervention Appropriateness Measure
Time frame: Week 10
The appropriateness of the intervention is assessed using this measure. The scoring is from 1 to 5, higher scores are better.
3 secondary outcomes
General Self Efficacy
Time frame: Week 1 and 10
Relationship Closeness Scale
Time frame: Week 1 and 10
Sense of Belonging
Time frame: Week 1 and 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 33850100Cadematori C, Alpajora B, Sivori T, Betz S, Gerhardt N, Dunn W, Mulcahey MJ. Preliminary examination of Coaching in Context with clients with spinal cord injury. Spinal Cord Ser Cases. 2021 Apr 13;7(1):27. doi: 10.1038/s41394-021-00391-9.
- Background: PubMed 35145338Mulcahey MJ, Gerhardt N, Alpajora B, Thielen CC, Dunn W. Coaching-in-Context With Informal Maternal Care Partners of Children With Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2022 Winter;28(1):99-113. doi: 10.46292/sci21-00045. Epub 2022 Jan 19.
- Background: PubMed 36312841Potvin MC, West EK, Morales AN, Sailor KS, Coronado N. "I Could Really Use This": Occupational Therapy Students' Perceptions of Learning to Coach. Occup Ther Int. 2022 Oct 13;2022:2266326. doi: 10.1155/2022/2266326. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Coaching in people with Students and Spinal Cord Injury, run by Thomas Jefferson University at 1 site 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 21 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Canadian Occupational Performance Measure (time frame: Week 1 and 10). The study lists 4 primary outcomes in all. 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 NCT07083713, which also lists 3 linked publications.
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 24 Jul 2025.