Group Coaching Study for Life Goals

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - People with four types of chronic conditions are included.
1. 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. 2. 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.

Exclusion Criteria:

- Less than 18 years

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07083713
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Thomas Jefferson University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Students, Spinal Cord Injury, Ehlers Danlos Syndrome, Care Givers
Additional Details

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. 1. 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. 2. 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.

Arms & Interventions

Arms

Experimental: Group coaching

Group coaching 10 sessions

Interventions

Behavioral: - Group Coaching

Group coaching using a protocol developed with Coaching in Context model

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Thomas Jefferson University, Philadelphia 4560349, Pennsylvania 6254927

Status

Address

Thomas Jefferson University

Philadelphia 4560349, Pennsylvania 6254927, 19107