TraumaP2FHHNCT04322903
Passport to Freedom: Health and Housing
A study testing Passport to Freedom (P2F) in people with Trauma, run by Johns Hopkins University.
Trial summary
The purpose of the Passport to Freedom (P2F) Health and Housing is to provide formerly homeless women a supportive group to process the impact of trauma on the women's overall health and wellbeing, learn strategies to reduce the symptoms of trauma and stress, and increased ability to cope with everyday stress while… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Passport to Freedom (P2F)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 years to 55 years, may be parents
- Able to read and write English
- Formerly homeless and currently living in permanent supportive housing through the Women's Housing Coalition Program.
Who cannot join
- Under 18 years of age
- Inability to speak or write English
About this study
The purpose of the Passport to Freedom (P2F) Health and Housing is to provide formerly homeless women a supportive group to process the impact of trauma on the women's overall health and wellbeing, learn strategies to reduce the symptoms of trauma and stress, and increased ability to cope with everyday stress while maintaining permanent housing.
Read the detailed description
The proposed project will use a mixed method design to examine the feasibility and effectiveness of the Passport to Freedom (P2F) Program, an intervention for formerly homeless women currently housed through a supportive permanent housing program. P2F involves: three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss the women's perception of the intervention. By the end of the program, women will have improved emotional self-regulation in response to everyday stress, positive perception of managing women's overall health, and increased confidence in maintaining stable housing.
- Conditions
- Trauma
- Being tested
- Passport to Freedom (P2F)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passport to Freedom (P2F)Behavioural
During the P2F sessions, the women learn to understand and process the impact of multiple traumas on women's lives and health and learn specific strategies to overcome the symptoms of trauma and everyday stress. Each session will begin and end with a mindfulness exercise to provide different strategies the women can use when these women are in a stressful situation. At the end of each session, the participants will complete a session evaluation. The women will also have a home visit or telephone call with a community health navigator who will conduct a social determinant of health screenings assessment to determine what identified social barriers these women may have. The community health navigator will help with linking the participant to a community agency that addresses the identified problem. Four weeks after the completion of the program, the women will be contacted for a follow-up interview to learn the effectiveness of the program sessions.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-informed mindfulness-based stress reduction program | Experimental | The program includes three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss perception of the intervention. Receives: Behavioral: Passport to Freedom (P2F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in confidence in managing health as assessed by the Perceived Health Competence Scale
Women will report confidence in managing health based on Pre/Post Perceived Health Competence Scale (PHCS) scores. The questionnaire uses the Likert strongly agree to strongly disagree scale to assess agreement with 8 belief statements. Higher scores indicate greater perceived health competence and lower scores indicate less perceived health competence.
Measured: At the time of consent and 4 weeks after intervention
Change in emotional response to stress as assessed by the Difficulties in Emotion Regulation Scale
Women will report level of self-regulation of emotions based on Pre/Post Difficulties in Emotion Regulation Scale (DERS) scores. The scale uses a 1-5 Likert scale to assess frequency of emotional regulation. Higher scores indicate a greater difficulty with emotional regulation and lower scores indicate less difficulty with emotion regulation.
Measured: At the time of consent and 4 weeks after intervention
Change in stress as assessed by the Everyday Stressor Index
Women will report stress based on Pre/Post Everyday Stressor Index (ESI). The ESI uses a 1-4 Likert scale for 20 questions that assess role overload, financial concerns, parenting worries, employment problems and interpersonal conflict. Higher scores indicate a higher level of daily stress, lower scores indicate a lower level of daily stress.
Measured: At the time of consent and 4 weeks after intervention
Perception of the overall program as assessed by a semi-structured interview questions
Semi-structured interview questions
Measured: 4 weeks after the intervention
Perception of ability to maintain stable housing as assessed by a semi-structured interview questions
Semi-structured interview questions
Measured: 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: Due to COVID 19 restrictions and protocol could not to be implemented safely for participants and researchers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Urban Health Institute
- Responsible party
- Sponsor
- Investigators
- Kim Hill, MS, Study chair, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322903
- Sponsor's protocol ID
- IRB00239900
- Acronym
- P2FHH
- Status last verified
- Jul 2020
- First submitted
- 24 Mar 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passport to Freedom: Health and Housing
- ClinicalTrials.gov ID
- NCT04322903
- Acronym / sponsor ID
- P2FHH / IRB00239900
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID 19 restrictions and protocol could not to be implemented safely for participants and researchers.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Urban Health Institute
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 Mar 2020 (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.
The purpose of the Passport to Freedom (P2F) Health and Housing is to provide formerly homeless women a supportive group to process the impact of trauma on the women's overall health and wellbeing, learn strategies to reduce the symptoms of trauma and stress, and increased ability to cope with everyday stress while maintaining permanent housing.
Detailed description
The proposed project will use a mixed method design to examine the feasibility and effectiveness of the Passport to Freedom (P2F) Program, an intervention for formerly homeless women currently housed through a supportive permanent housing program. P2F involves: three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss the women's perception of the intervention. By the end of the program, women will have improved emotional self-regulation in response to everyday stress, positive perception of managing women's overall health, and increased confidence in maintaining stable housing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma-informed mindfulness-based stress reduction program | Experimental | Behavioral: Passport to Freedom (P2F)The program includes three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss perception of the intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women 18 years to 55 years, may be parents
- Able to read and write English
- Formerly homeless and currently living in permanent supportive housing through the Women's Housing Coalition Program.
Key exclusion criteria (2 listed)
- Under 18 years of age
- Inability to speak or write English
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 |
|---|---|---|
| Passport to Freedom (P2F)During the P2F sessions, the women learn to understand and process the impact of multiple traumas on women's lives and health and learn specific strategies to overcome the symptoms of trauma and everyday stress. Each session will begin and end with a mindfulness exercise to provide different strategies the women can use when these women are in a stressful situation. At the end of each session, the participants will complete a session evaluation. The women will also have a home visit or telephone call with a community health navigator who will conduct a social determinant of health screenings assessment to determine what identified social barriers these women may have. The community health navigator will help with linking the participant to a community agency that addresses the identified problem. Four weeks after the completion of the program, the women will be contacted for a follow-up interview to learn the effectiveness of the program sessions. | Behavioural | Trauma-informed mindfulness-based stress reduction program |
Primary outcome
Change in confidence in managing health as assessed by the Perceived Health Competence Scale
Time frame: At the time of consent and 4 weeks after intervention
Women will report confidence in managing health based on Pre/Post Perceived Health Competence Scale (PHCS) scores. The questionnaire uses the Likert strongly agree to strongly disagree scale to assess agreement with 8 belief statements. Higher scores indicate greater perceived health competence and lower scores indicate less perceived health competence.
Change in emotional response to stress as assessed by the Difficulties in Emotion Regulation Scale
Time frame: At the time of consent and 4 weeks after intervention
Women will report level of self-regulation of emotions based on Pre/Post Difficulties in Emotion Regulation Scale (DERS) scores. The scale uses a 1-5 Likert scale to assess frequency of emotional regulation. Higher scores indicate a greater difficulty with emotional regulation and lower scores indicate less difficulty with emotion regulation.
Change in stress as assessed by the Everyday Stressor Index
Time frame: At the time of consent and 4 weeks after intervention
Women will report stress based on Pre/Post Everyday Stressor Index (ESI). The ESI uses a 1-4 Likert scale for 20 questions that assess role overload, financial concerns, parenting worries, employment problems and interpersonal conflict. Higher scores indicate a higher level of daily stress, lower scores indicate a lower level of daily stress.
Perception of the overall program as assessed by a semi-structured interview questions
Time frame: 4 weeks after the intervention
Semi-structured interview questions
Perception of ability to maintain stable housing as assessed by a semi-structured interview questions
Time frame: 4 weeks after the intervention
Semi-structured interview questions
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No. Individual patient data will not be shared.
Related trials for Trauma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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.
Kim Hill, MS study chair
Johns Hopkins School of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Passport to Freedom (P2F) in people with Trauma, run by Johns Hopkins University.
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 3 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: withdrawn, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 confidence in managing health as assessed by the Perceived Health Competence Scale (time frame: At the time of consent and 4 weeks after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020.