NCT04322903

Brief 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 maintaining permanent housing.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

March 24, 2020

Last Update Submit

July 24, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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

    4 weeks after the intervention

  • Perception of ability to maintain stable housing as assessed by a semi-structured interview questions

    Semi-structured interview questions

    4 weeks after the intervention

Study Arms (1)

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.

Behavioral: Passport to Freedom (P2F)

Interventions

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.

Trauma-informed mindfulness-based stress reduction program

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Under 18 years of age
  • Inability to speak or write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Kim Hill, MS

    Johns Hopkins School of Nursing

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

March 26, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Individual patient data will not be shared.