An interventional study of Up To Me Intervention + No Booster and Up To Me Intervention + Booster in Mental Illness, Behavior Disorders and Severe Mental Illness, sponsored by University of South Florida. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-27.
Sponsored by University of South Florida · Not applicable, Interventional, and Supportive care
This is a three-lesson, disclosure-based stigma reduction program meant to reduce barriers to community living and participation for college students with psychiatric disabilities. The goal is to improve community living and participation of individuals with psychiatric disabilities within their postsecondary community using the Honest Open Proud (HOP) program. There are 3 specific objectives of the project:1) evaluate program fidelity, 2) assess program feasibility, and 3) conduct a randomized controlled trial of the HOP program with college students with mental illness to examine its efficacy. Anticipated outcomes include increases in 1) community integration, 2)self-esteem and self-efficacy, 3) empowerment and self-determination, 4) disclosure of mental illness in order to obtain needed support, and 5) care seeking/service engagement for mental illness. Ultimately, we expect to see increased academic persistence and achievement among HOP program completers.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's planned enrollment of 201 is above the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Exclusion Criteria:
This arm will have n=67 participants. The Up To Me behavioral intervention will be administered via 2-hour sessions over three consecutive weeks. During these sessions, participants will complete worksheets from the Up To Me workbook.
Behavioral: Up To Me Intervention + No Booster
This arm will have n=67 participants. The Up To Me behavioral intervention will be administered via 2-hour sessions over three consecutive weeks. During these sessions, participants will complete worksheets from the Up To Me workbook. Additionally, participants randomized to this arm will complete an additional session 4 weeks after the third session of the intervention.
Behavioral: Up To Me Intervention + Booster
This arm will have n=67 participants. Those randomized to this arm will be engaged in "treatment as usual", participating in the same services and activities that they were engaged with prior to recruitment into the study.
Participants will complete two-hour sessions once a week over three weeks in which they complete modules in the Up To Me Workbook. These sessions are facilitated by a peer facilitator and a member of the USF Counseling center. Other members in the group sessions are university students who are peers who are also experiencing some form of shame around their mental health challenges.
In addition to the Up To Me Intervention, participants also complete a booster/additional session where additional topics of the Up To Me workbook are covered. This additional session occurs four weeks after the completion of the third session.
Self-Stigma of Mental Illness Scale-Short Form
Scores correspond with the four stage regressive model of self-stigma. The min of this scale is 1 or "I strongly disagree" and the max is 9 or "I strongly agree". Using this scale, an observed decrease would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Stigma Stress Scale
This scale includes 4 items measuring appraisal of stigma as a stressor (e.g., "prejudice against people with mental illness will have a negative impact on my future") and 4 items measuring perceived resources to cope with stigma (e.g., "I am prepared to deal with prejudice against people with mental illness"). The min on the scale is 1 or "Strongly disagree" to 7 or "Strongly agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Why Try Stigma Scale (WTSS)
The current version of the WTSS does not include items specific to the pursuit of postsecondary education. Therefore, the investigators will add two items for the purpose of this study: "I am not worthy of obtaining a college degree because I have a mental illness" and "I am not capable of obtaining a college degree because I have a mental illness." After the addition of the two aforementioned items, this scale includes 16 items on a seven-point agreement scale. The min on the scale is 1 or "Strongly disagree" to 7 or "Strongly agree". Using this scale, an observed decrease would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
The Empowerment Scale
Yields five factors: self-efficacy/self-esteem, power/powerlessness/community activism, righteous anger, and optimism/control over the future. This scale includes 28 items on a 4-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max of 4 or "Strongly Agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Self-Determination Scale
Participants respond to a vignette about a person, Harry, living with schizophrenia. The scale includes 14 items on a 9-point agreement scale. The minimum on the scale is 1 or "Strongly Agree" to 9 or "Strongly Disagree". Using this scale, an observed decrease would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
College Student Experiences Questionnaire (CSEQ Fourth Edition)
Following the design of the study conducted by Salzer examining the postsecondary experiences of students with psychiatric disabilities, the investigators will administer several scales from the CSEQ. The CSEQ assesses student campus experiences and engagement, relationships with others on campus, and the degree of satisfaction with their experience at a particular institution. Three indicators of academic integration will be included in this study. The first, Quality of Effort (QE), refers to the underlying assumption of the CSEQ: "The more effort students expend in using the resources and opportunities an institution provides for their learning and development, the more they benefit." This scale has 22 items on a 4-point frequency scale. The minimum on the scale is 1 or "Never" to the max (4) or "Very Often". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Peer Group Interactions Scale
The Peer-Group Interactions Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence. This scale has 7 items on a 7-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max (7) or "Strongly Agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Interactions with Faculty Scale
The Interactions with Faculty Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence; this scale focuses on assessing the quality of faculty interactions. This scale has 5 items on a 7-point agreement scale. The min on the scale is 1 or "Strongly Disagree" to the max (7) or "Strongly Agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Sense of Campus Belonging Scale (SoCB)
Sense of belonging is a psychological construct unique from engagement and integration, focusing on students' subjective feelings of connectedness. Hurtado and Carter developed a measure of cohesion including a subscale of sense of belonging including items concerning perceived "belonging," "fit," and being a "part" of the community. Each of the three items on the SoCB scale is rated on an 11-point Likert scale with a min of 0 or "Strongly DIsagree to the max (10) "Strongly agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Attitudes Towards Seeking Professional Psychological Help Scale (ATSPPHS)
The Attitudes Towards Seeking Professional Psychological Help Scale measures attitudes towards seeking help for mental health concerns from professional sources. This scale has 10 items on a 4-point agreement scale with a min of 1 or "Disagree" to a max of 4 "Agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Actual Help Seeking Questionnaire
The Actual Help Seeking Questionnaire (AHSQ) assesses recent help-seeking behavior and was adapted from Rickwood and Braithwaite. The AHSQ has been successfully used to measure help-seeking across different time contexts, sources of help, and types of problems. Recent help-seeking behavior is determined by listing a number of potential help sources and asking whether or not help has been sought from each of the sources during a specified period of time for a specified problem. This questionnaire has 14 items that represent sources of help-seeking. Using this questionnaire, an observed increase in sources used would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Grade Point Average (GPA)
GPA will be retrieved from University records at all measurement time points (baseline, post-test, and 1, 3, and 6- month follow-up). Students will be asked to sign a release form consenting that their GPA records be released to the study investigators. The investigators do realize GPA may lack sensitivity to change over time, however, the investigators include this variable as previous research in higher education has captured change over relatively short time periods (one to two years).
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Academic and Intellectual Development Scale
The Academic and Intellectual Development Scale is a subscale of Pascarella and Terenzini's scale assessing the academic and social considerations in student persistence; it focuses on assessing satisfaction with the institution's academics. This scale has 7 items on a 7-point agreement scale with a min of 1 or "Strongly Disagree" to a max of 7 or "Strongly Agree". Using this scale, an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Academic Persistence
Data on student registration status will be retrieved from University records at all measurement time points. Data on actual persistence will be coded: 1= withdrawal, 2= persisted. The investigators will ask students to sign a release consenting that their enrollment records be released to the study investigators. Intent to persist will be measured using a single item: "It is likely that I will re-enroll in the university next semester" (5= strongly agree, 1= strongly disagree). An observed increase would be a better outcome. In order to capture persistence and achievement over the entire course of the project (after 6-month follow-up is complete, The investigators will continue to collect data from the University records at five-month intervals (approximately once every semester) until the end of the project period. The investigators will request consent from all students to access these records.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Counseling Center Assessment of Psychological Symptoms
Collecting this data will allow us to control for symptom severity in our analyses. These measures were selected as they have strong psychometric properties and sensitivity to change, require minimal time to complete, and are also the assessments administered to all students receiving services at USF where the study will take place.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Diagnostic and Status Questionnaire
In addition to the Counseling Center tools, the investigators will provide the opportunity for participants to self-report diagnosis and disability. This tool was developed by the National Center for Science Education for patient self-report. This questionnaire assesses impairment symptoms on a 7-point scale with a min of 1 or "Not at all impaired" to a max of 7 (Very much impaired). Using this scale, a low score would be a better outcome.
Time frame: This measure will be collected at week 0 for all participants
Diagnostic and Status Questionnaire Past 4 weeks
In addition to the Counseling Center tools, the investigators will provide the opportunity for participants to self-report diagnosis and disability. This tool was developed by the National Center for Science Education for patient self-report. This questionnaire assesses impairment symptoms on a 7-point scale with a min of 1 or "Not at all impaired" to a max of 7 (Very much impaired). Using this scale, an observed decrease would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Behavioral Health Measure
Collecting this data will allow us to control for symptom severity in our analyses. These measures were selected as they have strong psychometric properties and sensitivity to change, require minimal time to complete, and are also the assessments administered to all students receiving services at USF where the study will take place. This measure has 20 items on a 5-point scale with a min 0 and a max of 5. For seven items, a score of 5 is a high and positive rating. For these items, an observed increase over time would be a better outcome. For the remaining items, a score of 5 is a high rating of distress and an observed decrease would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Recovery Assessment Scale
The Recovery Assessment Scale (RAS) is a 24-item measure based on a process model of recovery, the RAS attempts to assess aspects of recovery with a special focus on hope and self-determination. These items are measured on a 5-point agreement scale with a min of 1 or "strongly disagree" to a max of 5 or "strongly agree". Using this scale an observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Quality of Relationships Scale
A 3-item scale that measures the quality of an individual's relationship with a specific person. Items are measured on a 7-point rating scale with a min of 1 and max of 7. Where 1 is a low rating of the relationship quality and 7 is a high rating. An observed increase would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Up To Me Satisfaction Scale
This scale assesses participants' satisfaction with and feedback for the team regarding the primary intervention of the study. This measure is not being used to measure observed changes. The investigators are interested in the participants' satisfaction with the intervention. This scale includes 6 items on a 7-point agreement scale with a min of 1 or "Highly Agree" and a max of 7 or "Highly Disagree".
Time frame: This measure will be collected at week 7 if in the Up To Me Intervention + Booster or Up To Me Intervention + No Booster arms
Demographics Questionnaire
Provides background information on participants regarding their identities and experiences. This questionnaire is not being used to measure observed changes but to describe the study sample.
Time frame: This measure will be collected at week 0 for all participants
Peer Support and Advocacy Items
This scale was developed by the study investigators and is comprised of four items inquiring about the participant's involvement in organizations related to peer support or advocacy for mental illness. An observed increase in involvement would be a better outcome.
Time frame: Change from baseline to week 3, week 7, week 15 and 27 for all participants
Plan to share: Yes — Final data sets will be stored on the secure server of the USF Policy and Services Research Data Center. Others interested in accessing the data will be instructed to contact the PI, Dr. Kosyluk, or Co-I, Dr. Neal, and arrangements will be made to transfer the files via the FTP mentioned above. Information on the data sets will also be hosted on the website of the Temple University Collaborative on Community Inclusion (Salzer, PI) and the National Consortium on Stigma and Empowerment (Corrigan, Director). Drs. Kosyluk and Neal will include information about the data sets and how to access them on their USF Faculty profiles and respective research lab websites. Data will be available for sharing no sooner than one year after the completion of the study. There will be no cost associated with accessing the data files.
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