Trial Outcomes & Findings for Altitudes for Caregivers (NCT NCT06094647)

NCT ID: NCT06094647

Last Updated: 2025-08-14

Results Overview

This qualitative data will be collected post-treatment from Altitudes participants. Individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2025-08-14

Participant Flow

The research team attempted to recruit participants for a treatment as usual condition, but the coordinated specialty care (CSC) programs that were encouraged to refer caregivers indicated that family members of young people with first episode psychosis (FEP) were not interested in completing assessments without the option of joining the Altitudes program (treatment condition). Therefore, no participants were enrolled into the Treatment as Usual Arm.

Participant milestones

Participant milestones
Measure
Altitudes Condition
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Overall Study
STARTED
24
0
Overall Study
COMPLETED
24
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Altitudes for Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
57.38 years
STANDARD_DEVIATION 8.28 • n=5 Participants
57.38 years
STANDARD_DEVIATION 8.28 • n=5 Participants
Sex/Gender, Customized
Cisgender Female
17 Participants
n=5 Participants
17 Participants
n=5 Participants
Sex/Gender, Customized
Cisgender Male
6 Participants
n=5 Participants
6 Participants
n=5 Participants
Sex/Gender, Customized
Transgender Female
1 Participants
n=5 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
n=5 Participants
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
20 Participants
n=5 Participants
20 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
24 Participants
n=5 Participants
24 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: No participants were enrolled into the Treatment as Usual Arm. Two participants elected not to complete the post-treatment interview.

This qualitative data will be collected post-treatment from Altitudes participants. Individual interviews will discuss usage of the platform and any feedback participants may have. Feedback from participants will be summarized to include common themes regarding likes and dislikes of the platform, implementation within the clinical setting, and participant ideas for future directions.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=22 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Altitudes described as a valuable resource
17 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Clinical moderator was a useful source of support
17 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Life circumstances impacted engagement
14 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Reduced participation due to life demands or intentional avoidance (e.g., topic of psychosis)
9 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Altitudes platform was a space for connection, learning, hope, and/or normalizing their experiences
18 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Therapy materials were appropriated and added to their knowledge/understanding/skills
15 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Altitudes was easy to access, navigate, and use
19 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Caregivers mentioned wanting notifications or reminders
10 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Caregivers interested opportunities to meet other parents/carers
7 Participants
Qualitative Summaries of Participant Experience in Post-Treatment Feedback
Caregivers note interest in or benefits to tailored supports (like individual therapy)
7 Participants

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: No participants were enrolled into the Treatment as Usual Arm. All data collected are reported. Four participants elected not to complete the post-treatment assessment.

The Working Alliance Inventory for Guided Internet Interventions (WAI-I) is a 12-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always." Possible scores are averaged across items and range from 1 to 5. Higher scores indicate greater therapeutic alliance. Reported value is the average value at month 6 minus the average value at month 3.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Total Score
0.27 score on a scale
Standard Deviation 0.58

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: No participants were enrolled into the Treatment as Usual Arm. All data collected are reported. Four participants elected not to complete the post-treatment assessment.

The Working Alliance Inventory for Guided Internet Interventions (WAI-I) task and goals subscale is an 8-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores are averaged across items and range from 1 to 5. Higher scores indicate greater agreement between the therapist and client on tasks and goals.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Task and Goals Subscale
0.23 score on a scale
Standard Deviation 0.74

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: No participants were enrolled into the Treatment as Usual Arm. All data collected are reported. Four participants elected not to complete the post-treatment assessment.

The Working Alliance Inventory for Guided Internet Interventions (WAI-I) is a 4-item scale. Answers are on a 5-point scale with options "seldom", "sometimes", "fairly often", "very often", and "always". Possible scores are averaged across items and range from 1 to 5. Higher scores indicate stronger bond with the supporting therapist

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Working Alliance Inventory for Guided Internet Interventions (WAI-I) - Bond Subscale
0.35 score on a scale
Standard Deviation 0.77

PRIMARY outcome

Timeframe: Baseline, Up to Month 6

Population: No participants were enrolled into the Treatment as Usual Arm.

The Altitudes platform passively collects engagement data, including the number of therapeutic education modules started and completed as well as any posts, reactions, or comments made on the platform. The investigators will provide mean and standard deviation scores for each site usage category, for the Altitudes group only. The data was collected continuously from baseline up to month 6 as a count of occurences with the mean engagement with the Altitudes platform computed across this time frame.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Engagement With the Altitudes Platform
Posts on community page
2.92 number of occurrences
Standard Deviation 4.13
Mean Engagement With the Altitudes Platform
Comments on Other Users' Posts
9.79 number of occurrences
Standard Deviation 18.49
Mean Engagement With the Altitudes Platform
Reactions to Other Users' Posts
21.13 number of occurrences
Standard Deviation 33.98
Mean Engagement With the Altitudes Platform
Comments on the Talk-it-Out Page (e.g., problem-solving)
1.88 number of occurrences
Standard Deviation 2.76
Mean Engagement With the Altitudes Platform
Posts on the Talk-it-Out Page (e.g., problem-solving)
0.29 number of occurrences
Standard Deviation 0.46
Mean Engagement With the Altitudes Platform
Reactions on the Talk-it-Out Page (e.g., problem-solving)
3.54 number of occurrences
Standard Deviation 6.39
Mean Engagement With the Altitudes Platform
Number of Calls Attended with Clinical Moderator
5.71 number of occurrences
Standard Deviation 3.10
Mean Engagement With the Altitudes Platform
Number of Meet-ups attended
3.00 number of occurrences
Standard Deviation 1.92
Mean Engagement With the Altitudes Platform
Number of Journey Steps (therapy content)
16.25 number of occurrences
Standard Deviation 15.58
Mean Engagement With the Altitudes Platform
Number of Explore Steps (therapy content)
18.68 number of occurrences
Standard Deviation 18.03

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 15-item scale. Answers are on a 7-point Likert scale (1-7) with options "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 15 to 105 with higher scores reflecting better perceptions of their relationship with Altitudes moderators.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=19 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Health Care Climate Questionnaire (A-HCCQ) - Total Score
0.12 score on a scale
Standard Deviation 0.61

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 4-item scale. Answers are on a 7-point Likert scale with options "Not at all true"\[1\], "Somewhat true"\[4\], "Very true"\[7\] with a sliding scale between answers. Possible scores range from 4 to 28. Higher scores indicate stronger perceived competence and ability in using the Altitudes platform.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Perceived Competence Scale (A-PCS) - Total Score
0.19 score on a scale
Standard Deviation 0.99

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 20-item scale. The overall impressions of the platform scale is three 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 3 to 21. Higher scores indicate better overall impressions of the Altitudes platform.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Overall Impressions of Platform Subscale
0.50 score on a scale
Standard Deviation 1.25

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 20-item scale. The perception of other platform users subscale is four 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 4 to 28. Higher scores indicate better perception of interactions with other Altitudes participants.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Perception of Other Platform Users Subscale
0.30 score on a scale
Standard Deviation 1.16

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 20-item scale. The safety and confidentiality subscale is two 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 2 to 14. Higher scores indicate higher perceived safety and confidentiality when using the platform.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Safety and Confidentiality Subscale
0.25 score on a scale
Standard Deviation 1.03

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 20-item scale. The moderation and peer support subscale is three 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 3 to 21. Higher scores indicate higher regard of the moderators and peer support on the Altitudes platform.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Moderation and Peer Support Subscale
0.18 score on a scale
Standard Deviation 1.19

PRIMARY outcome

Timeframe: Month 3, Month 6

Population: Only participants who have completed both assessments have been included in this analysis. No participants were enrolled in the Treatment as Usual Arm.

The Altitudes Health Care Climate Questionnaire is a 20-item scale. The barriers to use subscale is six 7-point Likert scale answers with options of "Strongly Disagree", "Mildly Disagree", "Slightly Disagree", "Neutral", "Slightly Agree", "Mildly Agree", and "Strongly Agree". Possible scores range from 6 to 42. Lower scores indicate less issues with barriers to engaging with the platform.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=20 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Altitudes Usability Questionnaire (AUQ) - Barriers to Use Subscale
0.53 score on a scale
Standard Deviation 0.32

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The UCLA Loneliness scale is a 20-item scale. Answers are on a 4-point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in University of California, Los Angeles (UCLA) Loneliness Scale - Total Score
0.01 score on a scale
Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Multidimensional Scale of Perceived Social Support Survey is a 16-item scale. Answers are on a 7-point scale with options ranging from "very strongly disagree" to "very strongly agree". Possible scores range from 16 to 112. Higher scores reflect higher feelings of social support (more perceived social support).

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Multidimensional Scale of Perceived Social Support - Total Score [Alternative Form for Altitudes Participants, Original Form for Control Group]
0.01 score on a scale
Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". Possible scores range from 0 to 264 after appropriate items have been reversed scored. Higher scores indicate greater feelings of preparedness for caregiving whereas lower scores reflect feeling less prepared to provide caregiving.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Experience of Caregiving Inventory (ECI) - Total Score
2.54 score on a scale
Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". The positive experience subscale is 14 items with possible scores range from 0 to 56. Higher scores indicate greater feelings of preparedness and experiences with caregiving.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Experience of Caregiving Inventory (ECI) - Positive Experience Subscales
3.73 score on a scale
Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The ECI Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". The negative experience subscale is 52 items with possible scores range from 0 to 208. Higher scores reflect feeling less prepared to provide caregiving and more negative experiences in caregiving.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Experience of Caregiving Inventory (ECI) - Negative Experiences Subscale
1.34 score on a scale
Standard Deviation 4.72

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The FQ has two subscales: critical comments, and EOI. Each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The FQ is scored by adding together the ratings from the individual items. Possible scores range from 20 to 80 with higher scores indicating greater levels of expressed emotion.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Family Questionnaire of Expressed Emotion - Total Score
0.05 score on a scale
Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The critical comments subscale consists of 10 items and is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The critical comments subscale is scored by adding together the ratings from the individual items. Possible scores ranging from 10 to 40 with higher scores indicating greater levels of critical comments with their loved one.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Family Questionnaire of Expressed Emotion - Critical Comments Subscale
0.14 score on a scale
Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Family Questionnaire (FQ) is a 20-item, self-administered questionnaire that measures expressed emotion status (criticism and emotional over involvement (EOI)) of family members toward patients with mental illness. The EOI subscale consists of 10 items with each item is rated on a 4-point scale (1 = never/very rarely; 4 = very often). The EOI subscale is scored by adding together the ratings from the individual items. Possible scores ranging from 10 to 40 with higher scores indicating greater levels of emotional overinvolvement with their loved one.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Family Questionnaire of Expressed Emotion - Emotional Overinvolvement (EOI) Subscale
-0.10 score on a scale
Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The GHQ-12 is a 12-item scale. Answers are on a 4-point scale ranging from 0 "not at all" to 3 "much more than usual." Possible scores range from 0 to 36. Higher scores reflect worse outcomes (more frequent depressive symptoms).

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in General Health Questionnaire (GHQ) -12 Score - Total Score
-0.48 score on a scale
Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled into the Treatment as Usual Arm.

The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The problem-focused subscale is 8 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 8 to 32. Higher scores on each reflect more frequent use of problem focused coping.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Problem-Focused Subscale
0.46 score on a scale
Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled into the Treatment as Usual Arm.

The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The avoidant-focused subscale is 8 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 8 to 32. Higher scores on each reflect more frequent use of avoidance for coping.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Avoidant-Focused Subscale
0.48 score on a scale
Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled into the Treatment as Usual Arm.

The Brief-COPE is a 28-item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event. The emotion-focused subscale is 12 items. Answers are on a 4-point scale ranging from 1 "I haven't been doing this at all" to 4 "I have been doing this a lot." Possible scores range from 12 to 48. Higher scores on each reflect more frequent use of emotion focused coping.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Brief Coping Orientation to Problems Experienced (COPE) Scale - Emotion-Focused Subscale
1.18 score on a scale
Standard Deviation 0.81

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Self-Compassion Scale is a 12-item self-report questionnaire designed to measure an individual's self-compassion towards themselves as well as their feelings and emotions. It can be divided into six subscales with two questions for each: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, Over-identified. Answers are on a 5-point scale ranging from 1 "Almost never" to 5 "Almost always." Total score is calculated by totaling the mean of each subscales and reversing the negative subscales (self-judgment, isolation, and over-identification) then taking the mean of the summed subscales. Possible scores range from 1 to 5 with higher scores indicate increased self-compassion.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Self-Compassion Scale: Short Form (SCS) - Total Score
0.33 score on a scale
Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24-item is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. It can be divided into five subscales: Observing, Describing, Acting in Awareness, Non-judging, and Non-reactivity. Answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 24 to 120 once necessary questions (i.e., negative) have been reversed scored. Higher scores indicate more mindfulness and self-awareness.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Total Score
-0.47 score on a scale
Standard Deviation 1.48

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The observation subscale is 3 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 3 to 15 with higher scores indicate more observational awareness.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Observation Subscale
-.039 score on a scale
Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The description subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 after reverse scoring of appropriate items with higher scores indicate more to describe their feelings and experiences.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Description Subscale
-0.50 score on a scale
Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The mindful action subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 after appropriate items have been reversed scored with higher scores indicate more awareness around their actions and experiences.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Mindful Action Subscale
-0.06 score on a scale
Standard Deviation 0.46

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The non-judgemental subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 once appropriate items have been reversed scored with higher scores indicate more nonjudgmental thoughts towards their beliefs and feelings.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Judgmental Inner Experience Subscale
0.42 score on a scale
Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Five Facet Mindfulness Questionnaire: 24 is a 24-item self-report questionnaire designed to measure an individual's mindful self-awareness. The non-reactivity subscale is 5 items with answers are on a 5-point Likert scale of "Never or very rarely true", "Rarely true", "Sometimes true", "Often true", and "Very often true or always true". Possible scores range from 5 to 25 with higher scores indicate more mindful non-reactivity to thoughts and feelings.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in Five Facet Mindfulness Questionnaire: 24-item (FFMQ-24) - Non-Reactivity Subscale
0.08 score on a scale
Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline, Post Treatment (Month 6)

Population: No participants were enrolled in the Treatment as Usual Arm.

The Modified Psychosis Attitudes Survey is a 19-item self-report questionnaire designed to measure an individual's beliefs and attitude towards psychosis (e.g., identifying psychosis, interacting with individuals experiencing psychosis, etc.). The survey can be divided into 4 subscales: perceived confidence, optimism, fulfillment, and stress-vulnerability orientation. Answers range from "Very strongly disagree", "Strongly disagree", "Mildly disagree", "Neutral", "Mildly agree", "Strongly agree", "Very strongly agree". Total score is obtained with summing each question, after reverse scoring appropriate questions. Possible scores range from 19 to 133. Higher total score indicates an increased knowledge, optimism, and attitudes towards psychosis.

Outcome measures

Outcome measures
Measure
Altitudes Condition
n=24 Participants
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from two of the five FEP clinics (OASIS and SHORE) will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months. Altitudes USA: Experimental participants will be onboarded to the digital platform, including the different spaces and how to use the site. The site includes educational and therapeutic content that is tailored to each individual and their current needs and experiences, including psychoeducation, supporting their loved one, self-care, social support, and so on. Further, the platform includes a moderated social media function, where users and family peer workers can post text, images, videos, and comments to connect and share their experiences. The site is monitored by graduated students and trained clinicians.
Treatment as Usual
Approximately 30 individuals whose loved ones are experiencing FEP and receiving services from three of the five FEP clinics (Encompass, Eagle, and AEGIS) will be recruited to participate in treatment as usual offered by their respective clinic. Participants will then be asked to complete the same battery of measures as the experimental group at baseline, 3-months, and 6 months.
Mean Change in the Modified Psychosis Attitude Survey - Total Score
-0.01 score on a scale
Standard Deviation 0.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Post Treatment (Month 6)

The PCL-5 is a 20-item self-report measure of the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD). Included in the scale are four domains consistent with the four criteria of PTSD in DSM-5: Re-experiencing (criterion B), Avoidance (criterion C), Negative alterations in cognition and mood (criterion D), and Hyper-arousal (criterion E). Answers are on a 5-point scale including "Not at all," "A little bit," "Moderately," "Quite a bit," and "Extremely" and with total scores ranging from 0 to 80. Higher scores on the PCL-5 reflect more severe trauma-related symptoms.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Post Treatment (Month 6)

The PTGI is a 25-item self-report measure that assesses five domains of personal growth that may follow a stressful encounter. Answers are on a 6-point scale ranging from 0 "I did not experience this" to 5 "I experienced this change to a very great degree." Total scores on this scale range from 0 to 125. Higher scores reflect more positive changes in an individual's life following a stressful experience.

Outcome measures

Outcome data not reported

Adverse Events

Altitudes Condition

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelsey Ludwig, PhD

University of North Carolina at Chapel Hill

Phone: 919-962-1401

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place