Altitudes for Caregivers: A Pilot Study
Phase: NA
Conditions: Care Burden, Care Giving Burden, Caregiver Burnout, Caregiver Stress, Caregiver Wellbeing, Support, Family
Sponsor: University of North Carolina, Chapel Hill

 
 
Altitudes for Caregivers: A Pilot Study 
 
 
                                 NCT Number       NCT06094647 
                                 Document Date    07/10/2025 

Altitudes for Caregivers: A Pilot Study 
Altitudes for Caregivers Protocol US Version 3.0 
 
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Altitudes for Caregivers: 
A Pilot Study 
 
 
 
 
 
Version 3.0 
 
Protocol Date: July 10, 2025 
 
 
 
Kelsey Ludwig PhD 
Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) 
77 Vilcom Center Dr 
Chapel Hill, NC 27514 
Phone (919) 962-7149 
kelsey_ludwig@med.unc.edu 
 
David Penn, PhD 
Co-Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) 
77 Vilcom Center Dr 
Chapel Hill, NC 27514 
Phone (919) 843-7514 
Dpenn@ad.unc.edu 
 
Diana Perkins, MD, MPH 
Co-Principal Investigator 
University of North Carolina at Chapel Hill (UNC-CH) – School of Medicine 
200 N Greensboro St, Suite C-6 
Carrboro, NC 27510 
Phone (919) 360-1602 
diana_perkins@med.unc.edu 
 
 
 
 
 
 
 
 
 
 
 
 

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This study is sponsored by the North Carolina Department of Health and Human Services. 

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TABLE OF CONTENTS 
ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................................................... 5 
PROTOCOL SYNOPSIS.................................................................................................................................. 6 
Title................................................................................................................................................................... 6 
Funding ........................................................................................................................................................... 6 
Clinical Phase ................................................................................................................................................ 6 
Study Rationale ............................................................................................................................................ 6 
Study Objective(s) ...................................................................................................................................... 6 
Study Design ................................................................................................................................................. 6 
Subject Population Key Criteria for Inclusion and Exclusion: .................................................. 6 
Number of Subjects .................................................................................................................................... 7 
Study Duration ............................................................................................................................................. 7 
Study Phases ................................................................................................................................................. 7 
Evaluations .................................................................................................................................................... 9 
Safety Evaluations ...................................................................................................................................... 9 
Statistical and Analytic Plan ................................................................................................................... 9 
Data and Safety Monitoring Plan ....................................................................................................... 10 
INTRODUCTION........................................................................................................................................... 10 
Background and Rationale ................................................................................................................... 10 
Objectives .................................................................................................................................................... 13 
RESEARCH DESIGN & METHODS ........................................................................................................ 13 
Overview ..................................................................................................................................................... 14 
Overview of Altitudes ........................................................................................................................ 14 
Interactive Psychoeducation and Psychosocial Interventions ......................................... 14 
Expert Moderation ............................................................................................................................. 15 
Subjects ........................................................................................................................................................ 16 
Eligibility Criteria..................................................................................................................................... 16 
Inclusion criteria ................................................................................................................................. 16 
Exclusion criteria ................................................................................................................................ 17 
ASSESSMENT OF DATA ............................................................................................................................ 17 
Outcomes .................................................................................................................................................... 17 
STUDY PROCEDURES ................................................................................................................................ 17 
Screening  Procedures ........................................................................................................................... 17 
Baseline Procedures ............................................................................................................................... 18 
Intervention Period Procedures ........................................................................................................ 18 
Mid-Treatment Procedures ............................................................................................................ 18 

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Post-Treatment Procedures ........................................................................................................... 19 
DATA ANALYTIC PLAN ............................................................................................................................ 19 
Primary Outcome Measures ................................................................................................................ 19 
Secondary Outcome Measures ........................................................................................................... 21 
Tertiary/Exploratory Outcome Measures ..................................................................................... 22 
Power Analysis ......................................................................................................................................... 23 
Data Management .................................................................................................................................... 23 
RISKS AND BENEFITS ............................................................................................................................... 23 
Risks for all participants. ................................................................................................................. 23 
Risks for parent and caregivers only. ......................................................................................... 23 
Monitoring Risks ...................................................................................................................................... 23 
Altitudes safety protocol .................................................................................................................. 24 
Non-Significant Risk Documentation............................................................................................... 26 
Potential Benefits of the Research to Subjects and Others ..................................................... 26 
Confidentiality of Data ........................................................................................................................... 26 
Safety Management ................................................................................................................................... 27 
Adverse Events ......................................................................................................................................... 27 
Reporting of adverse events ........................................................................................................... 28 
RECRUITMENT STRATEGY .................................................................................................................... 28 
CONSENT PROCESS .................................................................................................................................... 28 
ETHICS.............................................................................................................................................................. 29 
Research ethics approval ...................................................................................................................... 29 
Protocol amendments ............................................................................................................................ 29 
Declaration of interests ......................................................................................................................... 29 
Access to data ............................................................................................................................................ 29 
Ancillary and post-trial care ................................................................................................................ 30 
Future projects ......................................................................................................................................... 30 
References .................................................................................................................................................. 30 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
A-HCCQ 
Altitudes Health Care Climate Questionnaire  
A-PCS 
Altitudes Perceived Competence Scale  
AUQ 
Altitudes Usability Questionnaire 
CBT 
Cognitive Behavioral Therapy 
CSC 
Coordinated Specialty Care 
FEP 
First Episode Psychosis 
FFMQ 
Five Facet Mindfulness Questionnaire 
GHQ 
General Health Questionnaire 
NC 
North Carolina 
NSR 
Non-significant Risk 
OASIS 
Outreach and Support Intervention Services 
PAS 
Psychosis Attitude Survey 
PI 
Principal Investigator 
PSS 
Peer Support Specialist 
PTGI 
Post-Traumatic Growth Inventory 
PTSD 
Post-Traumatic Stress Disorder 
SCS-SF 
Self Compassion Scale – Short Form 
SHORE 
Supporting Hope, Opportunities, Recovery and Empowerment 
UCLA 
University of California, Los Angeles 
UNC-CH 
University of North Carolina at Chapel Hill 
WAI-I 
Working Alliance Inventory – guided Internet interventions 
 
 

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PROTOCOL SYNOPSIS 
 
Title 
Altitudes for caregivers: A pilot study 
Funding  
This trial is funded by North Carolina Department of Health and Human Services & 
University of North Carolina at Chapel Hill 
Clinical Phase 
Pilot 
Study Rationale  
The purpose of the present study is to investigate the acceptability and feasibility of 
implementing a moderated online social media platform with therapeutic content, 
Altitudes, as a part of an adjunct services offered at first-episode psychosis (FEP) clinics 
across North Carolina, also known as coordinated specialty care (CSC) programs. 
Additionally, to further assess the secondary aim of impact on well-being, we will recruit 
a control group of caregivers. 
Study Objective(s) 
Examine the acceptability and feasibility of Altitudes at North Carolina (NC) FEP clinics 
as part of an adjunct clinical service through the following objectives: 
1) Assessment of any changes in psychological measures across the six-month 
intervention 
2) Ability to meet our recruitment targets 
3) Evaluation of the safety and privacy protocol 
4) Evaluation of the frequency and types of engagement on Altitudes 
Study Design 
This is a quasi-experimental open trial enrolling parents and caregivers of individuals 
with first episode psychosis (FEP) receiving care from CSC clinics across North Carolina. 
Parents and caregivers in the Altitudes condition, which will be drawn from 2 CSC clinics 
(OASIS, SHORE), will participate in the use of Altitudes, a novel digital intervention, which 
has previously demonstrated benefits to this population in an Australian pilot trial. They 
will also complete psychological measures as part of the study. Participants in the control 
condition from 3 other CSC clinics in North Carolina (Eagle, Encompass, AEGIS) will not 
have access to the digital intervention but may engage with standard clinical services at 
the CSC clinics. The control participants will complete measures at the same time points 
as the open trial participants at OASIS and SHORE clinics. 
Subject Population Key Criteria for Inclusion and Exclusion:  
Inclusion criteria:  
1) Parent or caregiver of a young person who is currently receiving treatment from 
a CSC program for FEP, or who have recently graduated from a CSC program 
2) Parent or caregiver must be at least 18 years of age  

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3) Participants recruited from Outreach and Support Intervention Services (OASIS) 
& SHORE (Supporting Hope, Opportunities, Recovery and Empowerment; i.e., two 
CSC programs in NC), as this is a pilot study, or Eagle, Encompass, and AEGIS 
clinics for participants part of the control group 
4) Parent or caregiver must have access to internet through a mobile phone, tablet, 
or computer 
Exclusion criteria: 
1) Parent or caregiver is currently engaged in legal action against the loved one 
receiving services from the CSC program 
2) Parent or caregiver does not speak English 
3) Parent or caregiver is under 18 years of age 
Number of Subjects 
Thirty parent or caregiver participants from OASIS and SHORE CSC clinics and 30 
parent or caregiver participants from Eagle, Encompass, and AEGIS. 
Study Duration 
Each subject’s participation will last approximately 6 months from baseline to post-
treatment. The entire study is expected to last approximately 12 months (including a 6-
month recruitment period). 
Study Phases 
Screening: Completed prior to the first virtual appointment via a telephone screen to 
confirm study eligibility. 
Baseline: Parents or caregivers who are deemed eligible schedule a virtual appointment 
with the study coordinator to obtain informed consent and complete the baseline 
assessments (Demographics & psychological measures). Specifically, all participants will 
be asked to complete the Experience of Caregiving Inventory (ECI; Szmukler), the Family 
Questionnaire of Expressed Emotion (Wiedemann et al., 2002), Brief COPE (Carver, 
1997), UCLA Loneliness Scale (Russell, 1996), Multidimensional Scale of Perceived Social 
Support (For control and Alternative form for Altitudes condition; Zimet et al., 1990), 
Modified Psychosis Attitudes Survey (PAS; Kopelovich et al., 2022), PTSD Checklist for 
DSM-5 (PCL-5, Weathers et al., 2013), Post Traumatic Growth Inventory (PTGI, Tedeschi 
& Calhoun, 1996), General Health Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-
Compassion Scale – Short Form (SCS-SF; Raes et al., 2011), and Five Facet Mindfulness 
Scale (FFMQ; Bohlmeijer et al., 2011). Additionally, all participants will complete a brief 
survey on engagement with services within the CSC program and outside the program 
(e.g., individual therapy, family groups outside of CSC, etc.). Altitudes condition 
participants are then oriented to the Altitudes platform if part of the open trial 
enrollment. 
Study Treatment: Participants in the Altitudes condition will be given access to the digital 
platform Altitudes for approximately 6 months. Weekly engagement is decided by the 
participant. Digital access is available daily and digital access to family peer worker and 
online therapists is made available during their engagement with the platform. Control 
participants will have not interaction with the platform but may engage in routine clinical 

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care for parents and caregivers at CSC clinics, such as multifamily group and treatment 
planning sessions 
Mid-treatment: Participants will be asked to complete a battery of measures assessing 
psychological domains such as social support, loneliness, and mood symptoms at the 
approximately 3-month timepoint (+/- 2 weeks). Specifically, participants will be asked 
to complete the Experience of Caregiving Inventory (ECI; Szmukler), the Family 
Questionnaire of Expressed Emotion (Wiedemann et al., 2002), Brief COPE (Carver, 
1997), UCLA Loneliness Scale (Russell, 1996), Multidimensional Scale of Perceived Social 
Support (For control and Alternative form for Altitudes condition; Zimet et al., 1990), 
Modified Psychosis Attitudes Survey (PAS; Kopelovich et al., 2022), PTSD Checklist for 
DSM-5 (PCL-5, Weathers et al., 2013), Post Traumatic Growth Inventory (PTGI, Tedeschi 
& Calhoun, 1996), General Health Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-
Compassion Scale – Short Form (SCS-SF; Raes et al., 2011), and Five Facet Mindfulness 
Scale (FFMQ; Bohlmeijer et al., 2011). Additionally, all participants will complete a brief 
survey on engagement with services within the CSC program and outside the program 
(e.g., individual therapy, family groups outside of CSC, etc.). Altitudes condition 
participants will also be asked to provide their perceptions of the Altitudes platform and 
clinical moderators via four brief questionnaires: the Altitudes Health Care Climate 
Questionnaire (A-HCCQ), Altitudes Usability Questionnaire (AUQ), and Altitudes 
Perceived Competence Scale (A-PCS), and Working Alliance Inventory for guided Internet 
interventions (WAI-I, Gomez Penedo et al., 2019). Participants in the control condition 
will be asked to complete all of the aforementioned measures except for the A-HCCQ, 
AUQ, A-PCS, and WAI-I.  
Post-treatment: Participants in the Altitudes condition will be asked to complete the 
battery of measures examining psychosocial constructs at the approximately 6-month 
timepoint (+/- 2 weeks). Specifically, Altitudes participants will be asked to complete the 
Experience of Caregiving Inventory (ECI; Szmukler), the Family Questionnaire of 
Expressed Emotion (Wiedemann et al., 2002), Brief COPE (Carver, 1997), UCLA 
Loneliness Scale (Russell, 1996), Multidimensional Scale of Perceived Social Support (For 
control and Alternative form for Altitudes condition; Zimet et al., 1990), Modified 
Psychosis Attitudes Survey (PAS; Kopelovich et al., 2022), PTSD Checklist for DSM-5 
(PCL-5, Weathers et al., 2013), Post Traumatic Growth Inventory (PTGI, Tedeschi & 
Calhoun, 1996), General Health Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-
Compassion Scale – Short Form (SCS-SF; Raes et al., 2011), Five Facet Mindfulness Scale 
(FFMQ; Bohlmeijer et al., 2011) and aforementioned Altitudes platform brief 
questionnaires: the Altitudes Health Care Climate Questionnaire (A-HCCQ), Altitudes 
Usability Questionnaire (AUQ), and Altitudes Perceived Competence Scale (A-PCS), and 
Working Alliance Inventory for guided Internet interventions (WAI-I, Gomez Penedo et 
al., 2019). Participants will complete a brief survey on engagement with services within 
the CSC program and outside the program (e.g., individual therapy, family groups outside 
of CSC, etc.). They will also be asked to participate in a qualitative interview focusing on 
the experience of Altitudes and deeper understanding of acceptability and feasibility of 
the platform. Participants in the control condition will complete all the aforementioned 
measures except for the four brief Altitudes questionnaires and the qualitative interview. 

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Evaluations 
Primary outcomes: Our primary objective is to examine the feasibility and acceptability of 
implementing Altitudes as a part of coordinated specialty care services provided by first-
episode psychosis clinics across the state of North Carolina. We will examine site usage 
information as well as collect data on carers’ perceptions of the platform to assess this 
outcome (e.g., its utility, approachability, and helpfulness). 
Secondary outcomes: Our second aim is to assess the extent to which carers engage with 
the platform (i.e., site usage information) is associated with improvements in expressed 
emotion, perceptions of caregiving, coping strategies, loneliness, social support, self 
compassion, mindfulness, and mood symptoms. We also plan to examine the associations 
between carers’ involvement in Altitudes and their loved one with FEP’s use of 
emergency services (e.g., ED visits). We will compare outcomes from the Altitudes and 
control groups to examine any improvements experienced by participants who engaged 
with the platform compared to routine clinical care. 
Exploratory outcomes: We would like to explore rates of trauma symptoms related to 
experiencing and providing support for a loved one who experienced an initial psychotic 
episode. One of the exploratory aims is to examine the extent to which their loved one’s 
initial psychotic episode and related experiences (e.g., psychiatric hospitalizations, 
changes in work/school engagement, etc.) might be associated with trauma-related 
symptoms. We are also interested in the extent to which engagement in Altitudes might 
promote post traumatic growth among caregivers of a young person with FEP. Trauma 
and post traumatic growth from caregivers in the treatment group will be compared to 
controls to assess the extent of impact of Altitudes on these outcomes. 
Safety Evaluations 
A safety plan for Altitudes was developed before participants joined the digital platform 
by research staff based on previous experience with digital interventions. All safety 
measures were approved by the director of each participating NC FEP clinic. 
Statistical and Analytic Plan 
Primary Outcomes: For Aim 1, we will use descriptive statistics to examine carers’ 
perceptions of the Altitudes platform and clinical moderators via four brief 
questionnaires: the Altitudes Health Care Climate Questionnaire (A-HCCQ), Altitudes 
Usability Questionnaire (AUQ), Altitudes Perceived Competence Scale (A-PCS), and 
Working Alliance Inventory for Guided Internet interventions (WAI-I, Gomez Penedo et 
al., 2019). Additionally, descriptive statistics will assess interactions with the platform to 
evaluate acceptability and engagement (e.g., logins, posts, reactions, completed activities, 
etc.) with the platform (i.e., acceptability and usability).  
Information gathered in the post-treatment qualitative interview will be analyzed to 
identify participants’ thoughts about the usefulness of Altitudes as well as feedback to 
improve the intervention for others. Qualitative analysis will be conducted on the 
feedback interviews using grounded theory. As with qualitative analysis, a codebook will 
be developed by the research team in which thematic analysis of all interviews will 
conducted. The codebook will include themes and subthemes with a focus on the 
different perceived strengths of the intervention as well as areas that need improvement. 

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Secondary Outcomes: The platform will collect information about frequency of 
engagement with Altitudes (i.e., site usage). Psychosocial outcomes will be summarized 
within and between conditions using univariate statistics (e.g., means, standard 
deviations). To evaluate change over time on psychosocial outcomes, we will utilize linear 
mixed models (LMM) including fixed effects of time, group, and group x time interactions 
and random effects at the participant level. We will calculate changes from baseline at 
each time point using least-squares means and standardized least-squares mean 
differences to estimate within- and between-group changes, respectively. To estimate 
magnitude of change from baseline, we will calculate effect sizes.  We will explore the 
relationship between baseline characteristics (e.g., age, gender) and engagement data 
(i.e., site usage information) on any changes in psychosocial outcome measures from 
baseline to midpoint and posttreatment using multiple linear regression. We will use 
Pearsons correlation coefficients to examine associations between carers’ involvement 
in Altitudes and their loved one with FEP’s use of emergency services (e.g., ED visits). If 
possible based on sample size, we will dichotomize engagement data (site usage) 
between low engagement and high engagement before comparing site usage with 
emergency service utilization. 
 
Exploratory Outcomes: We will use descriptive statistics (M, SD) to examine self-reported 
trauma symptoms among carers of individuals with FEP. Descriptive statistics (M, SD, & 
effect sizes) will also be used to examine any changes in posttraumatic growth from 
baseline to midpoint and baseline to post-treatment. We will evaluate change over time 
in trauma-related symptoms and post-traumatic growth both within- and between-
groups using LMMs in the same manner as specified in our analysis of secondary 
outcomes.  We will explore the relationship between baseline characteristics (e.g., age, 
gender) and engagement data (i.e., site usage information) on any changes in trauma-
related symptoms and posttraumatic growth orientation over time. 
 
Data and Safety Monitoring Plan 
Privacy and online safety will be managed in accordance with the 'Online social 
networking' guidelines published by 'Cybersmart', a national cybersafety and 
cybersecurity education program managed by the Australian Communications and Media 
Authority (ACMA). Online safety will be monitored by Altitudes moderators (clinicians 
involved in the project, family peer support workers, graduate students in the 
Department of Psychology and Neuroscience) with supervision from licensed clinical 
psychologists Drs. David Penn and Kelsey Ludwig. Dr. Diana Perkins will function as the 
Project Medical Officer. 
INTRODUCTION 
 
Background and Rationale  
Psychosis is one of the most debilitating health conditions, both mental or physical 
disorders, with significant impact on the individual as well as their family and supports. 
In response to these psychiatric disorders, known as schizophrenia-spectrum disorders, 
and to circumvent poor outcomes, early intervention services for first episode psychosis 

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(FEP) were established to assist these individuals and their families and supports. These 
services for FEP, called Coordinated Specialty Care (CSC) in the United States, have been 
evaluated to improve symptoms, social functioning, and quality of life for the individual 
[1]. Further, as the onset of psychosis typically occurs in late adolescence and early 
adulthood, CSC programs additionally provide support to family and supports through 
psychoeducation offered by a family therapist. Even with this additional support, family 
members often experience issues related to their health and wellbeing, including stress, 
anxiety, depression, and social isolation or lack of support. Further, CSC programs have 
limited office hours that often do not work into the schedule of families who are 
caregiving in addition to working. 
 
Family members and supports are often the young person’s caregiver and support during 
this initial onset. Research into the impact of this care for a loved one experiencing FEP 
has been assessed cross-sectionally and longitudinally via qualitative and quantitative 
data (i.e., interviews and questionnaires, respectively). Findings from these studies have 
discerned that family and supports are significantly involved in the life, care, and help-
seeking for their loved one [2,3,4]. Up to 90% of young people reside with family during 
the initial episode of psychosis [5]. At the onset of FEP, it is a period that is often 
overwhelming for both the individual and family. Families have compared this time as 
bereavement and losing their loved one to the illness or the future the family thought the 
individual would have [6]. In addition to the stress of coordinating care for their loved 
one, families experience moderate stress with twenty-six percent were assessed to 
experience severe stress in this stage [7]. Further, nearly two thirds of family caregivers 
experience at least mild depression [8]. During this period, the responsibilities of caring 
for a loved one have also shown to deplete social connection and network, which have 
shown to buffer stress [9]. 
 
Previously, it has been observed that caregiver re-appraisals promote caregiver coping 
with the situation and reduce stress [10]. Caregivers’ appraisals of their loved one’s 
disorder are also known to influence how they communicate with their loved one. For 
example, if a family member blames themselves for their loved one’s diagnosis, they are 
significantly more likely to become emotionally over-involved with their loved one [11]. 
Research has shown this to be an important issue to address as family communication 
patterns and dynamics influence the course of psychosis, in particular criticism and 
expressed emotion have been found to significantly increase their loved one’s risk of 
relapse in symptoms of psychosis [12]. Therefore, for the mental health of all family 
members, it is critical to identify ways to support them and reduce their stress by 
encouraging positive re-appraisal and by increasing the family members’ ability to 
appropriately respond to their loved one. 
 
Despite the abundance of research on the significant impact of psychosis on the lives of 
family members and their care for their loved one experiencing psychosis, there is a 
paucity and gaps in the existing scientific knowledge. There is little known about how 
caregivers’ self-efficacy, coping, and social supports influence and shield caregivers from 
the stress of their situation. The key construct of caregiver self-efficacy (i.e., a caregiver’s 
belief in their ability to complete tasks and reach goals associated with the caregiving 
role) is absent from psychosis research with the exception of a pilot from Australia. 
However, additional research is needed to assess whether this is an important target to 
intervene and improve outcomes for both family members and their loved ones [13]. 

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Social support is typically provided to caregivers via peer support programs but its 
impact upon caregiver stress in psychosis is poorly understood. 
 
Further, meta-analyses of randomized controlled trials (RCTs) of caregiver interventions 
in chronic psychosis has shown robust beneficial treatment effects leading to reduced 
rates of relapse in patients diagnosed with psychosis [14] and the individual trials have 
evaluated it to beneficial to caregivers [15] and such interventions have proven to be cost 
effective [16]. Such interventions are typically based on cognitive behavioral therapy 
principles with a particular focus on psychoeducation, training in structured problem 
solving and communication skills. In addition to individual family sessions, family 
interventions have also been structured as multi-family sessions (i.e., multifamily 
therapy) with the added component of encouraging support between families [17]. 
Correctly targeted family intervention in the early stages of FEP may alter the long-term 
trajectory of family stress [18] and may improve long-term outcomes for the individual 
experiencing FEP [5]. However, the considerably less evidence for the effectiveness of 
interventions in FEP than for chronic psychosis (i.e., chronic schizophrenia) [5]. 
 
Previously, a group in Australia, a partnership between Australian Catholic University 
and the University of Melbourne, implemented and published on their RCTs that 
evaluated a family intervention specifically developed for families with loved ones 
experiencing FEP and currently receiving treatment within their FEP programs [18]. 
Their 30-month follow-up study included cognitive behavioral therapy (CBT) sessions 
for families. These sessions were provided over a 7-month period and were compared to 
the gold standard specialist treatment as usual (STAU) provided within an FEP program, 
and not typical “usual care”. In this study, perceived stress related to caregiving was 
significantly improved in the CBT family condition compared to STAU at the 30-month 
follow up. To the best of our knowledge, this is the only published RCT to show such a 
treatment effect in FEP families. 
 
Despite the results from this study, similar interventions for families and supports have 
not been routinely implemented, particularly outside of Australia. One such concern for 
these interventions is the wide disparity between evidence of efficacy of family 
treatments in chronic psychosis and the low rate at which families actually receive 
evidence-based interventions [19,20]. A large reason for the low rate of families receiving 
evidence-based interventions is their lack of time and access. Therefore, similar to this 
aforementioned study and in partnership with the original developers, we are proposing 
to adapt the intervention into a novel online platform to optimize its usability and 
accessibility. To the best of our knowledge, this will be the first implementation of an 
online digital intervention for families with loved ones experiencing psychosis and 
engaging in the CSC family psychoeducation program in the United States. 
 
With the emergence of websites and apps that allow for interaction and collaboration 
(i.e., social media websites via Web 2.0) and the accessibility and availability of the 
internet via smart technology, there is the opportunity to deliver and evaluate an 
accessible intervention for families with loved ones in CSC programs. Implementing such 
a platform has the potential to be cost effective, easily disseminated and highly accessible 
due to 1) the number of caregivers the content can reach without the need of one-on-one 
support (i.e., family therapist visits); 2) communication can be shared asynchronously 
between a large population of caregivers by a small team of online therapists and family 

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peers; and 3) the ability to access the content, including psychoeducation, outside 
traditional office hours and in convenient spaces for caregivers, compared to typical 
office hours at CSC programs. Further, this platform captures data (e.g., patterns of 
system use and engagement) that offers a distinct opportunity to research determinants 
of any treatment effects. To the best of our knowledge, outside of the platform being 
implemented in Australia in which we are partnered, no other platform has been 
developed to study and address the specific needs of families and caregivers with loved 
ones in CSC programs. Outside of the Australian pilot, previous studies have 
demonstrated the acceptability of online interventions for caregivers of individuals with 
chronic schizophrenia but have not provided evidence that the effectiveness of face-to-
face interventions, relative to treatments as usual, and how they can be translated to an 
online platform. 
 
Previously the group in Australia as well as our group have successfully developed and 
piloted Moderated Online Social Therapy (MOST; known as Horyzons in North Carolina) 
model for young people recovering from psychosis. MOST integrates purpose-built online 
social networking, expert and peer moderation, and evidence-based psychoeducation 
within a single platform. The group in Australia adapted the platform for caregivers called 
“Altitudes”. The platform is based on Horyzons, which was originally built for individuals 
experiencing FEP. The MOST model [21] provides unique opportunity for caregivers to 
share information and resources with the support of trained experts and peer 
moderators. Altitudes will be further adapted for caregivers in the United States and 
further provide a unique opportunity to extend the availability of evidence-based family 
intervention for FEP families in North Carolina. 
 
The efficacy of the Altitudes platform for North Carolinian caregivers will be assessed as 
an open trial with a quasi-experimental design. The primary aim of this trial is to examine 
the acceptability and feasibility of the platform as an adjunct to standard of care in CSC 
programs for families with loved ones experiencing FEP. The secondary aim is to evaluate 
the platform’s effect on caregiver stress, mental and physical health over a 6-month 
intervention period in comparison to a matched control group of caregivers..  
 
Objectives  
This program is for families and caregivers of young people diagnosed with a first episode 
of psychosis. The purpose of the study is to assess the feasibility, acceptability, and 
efficacy of implementing Altitudes as part of routine care received by families in first 
episode psychosis clinics in North Carolina. Altitudes is an online platform that 
integrates: 1) peer-to-peer family online social networking; 2) tailored interactive 
psychoeducation and psychosocial intervention; and 3) trained moderation. Altitudes 
was developed and first tested in Australia but has yet to be adapted and evaluated as 
part of care in family and supports in the United States. Further, efficacy will be more 
rigorously evaluated with a control group of caregivers who are receiving clinical 
services but will not have access to the platform over the course of the six months. 
RESEARCH DESIGN & METHODS 
Participants, interventions, and outcomes 
 

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Overview 
Participants in the Altitudes condition (parents and caregivers) will be given access to 
the Altitudes platform (which is considered a “non-significant risk” medical device and is 
described below) from their date of enrollment up to 6 months. Altitudes will be 
monitored daily (one hour per day) by trained family peer support specialists, master's 
level clinicians, Drs. David Penn and Kelsey Ludwig, and/or graduate students in the 
Department of Psychology and Neuroscience at UNC.  To facilitate and monitor 
engagement, a protocol is in place that directs moderators to contact participants via text 
message and/or email if he/she/they have not logged onto the platform for two weeks at 
the beginning of the service, primarily to assess for and troubleshoot logging into 
Altitudes or navigating the site. If a participant remains inactive for an additional two 
weeks, moderators will contact participants by phone to check in about any issues and 
discuss participants’ goals for engaging in Altitudes. From that point forward, 
participants will be encouraged to contact moderators as needed with questions or help-
seeking. Moderators will check in with participants monthly throughout the study to 
ensure Altitudes is meeting their treatment needs and to tailor content to the carers’ 
interests. Caregiver participants may opt out of receiving monthly check-ins. Licensed 
clinical psychologists, Drs. David Penn and/or Kelsey Ludwig, will lead weekly 
supervision calls to ensure appropriate care and support of participants involved in this 
project, to discuss case conceptualization and suggestions for engaging individuals on the 
platform, as well as to monitor any potential safety concerns. 
 
Overview of Altitudes. Altitudes is an online social media platform that integrates: 1) 
peer-to-peer online social networking; 2) tailored interactive psychoeducation and 
psychosocial interventions; and 3) expert moderation. 
 
Peer-to-peer online social networking (the “Community”). The ‘community’ page includes 
a web feed where participants can post comments, information, upload pictures and 
videos, and react to different content. Moreover, the system includes a ‘wall’ function 
displaying the activity of individual users, and a ‘network’ (similar to a ‘friends’ function). 
The open trial also incorporates the participation of family peer support workers. Family 
peer supports are individuals with loved ones who have lived experience of severe 
mental illness who are familiar with the Altitudes platform.  These individuals are part of 
the investigational staff who will be interacting with participants for research purposes. 
Their primary function will be to induct individuals to the platform, reach out to inactive 
participants, answer any questions parents or caregivers may have about the site, and 
help facilitate discussion in the ‘Community’ and other sharing areas of the platform. 
Research staff at the university will train and supervise all Altitudes family peer support 
workers. 
 
Interactive Psychoeducation and Psychosocial Interventions. Altitudes includes a 
range of tailored interactive psychoeducation pathways divided into separate steps. 
These pathways target key educational information in early psychosis including: (a) 
introduction to psychosis, (b) different phases of psychosis (and what to expect), (c) 
causes of psychosis and potential relapse, as well as d) strategies to cope with increased 
demands of caregiving and other stressors. The platform is self-directed and individuals 
are able to select which pathways they would like to utilize based on their treatment 
goals. All pathways are available to Altitudes participants in this study. 
 

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Expert Moderation. Family peer support workers, providers with significant experience 
in the psychosocial treatment, as well as graduate students with relevant 
clinical/research experience with FEP will serve as expert moderators. Their role is to 
provide guidance, monitor participants’ status and ensure the safety of the social 
networking environment. The moderator reviews interactivity in the social networking 
space and information from individual participants’ modules to monitor risk. The 
Altitudes Moderation Checklist will be completed by each moderator every time 
he/she/they moderates the platform. The checklist is designed to ensure moderators 
complete the appropriate safety checks during the moderation session, and to give 
moderators ideas as to how to engage users. 
 
Treatment period. At the mid-treatment assessment period (approximately 10-14 weeks 
after an Altitudes participant is onboarded to the platform), clients will meet with the 
study coordinator over secure video conferencing. The study coordinator will use screen 
sharing to complete all assessment measures with the individual. Control participants 
will also meet via secure video conferencing with research staff approximately 10-14 
weeks after their initial battery assessment. 
 
After Altitudes participants have engaged with the platform for 24 weeks, they will be 
provided with an optional feedback form as a way of better understanding their 
experience with the platform and collecting suggestions for improving the site. 
Additionally, we will conduct individual feedback interviews (lasting approximately 45 
minutes) with parents and caregivers. These interviews will address participants' social 
relationships, experiences with loneliness, and thoughts about connecting with 
others through Altitudes. Control participants will also complete the same measure 
battery via video conferencing at approximately 24 weeks after their initial survey visit. 
 
To evaluate the extent to which engagement in Altitudes may have impacted treatment 
participants' psychological health and perceptions of their social environment in 
comparison to the control group, all individuals will be asked to complete a battery of 
psychological measures at baseline, mid-treatment, and post-treatment visits. All 
measures will be administered by a member of the study team via secure Zoom. They will 
additionally complete a brief engagement measures on services they are accessing (e.g., 
services through the CSC program, individual therapy, group therapy at an outside 
organization, etc.). 
 
At each of the three timepoints, all participants will be asked to complete the Experience 
of Caregiving Inventory (ECI; Szmukler), the Family Questionnaire of Expressed Emotion 
(Wiedemann et al., 2002), Brief COPE (Carver, 1997), UCLA Loneliness Scale (Russell, 
1996), Multidimensional Scale of Perceived Social Support (For control and Alternative 
form for Altitudes condition; Zimet et al., 1990), Modified Psychosis Attitudes Survey 
(PAS; Kopelovich et al., 2022), PTSD Checklist for DSM-5 (PCL-5, Weathers et al., 2013), 
Post Traumatic Growth Inventory (PTGI, Tedeschi & Calhoun, 1996), General Health 
Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-Compassion Scale – Short Form (SCS-
SF; Raes et al., 2011), and Five Facet Mindfulness Scale (FFMQ; Bohlmeijer et al., 2011). 
 
At baseline, all participants will be asked to complete a brief demographic questionnaire 
and answer a small number of clinical questions about their loved one (e.g., “Of the 
options provided below, what stage of recovery best describes your loved one?”).  

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At midpoint, Altitudes condition participants will also be asked to provide their 
perceptions of the Altitudes platform and clinical moderators via four brief 
questionnaires: the Altitudes Health Care Climate Questionnaire (A-HCCQ), Altitudes 
Usability Questionnaire (AUQ), and Altitudes Perceived Competence Scale (A-PCS) and 
Working Alliance Inventory for guided Internet interventions (WAI-I, Gomez Penedo et 
al., 2019). 
At posttreatment, Altitudes condition participants will be asked to participate in a 
qualitative interview focusing on the experience of Altitudes and deeper understanding 
of acceptability and feasibility of the platform. 
As this platform will be provided as an adjunct to CSC clinical care, pertinent clinical 
impressions and other relevant clinical information will be shared with the individual’s 
clinical team at their respective FEP clinic. 
 
All individual interviews will be conducted virtually via secure Zoom and will be led 
by the Altitudes study coordinator and/or a graduate student in clinical psychology at 
UNC-Chapel Hill. All feedback sessions will be digitally recorded, and will be de-identified 
and transcribed by a member of the research team or a transcription service.  The 
purpose of these recordings and transcriptions is to allow the research team to examine 
the feedback provided in the interviews for the purposes of improving the platform to 
better support families and caregivers in supporting their loved ones experiencing 
psychosis via psychoeducation and skills such as healthy coping mechanisms. 
 
Subjects 
Up to 30 total Altitudes participants will be recruited from two of the FEP clinics in North 
Carolina (OASIS & SHORE) as it is a pilot study, specifically family members of individuals 
experiencing FEP. An additional 30 control participants will be recruited from three other 
FEP clinics in North Carolina (Eagle, Encompass, and AEGIS). All participants will have a 
loved one currently enrolled in or recently graduated from a CSC program. Demographic 
and clinical information that will be collected as self-report for possible use as covariates 
includes: 1) participant demographics: age, sex/gender identity, race/ethnicity, level of 
education, current zip code, relationship to loved one, employment status, proximity to 
the loved one with psychosis (e.g., cohabitating, living in different states), hours of contact 
with loved one per week on average, number and ages of any other children; and 2) young 
person with psychosis’ demographics and relevant clinical information: age, sex/gender 
identity, level of education, stage of recovery, and level of education. 
 
 
Eligibility Criteria 
Inclusion criteria for the study will be family (i.e., parent or other loved one in a 
caregiving role such as a grandparent, godparent, etc.) of a young person who is currently 
receiving treatment from a CSC program for first episode psychosis, or who have recently 
graduated from a CSC program. For the parent or caregiver to be eligible, the parent or 
caregiver must be at least 18 years of age. More than one family member will be eligible 
to participate from each family. Altitudes participants will be recruited from only two 
North Carolina CSC programs (OASIS & SHORE), as this is a pilot study, while the control 
participants will be recruited from three other CSC programs (Eagle, Encompass, and 

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AEGIS). Additionally, the parent/caregiver must have access to the internet through a 
mobile phone, tablet, or computer. 
 
Exclusion criteria: Family who are currently engaged in legal action against the 
identified individual, do not speak English, or under 18 years of age. 
ASSESSMENT OF DATA 
At this stage of treatment development, specific outcomes include examining the 
feasibility and acceptability of implementing Altitudes at NC FEP clinics for parents and 
caregivers through the following objectives: 
1) Ability to meet our recruitment targets 
2) Evaluation of the safety and privacy protocol 
3) Evaluation of the frequency and types of engagement on Altitudes 
4) Examination of carers’ perceptions of the platform (e.g., its utility, approachability, 
and helpfulness) 
5) Assessment of any changes in psychological measures across the six-month 
intervention 
 
Outcomes  
We hypothesize that caregivers of individuals with psychosis will utilize the Altitudes 
platform and perceive it to be useful and beneficial for their understanding of their loved 
one's mental health issues. We also hypothesize that engagement in Altitudes will 
contribute to increased utilization of adaptive coping strategies, reduced expressed 
emotion in the familial milieu, and improved understanding of psychosis in comparison 
to the control participants.  
STUDY PROCEDURES 
 
Screening  Procedures 
The research study coordinator will communicate with clinicians and other members of 
the treatment team to explain the project and discuss eligibility criteria for the study. If 
agreed to by the clinical team at each site, the research team will  attend the beginning or 
end of multifamily group (MFG) sessions at OASIS & SHORE to provide an overview of 
Altitudes and answer any questions that potential participants might have about the 
study. Research staff will additionally contact the other three clinics (Eagle, Encompass,, 
AEGIS, and We2Care) about control participants and attend their MFG to provide 
information to prospective participants. Clinical team members will be asked to review 
their current caseloads to identify potentially eligible participants (i.e., parents and 
caregivers of patients who are currently receiving services or recently graduated from 
one of the programs). The study coordinator and/or research assistant (RA) will engage 
in discussion with the treatment team to help identify appropriate individuals for 
inclusion in the project. When participants have been identified and expressed interest 
in participation to their clinician or other treatment provider, the research study 
coordinator or RA will reach out to the individual in their preferred method of contact 
(i.e., in person at the clinic or via phone/email) to discuss the project and complete an 
initial screen to confirm the inclusion and exclusion criteria. Participants will then be 

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given the highlights of the study and their participation via phone after their screening. 
Highlights will include the study, its aims, what they will be asked to do, the timeframe of 
their participation, and that it is completely voluntary and they can withdraw consent at 
any time, for any reason, without penalty. Additionally, in the email to review the 
document and at the top of the consent forms in DocuSign there will be a phone number 
for them to contact and explicitly state to call the number if they have any questions prior 
to signing the documents. 
 
With approval from the IRB & clinic directors, the research time will post flyers with a 
description of the study and eligibility criteria in the clinic waiting rooms to allow for 
caregivers to self-refer and/or to enable clients with FEP to share information about the 
study with their loved ones. If individuals self-refer (in response to flyers), the RA and PI 
will consult with the treatment team first before screening the individual (i.e., to confirm 
their loved one is currently receiving or recently graduated from the CSC program).  
 
Baseline Procedures 
The study coordinator will meet virtually with prospective participants for about 1 hour 
to complete all baseline measures. The demographic form will be completed first, which 
collects basic information about sex, age, ancestry, education, current zip code, and basic 
information on their loved one, including their loved one age, duration of illness, and 
length of time in the CSC program. After completing these documents, the study 
coordinator will guide participants through virtual copies of the demographic questions 
and psychological measures , including the Experience of Caregiving Inventory (ECI; 
Szmukler), the Family Questionnaire of Expressed Emotion (Wiedemann et al., 2002), 
Brief COPE (Carver, 1997), UCLA Loneliness Scale (Russell, 1996), Multidimensional 
Scale of Perceived Social Support (For control and Alternative form for Altitudes 
condition; Zimet et al., 1990), Modified Psychosis Attitudes Survey (PAS; Kopelovich et 
al., 2022), PTSD Checklist for DSM-5 (PCL-5, Weathers et al., 2013), Post Traumatic 
Growth Inventory (PTGI, Tedeschi & Calhoun, 1996), General Health Questionnaire-12 
(GHQ-12; Goldberg, 1972), Self-Compassion Scale – Short Form (SCS-SF; Raes et al., 
2011), and Five Facet Mindfulness Scale (FFMQ; Bohlmeijer et al., 2011). Additionally, all 
participants will complete a brief survey on engagement with services within the CSC 
program and outside the program (e.g., individual therapy, family groups outside of CSC, 
etc.). 
 
For Altitudes participants only, once all baseline study measures are complete, the study 
coordinator will conduct a 20- to 30-minute orientation of the Altitudes platform, 
including creation of an Altitudes profile and orientation to the features of the site. All 
participants will be compensated $20.00/hour prorated to the nearest half hour for 
completion of this visit and their time. 
 
Intervention Period Procedures 
Mid-Treatment Procedures 
The study coordinator will meet virtually with all participants for approximately 30 
minutes to complete the mid-treatment measures. All participants will complete virtual 
copies of the  Experience of Caregiving Inventory (ECI; Szmukler), the Family 
Questionnaire of Expressed Emotion (Wiedemann et al., 2002), Brief COPE (Carver, 
1997), UCLA Loneliness Scale (Russell, 1996), Multidimensional Scale of Perceived Social 

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Support (For control and Alternative form for Altitudes condition; Zimet et al., 1990), 
Modified Psychosis Attitudes Survey (PAS; Kopelovich et al., 2022), PTSD Checklist for 
DSM-5 (PCL-5, Weathers et al., 2013), Post Traumatic Growth Inventory (PTGI, Tedeschi 
& Calhoun, 1996), General Health Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-
Compassion Scale – Short Form (SCS-SF; Raes et al., 2011), and Five Facet Mindfulness 
Scale (FFMQ; Bohlmeijer et al., 2011). Additionally, all participants will complete a brief 
survey on engagement with services within the CSC program and outside the program 
(e.g., individual therapy, family groups outside of CSC, etc.). At midpoint, Altitudes 
participants will also be asked to provide their perceptions of the Altitudes platform and 
clinical moderators via four brief questionnaires: the Altitudes Health Care Climate 
Questionnaire (A-HCCQ), Altitudes Usability Questionnaire (AUQ), and Altitudes 
Perceived Competence Scale (A-PCS) and Working Alliance Inventory for guided Internet 
interventions (WAI-I, Gomez Penedo et al., 2019). All participants will be compensated 
$20.00/hour prorated to the nearest half hour for completion of this visit and their time. 
 
Post-Treatment Procedures 
The study coordinator will meet virtually with family and support participants for 
approximately 1-1.5 hours to complete the post-treatment measures; however, visits for 
control participants is likely to be closer to a half hour. All participants will complete 
virtual copies of the Experience of Caregiving Inventory (ECI; Szmukler), the Family 
Questionnaire of Expressed Emotion (Wiedemann et al., 2002), Brief COPE (Carver, 
1997), UCLA Loneliness Scale (Russell, 1996), Multidimensional Scale of Perceived Social 
Support (For control and Alternative form for Altitudes condition; Zimet et al., 1990), 
Modified Psychosis Attitudes Survey (PAS; Kopelovich et al., 2022), PTSD Checklist for 
DSM-5 (PCL-5, Weathers et al., 2013), Post Traumatic Growth Inventory (PTGI, Tedeschi 
& Calhoun, 1996), General Health Questionnaire-12 (GHQ-12; Goldberg, 1972), Self-
Compassion Scale – Short Form (SCS-SF; Raes et al., 2011), and Five Facet Mindfulness 
Scale (FFMQ; Bohlmeijer et al., 2011). Additionally, all participants will complete a brief 
survey on engagement with services within the CSC program and outside the program 
(e.g., individual therapy, family groups outside of CSC, etc.). After completing these virtual 
measures, the study coordinator will lead Altitudes participants only through a feedback 
survey and individual feedback interview regarding the Altitudes platform, their online 
therapist, the Family PSS, and the community newsfeed. Altitudes participants will be 
welcomed to share their opinions regarding their experience, including suggestions for 
how to improve Altitudes in the future. All participants will be compensated $20.00/hour 
prorated to the nearest half hour for completion of this visit and their time. 
DATA ANALYTIC PLAN 
 
Primary Outcome Measures* 
*Primary outcomes solely apply to those in the Altitudes condition 
 
1. Qualitative Summaries of Participant Experience in Post-Treatment Feedback 
[Time Frame: up to 6 months] 
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 

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common themes regarding likes and dislikes of the platform, implementation 
within the clinical setting, and participant ideas for future directions. 
 
2. Quantitative Summaries of Participant Experience in Post-Treatment Feedback 
[Time Frame: up to 6 months] 
This quantitative data will be collected post-treatment from Altitudes 
participants. Feedback forms will prompt participants to answer questions 
regarding their experience with the platform on a scale of 1 to 5, with higher 
scores reflecting a more positive experience. Frequency counts will be included 
here. 
 
3. Mean change in Working Alliance Inventory for Guided Internet Interventions 
(WAI-I) – Total Score [Time Frame: Mid-treatment, post-treatment, up to 6 weeks] 
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. 
 
4. Mean change in Working Alliance Inventory for Guided Internet Interventions 
(WAI-I) – Task and goals subscale [Time Frame: Mid-treatment, post-treatment, 
up to 6 weeks] 
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. 
 
5. Mean change in Working Alliance Inventory for Guided Internet Interventions 
(WAI-I) – Bond subscale [Time Frame: Mid-treatment, post-treatment, up to 6 
weeks] 
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 
 
6. Mean change in Perceived Autonomy Support Scale – Total Score [Time Frame: 
Mid-treatment, post-treatment, up to 6 weeks] 
The Perceived Autonomy Support Scale is a 6-item scale. Answers are on a 7-point 
scale ranging from “strongly disagree”, “moderately disagree”, “slightly disagree”, 
“neutral”, “slightly agree”, “moderately agree”, and “strongly agree”. Possible 
scores are averaged across all 6 items. Higher scores indicate greater global 
support of client autonomy from the treatment provider or team. 
 

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Secondary Outcome Measures 
 
1. Descriptive statistics examining Site Usage Information [Time Frame: Duration of 
the trial, from onboarding at baseline through post-treatment] 
The Altitudes platform passively collects engagement data, including the number 
of therapeutic pathways started and completed as well as any posts or comments 
made on the platform. We will provide mean and standard deviation scores for 
each site usage category, as well as a range, for the Altitudes group only. 
Depending on sample size, we will categorize users in low or high engagement 
groups. 
 
2. Mean Change in UCLA Loneliness Scale Score [Time Frame: Baseline, Post-
treatment, up to 14 weeks] 
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. 
 
3. Mean Change in Multidimensional Scale of Perceived Social Support - total score 
[Time Frame: Baseline, Post-treatment, up to 14 weeks]; Alternative form for 
Altitudes participants, original form for control group. 
The MOS 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).  
 
4. Mean Change in the Experience of Caregiving (ECI) Score [Time Frame: Baseline, 
Post-treatment, up to 14 weeks] 
The  Experience of Caregiving (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. Higher scores indicate 
greater feelings of preparedness for caregiving whereas lower scores reflect 
feeling less prepared to provide caregiving.  
 
5. Mean Change in Family Questionnaire of Expressed Emotion - Total Score [Time 
Frame: Baseline, Post-treatment, up to 14 weeks]. The Family Questionnaire of 
Expressed Emotion is a part of the PhenX Toolkit. 
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 

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from the individual items, with higher scores indicating greater levels of 
expressed emotion. 
 
6. Mean Change in General Health Questionnaire-12 Score [Time Frame: Baseline, 
Post-treatment, up to 14 weeks] 
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).  
 
7. Mean Change in the Brief COPE scale [Time Frame: Baseline, Post-treatment, up to 
14 weeks] 
The Brief-COPE is a 28-item self-report questionnaire designed to measure 
effective and ineffective ways to cope with a stressful life event. It can be divided 
into three subscales: problem-focused (8 items), emotion-focused (12-items), and 
avoidant (8-items) coping styles. 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.” Higher scores on 
each reflect more frequent use of that style of coping. 
 
Tertiary/Exploratory Outcome Measures 
 
1. Mean Change in the PTSD Checklist for DSM-5 [Time Frame: Baseline, Post-
treatment, up to 14 weeks] 
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. 
 
2. Mean Change in the Posttraumatic Growth Inventory Score [Time Frame: Baseline, 
Post-treatment, up to 14 weeks] 
The PTGI is a 21-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 105. Higher scores reflect 
more positive changes in an individual’s life following a stressful experience. 
 
 

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Power Analysis 
We did not conduct a priori power calculations to determine a sample size with 80% 
power because this is an exploratory pilot study and will inform future well-powered 
trials of Altitudes in the United States. 
 
Data Management 
We will use the Research Electronic Data Capture (REDCap) system to facilitate data 
entry and management. We will leverage features in REDCap such as real-time data 
validation, built-in integrity checks, and other mechanisms for ensuring data quality (i.e., 
double data entry). Our team will use the Atlas.ti program for qualitative analysis. All 
analyses will be conducted by the study research coordinator (Elizabeth Fraser) and 
graduate student (Bryan Stiles). 
RISKS AND BENEFITS 
 
Risks for all participants. Identifying research subjects by a study number on all 
research documents minimizes risk of breach of confidentiality. Study documents that 
must contain personal information, such as the document that links study ID number to 
personal identifying information (necessary due to the longitudinal nature of this study) 
are kept in locked filing cabinets in locked rooms and/or are on password protected 
servers that only research staff have access to. Research data is kept on password-
protected drives, and our computer systems are HIPAA compliant. All study staff 
participate in annual human subjects training that includes education about 
responsibilities to minimize risk that confidentiality may be breached. 
 
Risks for parent and caregivers only. Risk of anxiety, shame, and/or embarrassment 
due to experiences using this online platform is minimized by completion of an Altitudes 
induction procedure. This will also be mitigated through the use of consistent moderating 
of the site as well as moderators’ use of a nonjudgmental clinical attitude. The informed 
consent process will be completed in private spaces within the clinic/research setting or 
via video conferencing will be done in secure locations and on secure servers. The 
participant will be instructed via email or phone call before the interview to find a private 
location to complete the induction to the platform. All documents such as consent and 
questionnaires will be sent to the participant using a secure UNC email account. 
Documents will not contain confidential information. 
 
Monitoring Risks 
To address subject anxiety or embarrassment due to revealing personal information, we 
have trained research staff who are experienced in working with individuals with 
schizophrenia spectrum disorders and their families or supports. They have been trained 
to put subjects at ease, let them take their time, and to conduct interviews in private 
rooms.  
 
To address the issue of accidental disclosure of personal information to others outside of 
the research staff, we will identify research subjects by study number on all research 
documents to minimize the risk of breach of confidentiality. Study documents that must 
contain personal information, including the informed consent document, and the 

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document that links study ID number to personal identifying information are kept in 
locked filing cabinets in locked rooms or on password-protected drives. Research data 
will be kept on password-protected drives, and our computer systems are HIPAA 
compliant. All study staff participate in annual human subject training that includes 
education about responsibilities to minimize risk that confidentiality may be breached. 
 
Altitudes safety protocol  
A rigorous safety protocol has been developed by the researchers in conjunction with 
experts from the computing and information systems discipline. The safety protocol is 
comprised of 3 levels of security including: 1) system and privacy protection, 2) online 
safety, and 3) clinical safety. 
 
System and privacy protection. A range of measures are in place to help ensure the security 
of the website. The platform is hosted on the State of North Carolina’s AWS server. The 
State has significant measures in place to prevent unauthorized access to the server. In 
addition, the web application includes measures to secure the application and database 
against unauthorized access. These measures conform to industry best practice as 
defined by the Open Web Application Security Project (www.OWASP.org). 
Online safety. Privacy and online safety will be managed in accordance with the 'Online 
social networking' guidelines published by 'Cybersmart', a national cybersafety and 
cybersecurity education program managed by the Australian Communications and Media 
Authority (ACMA). Cybersmart is designed to meet the needs of its target audiences of 
young people, parents, teachers and library staff. Information about Cybersmart can be 
found at https://www.esafety.gov.au/, while the guidelines are available at 
https://www.acma.gov.au/. 
Safe and informed orientation to the system will be a priority for the research team. A 
family peer support specialist, online moderator, and/or research staff from UNC Chapel 
Hill will meet with each Altitudes participant to provide them with login details, help set 
up their account, and orient them to the Altitudes system, including details of the terms 
of use. Hard copies of ‘Altitudes Terms of Use’ will be provided to users, which will be made 
available online and in printed form. Participants will be required to sign the hard copy 
as well as accepting the terms of use on entry into the system. The system also includes a 
"report function" which enables users at any time to indicate to the moderator a concern 
about any material posted by a user, including concern about potential abuse. The 
moderator will assess the basis of the report and respond accordingly, which can include 
the removal of the material and in some cases the deactivating or restriction of the user's 
account.  
In addition, users will be able to "switch off" their profile and hide all of their existing 
comments on the system should they become concerned about their privacy during their 
course of participation. The limits of the moderator to respond (e.g., in a timely manner 
to emergencies) will also be fully explained. In order to protect the privacy of users who 
discontinue using the system, any accounts that have not been activated for one month 
may be deactivated following a follow-up telephone call from a moderator. Specifically, 
our disengagement protocol states that a participant will receive an email/call/text 
message if they have not logged onto the platform for two weeks. If another two weeks 
pass, we will call this person to check in about any potential issues or concerns. As noted 

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above, the moderation team will check in with participants on a monthly basis to ensure 
they are able to navigate the site with ease and to answer any questions they might have 
about the platform and any of its components/capabilities. Participants can opt out of 
these regular check ins from moderators at any time. If participants do not comply with 
the guidelines for safe use of Altitudes (e.g., discriminatory comments towards other 
users; disclosing identifying details of the identified patient) they will be excluded from 
the system. 
Clinical safety: Although highly unlikely for the parent or caregiver, it is possible that 
participants may post information indicative of a clinical risk in their loved one, although 
participants will be advised that the service cannot respond to emergencies. Nonetheless, 
clinical risk will be monitored through manual and automated procedures. Information 
related to clinical risk will be screened daily by moderators and/or research staff . This 
information can include: 1) posts made by participants, which disclose evidence of 
deterioration in mental state of the young person in the care of participants; 2) 
participants reports or complaints on posts made by other users; and 3) automatically 
detected and blocked words posted by participants in the system. Additionally, clinical 
and family peer moderators will analyze the ‘Community’ feed to ensure that 
misinformation and falsehoods are not being spread by users of the platform.  
Any detected increased risk will activate the Altitudes safety protocol which includes a 
number of potential actions. Initially, the moderator will conduct a risk assessment based 
upon available information, inform the research team, and advise the participant on 
appropriate action, such as emergency services when necessary. In addition, the system 
incorporates visible emergency guidelines and contact information (i.e., on every 
webpage). Telephone numbers and contact details will be provided on each page of the 
website. 
An automated keyword system has also been built in Altitudes which will be activated 
each time a participant posts a contribution containing potentially offensive words. When 
these words are detected the contribution will be blocked and the participant will be sent 
an automated email explaining that the message has been blocked and if they are facing 
distress then they should contact the emergency contact number as soon possible or if 
they are not facing distress they may like to consider rephrasing their post. An automated 
email will also be sent to the Altitudes moderator containing the attempted post.  
In addition, a message will be available on each page providing a mobile telephone 
number carried by a member of the research team for any emergencies that are related 
specifically to the use of the Altitudes’ system (e.g., highly inappropriate use of the 
system). Further, each page includes an “In Case of Emergency” link that provides about 
way to contact emergency services (911), the UNC crisis line (984-974-3950), and crisis 
services (http://crisissolutionsnc.orge/ ; [988]). 
Withdrawal criteria. Temporary or permanent withdrawal from Altitudes will be 
triggered by repeated inappropriate use of the system. This can include either suspension 
of a users' Altitudes account or restrictions regarding participation and use of Altitudes 
(i.e., the user is able to access therapeutic content and support from moderators but 
cannot post comments or participate in existing threads within the social network).  

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Non-Significant Risk Documentation 
The present study has been deemed of non-significant risk (NSR) to participants. 
 
Potential Benefits of the Research to Subjects and Others 
While the field is still in its infancy, there is preliminary evidence that online 
interventions combining therapy, social networking opportunities, and expert and peer 
moderation may be well received by individuals whose loved ones are experiencing FEP, 
as it develops skills and offers a support network of people with similar experiences. 
Further, it increases accessibility and availability of evidence-based resources for parents 
and caregivers whose schedules are already overextended and are unable (or have to 
take time off work) to attend family therapy appointments at the CSC outpatient clinics. 
The proposed study will expand this growing body of work by testing the clinical utility 
of this intervention when implemented as an adjunct service of CSC clinics in North 
Carolina. 
 
Benefits to treatment participants. The proposed study may increase the family and 
supports’ sense of belonging and social support. Additionally, if they engage with the 
educational material, they may learn effective strategies to reduce stress and improve 
mood, better understand their loved one and their experience, as well as identify ways to 
support their loved one in their recovery from psychosis. 
 
Benefits to control participants. While control participants may not receive direct benefits 
from this study, they will contribute to the scientific knowledge underlying Altitudes with 
the hopes of expanding this novel digital intervention to all families receiving services in 
CSC programs. 
 
Confidentiality of Data 
Names and associated contact information for potential subjects during the recruitment 
phase will be stored in a manner similar to that used to store study data. This information 
will be kept in a locked file cabinet in a locked office at UNC or within the administrative 
or secure storage areas of the FEP clinics involved in this project. Contact information 
will be destroyed immediately after it is ascertained that an individual does not want to 
participate in the study. Individuals who decline to participate will have their names 
retained on a secure password protected network to ensure that they are not contacted 
more than once regarding participation. 
 
A member of the research team will meet individually with the parent or caregiver to 
explain the components of the Altitudes platform (or the study in general in the case of 
participants in the control group), elicit and answer any questions the potential 
participant may have after the screening then informed consent will be obtained via the 
DocuSign system. Altitudes participants will also create a profile on the platform and 
answer questions about their caregiving experience (e.g., their loved one’s stage of 
recovery), which are introduced to each participant during the onboarding to the 
Altitudes platform.  This data will be linked to other sources of information, including the 
record of their interactions within the Altitudes system (e.g., number of posts/comments 
in the ‘Community’). 
 

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The Altitudes system and data generated by users of Altitudes will be hosted on a secure 
web server. A range of measures are in place to ensure the security of the Altitudes 
website and the data generated by users. In addition, the team who developed the web 
application has placed measures within the application to secure the application and 
database against unauthorized access. These measures conform to industry best practice 
as defined by the Open Web Application Security Project (www.OWASP.org). All data 
collection visits will be conducted via secure Zoom. All interviews will also be conducted 
via secure Zoom and will be digitally recorded (via Zoom or using audio recorders) for 
the purposes of transcription. These recordings and transcripts will be immediately 
uploaded to a secure, password-protected server and deleted from local devices. The 
project electronic database (including all transcripts from interviews) will be password 
protected and stored securely, and will only be directly accessible by the research staff, 
clinicians and family peer support workers, involved in this project, or the principal 
investigator. 
 
As this research program is being implemented in clinical settings, it is possible that FEP 
clinicians will create notes that indicate the participant is involved in the project, describe 
any issues that may arise, etc. that will be connected to their medical record. These 
documents will be stored in approved medical record systems on HIPAA-compliant 
computers.   
 
If researchers complete inductions or introductions to the site via video conference, the 
video or audio from these interviews will not be saved or recorded. Audio from 
qualitative interviews will be stored on a secure, password-protected server.  
 
Identifiable data will only be shared with the clinicians of participants in the study with 
the permission of the participants (obtained during informed consent). Clinicians will be 
contacted if issues arise related to safety during the trial. As part of the informed consent 
process, all participants will be asked to provide the name and contact info of an 
emergency contact that we may contact if we become concerned about their safety or the 
safety of their loved one (e.g., physical and/or mental health) during the trial. Any 
limitations to privacy and confidentiality, including any indication of neglect or abuse of 
a minor, elder, or other vulnerable group, will be explicitly discussed with all participants 
during the informed consent process. We will not be sharing any confidential information 
with anybody outside of these clinicians. 
 
Identifiable data will be maintained for 5 years following study completion. At that point, 
hard copies of identifiable data including consent forms and contact information will be 
shredded. Electronic data will be de-identified upon entry, with the exception of the 
subjects' birth dates for the purposes of calculating their exact age. 
Safety Management 
 
Adverse Events 
System and privacy protection will be monitored by the study staff. Online safety will be 
monitored by the clinical and family peer moderators with supervision from the senior 
researcher staff (Drs. David Penn and Kelsey Ludwig). The moderators will have the 
authority to respond to online reports (e.g., remove offending material from the system) 

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and automated emails. 
 
Clinical safety will be monitored proactively by the moderators through daily monitoring 
of the activity on Altitudes (i.e., twice a day during the weekdays and once a week on 
weekend days). In addition, information related to the well-being of participants could 
be brought to the attention of the research team from two potential sources: a) the online 
moderators via daily monitoring of the site; and b) the research coordinator at an 
interview.  
The research team will respond according to a risk management algorithm, which 
outlines the required response to potential indicators of clinical risk in terms of the 
source of the information. If the online moderator becomes aware of potential indicators 
of risk in the online application they will conduct an initial risk assessment, make the 
appropriate clinical response and inform the supervisor. If the study research 
coordinator becomes aware of an indicator of clinical risk they will inform their 
supervisor who will again respond clinically. The principal investigator will assess the 
criteria for withdrawal and potential suspension of usage restriction to a user’s Altitudes 
account. The principal investigator will have ultimate responsibility for withdrawing 
participants from the study or restricting their Altitudes account.  
Reporting of adverse events 
Any adverse outcomes for participants, such as exposure to potentially harmful 
interactions through social networking, will be reported to University of North Carolina 
at Chapel Hill’s (UNC-CH) Institutional Review Board (IRB). If a participant informs the 
moderators of an adverse event relating to the young person in their care or of any signs 
of deterioration in their mental health, the Altitudes moderators will communicate with 
the relevant clinicians where indicated.  
RECRUITMENT STRATEGY 
For recruitment, research staff have partnered with CSC clinics in previous studies and 
consultation. For this reason, research staff have extensive knowledge regarding 
recruiting from this target population. Research staff will inform the CSC providers and 
PSS about the study and its eligibility criteria to allow the treatment team the ability to 
identify potentially eligible participants. The treatment team will then approach potential 
parent and caregiver participants to gauge their interest in participating on the digital 
platform. If the person expresses interest or would like to know more about the study, 
the provider or PSS will pass along their information to research staff via referral forms 
to contact them to further discuss specifics about the study (e.g., describe the social 
networking and educational aspects of the platform). If the individual is still interested in 
participating, the client will be screened for eligibility. Upon meeting eligibility criteria, 
the individual will be scheduled for a baseline visit.  
CONSENT PROCESS 
As screening will occur prior to informed consent, participants will be given a brief 
overview of the study (see participant screening document). Prior to administering 
eligibility screening questions, participants will be asked if they are still interested and 
give verbal consent to complete the screening form. If the participant verbally consents 
to screening this will be documented prior to administering the screening questions. 
Upon verification of eligibility, participants will be given the highlights of the study and 

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their participation via phone after their screening. Highlights will include the study, its 
aims, what they will be asked to do, the timeframe of their participation, and that it is 
completely voluntary and they can withdraw consent at any time, for any reason, without 
penalty. Additionally, in the email to review the document and at the top of the consent 
forms in DocuSign there will be a phone number for them to contact and explicitly state 
to call the number if they have any questions prior to signing the documents. The 
participant will then be scheduled for a baseline visit (see below). If the individual is not 
eligible, they will be thanked for their time and notified that they are not currently eligible 
for the study. 
A member of the research team will meet individually with the client in order to explain 
the components of the study (including the Altitudes platform), elicit and answer any 
questions the participant may have during the screening phone call.  Participants will 
then provide informed consent via the DocuSign platform. For Altitudes participants, it 
will be explained that their data will be linked to other sources of information, including 
the record of their interactions within the Altitudes system (e.g., number of 
posts/comments on the ‘Community’), but the data exported from the site will be de-
identified before storage on password protected drives located on secure servers.  All 
participants will be provided with a copy of the consent form and research staff will 
encourage each participant to contact the principal investigator or IRB for any questions 
they may have related to the study or their rights as a research participant. There are also 
several procedures in place to ensure that prospective participants fully understand the 
procedures, risks, and protections of the study. First, the consent form is written in easy-
to-understand language. Second, participants will know the number and email of the 
person to call if they have any questions prior to signing the document. Participants will 
have the option to provide electronic consent via DocuSign’s Part 11 compliant electronic 
consent platform (i.e., electronic signature and verification) or in person on paper with 
wet ink signatures if preferred. 
ETHICS  
 
Research Ethics Approval  
Research ethics approval for the Altitudes Pilot will be sought from University of North 
Carolina at Chapel Hill’s IRB. 
 
Protocol Amendments 
Any modifications to the research protocol and conduct of the study will be notified to 
UNC’s IRB prior to their enactment. Approval from UNC’s IRB will be sought for any 
proposed protocol amendment including changes to eligibility criteria, outcomes, 
analysis and changes to research personnel.  
 
Declaration of interests 
The researchers report no financial or competing interests for the conduct of the trial. 
Access to Data 
Personnel who will have access to one or more sources of information collected through 

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the course of this study include all of the listed research staff in the IRB application (all 
data) and the study moderators (the online data captured within the Altitudes system). 
Ancillary and Post-Trial Care 
At the completion of the study, identifiable and deidentified data will be stored securely 
(i.e., hard copies will be stored in locked cabinets within locked offices and electronic will 
be in secure databases on secure computers). Three years after completion of the study, 
identifiable data will be properly and confidentially destroyed. Five years after the final 
publication arising from the deidentified data will be properly disposed and destroyed 
(i.e., electronic data will be deleted and paper data will be confidentially disposed).   
Future Projects 
We will seek permission from participants to use the data we collect for this study for 
projects that are not described here but that are closely related. Any future projects using 
the data will have been approved by UNC’s IRB. The deidentified data will only be used 
and researchers will not have access to participant’s identifiable data.  
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