Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support
Phase: NA
Conditions: Psychotic Disorders
Sponsor: Temple University

Study Protocol and Statistical Analysis Plan 
 
Facilitating Emerging Adult Engagement in Evidence-Based Treatment for 
Early Psychosis through Peer-Delivered Decision Support 
 
NCT04532034 
 
July 22, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Study Protocol 
 
1) Abstract of the study 
The purpose of this research is to conduct a pilot study of a decision support 
intervention for young adults with early psychosis who are participating in 
early intervention services, also known as coordinated specialty care (CSC).  
We will utilize a single-group, pre-post, convergent mixed methods design to 
explore whether and how the intervention addresses decision-making needs. 
The impact of the intervention on secondary outcomes (e.g., engagement in 
the program) will also be assessed. Additionally, we will evaluate the 
feasibility of research and intervention procedures, and the acceptability of 
information and support from the interventionist. 
 
2) Protocol Title 
Facilitating Emerging Adult Engagement in Evidence-Based Treatment for 
Early Psychosis through Peer-Delivered Decision Support Part 2 
3) Sponsor / Funding 
This study is funded by the National Institute of Mental Health under 
award number K08MH116101 
 
4) IRB Review History 
This study is a follow-up study to another protocol previously reviewed by 
the Temple IRB (protocol # 25075).  
5) Investigator 
Elizabeth Thomas, PhD 
Department of Social and Behavioral Sciences 
1700 N. Broad St. 
Suite 313 
Philadelphia, PA 19121 
Phone: 215-204-1699 
 
6) Objectives 
The purpose of this study is to evaluate a decision support intervention 
with emerging adults participating in CSC services. A peer specialist (i.e., 
trained mental health provider with lived experience of a mental health 

condition) or other staff person at the participating CSC programs will 
serve as “decision coaches” to participants to help them make decisions 
about their care. It is hypothesized that participants will experience a 
reduction in decision-making needs after participating in the intervention, 
and that study and intervention procedures will demonstrate feasibility and 
acceptability.  
 
7) Background 
Service disengagement among emerging adults with early psychosis (i.e., 
premature treatment drop-out) is a prevalent problem, with recent 
estimates between 20-40%. This is particularly concerning given that 
service disengagement during early psychosis is a risk factor for relapse, 
persistent symptoms, and poorer prognosis. Further, as emerging 
adulthood is characterized by key developmental milestones, young 
people who do not receive appropriate services during this time are at 
greater risk for health problems and poorer functional outcomes as they 
age. As such, service disengagement is a performance indicator for 
evaluating the quality of early psychosis care. While some CSC programs 
demonstrate relatively low rates of disengagement, others using similar 
approaches have had more retention difficulties, suggesting that current 
strategies are not sufficient to address disengagement in all contexts. 
Especially needed are interventions that promote early engagement (i.e., 
help-seeking, appointment attendance, engagement in treatment 
processes) to foster long-term retention and, thus, better outcomes.   
Research suggests that decision support may be a particularly efficacious 
approach for increasing service engagement. First, a number of modifiable 
treatment decision-making needs (e.g., knowledge deficiencies, lack of 
social support) contribute to decisional conflict, which, in turn, is 
associated with discontinuance of chosen options and decisional regret. 
Second, studies demonstrate that decision support interventions that 
address these decision-making needs are associated with increased 
service engagement.  
The effectiveness of decision support sets the stage for the development 
and preliminary analysis of a decision support intervention to facilitate 
treatment decision-making and enhance early CSC engagement. 
8) Setting of the Human Research 
Recruitment will occur at Horizon House, Inc., CMSU Behavioral 
Health and Developmental Services (CMSU), and On My Way CSC 
programs (i.e., PEACE, CMSU, On My Way) that serve emerging 
adults with early psychosis. Participants will receive the study 
intervention at the CSC program from which they were recruited. 
Research interviews will occur at Temple University, in a conference 

room at 1700 N. Broad, or at an agreed upon location at the CSC 
programs.  
In the event that in-person interactions with participants are 
prohibited due to COVID-19, recruitment, research interviews, and 
intervention meetings will be conducted remotely via telephone or 
videoconference (depending on participants’ preferences). We 
will use a HIPAA-compliant version of Zoom for all 
videoconference meetings. 
9) Resources Available to Conduct the Human Research 
We will recruit and collect data from 20 individuals enrolled in the CSC 
programs who will participate in the intervention. Given that this study’s 
purpose is to collect preliminary data about the intervention’s impact on 
decision-making needs, the sample size is based on pragmatics rather 
than power, consistent with recommendations for pilot studies. We used 
the current rate of enrollment at the CSC program and a conservative 
estimate of study enrollment of 40% to arrive at the projected N. 
Research staff for this study include the research assistant, the decision 
coaches at each of the CSC programs, and PI. The research assistant will 
dedicate at least 20 hours per week to recruitment and data collection 
during the study period. The decision coaches are also expected to 
dedicate at least 10 hours per week delivering the intervention, 
documenting contacts with participants, and participating in supervision 
via videoconference with the PI. The PI will dedicate at least 10 hours per 
week overseeing and managing the implementation of the study, 
supervising project staff, analyzing data, and completing other project 
tasks as needed.  
Research staff for this study have received extensive training, including 
completion of the CITI social and behavioral health human subjects 
training. During weekly staff meetings, the research team will discuss 
ongoing issues regarding the research to ensure procedures are followed 
and issues are addressed appropriately.  
Research staff have private, furnished office spaces at Temple University 
with access to Internet jacks, telephones, lockable file cabinets, 
teleconference equipment, and standard office equipment and supplies to 
facilitate research-related activities.  
The CSC programs are equipped with a large workspace for employees 
that includes Internet jacks, telephones, lockable file cabinets, and 
standard office equipment and supplies. They have conference areas with 
teleconference capability that will be available for recruitment as well as 
private rooms that will be available for intervention meetings, telephone 
calls, and research interviews with participants.  

10) 
Prior Approvals 
Review of this research is also required by the IRB for the City of 
Philadelphia. 
 
11) 
Study Design 
a) Recruitment Methods 
Recruitment will occur at Horizon House, Inc., CMSU Behavioral Health and 
Developmental Services, and On My Way’s programs (i.e., PEACE, CMSU, On 
My Way) that serve emerging adults with early psychosis.  Recruitment 
strategies that will be utilized to enroll participants in the study include distributing 
recruitment materials (e.g., study flyers, recruitment video), and completing site 
presentations. Recruitment materials will be provided to study sites for 
distribution to potential participants, and will be posted to our lab website and 
social media platforms. Additionally, we will also collaborate with CSC staff 
members who will provide information about the study to potentially eligible 
individuals, and the research assistant will conduct follow ups with those 
interested in participation for screening.  
 
b) Inclusion and Exclusion Criteria 
 
The research assistant will determine eligibility in person at the CSC programs or 
over the telephone/videoconference by using a screening questionnaire with 
study criteria questions. Screenings conducted at the CSC programs will be 
conducted in a private room. Screen failures will be notified that they are 
ineligible for the study, but that this will not have an impact on their ability to 
continue to access CSC services. All information/materials collected during 
screening will be stored in a locked office in a locked filing cabinet and within 
password-protected and encrypted electronic files. 
 
Inclusion criteria are: 1) 18-30 years of age; 2) experiencing early psychosis, 
defined as psychosis lasting 18 months or less between the time when threshold 
symptom criteria were reached (as determined by the admitting CSC program 
assessor) and the date of CSC program enrollment; 3) able to speak/understand 
English; 4) able to provide informed consent as assessed by research staff; and 
5) enrolled in the CSC program for any period of time.  
Exclusion criteria are: having a legal guardian or diagnosis of dementia, delirium, 
or intellectual disability as determined by the admitting CSC program psychiatrist. 
No individuals from special populations will be included. 
 

c) Local Number of Subjects 
The research assistant will recruit 20 individuals enrolled in the CSC 
programs to participate in the decision support intervention.  
d) Study Timelines 
Participants will complete two research interviews (approximately 1.5 
hours for the baseline assessment and 2 hours for the post-intervention 
assessment). Between these two research interviews, they will participate 
in the study intervention on a weekly or biweekly basis for approximately 
1-3 months, and repeat one of the measures that was completed during 
the baseline assessment (which is expected to take about 10 minutes) 
(see Procedures section below). Intervention meetings are expected to 
last 45-60 minutes each. We expect to enroll 2-3 participants per month, 
and estimate that recruitment and data collection will end in January 2022. 
Data analysis and reporting is expected to be completed by April 2023. 
e) Study Endpoints 
The primary endpoint is participants’ treatment decision-making needs, as 
assessed by the Decisional Conflict Scale (DCS) and a qualitative 
measure designed to parallel items from the DCS.  
We will also assess feasibility of study and intervention procedures by 
tracking data pertaining to recruitment, retention, and assessment 
procedures using CONSORT guidelines, and data related to 
implementation of the intervention (e.g., fidelity, number and duration of 
intervention meetings by participant, implementation barriers and 
facilitators). These data will be collected from fidelity checklists and 
contact notes completed by the decision coach. 
Acceptability of the study intervention will be assessed via quantitative and 
qualitative questions about participants’ level of satisfaction and 
experiences with the intervention. Exploratory, secondary 
outcomes/measures include: 
Multidimensional Scale of Perceived Social Support: This scale assesses 
perceived adequacy of support in the following areas: family, friends, and 
significant other. 
Control Preference Scale: This measure assesses patients’ preferences 
for participation in treatment decision-making.  
Perceived Involvement in Care Scale: This scale measures perceived 
clinician facilitation of patient involvement in decision-making, perceived 
level of information exchange between patient and provider, and 
perceived level of the patient’s own involvement in medical decision-
making.  

Birchwood Insight Scale: A scale that measures dimensions of insight in 
the following areas: ability to re-label symptoms, awareness of mental 
illness, and recognition of a need for treatment.  
Recovery Assessment Scale: This scale measures personal recovery and 
consists of 5 factors: personal confidence and hope, willingness to ask for 
help, goal and success orientation, reliance on others, and not being 
dominated by symptoms.  
Internalized Stigma of Mental Illness Scale (ISMI): This measure is 
designed to assess individuals’ experience of stigma related to mental 
illness. 
Empowerment Scale: A scale that measures empowerment, control, self-
determination, and decision making in the recovery process.  
Decision-Self-Efficacy Scale: This measure assesses confidence in 
making an informed treatment choice.   
Service Use and Resources Form (SURF-M): SURF-M is a self-report 
measure that assesses service use over the past month from diverse 
sources of inpatient and outpatient care including antipsychotic medication 
with daily doses, and other psychotropic and non-psychotropic medication. 
Brief Adherence Rating Scale (BARS): This scale assesses antipsychotic 
medication adherence of patients in outpatient settings. 
Intent to Attend Measure: A measure that assesses participants’ intention 
to engage in the coordinate specialty care program. 
Service Engagement Scale: A clinician-rated scale that measures 
engagement in community mental health services. 
Working Alliance Inventory: This 36-item scale assesses the strength of 
the therapeutic alliance with participants’ therapists in three domains: 
agreement on goals, assignment of tasks, and the development of bonds. 
Intentional Peer Support Scale: A scale designed to measure the 
relationship between the decision coach and patient. 
Satisfaction with Decision Scale: This scale assesses a patient’s 
satisfaction with a health care decision. 
 
Procedures Involved in the Human Research 
Screening and recruitment will be ongoing through January 2023. 
Participants will complete a baseline assessment with the research 
assistant prior to engaging in the decision support intervention. During the 
study period, participants will engage in the experimental decision support 
intervention and will maintain access to other services and supports 
normally available to them through the CSC program (e.g., medication, 
therapy). The PI will assess when the participant has determined what 

decision they would like to work on with the decision coach via contact 
notes and supervision sessions. The PI will notify the research assistant 
when this determination has been made, and the research assistant will 
contact the participant at that time to have them complete the Decisional 
Conflict Scale a second time. Participants will not be offered additional 
payment for completing this measure at this time point. Upon completion 
of the intervention, participants will complete a post-intervention 
assessment with the research assistant. At post-intervention, participants 
will be asked to provide permission to audio-record responses to 
qualitative questions that are part of the qualitative assessment of 
decision-making needs and acceptability measure. Participants must 
provide permission to audio-record these portions of the research 
interview in order to participate in the study. At baseline and post-
intervention, the study team will reach out to participants’ 
psychiatrists/therapists in order to have them complete a questionnaire 
(Service Engagement Scale). A schedule of assessments collected at 
each time point is presented in Table 1. 
 
Table 1. Assessment Schedule 
 
Baseline During 
Intervention 
Post-
Intervention 
Demographics/Clinical 
characteristics 
X 
 
 
Multi-dimensional Scale of 
Perceived Social Support 
X 
 
X 
Control Preference Scale 
X 
 
X 
Perceived Involvement in Care 
Scale 
X 
 
X 
Birchwood Insight Scale 
X 
 
X 
Recovery Assessment Scale 
X 
 
X 
Internalized Stigma of Mental 
Illness Scale 
X 
 
X 
Empowerment Scale 
X 
 
X 
Decision Self-Efficacy Scale 
X 
 
X 
Service Use and Resource Form 
for Monthly Items 
X 
 
X 

Brief Adherence Rating Scale 
X 
 
X 
Intent to Attend Measure 
X 
 
X 
Service Engagement Scale 
X 
 
X 
Decisional Conflict Scale 
X 
X 
X 
Working Alliance Inventory 
X 
 
X 
Intentional Peer Support Scale 
 
 
X 
Satisfaction with Decision Scale 
 
 
X 
Qualitative Measure of Decision-
Making Needs 
 
 
X 
Acceptability Measure 
 
 
X 
 
Decision coaching, a process of non-directive support by a trained but neutral 
individual, is used to facilitate treatment decision-making through assessment of 
decision-making needs and delivery of specific intervention components to 
address them. These components may include facilitating access to information, 
clarifying values, helping a person obtain the needed support to make a decision, 
and screening for implementation barriers. Following standards of practice for 
decision coaching, the decision coach will evaluate individuals’ decision-making 
needs and provide coaching tailored to these needs via 
telephone/videoconference or in face-to-face meetings. Individuals will be invited 
to speak with the decision coach as long and as many times as are necessary to 
make a treatment decision; however, it is expected that participation in the 
intervention will last approximately 3 months and it is suggested that individuals 
participate in the intervention on a weekly or biweekly basis. Participants will be 
asked to provide permission to audio record intervention meetings so that fidelity 
may be assessed. Participants may opt out of audio recording of intervention 
sessions and will still be able to participate in the intervention.   
The research assistant will routinely administer an adverse events checklist at 
each study visit, and the decision coach will monitor for adverse events during 
each intervention meeting. If an adverse event occurs during a participant’s 
participation in the study, the interventionist or research assistant will facilitate 
participants’ access to prompt medical or professional care as appropriate, 
document the event on an adverse event reporting log, and immediately submit 
documentation of the event to the IRB and NIMH as appropriate.  
 
f) Data Management  

Continuous and normally distributed variables will be summarized with 
means and standard deviations. Dichotomous variables will be 
summarized with frequencies and percentages.  
To examine within-group differences in quantitative measures pre- and 
post-intervention, we will conduct paired samples t-tests.  
Audio-recorded responses to qualitative questions about decision-making 
needs will be professionally transcribed verbatim. The research assistant 
and PI will analyze transcripts using the Constant Comparison Method. 
The parallel structure of the qualitative interview to the Decisional Conflict 
Scale will enable quantitative and qualitative data to be merged and 
reported through narrative weaving. Integration of these data will provide a 
more nuanced understanding of whether and how the intervention 
addresses decision-making needs than use of either type of data alone, 
and will be most informative for intervention refinement. Should 
quantitative and qualitative analyses yield discrepant findings, we will 
assess reasons for conflicting results (e.g., low power, question 
structure/content) and revise procedures accordingly. 
Audio-recorded responses to qualitative acceptability questions will also 
be professionally transcribed verbatim. The research assistant and PI will 
analyze transcripts using the Constant Comparison Method. As open-
ended questions do not parallel quantitative acceptability questions, 
acceptability data will be interpreted and reported contiguously.  
Steps that will be taken to secure the data are described in the Privacy 
and Confidentiality section. 
g) Withdrawal of Subjects 
Participation is voluntary and there is no penalty if an individual chooses 
not to join the research study; their services will not be affected. If an 
individual enrolls in the study and later chooses to withdraw from the 
study, they may do so at any time without any penalty to them. They can 
simply withdraw from the study by telling the research staff in person when 
they are at study sites, or by contacting research staff by telephone or 
email.  
Participants will be withdrawn from the study if they appear to be under 
the influence of alcohol or illegal drugs or are hostile to research staff. In 
such cases, they will not be paid for their time. 
12) 
Risks to Subjects 
During the research interviews and participation in the study intervention, 
topics may come up that are distressing or triggering, including diagnoses, 
symptoms, and negative treatment experiences. We will attempt to 

minimize this risk by detailing what topics will be covered before 
participants begin the interview and intervention.    
Participants may become fatigued or uncomfortable during research 
interviews. We will attempt to minimize these risks by allowing participants 
to schedule the remainder of the interview/assessment for another time, 
and by informing them that they may omit questions, or simply discontinue 
the interview/assessment, at any time. 
In the event that a participant has been harmed by the research, we will 
facilitate prompt receipt of their psychiatric or medical care. However, 
participants will be responsible for the costs of such psychiatric or medical 
treatment, directly or through medical insurance and/or other forms of 
medical coverage. Temple University and research staff will not be 
responsible for the cost of this treatment. This has been made explicit on 
the informed consent forms. 
 
13) 
Potential Benefits to Subjects 
There is no direct benefit from taking part in the research other than 
expanding knowledge that may inform policies and practices at the 
societal level. 
 
14) 
Privacy and Confidentiality 
 
PHI collected during the study is limited to participant’s self-reported contact 
information (e.g., name, address) and psychiatric diagnosis. PHI will not be 
disclosed, except as may be required by law. Any information about child abuse 
or intent to harm self or others will be reported to authorities, as required by law. 
Research staff will be the only people with access to this data, with the exception 
of authorized representatives of the Temple University or Philadelphia 
Institutional Review Board (IRB), the National Institute of Mental Health (the 
study sponsor), and the Office of Human Research Protections (OHRP).  
 
Completed interviews will contain a coded identification number to prevent loss of 
confidentiality, and any identifying information will be removed from interview 
transcripts. Confidentiality of data files will be achieved by separating code 
numbers from individual identifying information. Information taken about 
participants will only be kept electronically in encrypted, password protected files 
and hard copies will be stored in locked cabinets in a locked office.  Data sources 
containing identifiers (i.e., regulatory documents such as the eligibility screener 
and contact information form, clinical characteristic form) will always be kept 
separate from other research data in encrypted, password-protected files. 
Participant files will only be made available to personnel involved in the study 
through the use of access privileges and passwords. All published reports will 
contain data reported either in aggregate form (where no individual responses 

can be identified), or in composite individual examples that are constructed so 
that identification is impossible.  Individual examples or quotations that may be 
presented in published reports will use pseudonyms, so that participants’ identity 
will be protected. Audio recordings will be secure and confidential per the 
transcription service provider’s non-disclosure agreement and encryption 
software. Audio-recordings will be immediately deleted from the recorder after 
successful uploading to the transcription provider’s secure site. All other data 
collected from this study will be kept for 7 years after the last publication. 
 
In accordance with study sponsor guidelines, this study will be registered and de-
identified results information (including participant flow, demographic and 
baseline characteristics, outcomes and statistical analyses, adverse events, the 
protocol and statistical analysis plan, and administrative information) will be 
submitted to ClinicalTrials.gov. 
 
15) 
Economic Burden to Subjects 
There are no costs to participants associated with participation in this 
research study. 
16) 
Subject Compensation 
 
Participants will receive $20 for completing the baseline assessment and an 
additional $30 for completing the post-intervention assessment. Participants will 
be paid via electronic gift cards. Upon each payment, they will sign a receipt form 
to document that they were paid.  
 
17) 
Consent Process 
A particular issue related to our studies is that the research literature has long 
suggested that persons diagnosed with schizophrenia have cognitive 
impairments and that this is associated with impaired ability to make informed 
consent decisions.  This has led some to conclude that people with 
psychiatric impairments cannot provide informed consent and therefore 
should not participate in research.  Peer advocates have criticized this 
perspective as taking away their rights to participate in research.  Carpenter 
et al. (2000) also found evidence, however, that more exhaustive consent 
procedures could enhance ability to consent.  This educational remediation 
approach included multiple sessions where information was provided multiple 
times, questions were asked, and potential participants were prompted to 
help them fully understand the protocol.  Our consent procedures will utilize 
these methods in addition to the INVESTIGATOR GUIDANACE: Informed 
Consent (HRP-802).  
Our process for ensuring that all study participants provide fully informed 
consent will involve the following steps -- The first line of screening will be 
through contact between the research assistant or PI and the potential 

participants. The research assistant or PI will meet with potential participants 
in a private room at Temple University or at the CSC programs, or via 
telephone or videoconference. The research assistant or PI provides a brief 
overview of the study and makes an initial assessment of their ability to 
understand and recall the following issues: what participants are asked to do, 
the voluntary nature of the study, data collection procedures, and nature of 
confidentiality.  An interview is scheduled with those who are able to recall the 
information provided and demonstrate an understanding of all areas.  Those 
who have problems with the initial assessment are asked if they can be 
contacted at a later time to discuss the project.  A second assessment is 
conducted with the research assistant or PI.  This assessment will assess 
recall from the previous conversation.  Perfect recall is not expected.  Poorly 
recalled information will be targeted during the review of the informed consent 
form and study procedures.  The research assistant or PI will spend up to an 
hour with potential participants reviewing the consent forms.  All forms are 
read aloud with the potential participant and they are again asked to recall 
information about the study.  Prompts are given to facilitate recall.  If the 
potential participant is able to recall pertinent information about the study 
without prompts, they are viewed as being able to give informed consent and 
will proceed with signing the consent form. If the research assistant or PI 
obtains informed consent from participants via telephone/videoconference, 
the participant will electronically sign the consent form in RedCap. All consent 
forms will be maintained in the case file along with all identifying information 
in a locked cabinet that is kept in a secure office. 
18) 
Sharing of Results or Incidental Findings with Subjects 
After qualitative interview transcription, participants will be offered the 
opportunity to review their interview transcripts in order to ensure that 
meaning and ideas are accurately represented. Transcript copies will be 
emailed to participants via TUSafesend (a Temple University resource that 
provides a secure method for transferring files containing 
confidential information) or mailed to participants in opaque envelopes 
marked “confidential” (depending on the participant’s preference). On a 
separate page, participants will be asked to provide written feedback 
regarding whether the transcripts match their experience, and will be 
invited to make changes or additions to their statements. Participants will 
be provided with instructions for how to return comments via TUSafesend. 
Pre-paid return postage for mailed transcripts will be provided for 
participants to return comments to the researchers if they so choose. The 
contact information of the research assistant will also be provided in case 
participants have questions or prefer to offer their feedback verbally. We 
will allow two weeks for participants to return feedback before proceeding 
with further analysis. Participants will not receive additional compensation 
for providing this feedback. 
 

Statistical Analysis Plan 
 
Demographic and clinical variables will be summarized with means and standard 
deviations. Dichotomous variables will be summarized with frequencies and 
percentages. Parameter estimates will be bound by 95% confidence intervals. Analyses 
will be conducted using SPSS Version 24. Feasibility data will also be reported using 
descriptive statistics.  
Mixed Methods Analysis. Quantitative acceptability data will be reported using 
descriptive statistics. Per qualitative analysis recommendations,71 open-ended 
acceptability questions will be audio-recorded and professionally transcribed verbatim. 
The research assistant will proofread transcripts, making notes regarding participants’ 
experiences with the intervention in each interview. The research assistant and PI will 
then use notes to create an initial draft of coding categories. Then, using the Constant 
Comparison Method,72 the research assistant and PI will independently code each 
transcript and discuss differences in coding to consensus, which could involve creating 
new codes or collapsing existing ones. After refining the code list, the final coding of 
each interview will be double-checked for accuracy. Data analysis will be facilitated 
using NVivo software. Member checking will be accomplished by inviting participants to 
review and provide feedback on their interview transcripts and on the codes developed. 
Initial analysis from the first three interviews will be conducted to inform subsequent 
data collection. As open-ended questions do not parallel survey questions, acceptability 
data will be interpreted and reported contiguously.103 Findings will inform intervention 
refinement for the R01.  
To examine within-group differences in quantitative decision-making targets pre- 
and post-intervention, we will conduct a paired samples t-test using DCS Factors 
Contributing to Uncertainty subscale scores. Responses to open-ended questions about 
decision-making targets will be analyzed qualitatively using the same procedure 
described previously. The parallel structure of the qualitative interview to the DCS will 
enable quantitative and qualitative data to be merged and reported through narrative 
weaving.103 Integration of these data will provide a more nuanced understanding of 
whether and how the intervention engages decision-making targets than use of either 
type of data alone, and will be most informative for intervention refinement. Should 
quantitative and qualitative analyses yield discrepant findings, we will assess reasons 
for conflicting results (e.g., low power, question structure/content) and revise 
procedures accordingly for the R01 study.103