Psychotic Disorders
Conditions
Keywords
Decision Support Techniques, Young Adult
Brief summary
The purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (CSC). 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.
Detailed description
The overarching goal of this study is to pilot test a peer-delivered decision support intervention (in the form of decision coaching) that is designed to enhance emerging adults' treatment decision-making and service engagement after enrollment in a coordinated specialty care (CSC) program. Based on an experimental therapeutics approach, this mixed methods pilot trial will assess feasibility, acceptability, and the intervention's potential impact on key decision-making needs (i.e., decision-making targets). We will track feasibility data related to study and intervention procedures, and collect acceptability and outcome data from 20 emerging adults who will participate in the intervention after enrollment in the CSC program. Quantitative analysis related to decision-making targets will provide preliminary evidence regarding whether the intervention impacts these targets, while qualitative analysis will explain how it may do so. Merged results from these two sets of data will inform intervention refinement by providing a nuanced understanding of the intervention's potential to engage decision-making targets from the perspective of emerging adults.
Interventions
BEHAVIORALPeer-Delivered Decision Support Intervention
An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
Sponsors
National Institute of Mental Health (NIMH)
Temple University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* 18-30 years of age * 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 * Able to speak/understand English * Able to provide informed consent as assessed by research staff * Enrolled in the CSC program for any period of time
Exclusion criteria
* having a legal guardian * Diagnosis of dementia, delirium, or intellectual disability as determined by the admitting CSC program psychiatrist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decisional Conflict Scale | Baseline, through intervention completion (up to 3 months) | Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Total scores on the Decisional Conflict Scale are calculated as: (sum of all items scores / the total number of items) x 25. For this study, 9 items were included. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peer-Delivered Decision Support Intervention Peer-Delivered Decision Support Intervention: An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Peer-Delivered Decision Support Intervention |
|---|---|
| Age, Continuous | 22.42 years STANDARD_DEVIATION 2.47 |
| Decisional Conflict Scale | 26.39 units on a scale STANDARD_DEVIATION 7.55 |
| Race/Ethnicity, Customized African American | 6 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Change in Decisional Conflict Scale
Change was calculated as the Decisional Conflict Scale value at intervention completion minus the value at baseline. Total scores on the Decisional Conflict Scale are calculated as: (sum of all items scores / the total number of items) x 25. For this study, 9 items were included. Scores on the Decisional Conflict Scale range from 0-100, with higher scores indicating a worse outcome.
Time frame: Baseline, through intervention completion (up to 3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer-Delivered Decision Support Intervention | Change in Decisional Conflict Scale | 0.55 score on a scale | Standard Deviation 18.68 |
p-value: 0.95t-test, 2 sided