Psychotic DisordersNCT04532034
Facilitating Engagement in Evidence-Based Treatment for Early Psychosis
A study testing Peer-Delivered Decision Support Intervention in people with Psychotic Disorders, run by Temple University at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Peer-Delivered Decision Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2020to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- having a legal guardian
- Diagnosis of dementia, delirium, or intellectual disability as determined by the admitting CSC program psychiatrist
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Child and Family Focus (On My Way Program)
Broomall, Pennsylvania, 19008
CMSU Behavioral Health & Developmental Services
Danville, Pennsylvania, 17821
Horizon House
Philadelphia, Pennsylvania, 19150
About this study
Official title: Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support
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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- Peer-Delivered Decision Support Intervention
- Keywords
- Decision Support Techniques, Young Adult
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Delivered Decision Support InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Delivered Decision Support Intervention | Experimental | Not described Receives: Behavioral: Peer-Delivered Decision Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, through intervention completion (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Thomas, Ph.D., Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532034
- Sponsor's protocol ID
- 261047
- Other IDs
- K08MH116101
- Status last verified
- Mar 2024
- First submitted
- 21 Jul 2020
- Last updated
- 17 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas EC, Lucksted A, Siminoff LA, Hurford I, O'Connell M, Penn DL, Casey I, Smith M, Suarez J, Salzer MS. Case Study Analysis of a Decision Coaching Intervention for Young Adults with Early Psychosis. Community Ment Health J. 2025 Jul;61(5):874-889. doi: 10.1007/s10597-024-01425-w. Epub 2025 Jan 3.
PubMed 39746883Thomas EC, Suarez J, Lucksted A, Siminoff LA, Hurford I, Dixon LB, O'Connell M, Penn DL, Salzer MS. Facilitating treatment engagement for early psychosis through peer-delivered decision support: intervention development and protocol for pilot evaluation. Pilot Feasibility Stud. 2021 Oct 24;7(1):189. doi: 10.1186/s40814-021-00927-8.
PubMed 34689830
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Emerging Adults Engagement in Evidenced-Based Treatment for Early Psychosis Through Peer-Delivered Decision Support
- ClinicalTrials.gov ID
- NCT04532034
- Acronym / sponsor ID
- 261047
- Conditions
- Psychotic Disorders
- Keywords
- Decision Support Techniques, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer-Delivered Decision Support Intervention | Experimental | Behavioral: Peer-Delivered Decision Support Intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- having a legal guardian
- Diagnosis of dementia, delirium, or intellectual disability as determined by the admitting CSC program psychiatrist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Delivered Decision Support InterventionAn 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. | Behavioural | Peer-Delivered Decision Support Intervention |
Primary outcome
Change in Decisional Conflict Scale
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39746883Thomas EC, Lucksted A, Siminoff LA, Hurford I, O'Connell M, Penn DL, Casey I, Smith M, Suarez J, Salzer MS. Case Study Analysis of a Decision Coaching Intervention for Young Adults with Early Psychosis. Community Ment Health J. 2025 Jul;61(5):874-889. doi: 10.1007/s10597-024-01425-w. Epub 2025 Jan 3.
- Derived from this study: PubMed 34689830Thomas EC, Suarez J, Lucksted A, Siminoff LA, Hurford I, Dixon LB, O'Connell M, Penn DL, Salzer MS. Facilitating treatment engagement for early psychosis through peer-delivered decision support: intervention development and protocol for pilot evaluation. Pilot Feasibility Stud. 2021 Oct 24;7(1):189. doi: 10.1186/s40814-021-00927-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Thomas, Ph.D. principal investigator
Temple University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Delivered Decision Support Intervention in people with Psychotic Disorders, run by Temple University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Decisional Conflict Scale (time frame: Baseline, through intervention completion (up to 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532034, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.