Severe Mental DisorderNCT06492434
Enhancing Community Participation Through Peer-Delivered Decision Support
A study testing Peer decision coaching in people with Severe Mental Disorder, run by Temple University at 2 sites in United States.
Trial summary
The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI). Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Severe Mental Disorder
- What is being tested?
- Peer decision coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 a SMI, as determined by: (a) self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder, and (b) self-reported current or past functional impairment due to experiencing mental health challenges in one or more major life areas (i.e., work school, social activities)
- Able to identify at least 2 areas of community participation that individuals want to be doing more in in the next 6 months
- Current sufficiency of community participation (i.e., number of important participation areas done enough / number of important participation areas) of 50% or less.
Who cannot join
- Unable to provide informed consent, as assessed by research staff using an active recall method
- limited ability to act on decisions due to self-reported legal, residential, or guardianship restrictions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Copeland Center for Wellness and Recovery
Brattleboro, Vermont, 05302
Temple University
Philadelphia, Pennsylvania, 19122
About this study
Official title: Enhancing Community Participation Outcomes Among Young Adults With Serious Mental Illnesses Through Peer-Delivered Decision Support
The purpose of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).
Read the detailed description
The overarching goal of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illnesses (SMI). We will use a single-group, pre-post, convergent mixed methods design to explore implementation and whether and how the intervention impacts decision-making and community participation outcomes. We will aim to recruit 40 participants in this intervention study. This design will enable us to link themes regarding participants' experience of the intervention with quantitative measures of decision-making and community participation.
- Conditions
- Severe Mental Disorder
- Being tested
- Peer decision coaching
- Keywords
- Peer specialists, Decision Support Techniques, Young Adult
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer decision coachingBehavioural
Peer Decision Coaching is a brief, personalized intervention grounded in evidence-based decision- and peer support principles. During the intervention, a trained peer specialist supports the young person in identifying a decision related to community participation that they need to make, such as whether to work or go to school, helping them address decision-making needs, and assisting them with developing and implementing a decision-making plan. Ultimately, the intervention aims to support young people in pursuing their community participation interests and goals.
| Study group | Role | What they receive |
|---|---|---|
| Peer decision coaching arm | Experimental | All participants will engage in the Peer Decision Coaching intervention. Receives: Behavioral: Peer decision coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decisional conflict scale
The Factors Contributing to Uncertainty subscale of the Decisional Conflict Scale measures decision-making needs. Possible scores range from 0 to 36, with higher scores indicating a worse outcome.
Measured: Baseline, through intervention completion (up to 3 months)
Change in decision self-efficacy scale
The Decision Self-Efficacy Scale assesses confidence in making an informed choice. Possible scores range from 0 to 44, with higher scores indicating a better outcome.
Measured: Baseline, through intervention completion (up to 3 months)
Decision-making behaviors at post-intervention
Number of behaviors (range: 0-6) endorsed on Decision-Making Behaviors scale at post-intervention.
Measured: Post-intervention (up to 3 months post-baseline)
Decision Satisfaction Scale Score at post-intervention
The Decision Satisfaction Scale assesses a person's satisfaction with a health decision. Possible scores range from 6-30, with higher scores indicating a better outcome.
Measured: Post-intervention (up to 3 months post-baseline)
Change in Temple University Community Participation Measure (sufficiency)
Sufficiency scores on the Temple University Community Participation Measure assess how satisfied individuals are with their amount of community participation in areas that are important to them. Possible scores range from 0-100, with higher scores indicating a better outcome.
Measured: Baseline, through intervention completion (up to 3 months)
Change in Temple University Community Participation Measure (breadth ratio)
Breadth ratio scores on the Temple University Participation Measure assess breadth of participation in areas considered important to a person. Possible scores range from 0-100, with higher scores indicating a better 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 posted9 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- Elizabeth Thomas, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492434
- Sponsor's protocol ID
- 270034
- Other IDs
- 90IFRE0068
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Community Participation Outcomes Among Young Adults With Serious Mental Illnesses Through Peer-Delivered Decision Support
- ClinicalTrials.gov ID
- NCT06492434
- Acronym / sponsor ID
- 270034
- Conditions
- Severe Mental Disorder
- Keywords
- Peer specialists, Decision Support Techniques, Young Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
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 study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illness (SMI).
Detailed description
The overarching goal of this study is to pilot test a peer-delivered decision support intervention ("peer decision coaching") designed to enhance decision-making about community participation among young adults with serious mental illnesses (SMI). We will use a single-group, pre-post, convergent mixed methods design to explore implementation and whether and how the intervention impacts decision-making and community participation outcomes. We will aim to recruit 40 participants in this intervention study. This design will enable us to link themes regarding participants' experience of the intervention with quantitative measures of decision-making and community participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer decision coaching arm | Experimental | Behavioral: Peer decision coachingAll participants will engage in the Peer Decision Coaching intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years of age;
- Experiencing a SMI, as determined by: (a) self-reported psychiatric diagnosis of schizophrenia-spectrum or major affective disorder, and (b) self-reported current or past functional impairment due to experiencing mental health challenges in one or more major life areas (i.e., work school, social activities)
- Able to identify at least 2 areas of community participation that individuals want to be doing more in in the next 6 months
- Current sufficiency of community participation (i.e., number of important participation areas done enough / number of important participation areas) of 50% or less.
Key exclusion criteria (2 listed)
- Unable to provide informed consent, as assessed by research staff using an active recall method
- limited ability to act on decisions due to self-reported legal, residential, or guardianship restrictions.
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 decision coachingPeer Decision Coaching is a brief, personalized intervention grounded in evidence-based decision- and peer support principles. During the intervention, a trained peer specialist supports the young person in identifying a decision related to community participation that they need to make, such as whether to work or go to school, helping them address decision-making needs, and assisting them with developing and implementing a decision-making plan. Ultimately, the intervention aims to support young people in pursuing their community participation interests and goals. | Behavioural | Peer decision coaching arm |
Primary outcome
Change in decisional conflict scale
Time frame: Baseline, through intervention completion (up to 3 months)
The Factors Contributing to Uncertainty subscale of the Decisional Conflict Scale measures decision-making needs. Possible scores range from 0 to 36, with higher scores indicating a worse outcome.
Change in decision self-efficacy scale
Time frame: Baseline, through intervention completion (up to 3 months)
The Decision Self-Efficacy Scale assesses confidence in making an informed choice. Possible scores range from 0 to 44, with higher scores indicating a better outcome.
Decision-making behaviors at post-intervention
Time frame: Post-intervention (up to 3 months post-baseline)
Number of behaviors (range: 0-6) endorsed on Decision-Making Behaviors scale at post-intervention.
Decision Satisfaction Scale Score at post-intervention
Time frame: Post-intervention (up to 3 months post-baseline)
The Decision Satisfaction Scale assesses a person's satisfaction with a health decision. Possible scores range from 6-30, with higher scores indicating a better outcome.
Change in Temple University Community Participation Measure (sufficiency)
Time frame: Baseline, through intervention completion (up to 3 months)
Sufficiency scores on the Temple University Community Participation Measure assess how satisfied individuals are with their amount of community participation in areas that are important to them. Possible scores range from 0-100, with higher scores indicating a better outcome.
Change in Temple University Community Participation Measure (breadth ratio)
Time frame: Baseline, through intervention completion (up to 3 months)
Breadth ratio scores on the Temple University Participation Measure assess breadth of participation in areas considered important to a person. Possible scores range from 0-100, with higher scores indicating a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
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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, PhD principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer decision coaching in people with Severe Mental Disorder, run by Temple University at 2 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 4 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.