First Episode Psychosis (FEP)NCT04018521
Use of Parent Connectors in First Episode Psychosis (FEP)
A study testing PPN in people with First Episode Psychosis (FEP), run by NYU Langone Health.
Trial summary
This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- First Episode Psychosis (FEP)
- What is being tested?
- PPN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 23 Feb 2022
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Who cannot join
- NA
About this study
This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. This PPN model will be used to enhance the delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). This research project has potential to add value to the CSC model through the inclusion of a feasible, low burden intervention that may improve family participation in services and Y/YA outcomes. Using random assignment, this study will examine the feasibility and preliminary impact of an accelerator strategy-the inclusion of peer parent navigators or PPNs-in CSC teams.
- Conditions
- First Episode Psychosis (FEP)
- Being tested
- PPN, CSC Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPNBehavioural
Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).
CSC Usual CareBehavioural
standard of care provided to youth following first episode of psychosis
| Study group | Role | What they receive |
|---|---|---|
| Parent Connectors | Active comparator | trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services Receives: Behavioral: PPN; Behavioral: CSC Usual Care |
| Usual Care | Active comparator | Coordinated Specialty Care (CSC) Receives: Behavioral: CSC Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Empowerment Scale (FES)
A 34 item self reported instrument designed to measure empowerment status. The scale measures levels of empowerment, such as family, service system and community, and is rated on a likert scale, scale, ranging from1 (not true at all) to 5 (very true). The FES produces scores for three subscales based on level of empowerment:Family (12 items), Service system (12 items), and Community/ Political (10 items).
Measured: 9 Months
Patient Activation Measure (PAM)
100-point quantifiable scale determining patient engagement in healthcare
Measured: 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Aug 2021 (estimated)
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Why it stopped: inventional part of the study is registered under NCT05195489
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode Psychosis (FEP)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018521
- Sponsor's protocol ID
- 19-00702
- Other IDs
- 18-A1-00-007376
- Status last verified
- Mar 2022
- First submitted
- 9 Jul 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Parent Connectors in First Episode Psychosis (FEP)
- ClinicalTrials.gov ID
- NCT04018521
- Acronym / sponsor ID
- 19-00702
- Conditions
- First Episode Psychosis (FEP)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inventional part of the study is registered under NCT05195489
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 12 Jul 2019 (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.
This study proposes to adapt an evidence based peer parent navigator (PPN) intervention, called Parent Connectors, in which trained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newly enrolled youth or young adults (Y/YA) in FEP services. This PPN model will be used to enhance the delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). This research project has potential to add value to the CSC model through the inclusion of a feasible, low burden intervention that may improve family participation in services and Y/YA outcomes. Using random assignment, this study will examine the feasibility and preliminary impact of an accelerator strategy-the inclusion of peer parent navigators or PPNs-in CSC teams.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Connectors | Active comparator | Behavioral: PPN, Behavioral: CSC Usual Caretrained and supervised PPNs deliver weekly telephone-based support for six to nine months to parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services |
| Usual Care | Active comparator | Behavioral: CSC Usual CareCoordinated Specialty Care (CSC) |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents or caregivers of all newlyenrolled youth or young adults (Y/YA) in FEP services
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| PPNDelivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY). | Behavioural | Parent Connectors |
| CSC Usual Carestandard of care provided to youth following first episode of psychosis | Behavioural | Parent Connectors, Usual Care |
Primary outcome
Family Empowerment Scale (FES)
Time frame: 9 Months
A 34 item self reported instrument designed to measure empowerment status. The scale measures levels of empowerment, such as family, service system and community, and is rated on a likert scale, scale, ranging from1 (not true at all) to 5 (very true). The FES produces scores for three subscales based on level of empowerment:Family (12 items), Service system (12 items), and Community/ Political (10 items).
Patient Activation Measure (PAM)
Time frame: 9 Months
100-point quantifiable scale determining patient engagement in healthcare
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PPN in people with First Episode Psychosis (FEP), run by NYU Langone Health.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Family Empowerment Scale (FES) (time frame: 9 Months). The study lists 2 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 4 Apr 2022.