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LonelinessNavigatorsNCT06594029

Community Navigators

A study testing Community Navigator Intervention in people with Loneliness and Social Isolation, run by Temple University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The Temple University Collaborative on Community Inclusion (TU Collaborative) is testing a community navigation intervention study based upon effective health navigation models by conducting a randomized controlled trial of the intervention to establish feasibility, efficacy, and outcomes among adults with serious… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Loneliness, Social Isolation, Mental Health Issue
What is being tested?
Community Navigator Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
No sites listed yet
Study dates
Sep 2024to Jun 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

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 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • meet the criteria for an SMI diagnosis of schizophrenia, schizoaffective, bipolar, or major depression diagnosis based on the MINI,
  • are over the age of 18-years-old
  • are fluent in English: As current intervention materials and research and intervention personnel are only fluent in English, only participants who can communicate in written and spoken English are eligible for enrollment.
  • have a permanent residence without constraints on participation (free to come and go from residence without restrictions) 2
  • have the ability to provide informed consent.

Who cannot join

  • inability to provide consent (legal guardian)
  • unable to speak and understand English

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Bryan Mccormick, PhD contact

215-204-6817

bryan.mccormick@temple.edu

Tabea Neumann, M.Sc. contact

tabea.neumann@temple.edu

About this study

Official title: Community Participation Navigators: Testing a Peer Intervention for Adults With Serious Mental Illnesses

The Temple University Collaborative on Community Inclusion (TU Collaborative) is testing a community navigation intervention study based upon effective health navigation models by conducting a randomized controlled trial of the intervention to establish feasibility, efficacy, and outcomes among adults with serious mental illness (SMI).

Read the detailed description

The study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to support and enhance community participation for adults with serious mental illness (SMI) receiving community mental health services. The intervention is based on two evidence-based strategies. The first is the patient navigation interventions, which are used to assist people with SMI to identify and overcome barriers to accessing care. The second is the Capability, Opportunity, Motivation model of behavior change (COM-B model) which evaluates how each of these factors influences behavior. Participants will be assigned to one of two groups, the Community Navigator condition, or a control group. Those in the intervention arm will develop a community support plan with a peer support specialist community navigator and those in the control arm will receive printed information on the importance, skills, and opportunities for participation. Over the course of the 6-month intervention, participants in the intervention arm, with support from the peer support specialist will develop an initial participation plan, and through weekly meetings online or in-person will monitor their progress and make changes as needed. Recruitment will occur only in Philadelphia in collaboration with residential treatment service providers including: Merakey, Horizon House, COMHAR, Inc, and potential others. Data collection for all participants will take occur at baseline and at the end of the 6-month intervention. We aim to recruit and enroll 96 participants for a 16-month period in a randomized control trial of a community navigation intervention. Participants will be randomly assigned to either the intervention or an informational control group. The intervention group will meet with a peer support specialist once a week for 60-90 minutes. Enrollment will occur over 16 months, with 6 participants joining each month from behavioral health residential service sites. Each participant will have two meetings with a research assistant - an intake interview and an exit interview after 6 months. The primary analyses are expected months after the study initiation.

The aim of the research study is to determine the efficacy of a peer-support intervention to navigate community opportunities and resource to increase participation among adults with SMI and to determine if participation in the intervention increases social connections and decreases loneliness. The existing navigation approaches in health care have employed peer-delivered services and demonstrated significant effects. The program theory of this intervention is based on existing models of peer-delivered health navigation approaches.

Being tested
Community Navigator Intervention, Control Group
Keywords
peer support, community participation, Serious Mental Illness
Medical subject headings
Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community Navigator InterventionBehavioural

    see previous section

  • Control GroupOther

    Participants receive information on how to increase their community participation

Study groups in NCT06594029
Study groupRoleWhat they receive
Community Navigator InterventionExperimentalWeekly meetings between participant and a peer specialist. The peer specialist will help participants identify participation interests, set participation goals, and to achieve those goals while increasing confidence and competence in community participation. Initially, participants will develop a plan for community participation which includes a list of meaningful activities, identifying potential barriers and facilitators to participation. At each weekly meeting, the peer specialist will work with participants to determine what aspects of the plan are working and modify it based on any newly identified barriers, opportunities, or changes to the participants' interests or motivation. The sessions are designed to meet the participants where they are on their journey towards participating in the community. Each successive session will encourage growth and independence through peer support that is tailored to each participant's particular needs and ability.
Receives: Behavioral: Community Navigator Intervention
Active control groupActive comparatorReceive information on community participation for adults with your health condition
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temple University Community Participation Scale (TUCP):

    self-reports of community participation in 22 different areas including going to a supermarket, participating in a community social group (like a book club or recreational sports team), going to a movie, or working for pay. Participants are asked to indicate the number of days in the past 30 days that they participated in each of the 22 areas, whether each participation area was important to them, and whether they felt they participated in each area enough, not enough, or too much. Recent research has found the measure to be reliable and valid. An updated version of this measure is included which adds questions related to relationships with intimate partners and children and digital participation.

    Measured: baseline, and post-treatment after 6 months

  2. WHO Disability Assessment Schedule

    measures each person's capability to participate. It assesses abilities in the areas of cognition, mobility, self-care, life activities, and participation. It contains 15-items.

    Measured: baseline, and post-treatment after 6 months

Secondary outcomes (8)

  1. Clinical Assessment Interview for Negative Symptoms

    assesses motivation and pleasure. It is a 13-item interview that asks questions about motivation for relationships, school and work, and recreation activities. It also measures the frequency of pleasurable social activities, school and work activities, and recreation activities.

    Measured: baseline, and post-treatment after 6 months

  2. Assessment Opportunity

    will be done through a series of 12 questions that focus on both social and structural opportunities for participation. Social opportunities refer to having someone to go with and structural opportunities are related to environmental factors such as transportation, time, and resources.

    Measured: baseline, and post-treatment after 6 months

  3. The Social Embeddedness Scale

    subscale of the social network questionnaire (Shaw et al., 2007) that is used to identify degrees of social contact. It contains six items focused on social contact (e.g., visits, conversations) with friends and family in the previous two weeks.

    Measured: baseline, and post-treatment after 6 months

  4. Interpersonal Mattering Scale (Moschella & Baynard, 2021; Elliott et al., 2004):

    This 12-item scale examines three dimensions of mattering, including awareness ( α=.87), importance (α =.89), and reliance (α =.86).

    Measured: baseline, and post-treatment after 6 months

  5. 3-Item UCLA Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2004)

    This brief measure of loneliness has shown satisfactory reliability and validity in the measurement of overall loneliness.

    Measured: baseline, and post-treatment after 6 months

  6. Lehman Quality of Life Interview (QLI)

    assesses the overall quality of life of people with mental illness through an interview. There are 11 items that across three domains: community inclusion, holistic health and functioning, and human and legal rights. The statement "[If homeless or in jail, the place where you typically sleep at night?]" will be removed from Q5 the questionnaire as it is not relevant to our study participants.

    Measured: baseline, and post-treatment after 6 months

  7. Recovery Assessment Scale (RAS-20):

    assesses self-determination and hope as it relates to recovery. It is frequently used as an outcome measure for program evaluations. It is a 20-item self-report measure. Items are scored on a 5-point Likert scale and range from strongly agree to strongly disagree

    Measured: baseline, and post-treatment after 6 months

  8. The MOS Social Support survey

    A 19-item measure with 4 support scales (Emotional/Informational, Tangible, Affectionate, and Positive Social Interaction) and an overall functional social support index that has been shown to have good reliability and validity.

    Measured: baseline, and post-treatment after 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionJun 2032 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06594029
Sponsor's protocol ID
90IFRE0061
Other IDs
31035
Acronym
Navigators
Status last verified
Jul 2024
First submitted
14 Jul 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All participants in the study will be required to complete informed consent forms which will include a clause about data preservation and sharing. Subjects will be assured that their identity will be protected and that no personally identifiable information (PII) will be disclosed as part of any data sharing. All data will be stored on Temple University's password protected, HIPAA-approved secure data server. However, because not all investigators who will need access to the data are at Temple, deidentified, anonymized data may be shared with other investigators via a secure file transfer system. All data in the study transferred between Temple University and collaborating institutions will be transferred through TUSafeSend using data encryption by way of a secure socket transfer protocol. TUSafeSend provides a secure method for transferring files containing confidential or other sensitive information, including HIPAA authorized data with PHI or PII.

Questions about this trial

What is this clinical trial studying?

A study testing Community Navigator Intervention in people with Loneliness and Social Isolation, run by Temple University.

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: opening soon, as of the sponsor's last update on 19 Sep 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bryan Mccormick, PhD (215-204-6817, bryan.mccormick@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temple University Community Participation Scale (TUCP): (time frame: baseline, and post-treatment after 6 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?

On the ClinicalTrials.gov record for NCT06594029.

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 19 Sep 2024.

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