Community Navigators

NCT06594029 | Not Yet Recruiting

• 2 other identifiers: 90IFRE006131035
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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 mental illness (SMI).

Conditions

Loneliness; Social Isolation; Mental Health Issue

Keywords

peer support; community participation; Serious Mental Illness

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, and post-treatment after 6 months

• 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.

  baseline, and post-treatment after 6 months

Secondary Outcomes (8)

• Clinical Assessment Interview for Negative Symptoms

  baseline, and post-treatment after 6 months

• Assessment Opportunity

  baseline, and post-treatment after 6 months

• The Social Embeddedness Scale

  baseline, and post-treatment after 6 months

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

  baseline, and post-treatment after 6 months

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

  baseline, and post-treatment after 6 months

Study Arms (2)

Community Navigator Intervention

EXPERIMENTAL

Weekly 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.

Behavioral: Community Navigator Intervention

Active control group

ACTIVE COMPARATOR

Receive information on community participation for adults with your health condition

Other: Control Group

Interventions

Community Navigator Intervention BEHAVIORAL

see previous section

Community Navigator Intervention

Control Group OTHER

Participants receive information on how to increase their community participation

Active control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Temple University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

MeSH Terms

Conditions

Social Isolation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Bryan Mccormick, PhD

CONTACT

215-204-6817; bryan.mccormick@temple.edu

Tabea Neumann, M.Sc.

CONTACT

tabea.neumann@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data analyst, research assistant conducting research interviews at baseline and post-treatment will be blind to participant allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): June 1, 2032
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share