Community Navigators
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorTemple University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
inability to provide consent (legal guardian)
unable to speak and understand English
Trial design
Design model
Parallel
Treatments tested in this trial
Community Navigator Intervention
Behavioralsee previous section
Control Group
Other interventionParticipants receive information on how to increase their community participation
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Community Navigator InterventionExperimental treatment 1 intervention
Group B: Active control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
baseline, and post-treatment after 6 months2
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.
Time frame
baseline, and post-treatment after 6 monthsSecondary outcomes
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.
Time frame
baseline, and post-treatment after 6 months2
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.
Time frame
baseline, and post-treatment after 6 months3
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.
Time frame
baseline, and post-treatment after 6 months4
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).
Time frame
baseline, and post-treatment after 6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Temple University
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: