Clinical trial NCT06594029: Community Navigators
Official title: Community Participation Navigators: Testing a Peer Intervention for Adults With Serious Mental Illnesses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Loneliness
Social Isolation
Mental Health Issue
Keywords: peer support
community participation
Serious Mental Illness
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-09-19
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

1. meet the criteria for an SMI diagnosis of schizophrenia, schizoaffective, bipolar, or major depression diagnosis based on the MINI,
2. are over the age of 18-years-old
3. 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.
4. have a permanent residence without constraints on participation (free to come and go from residence without restrictions) 2
5. have the ability to provide informed consent.

Exclusion Criteria:

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

Primary outcomes:
measure: Temple University Community Participation Scale (TUCP):
timeFrame: baseline, and post-treatment after 6 months
measure: WHO Disability Assessment Schedule
timeFrame: baseline, and post-treatment after 6 months
Secondary outcomes:
measure: Clinical Assessment Interview for Negative Symptoms
timeFrame: baseline, and post-treatment after 6 months
measure: Assessment Opportunity
timeFrame: baseline, and post-treatment after 6 months
measure: The Social Embeddedness Scale
timeFrame: baseline, and post-treatment after 6 months
measure: Interpersonal Mattering Scale (Moschella & Baynard, 2021; Elliott et al., 2004):
timeFrame: baseline, and post-treatment after 6 months
measure: 3-Item UCLA Loneliness Scale (Hughes, Waite, Hawkley, & Cacioppo, 2004)
timeFrame: baseline, and post-treatment after 6 months
measure: Lehman Quality of Life Interview (QLI)
timeFrame: baseline, and post-treatment after 6 months
measure: Recovery Assessment Scale (RAS-20):
timeFrame: baseline, and post-treatment after 6 months
measure: The MOS Social Support survey
timeFrame: baseline, and post-treatment after 6 months
Other outcomes:
Locations:
Study officials:
References: