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NCT Number: NCT06594029

Community Navigators

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).

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Community Navigator Intervention

Behavioral

see previous section

Control Group

Other

Participants receive information on how to increase their community participation

Primary outcomes

  1. Temple University Community Participation Scale (TUCP):

    Time frame: baseline, and post-treatment after 6 months

    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.

  2. WHO Disability Assessment Schedule

    Time frame: baseline, and post-treatment after 6 months

    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.

Secondary outcomes

  1. Clinical Assessment Interview for Negative Symptoms

    Time frame: baseline, and post-treatment after 6 months

    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.

  2. Assessment Opportunity

    Time frame: baseline, and post-treatment after 6 months

    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.

  3. The Social Embeddedness Scale

    Time frame: baseline, and post-treatment after 6 months

    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.

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

    Time frame: baseline, and post-treatment after 6 months

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

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

    Time frame: baseline, and post-treatment after 6 months

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

  6. Lehman Quality of Life Interview (QLI)

    Time frame: baseline, and post-treatment after 6 months

    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.

  7. Recovery Assessment Scale (RAS-20):

    Time frame: baseline, and post-treatment after 6 months

    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

  8. The MOS Social Support survey

    Time frame: baseline, and post-treatment after 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bryan Mccormick, PhD

CONTACT

[email protected]

215-204-6817

Tabea Neumann, M.Sc.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Temple University

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Acronym: Navigators

Important dates

Study start
2024
Primary completion
2025
Study completion
2032
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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