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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
see previous section
Participants receive information on how to increase their community participation
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 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.
Time frame: baseline, and post-treatment after 6 months
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 months
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 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 months
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 months
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.
Time frame: baseline, and post-treatment after 6 months
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.
Time frame: baseline, and post-treatment after 6 months
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
Time frame: baseline, and post-treatment after 6 months
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.
Time frame: baseline, and post-treatment after 6 months