Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594029
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Community Navigators
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Community Participation Navigators Testing a Peer Intervention for Adults With Serious Mental Illnesses
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Navigators
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None