Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510439
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Need to be Needed N2BN Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Trial of Need to be Needed N2BN Intervention to Improve Social Connection Reduce Social Isolation and Loneliness
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:
N2BN RCT
Brief Summary:
The proposed study is a randomized controlled trial RCT that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness SMI The intervention will focus on improving their sense of mattering by using acts of kindness and experiencing gratitude through volunteering 120 participants will be randomly assigned to the intervention group or the attention control group Over the course of the 12-month intervention participants in the intervention arm will receive weekly support from the interventionist The interventionist and the participant will collaboratively set goals and develop an initial intervention plan which is informed by the participants interests values and goals The attention control group will receive non-directive listening support through research assistants
Data collection for all participants will occur at baseline at the mid-point of the intervention at 6 months and at the end of the 12-month intervention Participants will be asked questions about quality of experience social context and satisfaction mattering components kindness gratitude and loneliness We will gather data on demographic background life transitions social network characteristics internalized stigma neighborhood climate depression and trait measures of mattering and loneliness during intake and exit interviews Additionally participants of the intervention arm will be asked to provide feedback about the intervention
Data collection for all participants will occur at baseline at the mid-point of the intervention at 6 months and at the end of the 12-month intervention Participants will be asked questions about quality of experience social context and satisfaction mattering components kindness gratitude and loneliness We will gather data on demographic background life transitions social network characteristics internalized stigma neighborhood climate depression and trait measures of mattering and loneliness during intake and exit interviews Additionally participants of the intervention arm will be asked to provide feedback about the intervention
Detailed Description:
The proposed study is a randomized controlled trial RCT that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness SMI receiving community mental health services Specifically the intervention will focus on improving their sense of mattering by using acts of kindness and experiencing gratitude through volunteering
This intervention is based on evidence-based models and takes a different approach than many loneliness and social connectedness interventions Using the CIVIC Framework and Mattering Wheel as a foundation this intervention has the potential to develop relationships of equality and reciprocity that extend beyond the intervention period This intervention also draws upon our own intervention research which utilized the Individualized Placement and Support model in a supported leisure intervention
Participants will be randomly assigned to the intervention group or the attention control group Those in the intervention arm receive weekly support of an interventionist leading the intervention which is based on the aforementioned frameworks and informed by the idiosyncratic experiences and values of the participant The control group will receive weekly non-directive listening support through research assistants and printed information on the importance skills and opportunities for participation
Over the course of the 12-month intervention participants in the intervention arm will receive weekly support from the interventionist The interventionist and the participant will collaboratively set goals and develop an initial intervention plan which is informed by the participants interests values and goals Participants will receive support through weekly meetings through the interventionist who will monitor their progress assist with problem solving and facilitates changes as needed The attention control group will receive weekly non-directive listening support through research assistants
Recruitment will occur only in Philadelphia in collaboration with outpatient treatment service providers Data collection for all participants will take occur at baseline at the mid-point of the intervention at 6 months and at the end of the 12-month intervention
The overall objective of the current study is to evaluate the outcomes associated with the Need to be Needed intervention This project aims to address the following research questions
RQ1a Is participation in the intervention associated with reductions in loneliness RQ1b Is participation in the intervention associated with reductions in social isolation RQ2 Are improvements in intervention targets mattering kindness gratitude predictive of social isolation and loneliness outcomes RQ3 Is the intervention acceptable to individuals with SMI RQ4 Is the implementation of this intervention feasible
Group Assignment
Once participants have completed the informed consent process and baseline data collection they will immediately be randomly assigned either the intervention or control group Randomization will be done in blocks of ten by assigned participant number ie 1 to 120 to prevent runs and enhance the probability of creating comparable groups
N2BN Intervention
The proposed Need to be Needed N2BN intervention is a 12-month supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention At the beginning of the intervention the interventionist will work with the participant to explore interests and identify opportunities for volunteering The exploration of interests and interest-based opportunities supports the participants autonomy and maximizes the benefits of volunteering Part of this exploration includes the identification of welcoming places using the tools developed by the Temple University Collaborative on Community Inclusion Welcoming places will then be explored to determine whether there are opportunities for volunteering within those locations Encouraging participants to volunteer in places where they already feel welcome may more rapidly facilitate engagement in volunteering and enhanced social connectedness
The chosen volunteer location must provide opportunity for consistent and sustained participation Participants will be encouraged and assisted by interventionist to identify a volunteer opportunity that would allow for at least weekly engagement Once a location is identified the interventionist will work with the participant to identify the necessary skills for volunteering in that role Consistent with the IPS model these skills will be practiced and refined while volunteering at the chosen site Each week the interventionist will meet with the participant to discuss the activities done while volunteering and how those activities contributed to the overall success of the program Additionally the interventionist will facilitate discussions about the people at the volunteer site and explore opportunities for relationship development
Because kindness and gratitude contribute to increases in social connectedness we will include opportunities to engage in and document acts of kindness and feelings of gratitude Throughout the first half of the intervention the participant will be encouraged to identify acts of kindness he or she engages in at the volunteer location This could include the volunteer activity alone or may include random acts of kindness that the participant initiates eg helping beyond the volunteer time offering to help another volunteer with something bringing someone a coffee just because among others
Participants will then be encouraged to expand these acts of kindness to their broader community This will start with opportunities to engage in random acts of kindness within ones welcoming places and then move to other community locations and relationships Participants will be encouraged to practice kindness within the four areas Ie community commitments relationships and self of the mattering wheel This provides an opportunity for participants to add value to multiple life domains
In the last half of the intervention participants will be introduced to the concept of gratitude and engaging in intentional expressions of gratitude Many interventions use writing as a strategy to document and express gratitude This includes letter writing journaling and writing social media posts Similarly this intervention will encourage participants to create a gratitude journal and also encourage participants to express their gratitude to others- via writing or other means of communication Participants will be encouraged to focus their journaling on gratitude related to individuals with whom they have either developed relationships or interacted with during the course of the intervention Similarly participants will be encouraged to document and express gratitude within the four areas Ie community commitments relationships and self of the mattering wheel This process allows participants to explore and document the value gained Additionally the participant and interventionist will discuss how the feelings of gratitude may lead to additional acts of kindness or ways to give back to the relationship
Throughout the intervention the interventionist will work closely with the participant to develop an individualized supports plan This may include developing a visual calendar to support engagement in the volunteer activities identifying natural supports to encourage ongoing participation or scheduling opportunities for touring the volunteer location prior to volunteering among others Many of these strategies were developed and used by our team when implementing a supported leisure intervention Additionally the interventionist will talk with the participant weekly about potential social connections and navigate strategies to nurture those potential relationships
Intervention frequency intensity and duration Interventionists will meet with participants initially to discuss supported volunteering concepts and develop an initial plan It is anticipated that this initial contact will require 2-3 hours of time and may occur in more than a single meeting This plan will be flexible as it is likely that participants will need multiple opportunities to identify and explore options for voluntarism Once the initial plan is developed the interventionist will make weekly contact either in person or via telephonevideoconference to support participants in achieving goals These weekly contacts 3x per month are expected to be brief 30-40 minutes and focused on information sharing and supported problem solving Interventionists will also schedule monthly plan reviews 1x per month with participants to review and revise supported volunteering individualized plans Both clients who are achieving goals as well as those falling short of their goals may want to revise or change their plan Over the course of the 12-month intervention it is projected that interventionists will engage with participants numerous times possibly up to 40-45 hours of contact Based on the planned enrollment of 10 participants per month with five randomized into the treatment condition the maximum number of individuals who could be supported per FTE navigator would be 20 participants This consumerstaff ratio is below what is typically seen in such services as supported employment or education
Control group
Participants assigned to the attention control condition will receive printed information on the importance and opportunities for volunteering and will be encouraged to review resources from the TU Collaborative website They will receive weekly 10-minute non-directive supportive listening sessions via telephonevideoconferencing with a Research assistant Research assistants are full-time staff members with an undergraduate degree in psychology Undergraduate students are not involved in performing the weekly check-ins with the control group The control group will not receive weekly 11 support through a trained clinician
This intervention is based on evidence-based models and takes a different approach than many loneliness and social connectedness interventions Using the CIVIC Framework and Mattering Wheel as a foundation this intervention has the potential to develop relationships of equality and reciprocity that extend beyond the intervention period This intervention also draws upon our own intervention research which utilized the Individualized Placement and Support model in a supported leisure intervention
Participants will be randomly assigned to the intervention group or the attention control group Those in the intervention arm receive weekly support of an interventionist leading the intervention which is based on the aforementioned frameworks and informed by the idiosyncratic experiences and values of the participant The control group will receive weekly non-directive listening support through research assistants and printed information on the importance skills and opportunities for participation
Over the course of the 12-month intervention participants in the intervention arm will receive weekly support from the interventionist The interventionist and the participant will collaboratively set goals and develop an initial intervention plan which is informed by the participants interests values and goals Participants will receive support through weekly meetings through the interventionist who will monitor their progress assist with problem solving and facilitates changes as needed The attention control group will receive weekly non-directive listening support through research assistants
Recruitment will occur only in Philadelphia in collaboration with outpatient treatment service providers Data collection for all participants will take occur at baseline at the mid-point of the intervention at 6 months and at the end of the 12-month intervention
The overall objective of the current study is to evaluate the outcomes associated with the Need to be Needed intervention This project aims to address the following research questions
RQ1a Is participation in the intervention associated with reductions in loneliness RQ1b Is participation in the intervention associated with reductions in social isolation RQ2 Are improvements in intervention targets mattering kindness gratitude predictive of social isolation and loneliness outcomes RQ3 Is the intervention acceptable to individuals with SMI RQ4 Is the implementation of this intervention feasible
Group Assignment
Once participants have completed the informed consent process and baseline data collection they will immediately be randomly assigned either the intervention or control group Randomization will be done in blocks of ten by assigned participant number ie 1 to 120 to prevent runs and enhance the probability of creating comparable groups
N2BN Intervention
The proposed Need to be Needed N2BN intervention is a 12-month supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention At the beginning of the intervention the interventionist will work with the participant to explore interests and identify opportunities for volunteering The exploration of interests and interest-based opportunities supports the participants autonomy and maximizes the benefits of volunteering Part of this exploration includes the identification of welcoming places using the tools developed by the Temple University Collaborative on Community Inclusion Welcoming places will then be explored to determine whether there are opportunities for volunteering within those locations Encouraging participants to volunteer in places where they already feel welcome may more rapidly facilitate engagement in volunteering and enhanced social connectedness
The chosen volunteer location must provide opportunity for consistent and sustained participation Participants will be encouraged and assisted by interventionist to identify a volunteer opportunity that would allow for at least weekly engagement Once a location is identified the interventionist will work with the participant to identify the necessary skills for volunteering in that role Consistent with the IPS model these skills will be practiced and refined while volunteering at the chosen site Each week the interventionist will meet with the participant to discuss the activities done while volunteering and how those activities contributed to the overall success of the program Additionally the interventionist will facilitate discussions about the people at the volunteer site and explore opportunities for relationship development
Because kindness and gratitude contribute to increases in social connectedness we will include opportunities to engage in and document acts of kindness and feelings of gratitude Throughout the first half of the intervention the participant will be encouraged to identify acts of kindness he or she engages in at the volunteer location This could include the volunteer activity alone or may include random acts of kindness that the participant initiates eg helping beyond the volunteer time offering to help another volunteer with something bringing someone a coffee just because among others
Participants will then be encouraged to expand these acts of kindness to their broader community This will start with opportunities to engage in random acts of kindness within ones welcoming places and then move to other community locations and relationships Participants will be encouraged to practice kindness within the four areas Ie community commitments relationships and self of the mattering wheel This provides an opportunity for participants to add value to multiple life domains
In the last half of the intervention participants will be introduced to the concept of gratitude and engaging in intentional expressions of gratitude Many interventions use writing as a strategy to document and express gratitude This includes letter writing journaling and writing social media posts Similarly this intervention will encourage participants to create a gratitude journal and also encourage participants to express their gratitude to others- via writing or other means of communication Participants will be encouraged to focus their journaling on gratitude related to individuals with whom they have either developed relationships or interacted with during the course of the intervention Similarly participants will be encouraged to document and express gratitude within the four areas Ie community commitments relationships and self of the mattering wheel This process allows participants to explore and document the value gained Additionally the participant and interventionist will discuss how the feelings of gratitude may lead to additional acts of kindness or ways to give back to the relationship
Throughout the intervention the interventionist will work closely with the participant to develop an individualized supports plan This may include developing a visual calendar to support engagement in the volunteer activities identifying natural supports to encourage ongoing participation or scheduling opportunities for touring the volunteer location prior to volunteering among others Many of these strategies were developed and used by our team when implementing a supported leisure intervention Additionally the interventionist will talk with the participant weekly about potential social connections and navigate strategies to nurture those potential relationships
Intervention frequency intensity and duration Interventionists will meet with participants initially to discuss supported volunteering concepts and develop an initial plan It is anticipated that this initial contact will require 2-3 hours of time and may occur in more than a single meeting This plan will be flexible as it is likely that participants will need multiple opportunities to identify and explore options for voluntarism Once the initial plan is developed the interventionist will make weekly contact either in person or via telephonevideoconference to support participants in achieving goals These weekly contacts 3x per month are expected to be brief 30-40 minutes and focused on information sharing and supported problem solving Interventionists will also schedule monthly plan reviews 1x per month with participants to review and revise supported volunteering individualized plans Both clients who are achieving goals as well as those falling short of their goals may want to revise or change their plan Over the course of the 12-month intervention it is projected that interventionists will engage with participants numerous times possibly up to 40-45 hours of contact Based on the planned enrollment of 10 participants per month with five randomized into the treatment condition the maximum number of individuals who could be supported per FTE navigator would be 20 participants This consumerstaff ratio is below what is typically seen in such services as supported employment or education
Control group
Participants assigned to the attention control condition will receive printed information on the importance and opportunities for volunteering and will be encouraged to review resources from the TU Collaborative website They will receive weekly 10-minute non-directive supportive listening sessions via telephonevideoconferencing with a Research assistant Research assistants are full-time staff members with an undergraduate degree in psychology Undergraduate students are not involved in performing the weekly check-ins with the control group The control group will not receive weekly 11 support through a trained clinician
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