Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06401655 |
Other study ID # |
HS26252 (H2023:356) |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 21, 2024 |
Est. completion date |
September 1, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of Manitoba |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This pilot study will utilize a longitudinal concurrent mixed-methods research design that
gathers and analyzes qualitative and quantitative data overtime about a new 10-session
financial coaching program the investigators have developed. The data collected will be used
to inform improvements to future related studies and programs for people living with acquired
brain injury (ABI).
These mixed-methods data from each method will be integrated to provide a comprehensive
understanding of the intervention (i.e., the financial coaching program). Each individualized
intervention per ABI-survivor participant will be completed over 3-4 months (i.e., 12-14
weeks).
Description:
The people to be recruited in the study include:
1. Adults living with acquired brain injuries (ABI; "ABI-survivor participant"), and
2. Close or trusted others of the adult participants who live with ABI (involvement with
the consent of the adult living with ABI; "Close-other support person").
The investigators will recruit participants through community partner organizations. The
principal investigator (Dr. Engel) has established relationship with community organizations.
The primary participants for this study are adults who live with Acquired Brain Injury (ABI;
i.e., ABI-survivor participants). However, with the consent and guidance of the ABI-survivor
participants, the investigators will invite up to one close-other (e.g., caregiver, family,
involved friend) of the ABI-survivor participant to take part in the study as a
support-person in the intervention with the ABI-survivor participant (involvement of
close-others is described more below).
The investigators will recruit up to five ABI-survivors (n=5), each who may or may not have a
support person involved in the study. This sample size will be sufficient to generate
required information for the study aim and objectives, as there will be some homogeneity to
the sample (i.e., adults living with ABI) while also looking for heterogeneity in other
participant qualities (i.e., gender, age, time since first brain injury).
The total time in this study for an ABI-survivor participant is 10 hours and 15 minutes which
includes 7.5 hours of intervention time and 2.75 hours of data collection time.
This is an individualized, in-person 10-session financial coaching intervention program. Each
session is 45-minutes. In total, participants will be asked to participate in up to 7 hours
and 30 minutes of intervention time with a trained Occupational Therapist. Each session will
happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months.
The Financial Coaching Program (FCp) will consist of 10 sessions that will last 45-minutes
per session. Each session will be in a 1:1 format with the participant and financial coach
(i.e., interventionist) who is a trained and registered Occupational Therapist. Participants
are welcome to invite a close other (e.g., family, caregiver, friend) to attend and
participate in sessions as a support person and as agreed upon during informed consent and
while getting started in the study; although, at any time the participant can choose to not
include or stop including their close other for some or all of the remaining FCp sessions.
FCp sessions will take place in a variety of spaces, dependent on the participant's
preference. Sessions can be completed in the participant's home, the meeting spaces of the
Manitoba Brain Injury Association, or office space in the College of Rehabilitation Science
building. Sessions can take place in another community space if requested by the participant.
The FCp will follow a Cognitive Orientation to daily Occupational Performance (CO-OP) format.
The CO-OP method will focus on building skills through the development and use of cognitive
strategies. These problem-solving strategies can then be used to improve performance in other
aspects of daily life and in new situations. The FCp financial coaches have been trained in
CO-OP basics online course and completed the certificate consolidation course.
During the FCp sessions, the participant will work with a financial coach to practice problem
solving skills and work toward achieving 3 financial goals: 2 of these goals will be
addressed directly during multiple FCp sessions and 1 goal will be "unaddressed" or
"untrained", only to be discussed in the last session related to generalization of learning
to other goals. The financial coach will not instruct participants but will instead work
collaboratively with them to develop strategies and action plans. The participant and
financial coach will agree on homework assignments to complete between sessions, which will
be reviewed at the beginning of each subsequent session.
The FCp will be facilitated by a financial coach (I.e, intervnetionists), who will be a paid
research staff member and part of the research team identified in the informed consent forms.
The financial coach is an occupational therapist with experience working with individuals
with brain injury. The financial coaches hired for this study have completed the following
additional training:
- Cognitive Orientation to Occupational Performance (CO-OP) comprehensive online course
and completed the certificate consolidation
- SEED Financial Empowerment Program certificate training for financial
literacy/capability facilitators (train-the-trainer program; https://seedwinnipeg.ca)
- Training through Prosper Canada Financial Empowerment Foundations