Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04645017 |
| Other study ID # |
STUDY20080152 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2021 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Intergenerational music programming has been shown to benefit both young people and older
adults in terms of quality of life, social connection, and promotion of positive cross-age
attitudes. During a time that older adults are facing increasing social isolation, a need
exists to offer meaningful programming that can reach older adults living with memory loss.
The investigators want to assess if an intergenerational music program that is delivered by
adolescent music facilitators is feasible and appropriate to both the young musicians and the
older adult participants. This program will be designed on Zoom but will able to be delivered
in the same manner in-person, offering it flexibility to reach a variety of participants.
This program is unique in that it brings together two populations who have shown to be
positively affected by engaging in music - adolescents and older adults with memory loss. As
a result of this work, teenage musicians will be empowered to adapt and share a music program
utilizing best research practices and create new connections with an older generation. Older
adults will receive a research-informed music program that will be geared to helping their
musical understanding and participation, as well as an opportunity to create new connections
with a younger generation. Findings from this work will generate a music program with clearly
defined ingredients that can be delivered and is accepted by both its facilitators and
participants, providing a foundation for future studies to assess outcomes such as social
connection, cognitive benefits, and emotional well-being.
This program will be built carefully utilizing stakeholder engagement from the adolescent
facilitators and older adult participants. Specifically, for Aim 1 the investigators will
explore the feasibility of the music program by its facilitators by conducting in-depth
interviews with a sample of adolescent facilitators before, during, and after they administer
the music intervention to discuss how best to adapt the program, as well as collecting
observations of the older adults to confirm engagement in the program. For Aim 2 the
investigators will assess its fidelity as the adolescent facilitators implement the program
and are assessed for adherence and competence. For Aim 3, the investigators will assess its
appropriateness, as adolescent facilitators and older adults will engage in focus groups.
Description:
The research team will use qualitative and convergent mixed methods approaches to develop and
assess the feasibility and appropriateness of an intergenerational music program for older
adults with memory loss. With a paucity of research assessing the potential of an
intergenerational music program delivered by adolescents to older adults, it's important to
carefully build and assess the intervention utilizing principles of feasibility and
appropriateness. As discussed in feasibility methodology, principle data collection
methodology includes qualitative methods with stakeholders.
Aim 1: Assess feasibility of delivering a music program to older adults for the young
musicians using qualitative methodology.
Initial development: Pre-interview questions will be generated by the study team based an
existing digital music program, and post-interview questions will be guided by observations
of facilitators' experiences delivering the program. A research team member will meet twice
with a board-certified music therapist to determine bounds and flexibility for program
adaptation and determine standards to include in the best- practice guide to familiarize
adolescents to work with older adults with memory loss. (See: Pitfalls)
Data Collection: The PI will coordinate interview times and conduct semi-structured, in-depth
interviews with the adolescent facilitators. Example questions will be "Are there any
important ingredients missing from this intervention?" Do each of the intervention's
ingredients have clarity when you imagine preparing a music class? What additional training
do you need to present to older adults with memory loss?" The interviews will last
approximately 30-45 minutes and will take place immediately after the intervention training
session, as well as at the mid-point of delivering classes and following the conclusion of
the final class. They will be audio- and video-recorded and transcribed verbatim. A research
assistant will transcribe each interview, de- identifying any family caregiver information,
in a Microsoft Word document.
Participants: Purposive sampling will be used to recruit an expert panel comprising of four
adolescent musicians. The inclusion criteria will be discussed in the Eligibility Criteria
section. Once identified, panelists will be contacted by a research assistant to share study
details and obtain consent. Participation in the interviews and facilitating the music
classes will be voluntary and musicians can withdraw from the study at any time. The PI will
coordinate interviews and facilitation times with the music facilitators. The musicians will
spend an estimated eight hours receiving the initial training, preparing for the classes,
facilitating the classes, and taking part in the interviews. Involvement for each musician
will take place over approximately two months.
Data Management: Transcribed interview data will be uploaded and managed in the digital
qualitative analysis software, NVivo. These data will be securely stored on a hard drive
designated for this study.
Data Analysis and Dependability: The PI will follow a standard content analysis approach.
This analytic approach helps researchers identify categories and patterns in transcribed data
in a deductive manner. We will derive and systematically apply coding rules that are based on
perceptions and feedback regarding each music intervention ingredient.
The PI will create this coding structure in NVivo and then conduct a meeting with the CO-I
(Rodakowski). During this session, researchers' ability to agree on coding of data will be
assessed and coding with which they encountered difficulty will be discussed. Twenty-percent
of the data will be independently coded by the two researchers. To measure intercoder
reliability, the PI will use the coding comparison query function in NVivo. A threshold will
be set at 80% agreement based on suggested values of intercoder reliability. Both researchers
will discuss disagreements and continue to code independently until this threshold is
reached. After which, the PI will finish the remaining data coding.
Expected outcome: Interview data with music facilitators will consist of information about
the feasibility of other adolescent music facilitators to implement the music program in
regards to each intervention ingredient. These findings will help the researchers making any
necessary adaptations to the intervention and update training for future music facilitators
prior to progressing to Aim 2, which will assess if the music program can be delivered with
fidelity.
Potential pitfalls: One potential pitfall is the lack of experience that the adolescent
facilitators may have with older adults with memory loss. To assist in their comfort, the PI
will develop a best-practice guide with the music therapist that anticipates some of the
issues when working with this population and provides suggestions of best practices.
Aim 2: Assess if the young musicians can deliver the music program with fidelity using
quantitative methodology.
Initial development: A fidelity review form will be generated by the study team based on the
adaptations to the digital music program.
Data Collection: The PI will assess video recordings of the digital music classes and rate
them for fidelity.
Participants: The PI will work with community youth music programs to purposively sample 15
adolescent music facilitators. Convenience sampling will be employed to recruit 30 older
adult participants from community wellness programs. The inclusion and exclusion criteria
will be discussed in the Eligibility Criteria section. Once identified, facilitators and
participants will be contacted by a research assistant to share study details and obtain
consent. Participation in the music classes will be voluntary and musicians and participants
can withdraw from the study at any time. The PI will coordinate facilitation times with the
participants and the music facilitators. The facilitators will spend an estimated seven hours
each, which include a training session, preparation for the classes and facilitation of the
classes. Involvement for each musician will take place approximately one month. The
participants will spend an estimated 45 hours attending digital music classes. The
involvement for participants will take place approximately over 12 months.
Data Management: Fidelity review forms will be entered into RedCap.
Data Analysis and Reliability: Within Microsoft Excel, the PI will calculate the fidelity
rates for each music facilitator.
Expected outcome: Fidelity rates will demonstrate if the music facilitators can deliver the
music intervention consistently. These findings will help the researchers making any
necessary adaptations to the intervention.
Potential pitfalls: One potential pitfall is the adolescent music facilitators experiencing
uncertainty during the process of facilitation due to their lack of experience teaching and
presenting. To mitigate this uncertainty, a training session will be offered prior to the
facilitation sessions a professional music facilitator will be present for each session to
assist with unforeseen circumstances or to help navigate any difficult discussions that may
arise.
Aim 3: Assess if the program is appropriate for both the young musicians and the older adult
participants using qualitative methodology.
Initial development: Focus group questions will be generated by the study team based on the
observations of the digital music program.
Participants: The PI will work with community youth music programs to purposively sample 15
adolescent music facilitators. Convenience sampling will be employed to recruit 30
participants from community wellness programs that serve older adults. The inclusion and
exclusion criteria will be discussed in the Eligibility Criteria section. Once identified,
facilitators and participants will be contacted by a research assistant to share study
details and obtain consent. Participation in the focus groups will be voluntary and musicians
and participants can withdraw from the study at any time. The PI will coordinate focus group
times with the participants and the music facilitators. The focus groups will last
approximately 30-45 minutes each.
Data Collection: Once consent is obtained and dates and times are confirmed, an appropriate
venue that is free from interruptions will be reserved to conduct focus groups. The PI will
follow a semi-structured guide to conduct one focus group with facilitator and another focus
group with participants. The semi-structured guide will ask both groups about practical
considerations such as the structure and technological features (volume level, font size in
presentations) of the music classes. Probing questions will be asked about appropriateness of
the classes delivered by the adolescent facilitators, opportunities that should be considered
in future iterations of the intervention, and potential skills learned or supported for
facilitators and participants. Focus groups will last approximately 30-45 minutes and will be
audio and video recorded. A research assistant will transcribe each focus group verbatim,
deidentifying any personal information, in a Microsoft Word document.
Data Management: Transcribed focus group data will be uploaded and managed in NVivo. These
data will be securely stored on a hard drive designated for this study.
Data Analysis and Dependability: The PI (Dorris) and Co-Investigator (Rodakowski) will
complete content analysis of the focus group data within NVivo.
Expected Outcome: Mechanisms for administering and interpreting the music program will be
discussed and barriers and facilitators for future growth of the program will be collected.
Increasing our understanding of what was appropriate and what needs future adaptation will
lead to a more successful iteration of the intervention's development.
Potential Pitfalls: One potential logistical pitfall is the recruitment of adolescent
facilitators to participate in focus groups given their demanding schedules and availability.
If facilitators are unable to attend the focus group but are willing to participate in the
study, we will offer the opportunity to partake in individual interviews or complete an
online survey in place of the focus group. Another potential logistical pitfall is the memory
of the participants causing barriers to remembering the music classes. The research team will
coordinate with the participants of the music program to discuss breaking the focus group
questions into 5-10 minute sessions at the end of each facilitated class.
