An interventional study of AMUSED and Reading Aloud in Dementia Severe, sponsored by Alaine E Hernandez, PhD. Completed at 8 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Alaine E Hernandez, PhD · Not applicable, Interventional, and Supportive care
The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who live in care facilities. The main questions it aims to answer are:
Participants will:
Meaningful activity has personal importance or usefulness, fosters a sense of fulfillment, and contributes to well-being, whether through cherished pastimes or goal-oriented endeavors. Persons with dementia (PWD) experience significant deficits in memory, communication, and functional abilities, which poses unique obstacles to engage in meaningful activities. When PWD lack sufficient activity, or if activities are poorly tailored to ability, PWD can demonstrate increased behavioral symptoms. Such symptoms impact the PWD and contribute to caregiver stress. Nonetheless, PWD across the severity continuum often respond favorably to music. Thoughtfully designed music-based interventions (MBIs) may offer PWD opportunities to engage in meaningful activity and socialize. However, empirical evidence to support the use of MBIs with this population is very limited. This pilot study advances a line of research to test and refine a randomized clinical trial design and gather preliminary data on intervention effectiveness beyond a single session.
The overall objectives of this quantitative pilot study are to (i) establish a well-refined clinical trial design, procedures, and outcome measures and (ii) obtain preliminary data of enduring effectiveness of a multimodal music therapy intervention for engaging persons with severe dementia (AMUSED) with regards to behavioral symptoms and speech. AMUSED uses live participant-preferred music and progressively layers singing, touch, and rhythmic instrument playing concurrent with participant behavioral responses. This MBI is grounded in the person-centered Clinical Practice Model for PWD, which provides guidelines for adjusting the degree of support and challenge offered to an individual. This Model is also used to enhance treatment fidelity.
This pilot study builds on a feasibility study that field tested logistics and demonstrated feasibility and acceptability of the AMUSED intervention protocol through a randomized cross-over trial design. The researchers refined recruitment, data collection, protocol training, and intervention processes. As in past similar work, the researchers demonstrated positive engagement during music therapy sessions. However, obtaining longer-term measures of treatment effects (i.e., neuropsychiatric inventory, Fitbit actigraphy, pulse oximetry, functional measures) proved impractical and unreliable in the care milieu. The researchers' recent qualitative work with long-term care staff revealed possible solutions to more feasibly measure such outcomes in a long-term care setting. The current pilot study builds on this past feasibility and qualitative work.
In this quantitative pilot study, the investigators will use a randomized clinical trial design to test methods and procedures that will be used in a future larger clinical trial. This will help enhance the rigor and reproducibility of this research. The aims of this pilot study are to: 1) determine whether the clinical trial protocol is feasible for a full-scale trial, 2) select the most appropriate primary outcome measure(s) of behavioral symptoms of dementia, and 3) determine if spontaneous speech offers a useful indicator of music-based intervention effectiveness in persons with severe dementia. Participants will be older adults with severe dementia who live in a long-term care facility. To isolate the effects of the music and obtain an estimate of cluster effects, care facilities will be randomly assigned to either receive music therapy or reading. Both conditions use the same structure, strategies, and dosage, with music being the key difference.
135 studies on the registry are indexed under Behavioral Symptoms; 18 are open to participants now.
This study's enrollment of 42 is below the median of 93 across 114 interventional studies indexed under Behavioral Symptoms.
Browse Behavioral Symptoms studies →Alaine E Hernandez, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
PARTICIPANT Inclusion Criteria:
PARTICIPANT Exclusion criteria:
FACILITIES - Inclusion Criteria:
FACILITIES - Exclusion Criteria:
-Does not meet one or more inclusion criteria.
Live delivery of a music therapy protocol that is designed to be led by a board-certified music therapist (MT-BC). Activity blocks are identical to the reading arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)
Behavioral: AMUSED
Live reading aloud of an age-appropriate book by a group leader to control for social attention and isolate the effects of music. Activity blocks are identical to the music therapy arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)
Behavioral: Reading Aloud
Delivered live by a board-certified music therapist (MT-BC) 40 min 2x/week for 12 weeks (24 total sessions; 16 total hours) in small groups of 3-5 people. A Multimodal mUSic therapy intervention for Engaging persons with severe Dementia (AMUSED) uses live participant-preferred music and progressively layers singing, touch, and rhythmic instrument playing concurrent with participant behavioral responses. Follows the Clinical Practice Model for Persons with Dementia and implementation strategies that promote cognition, attention, familiarity, audibility, structure, autonomy per participants' strengths, interests, preferences, culture, and momentary responses. Each small group works with the same music therapist throughout the study.
Delivered live by a trained research assistant ("interventionist") 40 min 2x/week for 12 weeks (24 total sessions; 16 total hours) in small groups of 3-5 people. The interventionist will read aloud from age-appropriate books (Chicken Soup for the Golden Soul by Jack Canfield; World of Wonders by Aimee Nezhukumatathil) selected to have sufficient material for all sessions, contain short stories to accommodate for attention span and session length, and offer choice. Follows implementation strategies identical to the music therapy arm (i.e., within the Clinical Practice Model for Persons with Dementia) that promote cognition, attention, familiarity, audibility, structure, autonomy per participants' strengths, interests, preferences, culture, and momentary responses. However, no music (including musical references) is used. Each small group works with the same reading interventionist throughout the study.
Mean Change from Baseline in Dementia Behavior at 12 Weeks
The Quick Dementia Behavior Observation Scale (QD-BOS) is an 18-item observational measure (est. 3 min. to complete). Section 1 contains the 11 sub-questions from the Neuropsychiatric Inventory-Nursing Home section C "agitation/aggression" and care staff rate the presence or absence of 8 behaviors in the past week (raw score 0-8), the frequency (raw score 1-4) and severity of behaviors (raw score 1-3), total score (frequency x severity, ranges 1-12), and occupational disruptiveness of those behaviors (raw score 0-5; all ranges higher score indicates worse behavior). Section 2 contains 5 questions regarding observed psychosocial well-being in the past week using a 5-point Likert-type scale (item range 1-5), and an optional open-ended item. Section 3 contains 1 question regarding job-related stress in the past week, using a 5-point Likert-type scale (range 1-5). A lower score indicates worse/less desirable behavior. Completed by care staff at baseline and every 4 weeks.
Time frame: Baseline, end of Week 12
Mean Change from Baseline in Dementia Behavior at 4 Weeks
The QD-BOS is an 18-item observational measure (est. 3 min. to complete). Section 1 contains the 11 sub-questions from the Neuropsychiatric Inventory-Nursing Home section C "agitation/aggression" and care staff rate the presence or absence of 8 behaviors in the past week (raw score 0-8), the frequency (raw score 1-4) and severity of behaviors (raw score 1-3), total score (frequency x severity, ranges 1-12), and occupational disruptiveness of those behaviors (raw score 0-5; all ranges higher score indicates worse behavior). Section 2 contains 5 questions regarding observed psychosocial well-being in the past week using a 5-point Likert-type scale (item range 1-5), and an optional open-ended item. Section 3 contains 1 question regarding job-related stress in the past week, using a 5-point Likert-type scale (range 1-5). A lower score indicates worse/less desirable behavior. Completed by care staff at baseline and every 4 weeks.
Time frame: Baseline, end of Week 4
Mean Change from Baseline in Dementia Behavior at 8 Weeks
The QD-BOS is an 18-item observational measure (est. 3 min. to complete). Section 1 contains the 11 sub-questions from the Neuropsychiatric Inventory-Nursing Home section C "agitation/aggression" and care staff rate the presence or absence of 8 behaviors in the past week (raw score 0-8), the frequency (raw score 1-4) and severity of behaviors (raw score 1-3), total score (frequency x severity, ranges 1-12), and occupational disruptiveness of those behaviors (raw score 0-5; all ranges higher score indicates worse behavior). Section 2 contains 5 questions regarding observed psychosocial well-being in the past week using a 5-point Likert-type scale (item range 1-5), and an optional open-ended item. Section 3 contains 1 question regarding job-related stress in the past week, using a 5-point Likert-type scale (range 1-5). A lower score indicates worse/less desirable behavior. Completed by care staff at baseline and every 4 weeks.
Time frame: Baseline, end of Week 8
Mean Change from Baseline in Dementia Behavior at 4-Week Follow-Up (16 Weeks)
The QD-BOS is an 18-item observational measure (est. 3 min. to complete). Section 1 contains the 11 sub-questions from the Neuropsychiatric Inventory-Nursing Home section C "agitation/aggression" and care staff rate the presence or absence of 8 behaviors in the past week (raw score 0-8), the frequency (raw score 1-4) and severity of behaviors (raw score 1-3), total score (frequency x severity, ranges 1-12), and occupational disruptiveness of those behaviors (raw score 0-5; all ranges higher score indicates worse behavior). Section 2 contains 5 questions regarding observed psychosocial well-being in the past week using a 5-point Likert-type scale (item range 1-5), and an optional open-ended item. Section 3 contains 1 question regarding job-related stress in the past week, using a 5-point Likert-type scale (range 1-5). A lower score indicates worse/less desirable behavior. Completed by care staff at baseline and every 4 weeks.
Time frame: Baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)
Mean Change from Baseline in Language Function at 12 Weeks
To evaluate change in Aphasia Quotient (AQ) from the bedside Western Aphasia Battery-Revised (WAB-R), a standardized assessment used to evaluate language abilities in individuals with aphasia. WAB-R has been used with persons with dementia to assess impact of cognitive change on language function. The AQ provides a summary measure of the severity of language impairment based on performance across several language domains, including spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding. Scores range from 0 to 100; A higher AQ score indicates better language function. Administered by masked outcome assessor in person at baseline and end of Week 12.
Time frame: Enrollment, end of Week 12
Mean Change from Baseline in Cognition at 12 Weeks
The Severe Impairment Rating Scale (SIRS) is used to evaluate the severity of cognitive and functional impairment in individuals with severe dementia, including memory, orientation, and daily living activities. Scores range from 0 to 52, with higher scores indicating more severe impairment. Administered by masked outcome assessor in person at baseline, end of Week 12, and at 4-week follow-up after removal of treatment.
Time frame: Enrollment, end of Week 12
Mean Change from Baseline in Cognition at 4-Week Follow-Up
The SIRS is used to evaluate the severity of cognitive and functional impairment in individuals with severe dementia, including memory, orientation, and daily living activities. Scores range from 0 to 52, with higher scores indicating more severe impairment. Administered by masked outcome assessor in person at baseline, end of Week 12, and at 4-week follow-up after removal of treatment.
Time frame: Baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)
Mean Change in Spontaneous Speech at Week 4
Spontaneous speech will be administered 1 hour before and 1 hour after session 8, during week 4, by a masked outcome assessor, who will follow a script of simple social responses, picture description task \[cookie theft\], and animal and vegetable naming. Responses will be audio recorded for lexical feature analysis using standard and AI approaches.
Time frame: Immediately before and immediately after session 8 at week 4
Mean Change in Spontaneous Speech at Week 8
Spontaneous speech will be administered 1 hour before and 1 hour after session 16, during week 8, by a masked outcome assessor, who will follow a script of simple social responses, picture description task \[cookie theft\], and animal and vegetable naming. Responses will be audio recorded for lexical feature analysis using standard and AI approaches.
Time frame: Immediately before and immediately after session 16 at week 8
Mean Change in Spontaneous Speech at Week 12
Spontaneous speech will be administered 1 hour before and 1 hour after session 24, during week 12, by a masked outcome assessor, who will follow a script of simple social responses, picture description task \[cookie theft\], and animal and vegetable naming. Responses will be audio recorded for lexical feature analysis using standard and AI approaches.
Time frame: Immediately before and immediately after session 24 at week 12
Plan to share: Yes — This is a small pilot study. Pilot data for preliminary effect size estimating will not be publicly shared. Researchers may request de-identified data and study materials from the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 6 months after publication. The principal investigator will consider sharing data and study materials prior to that time frame in consultation with the study team.
Access criteria: The principal investigator will share data, qualitative and quantitative analysis plans, and study materials with other researchers who provide a reasonable rationale for intended use, by email. Requests will be reviewed by the principal investigator Reschke-Hernandez, all co-investigators, and all study team members.
Ran from Mar 2025 to primary completion in Aug 2026, 17 months.
Of 68 non-industry interventional studies with no phase under Behavioral Symptoms, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 17 months is below that.
Counting every sponsor, half of 68 studies reached it within 27 months; a quarter within 16 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Alaine E Hernandez, PhD