Frontotemporal DementiaSTELLA-FTDNCT06613204
STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
A study testing STELLA-FTD Test in people with Frontotemporal Dementia and Caregiver Burden, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia, Caregiver Burden, Primary Progressive Aphasia (PPA)
- What is being tested?
- STELLA-FTD Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult caring for family member with FTD.
- Provides 4 or more hours of care/week. Does not have to reside with.
- Identifies at least 2 moderately upsetting behaviors in the person with FTD.
- Speaks and understands English to be able to participate in intervention.
- Owns a telephone (smartphone, cell phone or landline).
- Has email and mailing address to receive computer, study materials and surveys.
Show all 11Show fewer
- Provides informed consent to participate in the research.
- Lives in the US
- Diagnosis of FTD
- Family member of a Care Partner (this can be a relative, spouse, or close kin that is considered family).
- Lives in US
Who cannot join
- No Frontotemporal Degeneration diagnosis.
- Unable to leave Care Partner during STELLA-FTD sessions.
- Enrolled in hospice.
- Unable to find activity for Care Recipient during STELLA-FTD sessions to allow Care Partner to work privately with Guide and other Care Partners.
- Hearing and/or vision problems severe enough to prevent participation.
- Refuses to be video-recorded during STELLA-FTD sessions.
- Unwilling or unable to adequately follow study instructions and participate in study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Hailey Chatterton, MS, 503-568-9725, chatterton@ohsu.edu
About this study
The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent videoconference-based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the United States.
Read the detailed description
The study will enroll a total sample of up to 640 participants: 320 family Care Partners and their 320 Care Recipients with FTD. For our study "family Care Partner" includes any person who is considered "family" to the person with FTD, such as direct relations, fictive kin, close friends and neighbors. "Care Recipient" is defined as an individual with an FTD diagnosis noted by the AFTD: bv-FTD, PPA, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), or ALS with FTD. Care Recipients with FTD will not participate in intervention but will be consented (and thus enrolled) because data will be collected about them. The study will test to see if our program helps Care Partners.
The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour "live" video-based group sessions led by two guides. There will be two intervention groups, the control group and the test group. There will be up to 8 Care Partners per group, which allows for the development of mutual trust and commitment.
Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Both groups will receive information and support (via videoconferencing). The test group will receive a different program than the control group. Care Partners will fill out 6 long surveys while in the study, and a brief weekly survey.
- Conditions
- Frontotemporal Dementia, Caregiver Burden, Primary Progressive Aphasia (PPA), Corticobasal Syndrome
- Being tested
- STELLA-FTD Control, STELLA-FTD Test
- Keywords
- behavioral intervention, FTD
- Medical subject headings
- Frontotemporal Dementia, Caregiver Burden, Aphasia, Primary Progressive, Corticobasal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STELLA-FTD ControlBehavioural
Participants receive information about FTD and support via weekly group video-conference-based meetings.
STELLA-FTD TestBehavioural
The test group receives a information and support, but with a focus that is different from the Control Group
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Control group, receives information and support in a group setting (N=160 Care Partners). Receives: Behavioral: STELLA-FTD Control |
| Test Group | Experimental | Test group, receives information and support in a group setting, but program is different from control (N=160 Care Partners). Receives: Behavioral: STELLA-FTD Test |
| Care Recipients with FTD | No intervention | Care recipients are consented to inform them of their rights, but they do not take part in any activities (N=320 Care Recipients). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 96
Measured: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale
Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on reactivity indicate more Care Partner burden. Frequency range is 0 (no burden) to 4 (high burden). Frequency score range is 0 to 96
Measured: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Secondary outcomes (12)
Self-efficacy for symptom management and support service use
10-item scale to measure self-efficacy. Assesses caregiver certainty that they will use services and support programing. 1= not at all certain, to 10=very certain. Scores range from 10 to 100, with 100 being high certainty.
Measured: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Neuropsychiatric Inventory-Caregiver Self-efficacy Scale
Measures frequency of behaviors related to frontotemporal dementia and Care Partner confidence in managing behaviors. Frequency is rated on a scale of 1 (occasionally) to 4 (very frequently), severity is rated from 1 (mild) to 3 (severe), and caregiver distress is rated from 0 (no distress) to 5 (extreme or very severe). Total scores are calculated by multiplication of the frequency and severity for each symptom and the addition of all item scores, with a range of 0-144. The distress score total is calculated by the sum of all the individual domain scores, with a range of between 0 and 60. If a behavioral symptom is noted, the care partner is asked to about how confident they are in addressing it, Responses range from 4 (not at all confident), 3 (fairly confident), 2 (confident), and 1 (very confident).
Measured: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Preparedness for Caregiving Scale
10-item measure that assesses how prepared care partners feel to care for their family member with dementia. Ranges from 0 (not at all prepared) to 40 (very well prepared).
Measured: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Personalized Target Behavior Survey
On STELLA-FTD Website, measures frequency and reactivity of up to 3 personalized behaviors identified by Care Partners. Care partners rate how often the 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 4 for each Target behavior. Higher scores indicate higher frequency and burden.
Measured: 1 week pre-intervention, 8 week post intervention
Service and Support use survey
10-item survey that queries participants about service use. Score is not on a scale.
Measured: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey
18-item- survey on satisfaction, privacy, ease of use. Scores range from 1 (strongly disagree) to 5 (strongly agree). Total score ranged 18-90, higher scores are better
Measured: 1 week post intervention
Orbit Survey
Weekly survey of burden, service use, medication use. Score is not on a scale.
Measured: Weekly, starts at Week 1, ends after week 36.
Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency
Measures frequency of upsetting frontotemporal behaviors. 9 items, scores range from 0 (no behaviors) to 36 (all behaviors)
Measured: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity
Measures caregivers reactions to upsetting frontotemporal behaviors. 9 items, scores range from 0 (no reactivity) to 36 (high reactivity)
Measured: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration
This is an 8-item survey that assesses disease severity, with 0=no impairment to 3=severe impairment. Range is 0-24 (Sum of boxes)
Measured: One time assessment at enrollment
Ten Item Personality Inventory
10 items that assess personality type. Respondents note how they agree with each. personality type, from
1=Disagree strongly 2 = Disagree moderately 3 = Disagree a little 4 = Neither agree nor disagree 5 = Agree a little 6 = Agree moderately 7 = Agree strongly
Score is not on a scale.
Measured: Once, at Week 1 of intervention
Contact Survey
Nine questions query caregivers about if they contacted other caregivers in the study, and, if so, how often. Score is not on a scale
Measured: Week 13, 20, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start23 Jun 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- STELLA-FTD is a 36-week randomized controlled, repeated measures study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Allison Lindauer, Oregon Health and Science University
- Investigators
- Allison Lindauer, PhD, APRN, Principal investigator, Oregon Health and Science UniversityAimee Mooney, MA, CCC-SLP, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613204
- Sponsor's protocol ID
- STUDY00026023
- Other IDs
- R01AG084523
- Acronym
- STELLA-FTD
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2024
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data for journal articles and presentations, IPD via data request to OHSU
Publications
Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1.
PubMed 37655616
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
- ClinicalTrials.gov ID
- NCT06613204
- Acronym / sponsor ID
- STELLA-FTD / STUDY00026023
- Conditions
- Frontotemporal Dementia, Caregiver Burden, Primary Progressive Aphasia (PPA), Corticobasal Syndrome
- Keywords
- behavioral intervention, FTD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent videoconference-based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the United States.
Detailed description
The study will enroll a total sample of up to 640 participants: 320 family Care Partners and their 320 Care Recipients with FTD. For our study "family Care Partner" includes any person who is considered "family" to the person with FTD, such as direct relations, fictive kin, close friends and neighbors. "Care Recipient" is defined as an individual with an FTD diagnosis noted by the AFTD: bv-FTD, PPA, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), or ALS with FTD. Care Recipients with FTD will not participate in intervention but will be consented (and thus enrolled) because data will be collected about them. The study will test to see if our program helps Care Partners.
The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour "live" video-based group sessions led by two guides. There will be two intervention groups, the control group and the test group. There will be up to 8 Care Partners per group, which allows for the development of mutual trust and commitment.
Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Both groups will receive information and support (via videoconferencing). The test group will receive a different program than the control group. Care Partners will fill out 6 long surveys while in the study, and a brief weekly survey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- STELLA-FTD is a 36-week randomized controlled, repeated measures study.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: STELLA-FTD ControlControl group, receives information and support in a group setting (N=160 Care Partners). |
| Test Group | Experimental | Behavioral: STELLA-FTD TestTest group, receives information and support in a group setting, but program is different from control (N=160 Care Partners). |
| Care Recipients with FTD | No intervention | –Care recipients are consented to inform them of their rights, but they do not take part in any activities (N=320 Care Recipients). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult caring for family member with FTD.
- Provides 4 or more hours of care/week. Does not have to reside with.
- Identifies at least 2 moderately upsetting behaviors in the person with FTD.
- Speaks and understands English to be able to participate in intervention.
- Owns a telephone (smartphone, cell phone or landline).
Key exclusion criteria (7 listed)
- No Frontotemporal Degeneration diagnosis.
- Unable to leave Care Partner during STELLA-FTD sessions.
- Enrolled in hospice.
- Unable to find activity for Care Recipient during STELLA-FTD sessions to allow Care Partner to work privately with Guide and other Care Partners.
- Hearing and/or vision problems severe enough to prevent participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STELLA-FTD ControlParticipants receive information about FTD and support via weekly group video-conference-based meetings. | Behavioural | Control Group |
| STELLA-FTD TestThe test group receives a information and support, but with a focus that is different from the Control Group | Behavioural | Test Group |
Primary outcome
Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
Time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 96
Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale
Time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on reactivity indicate more Care Partner burden. Frequency range is 0 (no burden) to 4 (high burden). Frequency score range is 0 to 96
12 secondary outcomes
Self-efficacy for symptom management and support service use
Time frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Neuropsychiatric Inventory-Caregiver Self-efficacy Scale
Time frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Preparedness for Caregiving Scale
Time frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Personalized Target Behavior Survey
Time frame: 1 week pre-intervention, 8 week post intervention
Service and Support use survey
Time frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey
Time frame: 1 week post intervention
Orbit Survey
Time frame: Weekly, starts at Week 1, ends after week 36.
Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency
Time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity
Time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration
Time frame: One time assessment at enrollment
Ten Item Personality Inventory
Time frame: Once, at Week 1 of intervention
Contact Survey
Time frame: Week 13, 20, and 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Background: PubMed 37655616Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1.
- Individual participant dataSharing planned: Yes. Aggregated data for journal articles and presentations, IPD via data request to OHSU
Related trials for Frontotemporal Dementia
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen A: AADvac1
PSP - Progressive Supranuclear Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Not yet recruitingObservational study
Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease
Alzheimer's Disease, Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Lindauer, PhD, APRN principal investigator
Oregon Health and Science University
Aimee Mooney, MA, CCC-SLP study director
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STELLA-FTD Test in people with Frontotemporal Dementia and Caregiver Burden, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailey Chatterton, MS (503-568-9725, chatterton@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Memory and Behavior Problems Checklist, Frequency, Original Scale (time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.