Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT06460012

Conditions

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

STELLA-R Curriculum

Unrestricted Access

Limited Access

Study Details

Brief summary:

STELLA-R is a multicomponent, self-directed, online intervention designed to facilitate effective management of behavioral and psychological symptoms that are common in many types of dementia. The curriculum instructs care partners to use the ABC approach, a cognitive behavioral technique that teaches care partners to describe a Behavior, then consider the Activators and Consequences of a care recipient behavior. The goal of this intervention is to reduce care partner burden and decrease reactivity to upsetting behaviors.

Conditions

Caregiver Burden

Study ID

NCT06460012

Start date

Jul 2, 2024

Status verified date

Oct, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult caring for family member with ADRD
  • Age of 18 years or older
  • 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 study materials and surveys
  • Provides informed consent to participate in the research
  • Lives in Oregon, Washington or Idaho
  • Identifies two or more behavioral symptoms that are distressing to them (care partner)

Exclusion Criteria:

  • Vision problems severe enough to prevent participation
  • Unwilling or unable to adequately follow study instructions and participate in study procedures

Study Design

Enrollment

238 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Group

Care partners start the STELLA-R Curriculum immediately after enrollment.

active comparator: Waitlist Control Group

Care partners start the STELLA-R Curriculum 8 weeks after enrollment.

Interventions

STELLA-R Curriculum

The STELLA-R curriculum is presented utilizing the ABC analytic approach to address care recipient's distressing behaviors. Using the scaffold of the ABC pyramid, they will receive video instructions on how to fully define the Behaviors they want to address by observing, describing, and writing about them. The care partners will learn to identify the Activators, the triggers for the behaviors. Next, care partners will learn to consider what happens after the behaviors, the Consequences. This is an 8-week self-directed, online weekly curriculum.

Unrestricted Access

Following the STELLA-R curriculum, care partners will receive 8 weeks of unrestricted access to all lessons and resources.

Limited Access

Experimental and Waitlist Control group will experience 8 consecutive weeks of limited access to the STELLA-R website and resources. Waitlist Control will experience this from Week 1 to Week 8 while the Experimental Group will reach this phase from Week 17 to Week 24.

Primary outcome measure

  • Revised Memory and Behavior Problems Checklist (RMBPC) [ Time Frame: Week 1, Week 8, Week 16, Week 24 ]
  • Feasibility of STELLA-R Intervention [ Time Frame: 10 months ]
  • Acceptability of STELLA-R Intervention [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Allison Lindauer, PhD

(503) 449-8151lindauer@ohsu.edu

Christina Zonker, BA

(503) 816-8310zonkerc@ohsu.edu

Locations

Oregon Health & Science University, Layton Aging and Alzheimer's Disease Research Center

Recruiting

Portland, Oregon, United States, 97239

Contacts

Allison Lindauer, PhD

503-494-6976lindauer@ohsu.edu

Principal Investigator:

Allison Lindauer, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • caregivers
  • dementia
  • RMBPC
  • caregiver support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-10-23.