SHARE Adaptation Intervention for African-American Families

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This project aims to culturally adapt the SHARE program for African-Americans in early-moderate stage dementia and their care partner. Upon completion of the adaptation, a pilot randomized-control trial wil be confucted to compare the adaptaed SHARE program versus usual care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting

NCT04309500

Mild Cognitive Impairment Healthy Aging

COMPLETED NA

The Senior Companion Program Plus

NCT03602391

Family Alzheimer Dementia

COMPLETED NA

Dementia-Friendly Faith Villages to Support African American Families

NCT04983693

Dementia

COMPLETED NA

Neighborhood-based Physical and Social Activity for Older Black Caregivers and People Living With Dementia

NCT05658328

Caregiver Burden Depression Cognitive Impairment

COMPLETED NA

A Non-pharmacological Intervention for Patients With Alzheimer's Disease and Family Caregivers (Care Partners Program)

NCT03333252

Caregiver

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim 1: Review SHARE for Dementia materials with an Advisory Committee (AC; 6-10 African Americans with lived experience and experts) to identify distinct needs of African American care dyads and culturally adapt SHARE using this input. Deliverables: Develop SHARE V1 Culturally tailored V1 SHARE Counselor Manual, V1 SHARE Guide for Families, and V1 SHARE Counselor training Aim 2: Conduct focus groups with African American care dyads (n=2 groups; n=10 dyads total, or until saturation) and community service provider staff (n= 2 groups; n=10, or until saturation) to identify strengths and limitations of the V1 SHARE materials, procedures, and protocols. Deliverables: SHARE for African Americans (Version 2;V2); Culturally tailored V2 SHARE Counselor Manual, V2 SHARE Guide for Families, and V2 SHARE Counselor training Aim 3: Train SHARE counselors (n=20) to implement V2 of SHARE. Aim 4: Examine: a) the acceptability and feasibility and; 2) preliminary efficacy of the culturally adapted V2 of SHARE in a fully powered trial with 120 African American care dyads.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Dementia Moderate Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with two groups: Treatment (SHARE) and Control (Treatment as usual single session)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Research interviewers will be blinded to condition at Baseline (Time 1) only.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (SHARE Dyadic Intervention)

Treatment group dyads are comprised of a PLWD with mild to moderate dementia and his/her preferred CG. Following recruitment and the consent process and screening, baseline telephone interviews (T1) with trained interviewers from the Benjamin Rose Institute on Aging will be completed separately with all CGs and PLWDs. Treatment group dyads will receive the culturally adapted SHARE intervention compromised of up to five, 60- 90-minute, curriculum-guided sessions with a SHARE Counselor over a 8-10 week period. A (T2) follow-up interview will be conducted approximately two weeks after treatment group dyads complete their final session;.

Group Type EXPERIMENTAL

5+1 Adapted, early-stage dyadic care planning intervention

Intervention Type BEHAVIORAL

The intervention group will receive the adapted SHARE Dyadic program, consisting of five, 60-90-minute curriculum-guided sessions with a SHARE Counselor, plus one optional family session.

Control (Treatment as usual single session)

Control group dyads are comprised of a PLWD with mild to moderate dementia and his/her preferred CG. Following recruitment and the consent process and screening, baseline telephone interviews (T1) with trained interviewers from the Benjamin Rose Institute on Aging will be completed separately with all CGs and PLWDs. Control group participants will receive a treatment as usual equivalent: a standardized educational and resource single session with a packet of information. A (T2) follow-up interview will be conducted approximately approximately eight weeks after (T1) baseline interviews.

Group Type ACTIVE_COMPARATOR

Counseling session and printed resources

Intervention Type BEHAVIORAL

Control group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

5+1 Adapted, early-stage dyadic care planning intervention

The intervention group will receive the adapted SHARE Dyadic program, consisting of five, 60-90-minute curriculum-guided sessions with a SHARE Counselor, plus one optional family session.

Intervention Type BEHAVIORAL

Counseling session and printed resources

Control group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* African American dyads (both the caregivers and the care-recipient, an individual with an early-stage memory impairing condition (e.g., Alzheimer's disease, vascular dementia, cognitive impairment, etc.)
* Care-recipient lives at home.
* The caregiver (CG) and/or the person with dementia (PWD), or symptoms of memory loss must identify as African American.
* PWD must be at least 50 years old and CGs 18 or older,
* Ability to speak and read English,
* Experiencing signs and symptoms of mild to moderate dementia through family caregiver report on the Dementia Severity Rating Scale and meeting the National Institute on Aging and the Alzheimer's Association clinical criteria for probable AD.

Exclusion Criteria

* A mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
* A traumatic brain injury
* Intellectual or developmental disability
* Individuals experiencing extreme difficulty adjusting and coping to the diagnosis • Individuals living in an institutional setting

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No