NCT06257095

Brief Summary

The purpose of this study is to ascertain the feasibility and effectiveness of an 8-week social engagement program aimed at reducing depression and increasing social engagement among seniors who are transitioning out of Adult Protective Services (APS) for either elder abuse or self-neglect.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

February 5, 2024

Last Update Submit

February 5, 2024

Conditions

Keywords

social engagementAdult Protective Services (APS)elder abuseself neglect

Outcome Measures

Primary Outcomes (5)

  • Change in social isolation assessed by the Duke Social Support Index (DSSI-6)

    This is a 6-item questionnaire and each is measured from 1(hardly ever) to 3(most of the time) for a maximum score of 18, higher score indicating greater social support

    baseline, 4-week and 8-week follow-up

  • Change in loneliness as assessed by the University of California Los Angeles (UCLA )loneliness scale

    This is a 20-item questionnaire , each item is rated as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way") for a score range of 0-3,for a maximum score of 60, higher score indicating worse outcome

    baseline, 4-week and 8-week follow-up

  • Change in depression as assessed by the PATIENT HEALTH QUESTIONNAIRE (PHQ-9)

    This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) , for a maximum score of 27 , higher score indicating more depression

    baseline, 4-week and 8-week follow-up

  • Recurrence of Elder mistreatment (EM)

    This is a yes or no questionnaire that will be answered by adult protective services (APS)

    From participant's first call to 1 month post final call

  • Recurrence of self neglect (SN)

    This is a yes or no questionnaire that will be answered by adult protective services (APS)

    From participant's first call to 1 month post final call

Secondary Outcomes (2)

  • Change in anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)

    baseline, 4-week and 8-week follow-up

  • Change in resilience as assessed by the Brief Resilience Scale

    baseline, 4-week and 8-week follow-up

Study Arms (2)

Treatment

EXPERIMENTAL
Behavioral: Stepped-care social and mental health engagementBehavioral: APS Usual care

Usual Care

ACTIVE COMPARATOR
Behavioral: APS Usual care

Interventions

Each student will be matched to an older adult and the students will make one call o the older adult which lasts upto 1 hour each week for 8 weeks. Ending each call, the student will assess symptoms of depression anxiety through questionnaires. If the participant responds yes on two consecutive calls to any of these questions, they will be asked if they would like to receive a call from the University of Texas Health Science Center Trauma and Resilience Center to discuss free counseling services.

Treatment
APS Usual careBEHAVIORAL

Participants will receive a phone call for data collection. Then they will be offered to receive an abbreviated version of the stepped-care social and mental health engagement intervention, lasting only 6-weeks with the option to continue calls if agreeable between the student and older adult.

TreatmentUsual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Older Adults
  • an APS validated EM/SN case
  • able to provide informed consent
  • able to speaks English or Spanish,
  • community-dwelling,
  • able to hear sufficiently using the telephone
  • transitioning out of APS intervention (i.e. in the case closure phase of the APS service).
  • Student
  • college or university student
  • enrolled at one of the UTHealth graduate programs in Houston, University of Houston, Texas Southern University, Sam Houston State University, or Rice University
  • commit to making 8-weekly consecutive calls
  • complete the required 1-hour training and assessment.

You may not qualify if:

  • Older Adults
  • Individuals needing a proxy to consent
  • suspected or confirmed decision-making capacity impairments or uncontrolled psychiatric illnesses such as schizophrenia, paranoia, delusion, or delirium
  • Older adults transitioning to a nursing home, assisted-living, or residential care facility
  • Student
  • only engaging in the program to fulfill some educational requirement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

  • Jason Burnett, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

August 9, 2023

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations