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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06257095
Other study ID # HSC-MS-23-0344
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 9, 2023
Est. completion date June 1, 2025

Study information

Verified date February 2024
Source The University of Texas Health Science Center, Houston
Contact Jason Burnett, PhD
Phone (713) 873-4685
Email Jason.Burnett@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Stepped-care social and mental health engagement
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.
APS Usual care
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.

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston US Department of Health and Human Services, Administration on Community Living

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Change in anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7) This is a 7-item questionnaire , each is scored from 0(not at all) to 3(nearly every day), for a score range of 0-21 higher score indicating more anxiety baseline, 4-week and 8-week follow-up
Secondary Change in resilience as assessed by the Brief Resilience Scale This is a 6-item questionnaire, questions 1, and 5 are scored from 1(strongly disagree) to 5(strongly agree) and questions 2, 4 and 6 are reverse scored , for a score range of 6-30. The total score is then divided by the number of questions answered to get the final score. higher score indicating more resilience. baseline, 4-week and 8-week follow-up
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