- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06257095
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program
February 5, 2024 updated by: Jason Burnett, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jason Burnett, PhD
- Phone Number: (713) 873-4685
- Email: Jason.Burnett@uth.tmc.edu
Study Contact Backup
- Name: Sophia Wasik
- Phone Number: (713) 873-4685
- Email: Sophia.Wasik@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center at Houston
-
Contact:
- Sophia Wasik
- Phone Number: (713) 873-4685
- Email: Sophia.Wasik@uth.tmc.edu
-
Contact:
- Jason Burnett, PhD
- Phone Number: 713-873-4685
- Email: Jason.Burnett@uth.tmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
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.
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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in social isolation assessed by the Duke Social Support Index (DSSI-6)
Time Frame: baseline, 4-week and 8-week follow-up
|
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
Time Frame: baseline, 4-week and 8-week follow-up
|
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)
Time Frame: baseline, 4-week and 8-week follow-up
|
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)
Time Frame: From participant's first call to 1 month post final call
|
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)
Time Frame: From participant's first call to 1 month post final call
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)
Time Frame: baseline, 4-week and 8-week follow-up
|
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
|
Change in resilience as assessed by the Brief Resilience Scale
Time Frame: baseline, 4-week and 8-week follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jason Burnett, PhD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2023
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
February 5, 2024
First Submitted That Met QC Criteria
February 5, 2024
First Posted (Actual)
February 13, 2024
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-23-0344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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