Depression in Old AgeNCT06257095
Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program
A study testing Stepped-care social and mental health engagement in people with Depression in Old Age, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Old Age
- What is being tested?
- Stepped-care social and mental health engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older Adults
- an APS validated EM/SN case
- able to provide informed consent
- able to speaks English or Spanish
- able to hear sufficiently using the telephone
- transitioning out of APS intervention (i.e. in the case closure phase of the APS service).
Show all 11Show fewer
- Student
- college or university student
- enrolled in a health-related program
- commit to making 8-weekly consecutive calls
- complete the required 1-hour training and assessment.
Who cannot join
- 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
- Student
- -only engaging in the program to fulfill some educational requirement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jason Burnett, PhD, (713) 873-4685, Jason.Burnett@uth.tmc.edu
Jordan Broussard, MS, (713) 500-0321, Jordan.Broussard@uth.tmc.edu
About this study
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.
- Conditions
- Depression in Old Age
- Being tested
- Stepped-care social and mental health engagement, APS Usual care
- Keywords
- social engagement, Adult Protective Services (APS), elder abuse, self neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped-care social and mental health engagementBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Behavioral: Stepped-care social and mental health engagement; Behavioral: APS Usual care |
| Usual Care | Active comparator | Not described Receives: Behavioral: APS Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: From participant's first call to 1 month post final call
Secondary outcomes (4)
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
Measured: baseline, 4-week and 8-week follow-up
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.
Measured: baseline, 4-week and 8-week follow-up
Change in Anxiety as Assessed by the Generalized Anxiety Disorder 2-Item Scale (GAD-2)
This is a 2 item questionnaire and each is scored from 0(not at all) to 3( nearly every day).Total scores range from 0 to 6, with higher scores indicating greater anxiety symptom severity. A score of ≥3 is considered a positive screen for clinically significant anxiety.
Measured: baseline, 4-week and 8-week follow-up
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-2 (PHQ-2)
This is a 2 item questionnaire and each is scored from 0(not at all) to 3(nearly every day) for a total score range of 0-6,higher scores indicate greater depressive symptom severity
Measured: baseline, 4-week and 8-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start9 Aug 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Jason Burnett, The University of Texas Health Science Center, Houston
- Investigators
- Jason Burnett, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257095
- Sponsor's protocol ID
- HSC-MS-23-0344
- Status last verified
- May 2026
- First submitted
- 5 Feb 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adult Protective Services Client Outcomes: A Stepped-Care Social and Mental Health Engagement Program
- ClinicalTrials.gov ID
- NCT06257095
- Acronym / sponsor ID
- HSC-MS-23-0344
- Conditions
- Depression in Old Age
- Keywords
- social engagement, Adult Protective Services (APS), elder abuse, self neglect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Stepped-care social and mental health engagement, Behavioral: APS Usual care |
| Usual Care | Active comparator | Behavioral: APS Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Older Adults
- an APS validated EM/SN case
- able to provide informed consent
- able to speaks English or Spanish
- able to hear sufficiently using the telephone
Key exclusion criteria (5 listed)
- 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
- Student
- -only engaging in the program to fulfill some educational requirement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped-care social and mental health engagementEach 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. | Behavioural | Treatment |
| APS Usual careParticipants 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. | Behavioural | Treatment, Usual Care |
Primary outcome
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
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
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
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)
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)
4 secondary outcomes
Change in anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)
Time frame: 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
Change in Anxiety as Assessed by the Generalized Anxiety Disorder 2-Item Scale (GAD-2)
Time frame: baseline, 4-week and 8-week follow-up
Change in Depressive Symptoms as Assessed by the Patient Health Questionnaire-2 (PHQ-2)
Time frame: baseline, 4-week and 8-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Burnett, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped-care social and mental health engagement in people with Depression in Old Age, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Burnett, PhD ((713) 873-4685, Jason.Burnett@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in social isolation assessed by the Duke Social Support Index (DSSI-6) (time frame: baseline, 4-week and 8-week follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.