Spanish Intervention for Caregivers of Veterans With Stroke (RESCUE)

December 2, 2025 updated by: VA Office of Research and Development

Spanish Online & Telephone Intervention for Caregivers of Veterans With Stroke

This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This research study will test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. The investigators will adapt their previously pilot-tested problem-solving intervention and make it culturally-relevant for Hispanic caregivers. The investigators' main goal is to test the efficacy of a brief, telephone and online problem-solving intervention. The objectives are: 1) reduce caregiver burden and depression, 2) improve caregivers' problem-solving abilities, self-efficacy, and quality of life, 3) improve Veterans' functional abilities and determine the intervention's impact on Veterans' healthcare utilization, 4) determine budgetary impact, and 5) determine caregivers' perceptions of the intervention.

The investigators will conduct a two-arm (8-session intervention vs. standard care), , randomized controlled trial to test a problem-solving intervention for Spanish-speaking stroke caregivers that will be delivered over the telephone and online via the previously developed and nationally available Spanish version of the RESCUE website. A sample of 290 stroke caregivers will be randomly assigned to either an intervention or a standard care group. Eligibility criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group. We will determine caregiver status.

Baseline measurements will be conducted with the caregivers prior to the intervention. Post-test assessments will be collected at 1 and 12 weeks post-intervention. In addition, the investigators will obtain pre- and post-test measures of Veteran-related variables via Computerized Patient Record System (CPRS) electronic health records. Qualitative interviews will be conducted to assess caregivers' perceptions of the intervention. A general linear mixed model for repeated measures will be used to examine the relationship between treatment assignment and each outcome over time. The investigators will measure the budgetary impact of providing intervention by comparing the costs of the intervention group to the costs of the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927-3200
        • VA Caribbean Healthcare System, San Juan, PR
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608-1135
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
      • Orlando, Florida, United States, 32803
        • Orlando VA Medical Center, Orlando, FL
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans' Hospital, Tampa, FL

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Hispanic caregivers of Veterans with a primary diagnosis of stroke are eligible for participation if they meet the following criteria: 1) are the primary caregiver and provide the majority of care for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438 or ICD 10 codes 160.0 through 169.998) within the last year and who has at least two activity of daily living (ADL) deficits or a new or worsening neurological problem, 2) have Internet access and ability, (either themselves or via a relative or friend) 3) are reachable by cell or home phone, 4) Spanish is their preferred language, 5) have moderate to severe stress, and 6) ) identify self as Hispanic, and 7) agree to random assignment to the intervention or standard care group.

Random assignment to the intervention or standard care group. The investigators will determine caregiver status.

Exclusion Criteria: The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria or are managing end-of-life issues (stroke survivors are likely to die within five months following discharge).

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Care
The standard care group will receive the usual standard care they would receive had they not been enrolled in this study
Experimental: Problem Solving Intervention
Participants in the intervention group received an 8-week problem-solving session conducted over the phone by a trainer interventionist. The intervention consists of four components: 1. Introduction to the RESCUE website and the problem-solving method; 2. Illustrative example on how to use the problem-solving approach and the RESCUE website to address caregiving problems; 3. Individualized practice exercise to develop a personalized problem-solving plan; and 4. Summary of the problem-solving method.
Other: RESCUE Problem Solving Intervention
The RESCUE Problem Solving Intervention: This is an education and support intervention for caregivers of Veterans with stroke. The investigators taught study participants the COPE (Creativity, Optimism, Planning, Expert Advice) model of problem solving and guided them through the application of this model in their caregiver role. They also receive tailored stroke education, specific to their needs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Caregiver Depression at 9 Weeks
Time Frame: 9 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
9 weeks after baseline
Change in Caregiver Depression at 21 Weeks
Time Frame: 21 weeks after baseline
Caregiver depression as measured by the Center for Epidemiologic Studies Depression-20. The CES-D is a 20 item, four point Likert scale ranging from never (0) to most of the time (3). The minimum value is 0 and the maximum value is 60. The higher score means a worse outcome (more depressed). This tool has good reliability and validity.
21 weeks after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Caregiver Burden-Zarit - 9 Weeks
Time Frame: 9 weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
9 weeks
Change in Caregiver Burden-Zarit - 21 Weeks
Time Frame: 21 weeks
Changes in burden will be measured by the Zarit Burden Interview instrument. This 22 item instrument is scored on a 5-point Likert scale, ranging from 0 (Never) to 4 (Nearly Always). The minimum value is 0 and the maximum score is 88. Higher scores indicate higher burden.
21 weeks
Change in Caregiver Self-Efficacy-Obtaining Respite - 9 Weeks
Time Frame: 9 weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
9 weeks
Change in Caregiver Self-Efficacy-Obtaining Respite - 21 Weeks
Time Frame: 21 weeks
Change in Self-Efficacy is measured by the Revised Scale for Caregiving Self-Efficacy- Obtaining Respite subscale. The subscale contains 5 items which asks caregivers to rate their level of confidence (from 0% to 100%) to ask for assistance. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
21 weeks
Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 9 Weeks
Time Frame: 9 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
9 weeks
Changes in Caregiver Self-Efficacy- Controlling Upsetting Thoughts - 21 Weeks
Time Frame: 21 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Controlling Upsetting Thoughts subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
21 weeks
Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 9 Weeks
Time Frame: 9 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
9 weeks
Changes in Caregiver Self-Efficacy: Responding to Disruptive Behaviors - 21 Weeks
Time Frame: 21 weeks
Measured by Revised Scale for Caregiver Self Efficacy - Responding to Disruptive Behaviors subscale (Steffen et al 2002). The subscale contains 5 items which ask caregivers to rate their level of confidence (from 0% to 100%) in their ability to control negative thoughts related to caregiving. The subscale score is obtained by calculating the mean of the items, with a total score range of 0-100. Higher scores indicate higher self-efficacy. The subscale shows strong internal consistency and adequate test-retest reliability.
21 weeks
Change in Veteran's Functional Abilities- 9 Weeks
Time Frame: 9 weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
9 weeks
Change in Veteran's Functional Abilities- 21 Weeks
Time Frame: 21 weeks
Changes in Veteran functional abilities as measured by the Stroke Impact Scale-16 (SIS-16). The SIS-16 is a 16 item physical dimension instrument, developed as a brief standalone tool for measuring the physical aspects of stroke recovery. We modified this instrument to be administered to the caregiver about their evaluation of Veteran's functional ability. Scoring is based on a 5-point Likert scale, ranging from 16-80 points with 1 = an inability to complete the item & 5 = no difficulty experienced at all. Total Scores are transformed scores which have been standardized on a scale of 0-100 where higher scores indicate higher functional outcomes.
21 weeks
Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 9 Weeks
Time Frame: 9 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
9 weeks
Changes in Caregiver Health-Related Quality of Life - Physical Component Score - 21 Weeks
Time Frame: 21 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
21 weeks
Changes in Caregiver Health Related Quality of Life - Mental Health Component - 9 Weeks
Time Frame: 9 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
9 weeks
Changes in Caregiver Health Related Quality of Life - Mental Health Component - 21 Weeks
Time Frame: 21 weeks
Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life. There is no composite or overall score for the VR-12.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Positive Problem Orientation (PPO) at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Negative Problem Orientation (NPO) at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Rational Problem-Solving (RPS) at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Impulsivity/Carelessness Style (ICS) at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) -Change in Caregiver Problem Solving Abilities- Avoidance Style (AS) at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 9 Weeks
Time Frame: 9 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
9 weeks
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S) - Change in Caregiver Problem Solving Abilities- Problem Solving Total at 21 Weeks
Time Frame: 21 weeks
The Social Problem Solving Inventory Revised- Short Form (SPSI-R:S) is a 25-item, self-report instrument that evaluates characteristics of social problem solving, including problem solving orientation and problem solving performance. The SPSI-R:S consists of five subscores: positive problem orientation (PPO), negative problem orientation (NPO), rational problem solving style (RPS), impulsivity/carelessness style (ICS), and avoidance style (AS). Each sub-score contains five items that are scored on a five-point Likert-type rating scale, ranging from 0 (not at all true) to 4 (extremely true). Standardized scores range depending on the age of the person: Subscale PPO- 47-135; Subscale NPO= 74-162; Subscale RPS= 56-136; Subscale ICS= 73-162; Subscale AS= 76-157, Total SPSI= 29-140. Higher subscores on PPO and RPS, and lower subscores of NPO, ICS, and AS indicate good social problem solving.
21 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 9 Weeks
Time Frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
9 weeks
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - 21 Weeks
Time Frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
21 weeks
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 9 Weeks
Time Frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
9 weeks
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Emergency Room Visits - 21 Weeks
Time Frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
21 weeks
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 9 Weeks
Time Frame: 9 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
9 weeks
Veteran's Healthcare Utilization - Number of Participants With Hospitalizations - Unplanned Primary Care Visits - 21 Weeks
Time Frame: 21 weeks
Veterans' Healthcare Utilization as measured by a survey developed for this study to record the number, dates, and the reasons for all healthcare visits (hospitalizations, ER, clinic visits) Veterans had during the course of the study. The survey consisted of ten questions with combined response choices including categorical (yes/no) and open responses (what was the reason for the visit). While the utilization variables are numerical, they are count variables with positive skew; the majority of values are 0, but with some values ranging from 1-4. Thus, we analyzed the variables as categorical (yes/no), using Chi-Square tests and providing values as frequencies.
21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivette M Freytes, PhD MEd BA, North Florida/South Georgia Veterans Health System, Gainesville, FL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIR 15-117

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Depression

Clinical Trials on RESCUE Problem Solving Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings