Treatment Trials

10 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Psychosexual Educational Partners Program (PEPP)
Description

The purpose of this study is to compare two Psychosexual Educational programs for women who have completed treatment for breast or gynecological cancer and their partners in preparation for a well-powered phase III study. The investigators plan to enroll 30 dyads in a 2-arm pilot randomized controlled trial (RCT). The primary aim will be to assess the preliminary efficacy of the Psychosexual Educational Partners Program (PEPP) on sexual communication.

ENROLLING_BY_INVITATION
Improving Father-Child and Father-Partner Relationships Among Black and Hispanic Fathers
Description

Fathers play a unique role in the lives of children, with high quality interactions found to improve a child's executive functioning and general school achievement. Father involvement also has positive impacts on fathers themselves, with more involved fathers reporting more self-confidence in their parenting, more satisfaction with parenting, demonstration of more maturity, and reports of less psychosocial distress. However, poverty can have a negative association with fathers parenting and child outcomes, though paternal warmth can mediate this relationship. Children's Institute Inc will recruit and implement the 24/7 Dad program which is designed to provide a comprehensive evidenced-based fatherhood program that builds and strengthens father-child relationships. The curriculum for the primary workshops will be the 24/7 Dad curriculum, which addresses both the responsible parenting and healthy relationship areas in this project. A quasi-experimental interrupted time series (ITS) design allows for a continuous sequence of observations on a population, taken repeatedly over time.

RECRUITING
Relationship Checkups to Reduce Veteran Suicide Risk
Description

This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care. One approach is a 3-session couple-based program called the Brief Relationship Checkup (BRC). BRC has shown promise improving relationship health in Air Force primary care (including some mental health symptoms related to relationship functioning) but has never been tested for individuals with significant mental health concerns. The other approach is a high-quality delivery of three sessions of Co-Located Collaborative Care (CCC) with the Screened Veteran only. This program is the current standard of care for Veterans reporting mental health concerns in primary care (including mental health concerns related to their relationship) but has never been tested for individuals struggling with relationship concerns. The goal is to compare the benefits of the couples-based program vs. the individual-based program when it comes to reducing suicide risk factors at the relationship level and the individual level.

NOT_YET_RECRUITING
Effects of Aphasia Identification Cards on Service Workers' Comprehension of People With Aphasia
Description

The goal of this clinical trial is to learn whether healthy volunteers are more successful at understanding people with aphasia if they have first viewed an aphasia identification (ID) card. The main questions this study aims to answer are: * Does viewing an aphasia ID card improve healthy volunteers' understanding of the language errors made by people with aphasia? * Does viewing an aphasia ID card improve healthy volunteers' understanding of people with aphasia who make long pauses in their speech? Researchers will compare aphasia ID cards to a control condition (no ID card) to see whether aphasia ID cards improve healthy volunteers' understanding. Healthy volunteers will visit the study site for a single session (about 2 hours long). During the session they will: * Complete brief tests of their vision, hearing and thinking * Listen to sentences produced by a speaker with aphasia while their eye movements are recorded * Complete a survey about the experience of listening to the speaker with aphasia

Conditions
RECRUITING
Alcohol and Sexual Communication Among Couples in the Laboratory
Description

Intimate Partner Sexual Violence (IPSV) is a significant and understudied public health problem among sexual minority (SM) and heterosexual couples, yet little is known about factors that contribute to IPSV perpetration. This proposal aims to determine the acute effect of alcohol and sexual communication on IPSV. In this study, 240 couples (50% SM) who drink alcohol will be recruited from the Metro-Denver area. Upon arrival to the laboratory, a trained research assistant will check the participant's ID, verify that they adhered to the pre-session guidelines, administer a breath test to ensure a breath alcohol content (BrAC) of 0.00 and conduct a field sobriety test. They will also obtain informed consent for each member of the couple separately. Female participants will take a pregnancy test to ensure a negative result. All participants will complete measures to reverify eligibility criteria and be weighed to determine their correct alcohol dose. Partners will separately complete a baseline survey measuring demographic factors, alcohol use, sexual communication, and daily experiences. After completing the survey, participants will be assigned a beverage condition (alcohol or no-alcohol control) and couples will be randomly assigned to a sexual communication condition (direct verbal or indirect verbal). Participants will be seated in a room separate from their partner, where they will drink an alcoholic or no-alcohol control beverage. Upon reaching a breath alcohol content (BrAC) of .08, or immediately after drinking in the No-Alcohol control condition, participants will complete a laboratory assessment of sexual violence. The main hypotheses are: (1) one's alcohol use will increase IPSV toward partners who are also drinking, (2) one's alcohol use will increase IPSV among partners who use indirect, relative to direct, sexual communication, and (3) actor alcohol use will increase IPSV toward partners who are also drinking and use indirect, relative to direct, sexual communication.

RECRUITING
Developing a Communication Intervention for People With Memory Challenges and Their Care Partners
Description

The proposed research is consistent with broader public health goals focused on improving communication regarding end-of-life care and the Centers for Medicare and Medicaid Services' (CMS) call for increased patient engagement in advance care planning (ACP) as part of standard care. The proposed study will address this public health issue by developing a communication-based intervention designed to improve Alzheimer's Disease and Related Dementias (ADRD) patients' and care partners' engagement in ACP, distress and care partner burden, and completion of advance directives and receipt of goal-concordant care at the end-of-life. Therefore, this study is aligned with the National Institute on Aging's long-term goal to improve the quality of care for ADRD patients and CMS's goal to increase engagement in ACP.

COMPLETED
Trial of Print Messages to Support the Role of Partners in Promoting Provider Discussions About Prostate Cancer Screening Among AA Men
Description

The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.

Conditions
UNKNOWN
Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners
Description

RATIONALE: Participating in a therapy program may enhance communication and intimacy between men with prostate cancer and their partners. PURPOSE: This randomized clinical trial is studying how well therapy enhances communication and intimacy for men with early stage prostate cancer and for their partners.

ACTIVE_NOT_RECRUITING
Primary Progressive Aphasia Multicomponent Language Treatment Study
Description

Primary progressive aphasia (PPA) is a progressive neurological disorder that causes a gradual decline in communication ability as a result of selective neurodegeneration of speech and language networks in the brain. PPA is a devastating condition affecting adults as young as in their 50's, depriving them of the ability to communicate and function in society. As a result of improved diagnostic precision, PPA is now identified with greater accuracy and frequency and, increasingly, patients and their families seek options for behavioral treatments to ameliorate the devastating effects on their communication, prolong speech language skills, and maximize quality of life. Speech-language treatment outcomes from our group and others are encouraging, confirming that behavioral intervention may lead to improvements in trained behaviors and, for some interventions, lasting and generalized benefit. Most speech-language interventions for individuals with PPA that have been explored in the literature are restitutive, or impairment-based in nature, and have not addressed the full range of severity and phenotypic variability in this population. The investigators will evaluate the utility of a novel, multicomponent intervention that incorporates elements of restitutive (e.g., word finding strategic training, script training), compensatory (e.g., multimodal communication, communication book), and care partner-focused treatment to meet the needs of individuals varying in clinical presentation and severity.

RECRUITING
Peer Interventions for Preschoolers With Autism
Description

This proposal will evaluate a series of peer-mediated interventions (PMIs) for preschool children (3 to 6 years) with ASD and limited or no spoken language, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of PMIs for improving social communication in children with ASD. Peer-related social competence is vital to a wide range of child outcomes, such as improved communication and fewer behavioral problems. Unfortunately, approximately 30% of children with ASD remain minimally-verbal in kindergarten, restricting participation in inclusive activities. Recent studies report improved communication after a speech-generating device (SGD) is included in treatment. Effective interventions that can be modified is necessary to ensure optimal communication outcomes when children do not make anticipated progress. A strength of the study is that these interventions can be adopted by community-based, early service providers. All participants will receive an adapted Stay-Play-Talk (SPT) peer-mediated intervention that varies in active ingredients. With SMART designs, it is possible to test and identify alternative combinations of PMI approaches, such as the addition of a SGD. In this study, 132 preschoolers with ASD (and N=264 peers without disabilities) will be initially randomized to SPT and SGD with spoken peer input only (SPT Basic; peers taught to model language) or SPT and SGD with augmented peer input (SPT Plus; peers taught to use verbal language models concurrently with the SGD). Each child's response to treatment after 5 weeks will determine that child's next phase in the SMART design. Children showing a positive response will continue in their originally assigned group; slow responders will be randomly assigned to receive added treatment components to improve communication (either SPT Plus or SPT Advanced). SPT Advanced adds direct instruction strategies (i.e., adult prompts, reinforcers, and teaching trials) to increase child vocalizations in SGD interventions. The use of a SMART design extends our prior work by testing the systematic addition of selected peer-mediated strategies in combination with an SGD that allows for flexible application of interventions based on child response. The investigators have assembled an outstanding team of highly qualified investigators with complementary skills in preschool assessment, language intervention, clinical trials, and statistics.