{"title":"Protocol for a randomized clinical trial of strength at home parents: A trauma informed parenting intervention for veterans","authors":"","doi":"10.1016/j.conctc.2024.101363","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Post-traumatic stress disorder (PTSD) is highly prevalent in veterans and associated with impairments in family functioning, including parenting. There is a bidirectional relationship between PTSD and familial functioning such that impaired functioning is related to increases in trauma-related symptoms, and vice versa. Despite this known bidirectional association, there is currently no trauma-informed parenting intervention available for veterans within the Department of Veterans Affairs (VA). Strength at Home – Parents (SAHP) is an 8-session telehealth delivered psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with PTSD symptoms. This paper describes the methods of an individually randomized group therapy trial to test the efficacy of SAHP compared to a VA treatment as usual control condition<em>.</em>Methods are reported using SPIRIT guidelines.</p></div><div><h3>Methods</h3><p>One hundred and ninety veterans with elevated PTSD symptoms and parent-child functioning problems will be randomly assigned to the SAHP intervention or a treatment-as-usual control group. Outcomes are measured at 4 timepoints including baseline. The primary outcome is parenting stress. We will also examine changes in parenting behaviors, whether treatment gains are maintained over time, and will conduct an exploratory analysis to examine results separately by gender. Secondary outcomes include symptoms of PTSD and depression, family functioning, and child psychosocial functioning.</p></div><div><h3>Conclusion</h3><p>Study findings will determine the efficacy of SAHP, an intervention developed for ease of use and implementation within the VA to improve parenting stress and parenting behaviors in veterans with elevated PTSD symptoms and parenting difficulties.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001108/pdfft?md5=aa58fa654c80a366a3f8dcc05b03ebb6&pid=1-s2.0-S2451865424001108-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424001108","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Post-traumatic stress disorder (PTSD) is highly prevalent in veterans and associated with impairments in family functioning, including parenting. There is a bidirectional relationship between PTSD and familial functioning such that impaired functioning is related to increases in trauma-related symptoms, and vice versa. Despite this known bidirectional association, there is currently no trauma-informed parenting intervention available for veterans within the Department of Veterans Affairs (VA). Strength at Home – Parents (SAHP) is an 8-session telehealth delivered psychotherapy group that aims to improve parenting behaviors and overall parent-child and family functioning among U.S. military veterans with PTSD symptoms. This paper describes the methods of an individually randomized group therapy trial to test the efficacy of SAHP compared to a VA treatment as usual control condition.Methods are reported using SPIRIT guidelines.
Methods
One hundred and ninety veterans with elevated PTSD symptoms and parent-child functioning problems will be randomly assigned to the SAHP intervention or a treatment-as-usual control group. Outcomes are measured at 4 timepoints including baseline. The primary outcome is parenting stress. We will also examine changes in parenting behaviors, whether treatment gains are maintained over time, and will conduct an exploratory analysis to examine results separately by gender. Secondary outcomes include symptoms of PTSD and depression, family functioning, and child psychosocial functioning.
Conclusion
Study findings will determine the efficacy of SAHP, an intervention developed for ease of use and implementation within the VA to improve parenting stress and parenting behaviors in veterans with elevated PTSD symptoms and parenting difficulties.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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