[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657857":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":54,"studyPopulation":43,"armGroups":55,"interventions":68,"overallOfficials":77,"centralContacts":84,"locations":92,"responsibleParty":163,"collaborators":165,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":43,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":43,"enrollmentInfo":181,"targetDuration":43,"studyType":184,"phases":185,"briefSummary":187,"conditions":188,"keywords":43,"overallStatus":201,"whyStopped":43,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"New York University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":43},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Post-traumatic stress disorder (PTSD) Checklist 5","The PCL-5 will be used to assess severity and change in PTSD symptoms. The PCL-5 is a 20-item self-report measure with strong evidence of reliability and convergent validity. Participants indicate the degree to which they have been bothered by problems related to a traumatic experience in the past month (e.g., \"repeated, disturbing dreams of the stressful experience\"; \"feeling very upset when something reminded you of the stressful experience\") on a 5-point Likert scale (0=not at all; 1=a little bit; 2=moderately; 3=quite a bit; 4=extremely). Summed responses yield a continuous score ranging from 0 to 80; higher scores indicate greater symptom severity.","Four assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), post-treatment (approximately 17 weeks after baseline), and 6-month follow-up (approximately 41 weeks after baseline).",{"measure":14,"description":15,"timeFrame":12},"Patient Health Questionnaire-9 (PHQ-9)","The PHQ-9 will be used to assess severity and change in depressive symptoms. The PHQ-9 is a 9-item self-report measure with strong evidence of reliability and predictive and convergent validity. Participants indicate how often they have been bothered by particular problems within the past two weeks (e.g., \"feeling down, depressed, or hopeless\"; \"poor appetite or overeating\") on a 4-point Likert scale (0=not at all; 1=several days; 2=more than half the days; 3=nearly every day). Summed responses yield a continuous score ranging from 0 to 27; higher scores indicate greater symptom severity.",{"measure":17,"description":18,"timeFrame":19},"Adult Adolescent Parenting Inventory-version 2 (AAPI-2)","The AAPI-2 will be used to measure child-maltreatment risk. The AAPI-2 is a 40-item self-report measure with strong psychometric properties and predictive validity. Participants indicate how much they agree or disagree with statements about parenting and raising children (e.g., \"Time-out is an effective way to discipline children\") on a 5-point Likert scale (SD=Strongly disagree, D=Disagree, U=Uncertain, A=Agree, SA=Strongly agree). AAPI-2 is scored using a stencil to assign each answer a number; summed numbers for five parenting categories are converted into standard scores that are plotted on a profile chart to show risk for abusive or neglectful parenting behavior.","Three assessment timepoints: pre-treatment (baseline), post-treatment (approximately 17 weeks after baseline), and 6-month follow-up (approximately 41 weeks after baseline).",[21,24,27,30,33,36,40],{"measure":22,"description":23,"timeFrame":12},"Strengths and Difficulties Questionnaire (SDQ)","The SDQ will be used to assess child behaviors. The SDQ is a 25-item parent-report measure with good reliability, cross-informant correlation, and retest stability. Participant mothers indicate how true or untrue various statements about child behavior are relative to their participating child (e.g., \"Shares readily with other children, for example toys, treats, pencils\", \"Often fights with other children or bullies them\") on a 3-point Likert scale (0=not true; 1=somewhat true; 2=certainly true). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater behavioral difficulty.",{"measure":25,"description":26,"timeFrame":12},"Parenting Sense of Competence Scale (PSOC)","The PSOC will be used to assess parental functioning as reflected by parenting self-efficacy. The PSOC is a 17-item self-report measure with strong evidence of reliability and validity. Participants indicate how much they agree or disagree with statements related to parenting (e.g., \"Being a parent is manageable, and any problems are easily solved\"; \"My mother\u002Ffather was better prepared than I am to be a good parent\") on a 6-point Likert scale (1=strongly disagree; 2=disagree; 3=somewhat disagree; 4=somewhat agree; 5=agree; 6=strongly agree). Summed responses yield a continuous score ranging from 17 to 102; higher scores indicate greater parenting competency.",{"measure":28,"description":29,"timeFrame":12},"Difficulties in Emotion Regulation Scale (DERS)","DERS, which measures emotion regulation, will be evaluated as a potential mediator. DERS is a 36-item self-report measure with adequate reliability and construct and predictive validity. Participants indicate how true or untrue various statements about emotions are for them (e.g., \"I have no idea how I am feeling\"; \"I know exactly how I am feeling\") on a 5-point Likert scale (1=almost never; 2=sometimes; 3=about half the time; 4=most of the time; 5=almost always). Summed responses yield a continuous score ranging from 36 to 180; higher scores indicate greater emotion regulation difficulty.",{"measure":31,"description":32,"timeFrame":12},"Brief Cope","Brief Cope, which measures coping, will be evaluated as a potential mediator. Brief Cope is a 28-item self-report measure with adequate reliability and convergent and discriminant validity. Participants indicate how much or how often they have used various coping strategies (e.g., \"I used alcohol or other drugs to make myself feel better\"; \"I took action to try to make the situation better\") on a 4-point Likert scale (0=I didn't do this at all; 1=I did this a little bit; 2=I did this a medium amount; 3=I did this a lot). Summed responses within each of 14 subscales (e.g., substance use; active coping) yields a continuous score ranging from 0 to 6; higher scores indicate greater use of a particular coping strategy.",{"measure":34,"description":35,"timeFrame":12},"Dyadic Parent-Child Interaction Coding System-IV (DPICS)","Parent interaction will be videotaped and coded by independent assessors. 10% of recordings will also be coded at UC Davis Parent-Child Interaction Therapy (PCIT) Training Center by expert coders unaware of treatment condition. Positive scores include the number of observed praises, reflections, and behavioral descriptions used during the play session, and negative scores include the number of observed questions, commands, and negative talk. DPICS is administered for 15-minutes in total with three 5-minute sessions focusing on child-directed play (CDI), parent-directed play (PDI), and clean-up.",{"measure":37,"description":38,"timeFrame":39},"Treatment Acceptability and Expectations (TAE)","TAE is a 5-item measure developed by study co-investigator Dr. Marylene Cloitre, will be used to assess acceptability and feasibility of the intervention. Participants are asked to appraise the intervention (e.g., \"How logical does this type of treatment seem to you?\"; \"How successful do you think this treatment will be in reducing your trauma symptoms?\") on an 8-point Likert scale (0=not at all; 2=very little; 4=somewhat; 6=moderate; 8=extremely). Summed responses yield a continuous score ranging from 0 to 40; higher scores indicate greater acceptability.","Three assessment timepoints: mid-treatment (after session 11, approximately 11 weeks after baseline), post-treatment (approximately 17 weeks after baseline), and 6-month follow-up (approximately 41 weeks after baseline).",{"measure":41,"description":42,"timeFrame":19},"Military Stress of Life Survey","The Military Stress of Life Survey, a 14-item self-report measure adapted from the Department of Defense (DoD) Navy and Marine Stress of Life Survey, has been adapted for this study to assess lifetime and recent burden of military-related stressors. Participants indicate (0=no; 1=yes) whether they and their families have ever experienced various stressful situations associated with military life (e.g., \"A combat-related injury\"; \"Difficulty balancing the demands of family life and military duties\"), and if so, whether the experience occurred within the last 12 months. For every \"yes\" response, participants rate how stressful the particular experience was on a 4-point Likert scale (0=not stressful at all; 1=slightly stressful; 2=moderately stressful; 3=very stressful). Summed responses yield a continuous score ranging from 0 to 42; higher scores indicate a greater burden of military-related stressors.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"RANDOMIZED","PARALLEL","Parenting STAIR Modular (PSTAIR-M) is a 12 to 16-week intervention depending on the Modules selected for each individual participant. All participants receiving PSTAIR-M will receive Module 1. Module 1 is 11 sessions long and consists of four sessions focused on emotional regulation skill development, four focused on narrative exposure, and three involving dyadic parent coaching. Following Module 1, participants will complete the mid-treatment assessment; scores on this assessment will inform a shared decision-making session in which participants and clinicians will determine whether clients can proceed directly to a final termination session or if clients will continue on to Module 2. In Module 2, clients will receive three more sessions focused on skill development (2a), narrative exposure (2b), or parenting (2c).","TREATMENT",{"masking":50,"maskingDescription":51,"whoMasked":52},"SINGLE","Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions.",[53],"OUTCOMES_ASSESSOR","The study comprises two trials: A fully powered randomized controlled trial (RCT) (N=162; Trial 1) will be conducted in four continental US (CONUS) Cohen Veterans Network (CVN) clinics in Silver Spring, MD, Lawton, OK, Oklahoma City, OK, and Colorado Springs, CO. A pilot feasibility RCT (N=81; Trial 2) will be conducted in two overseas (OCONUS) CVN clinics at Camp Humphrey's and Osan Air Base in Pyeongtaek, South Korea. Eligible participants will be active-duty Service Members (SM) or their spouses with at least one child aged 2-10 who attest to lifetime trauma exposure and screen positive for PTSD and\u002For depression symptoms. Participants will be randomized to receive either PSTAIR-M or treatment-as-usual (TAU). PSTAIR-M will be delivered by CVN clinicians.\n\nParenting STAIR (PSTAIR) combines two existing evidence-based treatments (EBT), Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-CARE). Parenting-STAIR-Modular (PSTAIR-M) is a compact version of PSTAIR that includes a 12-session core (Module 1) and up to four additional sessions (Module 2), tailored by a decision rule and shared decision-making based on response to treatment.\n\nAssessments will occur at four timepoints: 1) pre-treatment (baseline); 2) mid-treatment (after session 11, approximately 11 weeks after baseline); 3) post-treatment (approximately 17 weeks after baseline); and 4) 6-month follow-up (approximately 41 weeks after baseline). Assessments will include self-report instruments and dyadic parenting observations.",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"Parenting STAIR Modular (PSTAIR-M)","EXPERIMENTAL","PSTAIR-M is a culturally adapted, 12-16-session modular intervention which combines elements of two existing EBTs: Skills Training in Affective and Interpersonal Regulation (STAIR), targeting maternal trauma and emotion dysregulation, and dyadic Parent-Child Care (PC-CARE), targeting parenting.",[61],"Behavioral: Parenting-STAIR Modular (PSTAIR-M)",{"label":63,"type":64,"description":65,"interventionNames":66},"Treatment as Usual (TAU)","ACTIVE_COMPARATOR","Treatment as usual (TAU) is defined as an established EBT that is already being delivered at the study sites on an ongoing basis. Possible EBTs include prolonged exposure, cognitive processing therapy, cognitive behavioral therapy, and emotion-focused therapy. Clinicians treating participants randomly assigned to TAU will determine the most appropriate course of treatment based on established clinic protocols for treatment assignment.",[67],"Behavioral: Treatment as Usual (TAU)",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"BEHAVIORAL","Parenting-STAIR Modular (PSTAIR-M)","12-16 PSTAIR-M treatment sessions (approximately 12-16 weeks).",[57],{"type":70,"name":63,"description":75,"armGroupLabels":76,"otherNames":43},"Weekly treatment sessions of an established EBT. The total number of sessions\u002Fweeks will be determined by the EBT and clinic protocols.",[63],[78,81],{"name":79,"affiliation":5,"role":80},"Kathrine S Sullivan, PhD","PRINCIPAL_INVESTIGATOR",{"name":82,"affiliation":83,"role":80},"Carl Castro, PhD","University of Southern California",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":43,"email":89},"Kathrine S S Sullivan, PhD","CONTACT","212-992-9710","pstair2@nyu.edu",{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},"Gina M Angelotti, MPH",[93,108,120,132,143,155],{"facility":94,"status":43,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Steven A. Cohen Military Family Clinics at Red Rock, Colorado Springs","Colorado Springs","Colorado","80916","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-104.82136,38.83388,{"lat":104,"lon":103},[107],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"facility":109,"status":43,"city":110,"state":111,"zip":112,"country":98,"countryCode":99,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Steven A. Cohen Military Family Clinic at Easterseals","Silver Spring","Maryland","20910",{"type":101,"coordinates":114},[115,116],-77.02609,38.99067,{"lat":116,"lon":115},[119],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"facility":121,"status":43,"city":122,"state":123,"zip":124,"country":98,"countryCode":99,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"The Steven A. Cohen Military Family Clinic at Red Rock, Lawton","Lawton","Oklahoma","73505",{"type":101,"coordinates":126},[127,128],-98.39033,34.60869,{"lat":128,"lon":127},[131],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"facility":133,"status":43,"city":134,"state":123,"zip":135,"country":98,"countryCode":99,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Steven A. Cohen Military Family Clinics at Red Rock, Oklahoma City","Oklahoma City","73159",{"type":101,"coordinates":137},[138,139],-97.51643,35.46756,{"lat":139,"lon":138},[142],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"facility":144,"status":43,"city":145,"state":43,"zip":146,"country":147,"countryCode":43,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Cohen Veterans Network, Camp Humphreys","Pyeongtaek-si","17984","South Korea",{"type":101,"coordinates":149},[150,151],127.08889,36.99472,{"lat":151,"lon":150},[154],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"facility":156,"status":43,"city":145,"state":43,"zip":157,"country":147,"countryCode":43,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Cohen Veterans Network, Osan Air Base","96266",{"type":101,"coordinates":159},[150,151],{"lat":151,"lon":150},[162],{"name":91,"role":87,"phone":88,"phoneExt":43,"email":89},{"type":164,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[166,168,169],{"name":167,"class":6},"University of California, Davis",{"name":83,"class":6},{"name":170,"class":171},"Cohen Veterans Network","UNKNOWN","100657857","parenting-stair-modular-for-military-fathers-and-oconus-families-100657857",false,"NCT07843654","Parenting-STAIR Modular for Military Fathers and OCONUS Families","Parenting-STAIR Modular for Military Fathers and OCONUS Families: Testing a Trauma-Informed Intervention to Strengthen Military Family Readiness and Resilience","Inclusion Criteria:\n\n* Parents who are an active-duty SM or the spouse of an active-duty SM;\n* With a child aged 2-10 (if more than one child in this age range, parent will identify the index child as having the most problematic behavior);\n* Legal guardian of the child with legal and physical custody;\n* Lifetime trauma exposure (LEC-5);\n* Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria \\[B, C, D, E\\] on the PCL-5) and\u002For depression (PHQ-9 score ≥8);\n* Able to speak and understand English or Spanish;\n* Eligible to receive services at a participating CVN clinic.\n\nExclusion Criteria:\n\n* High risk for suicide (Ask Suicide-Screening Questions (ASQ));\n* Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);\n* Disability affecting communication, such as deafness;\n* Index child with severe developmental disability;\n* Currently receiving another trauma-focused individual mental health treatment.","ALL","18 Years",{"count":182,"type":183},243,"ESTIMATED","INTERVENTIONAL",[186],"NA","The goal of this clinical trial is to learn if a family-based treatment called Parenting-STAIR-Modular (PSTAIR-M) can help military parents recover from trauma, strengthen emotion regulation skills, and improve parent-child relationships. Participants will be trauma-exposed active-duty Service Members (SM) or their spouses who screen positive for PSTD and\u002For depression, and one identified child (ages 2-10).\n\nThe main questions it aims to answer are: 1) Does PSTAIR-M reduce parental PTSD and depression symptoms, lower parenting stress, and improve child behavior compared to treatment-as-usual?; and 2) Is PSTAIR-M feasible and acceptable when delivered to military families stationed overseas?\n\nResearchers will compare PSTAIR-M to treatment-as-usual (TAU) to see if PSTAIR-M leads to greater improvements in parental PTSD, depression, parenting stress, emotion regulation, child maltreatment risk, and child behavior than usual care.\n\nParticipants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.",[189,190,191,192,193,194,195,196,197,198,199,200],"Depressive Symptoms","Emotional Depression","Depression","Parent Child Relationship","Parent-Child Relationship","Parent-Child Relations","Stress Disorder, Post Traumatic","PTSD","Parenting","Child Behavior","Emotional Regulation","Emotion Regulation","NOT_YET_RECRUITING","2026-09-25",{"date":204,"type":205},"2026-09-30","ACTUAL",{"date":207,"type":183},"2026-12-01",{"date":209,"type":183},"2030-08-31",{"name":5,"class":6},6]