protocolSection identificationModule nctId: NCT06262178, orgStudyIdInfo id: 23-1393, briefTitle: Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: New York University, class: OTHER, collaborators name: Cohen Veterans Network, collaborators name: University of California, Davis, descriptionModule briefSummary: The purpose of this study, which includes a clinical trial, is to adapt and assess the efficacy of Parenting-STAIR (PSTAIR), an intervention which combines existing evidence-based treatments Skills Training in Affective and Interpersonal Regulation (STAIR) and Parent-Child Care (PC-Care) to reduce symptoms of Post-traumatic Stress Disorder (PTSD) and improve parenting among military-connected mothers. Participants in the clinical trial will receive PSTAIR or trauma-focused treatment as usual (either prolonged exposure or cognitive processing therapy)., conditionsModule conditions: PTSD, conditions: Depression, conditions: Parent-Child Relations, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: PSTAIR combines elements of two existing Evidence-Based Treatments (EBTs): Skills Training in Affective and Interpersonal Regulation (STAIR), targeting maternal trauma and emotion dysregulation, and dyadic Parent-Child Care (PC-CARE), targeting parenting. We will shorten PSTAIR into a 10-15 session modular intervention and individualize treatment using an adaptive decision rule and shared decision making., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Parenting-STAIR, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Post-traumatic stress disorder (PTSD) Checklist 5, primaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), primaryOutcomes measure: Parenting Sense of Competence Scale (PSOC), secondaryOutcomes measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Diagnosis, secondaryOutcomes measure: Clinician Administered PTSD Scale Diagnostic and Statistical Manual (DSM) 5 (CAPS 5) Symptom Severity, secondaryOutcomes measure: Structured Clinical Interview for DSM 5 (SCID), secondaryOutcomes measure: Parenting Stress Index 4-Short Form (PSI4-SF), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale (DERS), secondaryOutcomes measure: Brief Cope, secondaryOutcomes measure: Dyadic Parent-Child Interaction Coding System-IV (DPICS), secondaryOutcomes measure: Treatment Acceptability and Expectations (TAE), secondaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), secondaryOutcomes measure: Eyberg Child Behavior Inventory (ECBI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False