Parenting-STAIR Modular for Military Fathers and OCONUS Families: Testing a Trauma-Informed Intervention to Strengthen Military Family Readiness and Resilience
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 243
- 试验地点
- 6
- 主要终点
- Post-traumatic stress disorder (PTSD) Checklist 5
研究概览
简要总结
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/or depression, and one identified child (ages 2-10).
The 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?
Researchers 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.
Participants 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.
详细描述
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/or depression symptoms. Participants will be randomized to receive either PSTAIR-M or treatment-as-usual (TAU). PSTAIR-M will be delivered by CVN clinicians.
Parenting 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.
Assessments 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blind to treatment arm. Coders blind to treatment arm will also code 10% of dyadic parenting sessions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents who are an active-duty SM or the spouse of an active-duty SM;
- •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);
- •Legal guardian of the child with legal and physical custody;
- •Lifetime trauma exposure (LEC-5);
- •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/or depression (PHQ-9 score ≥8);
- •Able to speak and understand English or Spanish;
- •Eligible to receive services at a participating CVN clinic.
排除标准
- •High risk for suicide (Ask Suicide-Screening Questions (ASQ));
- •Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);
- •Disability affecting communication, such as deafness;
- •Index child with severe developmental disability;
- •Currently receiving another trauma-focused individual mental health treatment.
研究组 & 干预措施
Parenting STAIR Modular (PSTAIR-M)
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.
干预措施: Parenting-STAIR Modular (PSTAIR-M) (Behavioral)
Treatment as Usual (TAU)
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.
干预措施: Parenting-STAIR Modular (PSTAIR-M) (Behavioral)
Parenting STAIR Modular (PSTAIR-M)
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.
干预措施: Treatment as Usual (TAU) (Behavioral)
Treatment as Usual (TAU)
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.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
Post-traumatic stress disorder (PTSD) Checklist 5
时间窗: 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).
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.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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).
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.
Adult Adolescent Parenting Inventory-version 2 (AAPI-2)
时间窗: Three assessment timepoints: pre-treatment (baseline), post-treatment (approximately 17 weeks after baseline), and 6-month follow-up (approximately 41 weeks after baseline).
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.
次要结局
- Strengths and Difficulties Questionnaire (SDQ)(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).)
- Parenting Sense of Competence Scale (PSOC)(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).)
- Difficulties in Emotion Regulation Scale (DERS)(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).)
- Brief Cope(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).)
- Dyadic Parent-Child Interaction Coding System-IV (DPICS)(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).)
- Treatment Acceptability and Expectations (TAE)(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).)
- Military Stress of Life Survey(Three assessment timepoints: pre-treatment (baseline), post-treatment (approximately 17 weeks after baseline), and 6-month follow-up (approximately 41 weeks after baseline).)