Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children
概览
- 阶段
- 不适用
- 干预措施
- Parenting-STAIR Modular (PSTAIR-M)
- 疾病 / 适应症
- PTSD
- 发起方
- New York University
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Post-traumatic stress disorder (PTSD) Checklist 5
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.
The main questions the study aims to answer are: 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?
Researchers will compare PSTAIR-M to treatment as usual (TAU) - other EBTs offered at participating study sites - to determine if PSTAIR-M is more effective in improving mental health and parenting.
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, and 4) have assessments audio and video recorded.
详细描述
The present study is a two-arm randomized controlled trial (RCT) conducted in a community mental health setting comparing Parenting STAIR Modular (PSTAIR-M), and treatment as usual (TAU). This study will enroll N=120 military-connected mothers (MCM) and one index child (aged 2-10) at three Cohen Veterans Network (CVN) clinics (Family Endeavors Clinics in El Paso, Killeen, and San Antonio, TX). Participants will be trauma-exposed MCM who screen positive for PSTD and/or depression and/or demonstrate low parenting self-efficacy, and one identified child (ages 2-10). MCM will be randomly assigned to either PSTAIR-M (N=80 mothers; 80 children) or treatment-as-usual (TAU; N=40 mothers; 40 children). PSTAIR-M and TAU will be delivered virtually 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). PSTAIR-M involves a compact version of PSTAIR in Module 1 and tailored options for Module 2, focusing on skills development (Module 2a), narrative exposure (Module 2b), or parental functioning (Module 2c), implemented based on response to Module 1. Assessments will occur at three timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline). Assessments will include self-report instruments and dyadic parenting observations.
研究者
入排标准
入选标准
- •Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran;
- •Has a child aged 2-10;
- •Legal guardian of index child with legal and physical custody;
- •Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));
- •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), and/or low parenting self-efficacy (PSOC score \<59);
- •Able to speak and understand English or Spanish;
- •Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.
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;
- •Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF)).
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)
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)
结局指标
主要结局
Post-traumatic stress disorder (PTSD) Checklist 5
时间窗: PCL-5 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 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: PHQ-9 will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 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.
Parenting Sense of Competence Scale (PSOC)
时间窗: PSOC will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).
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/father 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.
次要结局
- Difficulties in Emotion Regulation Scale (DERS)(DERS will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).)
- Brief Cope(Brief Cope will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).)
- Dyadic Parent-Child Interaction Coding System-IV (DPICS)(DPICS-IV observation will occur at three time points: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).)
- Treatment Acceptability and Expectations (TAE)(The TAE will be administered following the first treatment session and during the post-treatment assessment (approximately 17 weeks after baseline).)
- Strengths and Difficulties Questionnaire (SDQ)(SDQ will be administered at three assessment timepoints: pre-treatment (baseline), mid-treatment (after session 11, approximately 11 weeks after baseline), and post-treatment (approximately 17 weeks after baseline).)
- Military Stress of Life Survey(Military Stress of Life Survey will be administered at two assessment timepoints: pre-treatment (baseline) and post-treatment (approximately 17 weeks after baseline).)