Promoting Resiliency in Veteran Families With Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 主要终点
- Change in Eyberg Child Behavior Inventory (ECBI) from baseline to 12months
研究概览
简要总结
Family-centered prevention services for civilian dwelling military (CDM) families & children are rarely available in civilian communities or often framed around mental disorders and family deficits. As of June 2010, over 1 million military service members from various military conflicts have become veterans. Wartime deployments can adversely impact the psychological health of children as well as marital relationships, parent-child relationships & overall family functioning. Although young children in CDM families may never have to cope with another parental deployment, their families may continue to struggle with the lasting effects of wartime deployment that cannot be ameliorated by singularly treating the service member. There is a need for family-centered preventive interventions that effectively build resilience and mitigate war deployment-related family difficulties, especially given the potential adverse emotional & developmental impact of deployment separations and reintegration stress on young children and their parents. To address this need, this study proposes to test the efficacy of FOCUS-EC (Families OverComing Under Stress for Early Childhood), an established strength-based, family-centered preventive intervention that is culturally sensitive and socially accepted by active duty military communities & has promising program evaluation data. A randomized control trial will be conducted with 200 CDM families with young children, ages 3 to 5 years, recruited from Los Angeles & surrounding counties (200 veterans, 150 spouses, and 300 children). CDM families will be randomized to the FOCUS-EC intervention condition (n=100 families; 100 veterans, 75 spouses, 150 children) or web-based educational materials condition (n=100 families; 100 veterans, 75 spouses, and 150 children) and assessed at baseline, 3, 6, & 12 months. It is hypothesized that in the FOCUS-EC condition: 1) children will exhibit more positive social-emotional & behavioral outcomes & developmental competencies than children in the comparison condition, 2) families will exhibit more positive family environment, improved parenting, enhanced parent-child relationships, & fewer parent psychological health problems than families in the comparison condition. The investigators also aim to explore potential moderating effects of child health/development risk, military & deployment/separation history, exposure to combat/trauma during deployment, and veteran & spouse/partner background factors.
详细描述
In Phase I, the investigators modified FOCUS-EC for CDM families with young children, and developed a platform for the web-based educational materials. The intervention manual, training materials and assessments were also finalized. The research team already has well-developed manuals for FOCUS-EC, including an intervention manual, technical assistance manual, and training curriculum that have been used for various settings. Existing materials have been customized for CDM families and will be housed online. Materials will include information about child development and common reactions to early separations, as well as deployment and family stress. The team also has extensive experience developing online education for military families (for example, see www.focusproject.org). Online educational information is a common governmental strategy to serve CDM families; the proposed design enables a rigorous comparison of a facilitator-led interactive intervention (FOCUS-EC) to the provision of standardized online resources. Finally in Phase 1, to ensure that FOCUS-EC would meet the unique needs of CDM families, intervention sessions were modified and conducted with CDM families. The investigators believe that this customization with a small group of CMD families has been sufficient to identify the emerging needs of CDM families (e.g., challenges associated with the transition to civilian life, renegotiating family roles more permanently, shifting control or power between parents, reestablishing family routines and rituals, and redefining family relationships), incorporate culturally sensitive language that is common to this population, and tailor the FOCUS-EC for a home visit delivery model. Themes, current concerns, and language identified were incorporated into the FOCUS-EC for CDM families protocol. A similar approach was used to ensure that language used in FOCUS-EC was appropriate for various branches of the service in the preliminary work. The finalized intervention manual and training includes protocols and back-up procedures for clinical emergencies and ethical issues, as documented in the current technical assistance manual.
Phase 2:
All families will complete a baseline assessment, consisting of questionnaires, brief interviews, and family observational tasks.
After the baseline assessment, the family will be randomized into either the FOCUS-EC condition or a web-based education condition. Simple block randomization will be done. Families will be assigned to either the intervention or web-based resources control condition using a computer-generated randomization list with block sizes of 2, 4, and 6. The code for this randomization process can be found at: http://biostat.mc.vanderbilt.edu/wiki/Main/BlockRandomizationwithRandomBlockSizes. No stratification will be done for gender, age, site, etc.
Participants who are randomized to the web-based education condition will be provided with an account and password to a study-developed/supported website that will provide online resources with content comparable to and consistent with FOCUS-EC intervention sessions. That is, web-based materials will provide information on parent-child communication, emotion regulation, problem-solving, stress management, and family resilience. Participants will not be required to utilize these resources; they may access this website as often as they choose and implement the information and strategies as they wish.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Non-active duty OEF/OIF/OND veteran with at least one co-habiting child, ages 3 to 6 years old
- •Spouse/partner of OEF/OIF/OND veteran with at least one co-habiting child, ages 3 to 6 years old, can only participate if Veteran is participating
- •Co-habiting child (3 to 6 years) of OEF/OIF/OND veteran
- •Signed informed consents
- •Access to computer with webcam and internet access
排除标准
- •• Does not meet the inclusion criteria
- •Either parent does not want the child to participate
- •Participated in FOCUS-EC while on active duty
- •Active psychosis/mania (as assessed by staff)
- •Significant child developmental delays (as assessed by staff)
- •Families excluded from the study will be provided with a list of online resources.
结局指标
主要结局
Change in Eyberg Child Behavior Inventory (ECBI) from baseline to 12months
时间窗: Baseline and 12months
The Eyberg Child Behavior Inventory (ECBI) will be used to obtain the frequency of problem behaviors (Intensity subscale) and whether or not the behavior is problematic for the parent (Problem subscale). The ECBI has demonstrated strong reliability, including internal consistency (.88-.95), inter-rater reliability (.79-.86), and test-retest reliability (.86-.88). It also has appropriate criterion-related validity. Both of the ECBI subscales are highly correlated with CBCL Externalizing Behavior.
Change in Strengths and Difficulties SDQ from baseline to 12 months
时间窗: Baseline and 12months
The Strengths and Difficulties Questionnaire (SDQ) is a brief emotional and behavioral screening questionnaire for children and young people. The SDQ consists of 25 items equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior.
Change in Spence Child Anxiety Scale-Preschool Version (SCAS) from baseline to 12 months
时间窗: Baseline and 12months
The Spence Child Anxiety Scale-Preschool Version (SCAS) Separation Anxiety, General Anxiety, and Fear of Physical Harm subscales will be used to assess child anxiety. The SCAS shows high internal consistency and test-retest reliability and was acceptable in a community sample. Positive mood, negative mood and compliance will be coded from videotaped PCI tasks; anger and compliance will be coded from the videotaped WFI tasks.
Change in Brief Symptom Inventory (BSI-18) from baseline to 12 months
时间窗: Baseline and 12 months
Parental psychological distress will be measured using the Brief Symptom Inventory. The BSI-18 measures somatization, depression, and anxiety as well as the global severity index (GSI), including all 18 items. Anxiety and depression scores were calculated by averaging the six items pertaining to each subscale (Cronbach's α = 0.88, 0.89, respectively). Scores were calculated when no more than two items were missing per subscale.
Change in Patient Health Questionnaire (PHQ9) from baseline to 12 months
时间窗: Baseline and 12 months
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. There are two components of the PHQ-9: to assess symptoms and functional impairment to make a tentative depression diagnosis, and to derive a severity score to help select and monitor treatment. Reliability and validity of the PHQ-9 have indicated it has sound psychometric properties. Internal consistency of the PHQ-9 has been shown to be high.
Change in Parenting Stress Index (PSI-SF) from baseline to 12 months
时间窗: Baseline and 12months
Parenting stress was assessed using the 36-item Parenting Stress Index- Short Form (PSI-SF). The PSI-SF consists of three subscales: Parental Distress, Parent-Child Dysfuncitonal Interaciton (PC-DysFx), and Difficult Child. The Parental Distress subscale examines the degree of distress parents are experiencing in their parental role and was considered as a measure of parent psychological health (α = 0.89).
Change in Posttraumatic Diagnostic Scale (PDS) from baseline to 6 months
时间窗: Baseline and 6 months
Parent PTSD symptoms were assessed using the four-part Posttraumatic Diagnostic Scale (PDS). This study used the 17-item symptom severity section. Re-experiencing and Arousal scores were calculated by summing the five items pertaining to each subscale, and Avoidance scores by summing the seven items pertaining to the subscale (Cronbach's α = 0.94, 0.92, and 0.92, respectively). Total scores were calculated by summing all17 items (Cronbach's α = 0.96). PDS has high internal consistency and test-retest reliability.
Change in Parental Behavior with Preschooler Q-Sort from baseline to 12 months
时间窗: Baseline and 12months
Parents' perceptions of their sensitive parenting behaviors were assessed using nine items from the Parental Behavior with Preschooler Q-Sort, which were adapted as self-report questionnaire items (PBP-Sensitivity); the self-report items have shown predictive validity for a variety of child and parent characteristics.
Change in Parent Child Interaction (PCI)/NICHD Qualitative Rating from baseline to 12 months
时间窗: Baseline and 12 months
Each parent will also participate in a 15 minute videotaped parent-child interaction task based on the NICHD Study of Early Child Care "Three Bag" semi-structured free play procedure. Mothers and fathers will be provided with three different but comparable sets of developmentally appropriate toys, and instructed to play with the toys in a specified order. Qualitative ratings developed for the NICHD Study of Early Child Care will be used to assess parent behavior (sensitivity/supportive presence, intrusiveness, detachment/disengagement, positive regard, and negative regard) Two research assistants will be trained to reliability to code the videotaped parent-child interactions. Dr. Paley has used this coding system in her previous and current research. Approximately 20% of the interactions will be double-coded to assess inter-rater reliability. Coders will be blind to treatment condition.
Change in WFI- Whole Family Interaction/Young Family Interaction Coding System (YFICS) from baseline to 12 months.
时间窗: Baseline and 12 months
The WFI task will be used to assess family positive affect, negative affect, detachment, intrusiveness, and alliances. Families will be videotaped during a 15-minute play task in which they are asked to build something together with Duplos®. Ratings of the family interaction task will be made from videotapes using the Young Family Interaction Coding System (YFICS). The WFI has been predicted by parental attachment classifications and marital interactions and adequate reliability has been established for the YFICS. Coding will focus on the quality of interactions among all family members, rather than on interactions within any particular dyad.
次要结局
- Change from baseline to 12 months on Coping Self Efficacy (CSE) measure(Baseline and 12 months)
- Change from baseline to 12 months on Home Observation for Measurement of the Environment Early Childhood Version (HOME)(Baseline and 12 months)
- Change from baseline to 12 months on Ages and Stages Questionnaire: Social Emotional (ASQ:SE)(Baseline and 12months)
- Change from baseline to 12 months on Coparenting Questionnaire(Baseline and 12 months)
- Change from baseline to 12 months on McMaster Family Assessment Device (FAD)(Baseline and 12months)
研究者
Patricia E. Lester, MD
Principal Investigator
University of California, Los Angeles