跳至主要内容
临床试验/NCT05990322
NCT05990322尚未招募不适用

Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation

Stony Brook University0 个研究点目标入组 100 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Family Accommodation Scale

研究概览

简要总结

Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety never access care or drop out prematurely; commonly cited barriers to treatment are shortage of care, transportation limitations, financial burden, and gatekeeping behaviors by caretakers. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children. Single session interventions (SSIs), which have prevented and reduced child anxiety across numerous trials to date, may offer a promising solution, given their potential disseminability and cost-effectiveness. The proposed randomized trial will evaluate the effects of a novel, web-based, self-guided SSI designed to systematically reduce parent accommodation in economically insecure parents.

详细描述

Anxiety disorders are among the most common, debilitating forms of childhood psychopathology, affecting 8.3-27.0% of youth before the age of 18 (Costello, Egger, & Angold, 2005). Child anxiety increases risk for psychiatric comorbidities across the lifespan (Copeland, Angold, Shanahan, & Costello, 2014), creates significant burdens for caregivers (Ramos-Cerqueira et al., 2008), and carries societal costs (Beecham, 2014; Bodden, Dirksen, Bögels, 2008). Although numerous interventions have been developed to treat youth anxiety disorders (Kendall, Achenbrand, & Hudson, 2003), up to 82.2% of US youth with anxiety will not receive adequate care (Merikangas et al., 2011). Several reasons may explain this discrepancy, including the length and cost of existing evidence-based interventions (EBIs) and limited accessibility for families in need. As such, there is great need for accessible, scalable interventions that can ameliorate the global burden of youth anxiety, including those that help prevent the onset of anxiety in high-risk children.

The inaccessibility of mental health care to low-SES children is especially problematic given the heightened risk for mental health problems within this population. (Bøe et al., 2011; Keating & Hertzman, 2000; Mendelson et al., 2008). In fact, children and adolescents who are socioeconomically disadvantaged are 3 times more likely to experience mental health difficulties, relative to their more advantaged peers (Reiss, 2013). This may reflect the fact that low SES is closely related to various other risk factors to psychopathology, like weaker family support networks, increased community violence exposure, greater odds of caregivers using harsh discipline strategies, and more exposure to stressful family life events (Everson-Rose et al., 2011; Hill et al., 1996; Shaw et al., 1998; Stein et al., 2003). Access levels vary as well; an examination of nation-wide data of mental health access among adolescents indicate that low-income families are significantly less likely to connect to services (Newacheck et al., 2003). Unfortunately, even when lower-SES youth do access evidence-based treatments, they may benefit less than their more-advantaged peers. It is critical to develop interventions that can not only efficiently target mechanisms most critical to reducing child psychopathology-especially common, impairing problems like anxiety disorders- that are designed for accessibility among historically underserved populations. A simultaneous emphasis on developing and testing child anxiety interventions that are effective and accessible is necessary to adequately serve the lower-SES children and families they are presumably designed to help.

Single-session interventions (SSIs) may offer one potential solution to this gap in care. SSIs include core components of comprehensive EBIs delivered succinctly to improve the odds of access and completion (Schleider & Weisz, 2017a). In a recent meta-analysis of 50 RCTs, SSIs reduced youth mental health problems of multiple disorders, with SSIs targeting child anxiety producing the largest effects (mean g = 0.58; Schleider & Weisz, 2017b). Thus, well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for anxiety in youth. Given that family factors play a crucial role in the etiology of child anxiety, SSIs targeting parents and their interactions with offspring offer a novel approach to preventing youth anxiety (Degnan, Almas, Fox, 2010). Thus, the aim of this project is to test the acceptability and short-term effects of a novel, web-based SSI targeting parental accommodation: a well-established, potentially modifiable risk factor for child anxiety. Results may reveal a promising, targeted approach to scalable child anxiety prevention.

Research shows that parent accommodation can be systematically reduced via psychosocial intervention, and interventions targeting accommodation have helped mitigate child anxiety (Lebowitz, 2014). Translating core components of existing interventions that target parental accommodation into briefer, self-administered SSIs (i.e., those that do not involve a trained therapist) may improve families' access to empirically driven supports for child anxiety. It may also enhance the implementation of mental health interventions by lay providers who frequently interact with children (e.g. teachers and pediatricians). Thus, the goal of this project is to test a web-based, self-guided SSI (Project EMPOWER) targeting parental accommodation in a financially diverse sample.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Have at least one child between the ages of 4-10 years old
  • Spouse/partner has not taken part of this study before
  • Report clinical levels of child anxiety symptoms, per a score above a 7.5 on the Brief SPENCE Children's Anxiety Scale
  • Report economic insecurity, indicated by a score less than or equal to 44 on the Consumer Financial Protection Bureau Financial Well-Being Scale (CFPB)

排除标准

  • Participant is non-English speaking

结局指标

主要结局

Family Accommodation Scale

时间窗: Change from Baseline to 2-week and 4-week follow up

Family Accommodation Scale is a 9-item measure designed to assess the extent a caregiver accommodate a child's anxiety symptoms; example questions include: "how often did you assist your child in avoiding things that might make him/her more anxious?" and "have you modified your family routine because of your child's symptoms?" Items are rated from 0 (never) to 4 (daily). Scores range from 0-36 with higher scores indicating more frequent parental accommodation

Perceived pre-to-post SSI change

时间窗: Immediately after the SSI

This two-item measure assesses participants' perceived change in their ability to help their children manage distressing situations and their ability to provide validation to their children from pre- to post-SSI. Parents in both groups will rate this question on a 5-point scale of 1 (much less able) to 5 (much more able).

次要结局

  • Distress Tolerance Scale(Change from Baseline to 2-week and 4-week follow up)
  • Parental Stress Scale(Baseline)
  • Strengths and Difficulties Scale(Baseline)
  • Consumer Financial Protection Bureau Financial Well-Being Scale(Baseline)
  • Everyday Discrimination Scale(Baseline)
  • Patient Health Questionnaire(Baseline)
  • Brief SPENCE Children's Anxiety Scale(Change from baseline to 4-week follow-up)
  • Program Feedback Scale(Immediately after the SSI)
  • Penn State Worry Questionnaire(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jessica Schleider

Assistant Professor of Psychology

Stony Brook University

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