跳至主要内容
临床试验/NCT04453865
NCT04453865已完成不适用

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

Stony Brook University2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Perceived pre-to-post SSI change

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: a parenting behavior identified as a strong risk factor for anxiety in offspring. Study aims will be three-fold: (1) to examine the SSI's direct effects on parental accommodation, relative to an information-only control; (2) to assess the SSI's immediate effects on parents' perceived ability to help their children manage distressing situations; and (3) to evaluate the SSI's feasibility and acceptability. We will recruit parents reporting elevated anxiety levels, as children of anxious parents are at particular risk for developing anxiety symptoms themselves. Results may suggest a promising approach to preventing anxiety in at-risk children.

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. Child anxiety increases risk for psychiatric comorbidities across the lifespan) creates significant burdens for caregivers, and carries societal costs. Although numerous interventions have been developed to treat youth anxiety disorders, up to 82.2% of US youth with anxiety will not receive adequate care. Several reasons may explain this discrepancy, including the length and cost of existing evidence-based interventions (EBIs) and limited accessibility for families in need.

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. 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). Thus, well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for anxiety in youth. However, most existing SSIs for child anxiety target populations already experiencing clinical distress, and a need remains for options that may prevent anxiety in vulnerable children. 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. 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.

Parental Accommodation as a Modifiable Intervention Target. Parent accommodation refers to changes in caregiver behaviors that facilitate or maintain their child's avoidance or anxiety. Examples include modifying family routines (i.e., staying home from work to alleviate a child's fear of separating) or directly participating in a child's avoidance strategies (i.e., keeping a child home from school). Parent accommodation reduces immediate distress but maintains long-term avoidance of feared stimuli or situations and high levels of parent accommodation are associated with anxiety problems in offspring. Parent accommodation is further maintained by caregiver factors, including parental anxiety and tolerance for distress. For instance, accommodation is greater among parents reporting higher distress about their child's anxiety symptoms and perceptions that anxiety exposure is harmful for youth.

Research shows that parent accommodation can be systematically reduced via psychosocial intervention, and interventions targeting accommodation have helped mitigate child anxiety. 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 targeting parental accommodation. Parent participants will be randomized to either (a) Online Resources and Referrals (ORR) + parent accommodation SSI, or (b) ORR alone and delayed SSI access. We predict that parents will report larger declines in accommodation in the ORR+Accommodation SSI group, relative to the ORR + delayed SSI access group, from baseline to 2-week follow-up. We also predict that parents will perceive significant pre-to immediate-post-SSI increases in their ability to help their child manage distressing situations. Finally, we predict that participants will find the SSI to be acceptable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Report subclinical or greater anxiety symptoms, per a score of 40 or higher on the Penn State Worry Questionnaire (PSWQ)
  • Have at least one child between the ages of 4-10 years old
  • Live in the United States (US)

排除标准

  • Participant is non-English speaking

结局指标

主要结局

Perceived pre-to-post SSI change

时间窗: Immediately after the SSI

This single-item measure assesses participants' perceived change in their ability to help their children manage distressing situations from pre- to post-SSI: "compared to before you completed this program, how prepared do you feel to help your child manage distressing situations?" Parents in both groups will rate this question on a 5-point scale of 1 (much less able to help child manage distressing situations) to 5 (much more able to to help child manage distressing situations).

Family Accommodation Scale

时间窗: Change from Baseline Accommodation at 2-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.

次要结局

  • Program Feedback Scale(Immediately after the SSI)
  • Barriers to Access to Care Evaluation(Baseline)
  • Ruminative Response Scale(Baseline)
  • Distress Tolerance Scale(Change from Baseline Coping at 2-week follow up)
  • Penn State Worry Questionnaire(Baseline)
  • Coping with Children's Negative Emotions Scale(Baseline)
  • Revised Children's Anxiety and Depression Scale(Baseline)
  • Short Behavioral Inhibition Questionnaire(Baseline)
  • Co-Rumination Questionnaire(Baseline)
  • Adult Measure of Behavioral Inhibition(Baseline)
  • Patient Reported Outcomes Measurement Information System-Depression Short(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

研究点 (2)

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