Clinical trial NCT05990322: Empowering Economically Insecure Parents to Manage Child Anxiety
Official title: Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Project EMPOWER
Online Resources and Referrals
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2023-08-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Participant is non-English speaking

Primary outcomes:
measure: Family Accommodation Scale
timeFrame: Change from Baseline to 2-week and 4-week follow up
measure: Perceived pre-to-post SSI change
timeFrame: Immediately after the SSI
Secondary outcomes:
measure: Distress Tolerance Scale
timeFrame: Change from Baseline to 2-week and 4-week follow up
measure: Program Feedback Scale
timeFrame: Immediately after the SSI
measure: Penn State Worry Questionnaire
timeFrame: Baseline
measure: Consumer Financial Protection Bureau Financial Well-Being Scale
timeFrame: Baseline
measure: Brief SPENCE Children's Anxiety Scale
timeFrame: Change from baseline to 4-week follow-up
measure: Strengths and Difficulties Scale
timeFrame: Baseline
measure: Parental Stress Scale
timeFrame: Baseline
measure: Everyday Discrimination Scale
timeFrame: Baseline
measure: Patient Health Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: