Empowering Anxious Parents to Manage Child Avoidance Behaviors (EMPOWER)

Stony Brook University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Project EMPOWER; Other: Online Resources and Referrals

Study type: Interventional

Funder types: Other

Identifiers

NCT04453865

IRB2020-00069

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 300 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Participant is non-English speaking

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Project EMPOWER

Experimental group

Description:

Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete. The program includes 5 elements, based on current best-practices in SSI design (Schleider, Dobias, Sung, \& Mullarkey, 2020) and existing interventions targeting accommodation (Lebowitz \& Omer, 2014): (1) an introduction to the program's rationale; (2) psychoeducation around child anxiety and avoidance, along with how parental accommodation can inadvertently maintain child anxiety; (3) information on how parents can better identify children's patterns of avoidance and encourage brave behavior instead; (4) facilitating parents' creation of an "action plan" for promoting brave behavior and reduce avoidance in their own child; (5) a vignette exercise in which parents read about another family's difficulty managing their child's anxiety; parents identify the elements of the anxiety cycle and provide possible solutions to these parents based on what they learned.

Treatment:

Behavioral: Project EMPOWER

Online Resources and Referrals (ORR)

Other group

Description:

Online Resources and Referrals (ORR) is an information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment. ORR does not include any psychoeducational components regarding parental accommodation.

Treatment:

Other: Online Resources and Referrals