Clinical trial NCT04453865: Empowering Anxious Parents to Manage Child Avoidance Behaviors
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: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: Anxiety
Parenting
Accommodation
Online Intervention
Single Session Intervention
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants will be randomized via Qualtrics (1:1 allocation ratio) to either the Online Resources and Referrals (ORR) and the Parent Accommodation SSI or ORR alone and delayed SSI access. Those in the experimental condition (ORR+immediate SSI) will also complete immediate post-SSI questionnaires. Two weeks later, all parents-regardless of condition-will complete the 2-week follow up questionnaires. Parents in the ORR+delayed SSI condition will then be invited to complete the accommodation SSI and immediate post-SSI questionnaires. Thus, all participants will receive the accommodation SSI and complete immediate post-SSI questionnaires, either immediately or at 2-week follow-up.
Primary purpose: PREVENTION

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: 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Family Accommodation Scale
timeFrame: Change from Baseline Accommodation at 2-week follow up
measure: Perceived pre-to-post SSI change
timeFrame: Immediately after the SSI
Secondary outcomes:
measure: Program Feedback Scale
timeFrame: Immediately after the SSI
measure: Penn State Worry Questionnaire
timeFrame: Baseline
measure: Coping with Children's Negative Emotions Scale
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale
timeFrame: Baseline
measure: Barriers to Access to Care Evaluation
timeFrame: Baseline
measure: Adult Measure of Behavioral Inhibition
timeFrame: Baseline
measure: Short Behavioral Inhibition Questionnaire
timeFrame: Baseline
measure: Ruminative Response Scale
timeFrame: Baseline
measure: Distress Tolerance Scale
timeFrame: Change from Baseline Coping at 2-week follow up
measure: Co-Rumination Questionnaire
timeFrame: Baseline
measure: Patient Reported Outcomes Measurement Information System-Depression Short
timeFrame: Baseline
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
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