xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990322</url>
    </required_header>
    <id_info>
      <org_study_id>00195</org_study_id>
      <nct_id>NCT05990322</nct_id>
    </id_info>
    <brief_title>Empowering Economically Insecure Parents to Manage Child Anxiety</brief_title>
    <acronym>ProjectEmpower</acronym>
    <official_title>Empowering Anxious Parents to Manage Child Avoidance Behaviors: A Randomized Trial of a Single-Session Intervention Targeting Parent Accommodation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stony Brook University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Robert Wood Johnson Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stony Brook University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Efforts to develop and disseminate evidence based practices (EBPs) for youth anxiety have&#xD;
        made great strides. Still, up to 82.2% of youth who need mental health treatment for anxiety&#xD;
        never access care or drop out prematurely; commonly cited barriers to treatment are shortage&#xD;
        of care, transportation limitations, financial burden, and gatekeeping behaviors by&#xD;
        caretakers. As such, there is great need for accessible, scalable interventions that can&#xD;
        ameliorate the global burden of youth anxiety, including those that help prevent the onset of&#xD;
        anxiety in high-risk children. Single session interventions (SSIs), which have prevented and&#xD;
        reduced child anxiety across numerous trials to date, may offer a promising solution, given&#xD;
        their potential disseminability and cost-effectiveness. The proposed randomized trial will&#xD;
        evaluate the effects of a novel, web-based, self-guided SSI designed to systematically reduce&#xD;
        parent accommodation in economically insecure parents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Anxiety disorders are among the most common, debilitating forms of childhood psychopathology,&#xD;
        affecting 8.3-27.0% of youth before the age of 18 (Costello, Egger, &amp; Angold, 2005). Child&#xD;
        anxiety increases risk for psychiatric comorbidities across the lifespan (Copeland, Angold,&#xD;
        Shanahan, &amp; Costello, 2014), creates significant burdens for caregivers (Ramos-Cerqueira et&#xD;
        al., 2008), and carries societal costs (Beecham, 2014; Bodden, Dirksen, Bögels, 2008).&#xD;
        Although numerous interventions have been developed to treat youth anxiety disorders&#xD;
        (Kendall, Achenbrand, &amp; Hudson, 2003), up to 82.2% of US youth with anxiety will not receive&#xD;
        adequate care (Merikangas et al., 2011). Several reasons may explain this discrepancy,&#xD;
        including the length and cost of existing evidence-based interventions (EBIs) and limited&#xD;
        accessibility for families in need. As such, there is great need for accessible, scalable&#xD;
        interventions that can ameliorate the global burden of youth anxiety, including those that&#xD;
        help prevent the onset of anxiety in high-risk children.&#xD;
  &#xD;
        The inaccessibility of mental health care to low-SES children is especially problematic given&#xD;
        the heightened risk for mental health problems within this population. (Bøe et al., 2011;&#xD;
        Keating &amp; Hertzman, 2000; Mendelson et al., 2008). In fact, children and adolescents who are&#xD;
        socioeconomically disadvantaged are 3 times more likely to experience mental health&#xD;
        difficulties, relative to their more advantaged peers (Reiss, 2013). This may reflect the&#xD;
        fact that low SES is closely related to various other risk factors to psychopathology, like&#xD;
        weaker family support networks, increased community violence exposure, greater odds of&#xD;
        caregivers using harsh discipline strategies, and more exposure to stressful family life&#xD;
        events (Everson-Rose et al., 2011; Hill et al., 1996; Shaw et al., 1998; Stein et al., 2003).&#xD;
        Access levels vary as well; an examination of nation-wide data of mental health access among&#xD;
        adolescents indicate that low-income families are significantly less likely to connect to&#xD;
        services (Newacheck et al., 2003). Unfortunately, even when lower-SES youth do access&#xD;
        evidence-based treatments, they may benefit less than their more-advantaged peers. It is&#xD;
        critical to develop interventions that can not only efficiently target mechanisms most&#xD;
        critical to reducing child psychopathology-especially common, impairing problems like anxiety&#xD;
        disorders- that are designed for accessibility among historically underserved populations. A&#xD;
        simultaneous emphasis on developing and testing child anxiety interventions that are&#xD;
        effective and accessible is necessary to adequately serve the lower-SES children and families&#xD;
        they are presumably designed to help.&#xD;
  &#xD;
        Single-session interventions (SSIs) may offer one potential solution to this gap in care.&#xD;
        SSIs include core components of comprehensive EBIs delivered succinctly to improve the odds&#xD;
        of access and completion (Schleider &amp; Weisz, 2017a). In a recent meta-analysis of 50 RCTs,&#xD;
        SSIs reduced youth mental health problems of multiple disorders, with SSIs targeting child&#xD;
        anxiety producing the largest effects (mean g = 0.58; Schleider &amp; Weisz, 2017b). Thus,&#xD;
        well-targeted SSIs may offer cost-effective additions or alternatives to traditional care for&#xD;
        anxiety in youth. Given that family factors play a crucial role in the etiology of child&#xD;
        anxiety, SSIs targeting parents and their interactions with offspring offer a novel approach&#xD;
        to preventing youth anxiety (Degnan, Almas, Fox, 2010). Thus, the aim of this project is to&#xD;
        test the acceptability and short-term effects of a novel, web-based SSI targeting parental&#xD;
        accommodation: a well-established, potentially modifiable risk factor for child anxiety.&#xD;
        Results may reveal a promising, targeted approach to scalable child anxiety prevention.&#xD;
  &#xD;
        Research shows that parent accommodation can be systematically reduced via psychosocial&#xD;
        intervention, and interventions targeting accommodation have helped mitigate child anxiety&#xD;
        (Lebowitz, 2014). Translating core components of existing interventions that target parental&#xD;
        accommodation into briefer, self-administered SSIs (i.e., those that do not involve a trained&#xD;
        therapist) may improve families' access to empirically driven supports for child anxiety. It&#xD;
        may also enhance the implementation of mental health interventions by lay providers who&#xD;
        frequently interact with children (e.g. teachers and pediatricians). Thus, the goal of this&#xD;
        project is to test a web-based, self-guided SSI (Project EMPOWER) targeting parental&#xD;
        accommodation in a financially diverse sample.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Family Accommodation Scale</measure>
      <time_frame>Change from Baseline to 2-week and 4-week follow up</time_frame>
      <description>Family Accommodation Scale is a 9-item measure designed to assess the extent a caregiver accommodate a child's anxiety symptoms; example questions include: &quot;how often did you assist your child in avoiding things that might make him/her more anxious?&quot; and &quot;have you modified your family routine because of your child's symptoms?&quot; Items are rated from 0 (never) to 4 (daily). Scores range from 0-36 with higher scores indicating more frequent parental accommodation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived pre-to-post SSI change</measure>
      <time_frame>Immediately after the SSI</time_frame>
      <description>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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Distress Tolerance Scale</measure>
      <time_frame>Change from Baseline to 2-week and 4-week follow up</time_frame>
      <description>16 item measure assessing the extent to which one experiences and withstand distressing emotional states. Each item is rated on a 5-point Likert scale from 1 (strongly agree) and 5 (strongly disagree). Total score ranges from 16 to 80 with a higher score indicating higher levels of distress tolerance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Program Feedback Scale</measure>
      <time_frame>Immediately after the SSI</time_frame>
      <description>The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Penn State Worry Questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>16 item self-report questionnaire that asks individuals to rate how typical worry-related problems are for them, from 1 (not at all typical) to 5 (very typical). Scores range from 16-80; higher scores indicate more severe worry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Consumer Financial Protection Bureau Financial Well-Being Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>The CFPB Financial Well-Being Scale measures financial well-being as it relates to control over finances, capacity to absorb financial shock, and having the financial freedom to enjoy life. Parents are asked to answer 10 questions on a 0 to 4 Likert scale to generate a sum score, which is converted into a standardized score. Scores range from 14 to 95 with higher scores indicating a higher level of measure financial well-being.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief SPENCE Children's Anxiety Scale</measure>
      <time_frame>Change from baseline to 4-week follow-up</time_frame>
      <description>8-item measure assessing the severity of child anxiety symptoms on 4 domains: generalized anxiety, separation anxiety, panic/agoraphobia, and social anxiety. Parents are asked to report on how often their child experiences each anxiety symptom on a scale of 0 (never) to 4 (always). Total score ranges from 0 to 32, with higher scores indicating higher levels of anxiety in each domain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Strengths and Difficulties Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>25-item questionnaire that ask parents to answer questions about their 4 to 17 year old child to screen for 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior on a scale of 0 (not true) to 2 (certainly true). Total score ranges from 0 to 40 with higher scores indicating a higher severity of each domain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Stress Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>18 item measure of parental stress levels, parents rate on a scale of 1 (strongly disagree) to a 5 (strongly agree) scale on their perceived positive and negative experience of being a parent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Everyday Discrimination Scale</measure>
      <time_frame>Baseline</time_frame>
      <description>5 item questionnaire used to assess subjective experiences of discrimination. Participants use a scale of 1 (never) to 5 (at least once a week) to rate how often they have experienced discrimination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire</measure>
      <time_frame>Baseline</time_frame>
      <description>Patient Health Questionnaire (PHQ-4) is a 4 item scale measuring anxiety and depression. Participants rate each statement on a scale of 0 (not at all) to 4 (nearly every day) to rate the severity of their worry and depression</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Project EMPOWER</condition>
    <condition>Online Resources and Referrals</condition>
    <arm_group>
      <arm_group_label>Project EMPOWER</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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, &amp; Mullarkey, 2020) and existing interventions targeting accommodation (Lebowitz &amp; 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 &quot;action plan&quot; 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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Online Resources and Referrals</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Project EMPOWER</intervention_name>
      <description>Experimental Condition</description>
      <arm_group_label>Online Resources and Referrals</arm_group_label>
      <arm_group_label>Project EMPOWER</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have at least one child between the ages of 4-10 years old&#xD;
  &#xD;
            -  Spouse/partner has not taken part of this study before&#xD;
  &#xD;
            -  Report clinical levels of child anxiety symptoms, per a score above a 7.5 on the Brief&#xD;
               SPENCE Children's Anxiety Scale&#xD;
  &#xD;
            -  Report economic insecurity, indicated by a score less than or equal to 44 on the&#xD;
               Consumer Financial Protection Bureau Financial Well-Being Scale (CFPB)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participant is non-English speaking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>JENNA SUNG, MA</last_name>
      <phone>631-632-7800</phone>
      <email>Jenna.sung@stonybrook.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stony Brook University</investigator_affiliation>
      <investigator_full_name>Jessica Schleider</investigator_full_name>
      <investigator_title>Assistant Professor of Psychology</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990322
  org study id: 00195
  nct id: NCT05990322
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Family Accommodation Scale
  time frame: Change from Baseline to 2-week and 4-week follow up
  description: 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
  measure: Perceived pre-to-post SSI change
  time frame: Immediately after the SSI
  description: 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).
  measure: Distress Tolerance Scale
  time frame: Change from Baseline to 2-week and 4-week follow up
  description: 16 item measure assessing the extent to which one experiences and withstand distressing emotional states. Each item is rated on a 5-point Likert scale from 1 (strongly agree) and 5 (strongly disagree). Total score ranges from 16 to 80 with a higher score indicating higher levels of distress tolerance.
  measure: Program Feedback Scale
  time frame: Immediately after the SSI
  description: The program feedback scale asks participants to rate 7 statements regarding acceptability and feasibility; note whether they would recommend this activity to others; and share what they liked and would change about the SSI. The 7 statements are rated from 0 (Really Disagree) to 5 (Really Agree). Total score ranges from 0 to 35, with higher scores indicating a more positive program evaluation.
  measure: Penn State Worry Questionnaire
  time frame: Baseline
  description: 16 item self-report questionnaire that asks individuals to rate how typical worry-related problems are for them, from 1 (not at all typical) to 5 (very typical). Scores range from 16-80; higher scores indicate more severe worry.
  measure: Consumer Financial Protection Bureau Financial Well-Being Scale
  time frame: Baseline
  description: The CFPB Financial Well-Being Scale measures financial well-being as it relates to control over finances, capacity to absorb financial shock, and having the financial freedom to enjoy life. Parents are asked to answer 10 questions on a 0 to 4 Likert scale to generate a sum score, which is converted into a standardized score. Scores range from 14 to 95 with higher scores indicating a higher level of measure financial well-being.
  measure: Brief SPENCE Children's Anxiety Scale
  time frame: Change from baseline to 4-week follow-up
  description: 8-item measure assessing the severity of child anxiety symptoms on 4 domains: generalized anxiety, separation anxiety, panic/agoraphobia, and social anxiety. Parents are asked to report on how often their child experiences each anxiety symptom on a scale of 0 (never) to 4 (always). Total score ranges from 0 to 32, with higher scores indicating higher levels of anxiety in each domain.
  measure: Strengths and Difficulties Scale
  time frame: Baseline
  description: 25-item questionnaire that ask parents to answer questions about their 4 to 17 year old child to screen for 5 domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior on a scale of 0 (not true) to 2 (certainly true). Total score ranges from 0 to 40 with higher scores indicating a higher severity of each domain
  measure: Parental Stress Scale
  time frame: Baseline
  description: 18 item measure of parental stress levels, parents rate on a scale of 1 (strongly disagree) to a 5 (strongly agree) scale on their perceived positive and negative experience of being a parent.
  measure: Everyday Discrimination Scale
  time frame: Baseline
  description: 5 item questionnaire used to assess subjective experiences of discrimination. Participants use a scale of 1 (never) to 5 (at least once a week) to rate how often they have experienced discrimination
  measure: Patient Health Questionnaire
  time frame: Baseline
  description: Patient Health Questionnaire (PHQ-4) is a 4 item scale measuring anxiety and depression. Participants rate each statement on a scale of 0 (not at all) to 4 (nearly every day) to rate the severity of their worry and depression
  arm group label: Project EMPOWER
  arm group type: Experimental
  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.
  arm group label: Online Resources and Referrals
  arm group type: Placebo Comparator
  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.
  intervention type: Behavioral
  intervention name: Project EMPOWER
  description: Experimental Condition
  arm group label: Online Resources and Referrals
  arm group label: Project EMPOWER
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: JENNA SUNG, MA
  phone: 631-632-7800
  email: Jenna.sung@stonybrook.edu
  responsible party type: Principal Investigator
  investigator affiliation: Stony Brook University
  investigator full name: Jessica Schleider
  investigator title: Assistant Professor of Psychology
  sharing ipd: Undecided