<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/NCT04453865</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2020-00069</org_study_id>
    <nct_id>NCT04453865</nct_id>
  </id_info>
  <brief_title>Empowering Anxious Parents to Manage Child Avoidance Behaviors</brief_title>
  <acronym>EMPOWER</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>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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: a parenting behavior identified as a strong risk factor for anxiety in&#xD;
      offspring. Study aims will be three-fold: (1) to examine the SSI's direct effects on parental&#xD;
      accommodation, relative to an information-only control; (2) to assess the SSI's immediate&#xD;
      effects on parents' perceived ability to help their children manage distressing situations;&#xD;
      and (3) to evaluate the SSI's feasibility and acceptability. We will recruit parents&#xD;
      reporting elevated anxiety levels, as children of anxious parents are at particular risk for&#xD;
      developing anxiety symptoms themselves. Results may suggest a promising approach to&#xD;
      preventing anxiety in at-risk children.&#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. Child anxiety increases risk for&#xD;
      psychiatric comorbidities across the lifespan) creates significant burdens for caregivers,&#xD;
      and carries societal costs. Although numerous interventions have been developed to treat&#xD;
      youth anxiety disorders, up to 82.2% of US youth with anxiety will not receive adequate care.&#xD;
      Several reasons may explain this discrepancy, including the length and cost of existing&#xD;
      evidence-based interventions (EBIs) and limited accessibility for families in need.&#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. In a recent meta-analysis of 50 RCTs, SSIs reduced youth mental&#xD;
      health problems of multiple disorders, with SSIs targeting child anxiety producing the&#xD;
      largest effects (mean g = 0.58). Thus, well-targeted SSIs may offer cost-effective additions&#xD;
      or alternatives to traditional care for anxiety in youth. However, most existing SSIs for&#xD;
      child anxiety target populations already experiencing clinical distress, and a need remains&#xD;
      for options that may prevent anxiety in vulnerable children. Given that family factors play a&#xD;
      crucial role in the etiology of child anxiety, SSIs targeting parents and their interactions&#xD;
      with offspring offer a novel approach to preventing youth anxiety. Thus, the aim of this&#xD;
      project is to test the acceptability and short-term effects of a novel, web-based SSI&#xD;
      targeting parental accommodation: a well-established, potentially modifiable risk factor for&#xD;
      child anxiety. Results may reveal a promising, targeted approach to scalable child anxiety&#xD;
      prevention.&#xD;
&#xD;
      Parental Accommodation as a Modifiable Intervention Target. Parent accommodation refers to&#xD;
      changes in caregiver behaviors that facilitate or maintain their child's avoidance or&#xD;
      anxiety. Examples include modifying family routines (i.e., staying home from work to&#xD;
      alleviate a child's fear of separating) or directly participating in a child's avoidance&#xD;
      strategies (i.e., keeping a child home from school). Parent accommodation reduces immediate&#xD;
      distress but maintains long-term avoidance of feared stimuli or situations and high levels of&#xD;
      parent accommodation are associated with anxiety problems in offspring. Parent accommodation&#xD;
      is further maintained by caregiver factors, including parental anxiety and tolerance for&#xD;
      distress. For instance, accommodation is greater among parents reporting higher distress&#xD;
      about their child's anxiety symptoms and perceptions that anxiety exposure is harmful for&#xD;
      youth.&#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;
      Translating core components of existing interventions that target parental accommodation into&#xD;
      briefer, self-administered SSIs (i.e., those that do not involve a trained therapist) may&#xD;
      improve families' access to empirically-driven supports for child anxiety. It may also&#xD;
      enhance the implementation of mental health interventions by lay providers who frequently&#xD;
      interact with children (e.g. teachers and pediatricians). Thus, the goal of this project is&#xD;
      to test a web-based, self-guided SSI targeting parental accommodation. Parent participants&#xD;
      will be randomized to either (a) Online Resources and Referrals (ORR) + parent accommodation&#xD;
      SSI, or (b) ORR alone and delayed SSI access. We predict that parents will report larger&#xD;
      declines in accommodation in the ORR+Accommodation SSI group, relative to the ORR + delayed&#xD;
      SSI access group, from baseline to 2-week follow-up. We also predict that parents will&#xD;
      perceive significant pre-to immediate-post-SSI increases in their ability to help their child&#xD;
      manage distressing situations. Finally, we predict that participants will find the SSI to be&#xD;
      acceptable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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>
    <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.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Family Accommodation Scale</measure>
    <time_frame>Change from Baseline Accommodation at 2-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 single-item measure assesses participants' perceived change in their ability to help their children manage distressing situations from pre- to post-SSI: &quot;compared to before you completed this program, how prepared do you feel to help your child manage distressing situations?&quot; 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).</description>
  </primary_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>Coping with Children's Negative Emotions Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>Coping with Children's Negative Emotions Scale measures parents' reactive emotions to their child's negative affect in distressing situations. Six subscales exist, but only the &quot;distress reactions&quot; domain, reflecting parental distress in the context of child negative affect, will be used. Participants rate 12 questions from 1 (very unlikely) to 7 (very likely). Score ranges from 12-84; higher numbers indicate more distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revised Children's Anxiety and Depression Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>25 item measure assessing child's symptoms of anxiety and depression. Each question is rated on a 4-point scale from 0 (Never) to 3 (Always). Total score ranges from 0 to 75 with higher scores indicating higher levels of psychopathology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to Access to Care Evaluation</measure>
    <time_frame>Baseline</time_frame>
    <description>30 item self-report questionnaire that asks about barriers they faced in getting professional care for a mental health problem on a scale of 0 (not at all) to 3 (a lot). Scores range from 0 to 90; higher scores indicate a higher number of barriers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult Measure of Behavioral Inhibition</measure>
    <time_frame>Baseline</time_frame>
    <description>16 item measure assessing one's temperamental tendency to respond to social novelty and risk stimuli, with inhibition and avoidance. Each question is rated on a 3 point scale from 0 (no/hardly ever) and 2 (yes/most of the time). Total score ranges from 0 to 32 with a higher scores indicating a greater degree of inhibition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Behavioral Inhibition Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>14-item parent rated scale measuring temperamental characteristics referring to shyness, fearfulness, and withdrawal in young, preschool children. Each question is rated on a 7-point scale from 1 (Hardly Ever) to 7 (Almost Always). Total score ranges from 14 to 98, with higher scores indicating a greater degree of inhibition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ruminative Response Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>22 item questionnaire measuring two aspects of rumination: brooding and reflective pondering. Each question is rated on a 4-point scale from 1 (almost never) and 4 (almost always). Total score ranges from 22 to 88 with a higher score indicating higher ruminative tendencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Tolerance Scale</measure>
    <time_frame>Change from Baseline Coping at 2-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>Co-Rumination Questionnaire</measure>
    <time_frame>Baseline</time_frame>
    <description>27-item self-report inventory that measures the extent to which one co-ruminates with others. For brevity, the survey has been modified to consist of 8 items that range from 1 (Not at all true) to 5 (really true). Total score ranges from 8 to 40 with a higher score indicating higher levels of co-rumination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System-Depression Short</measure>
    <time_frame>Baseline</time_frame>
    <description>8 item self-report measure of depression. The questions are rated on a 5-point scale ranging from 1 (never) to 5 (always). Scores range from 8 to 40m higher scores indicating higher levels of depression.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Anxiety Disorders</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 (ORR)</arm_group_label>
    <arm_group_type>Other</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>Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete</description>
    <arm_group_label>Project EMPOWER</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Online Resources and Referrals</intervention_name>
    <description>Information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment.</description>
    <arm_group_label>Online Resources and Referrals (ORR)</arm_group_label>
    <other_name>ORR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Report subclinical or greater anxiety symptoms, per a score of 40 or higher on the&#xD;
             Penn State Worry Questionnaire (PSWQ)&#xD;
&#xD;
          2. Have at least one child between the ages of 4-10 years old&#xD;
&#xD;
          3. Live in the United States (US)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. 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>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-2500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Kendall, P. C., Aschenbrand, S. G., &amp; Hudson, J. L. (2003). Child-focused treatment of anxiety. Evidence-Based Psychotherapies for Children and Adolescents, 81-100.</citation>
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  <reference>
    <citation>Lebowitz, E. R., Omer, H., Hermes, H., &amp; Scahill, L. (2014). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice, 21(4), 456- 469. https://doi.org/10.1016/j.cbpra.2013.10.004</citation>
  </reference>
  <reference>
    <citation>Lebowitz ER, Panza KE, Su J, Bloch MH. Family accommodation in obsessive-compulsive disorder. Expert Rev Neurother. 2012 Feb;12(2):229-38. doi: 10.1586/ern.11.200.</citation>
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    <citation>Lebowitz ER, Scharfstein L, Jones J. Child-Report of Family Accommodation in Pediatric Anxiety Disorders: Comparison and Integration with Mother-Report. Child Psychiatry Hum Dev. 2015 Aug;46(4):501-11. doi: 10.1007/s10578-014-0491-1.</citation>
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    <citation>Ramos-Cerqueira AT, Torres AR, Torresan RC, Negreiros AP, Vitorino CN. Emotional burden in caregivers of patients with obsessive-compulsive disorder. Depress Anxiety. 2008;25(12):1020-7. doi: 10.1002/da.20431.</citation>
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    <citation>Salloum A, Johnco C, Lewin AB, McBride NM, Storch EA. Barriers to access and participation in community mental health treatment for anxious children. J Affect Disord. 2016 May 15;196:54-61. doi: 10.1016/j.jad.2016.02.026. Epub 2016 Feb 10.</citation>
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    <citation>Schleider JL, Dobias ML, Sung JY, Mullarkey MC. Future Directions in Single-Session Youth Mental Health Interventions. J Clin Child Adolesc Psychol. 2020 Mar-Apr;49(2):264-278. doi: 10.1080/15374416.2019.1683852. Epub 2019 Dec 4.</citation>
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  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</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>
  <keyword>Anxiety</keyword>
  <keyword>Parenting</keyword>
  <keyword>Accommodation</keyword>
  <keyword>Online Intervention</keyword>
  <keyword>Single Session Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04453865/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04453865
org study id: IRB2020-00069
nct id: NCT04453865
lead sponsor: 
has dmc: No
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: 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.
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.
allocation: Randomized
intervention model: Sequential Assignment
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
masking: None (Open Label)
measure: Family Accommodation Scale
time frame: Change from Baseline Accommodation at 2-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 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).
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: Coping with Children's Negative Emotions Scale
time frame: Baseline
description: Coping with Children's Negative Emotions Scale measures parents' reactive emotions to their child's negative affect in distressing situations. Six subscales exist, but only the "distress reactions" domain, reflecting parental distress in the context of child negative affect, will be used. Participants rate 12 questions from 1 (very unlikely) to 7 (very likely). Score ranges from 12-84; higher numbers indicate more distress.
measure: Revised Children's Anxiety and Depression Scale
time frame: Baseline
description: 25 item measure assessing child's symptoms of anxiety and depression. Each question is rated on a 4-point scale from 0 (Never) to 3 (Always). Total score ranges from 0 to 75 with higher scores indicating higher levels of psychopathology
measure: Barriers to Access to Care Evaluation
time frame: Baseline
description: 30 item self-report questionnaire that asks about barriers they faced in getting professional care for a mental health problem on a scale of 0 (not at all) to 3 (a lot). Scores range from 0 to 90; higher scores indicate a higher number of barriers.
measure: Adult Measure of Behavioral Inhibition
time frame: Baseline
description: 16 item measure assessing one's temperamental tendency to respond to social novelty and risk stimuli, with inhibition and avoidance. Each question is rated on a 3 point scale from 0 (no/hardly ever) and 2 (yes/most of the time). Total score ranges from 0 to 32 with a higher scores indicating a greater degree of inhibition.
measure: Short Behavioral Inhibition Questionnaire
time frame: Baseline
description: 14-item parent rated scale measuring temperamental characteristics referring to shyness, fearfulness, and withdrawal in young, preschool children. Each question is rated on a 7-point scale from 1 (Hardly Ever) to 7 (Almost Always). Total score ranges from 14 to 98, with higher scores indicating a greater degree of inhibition
measure: Ruminative Response Scale
time frame: Baseline
description: 22 item questionnaire measuring two aspects of rumination: brooding and reflective pondering. Each question is rated on a 4-point scale from 1 (almost never) and 4 (almost always). Total score ranges from 22 to 88 with a higher score indicating higher ruminative tendencies.
measure: Distress Tolerance Scale
time frame: Change from Baseline Coping at 2-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: Co-Rumination Questionnaire
time frame: Baseline
description: 27-item self-report inventory that measures the extent to which one co-ruminates with others. For brevity, the survey has been modified to consist of 8 items that range from 1 (Not at all true) to 5 (really true). Total score ranges from 8 to 40 with a higher score indicating higher levels of co-rumination.
measure: Patient Reported Outcomes Measurement Information System-Depression Short
time frame: Baseline
description: 8 item self-report measure of depression. The questions are rated on a 5-point scale ranging from 1 (never) to 5 (always). Scores range from 8 to 40m higher scores indicating higher levels of 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 (ORR)
arm group type: Other
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: Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete
arm group label: Project EMPOWER
intervention type: Other
intervention name: Online Resources and Referrals
description: Information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment.
arm group label: Online Resources and Referrals (ORR)
other name: ORR
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Stony Brook University
investigator full name: Jessica Schleider
investigator title: Assistant Professor of Psychology
mesh term: Anxiety Disorders
sharing ipd: Undecided
provided document: 