<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/NCT02259036</url>
  </required_header>
  <id_info>
    <org_study_id>MH102666</org_study_id>
    <secondary_id>1R34MH102666-01A1</secondary_id>
    <nct_id>NCT02259036</nct_id>
  </id_info>
  <brief_title>Using Smartphones to Enhance the Treatment of Childhood Anxiety</brief_title>
  <acronym>Smart-CAT</acronym>
  <official_title>Using Smartphones to Enhance the Treatment of Childhood Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary goal of this research study is to develop an interactive smartphone app that&#xD;
      could be used to increase the effectiveness of talk therapy such as cognitive behavioral&#xD;
      therapy (CBT) for child anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being&#xD;
      asked to participate in this study. Interested participants who contact the study will be&#xD;
      asked to undergo a brief phone pre-screen to determine initial eligibility.&#xD;
&#xD;
      After completing a phone pre-screen, potential participants for the Phase 2 trial will be&#xD;
      invited to the lab to complete a clinical intake interview. Clinical information will be&#xD;
      obtained from parent and child by a trained research staff member. The research staff member&#xD;
      will have specific training to a high degree of reliability in conducting the diagnostic&#xD;
      interviews relevant to this research study.&#xD;
&#xD;
      Participants that meet study criteria based on the clinical information obtained at the first&#xD;
      study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an&#xD;
      empirically validated talk therapy commonly used to treat children with anxiety. Children&#xD;
      will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program&#xD;
      (Kendall 1994) is an empirically supported child-focused CBT treatment for children with&#xD;
      anxiety disorders. Throughout the program, children are encouraged to practice techniques&#xD;
      learned during therapy sessions through homework or &quot;Show-That-I-Can&quot; (STIC) tasks. Parents&#xD;
      attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific&#xD;
      SmartCAT modules in the smartphone app as assigned at the end of each session. Participants&#xD;
      might be asked to interact with other children and adolescents or study staff as well as&#xD;
      leave the therapy building. This is to allow participants to become more comfortable in&#xD;
      situations that make them feel anxious by gradually exposing them to the specific situation.&#xD;
      Parents are not treated as co-clients, but are considered consultants to the child's&#xD;
      treatment and are asked to provide some collaboration and assistance in exposure planning and&#xD;
      homework.&#xD;
&#xD;
      Treatment will be delivered by Masters-level therapists who will have completed training in&#xD;
      CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr.&#xD;
      Kendall on difficult cases via videoconference. All sessions will be videotaped.&#xD;
&#xD;
      SMARTPHONE PROTOCOL:&#xD;
&#xD;
      Prior to the first therapy session, the child and a parent will be trained how to use the&#xD;
      SmartCAT app. Youth will be provided with an Android smartphone for the duration of the&#xD;
      study. If the child already has an Android phone, the app will be installed on the&#xD;
      participant's phone in order to decrease participant burden of carrying an additional phone.&#xD;
&#xD;
      Participants will be given a study-provided, pre-programmed smartphone on which they will&#xD;
      enter their responses to a series of questions about moods and daily experiences using an app&#xD;
      developed for this study. The child will receive an electronic notification message once per&#xD;
      day and will be prompted through a series of questions about what he/she is doing, who he/she&#xD;
      is with, how he/she is feeling, worries or stressful events, and how he/she coped with these&#xD;
      events. It should take the child approximately 5 minutes each time to complete the questions.&#xD;
      The child will only be prompted to answer these questions outside of school hours and on&#xD;
      weekends. Participant data will be securely sent to study therapists via a clinician portal&#xD;
      connected to the app to be reviewed weekly. The therapists may then integrate this&#xD;
      information into treatment and provide customized feedback to the patient.&#xD;
&#xD;
      Parents will be asked to complete an online diary to keep track of what skills their child&#xD;
      uses during the week. After completion of the initial screening visit, parents are asked to&#xD;
      complete the Skills Use Diary daily for seven days. After this seven day period, they will be&#xD;
      asked to complete a diary entry twice per week throughout 8 weeks of treatment, totaling 30&#xD;
      entries. At the end of treatment, subjects will again be asked to complete the diary daily&#xD;
      for another seven days. Participants will receive links to the online diary and instructions&#xD;
      for completion via email (see references and other attachments for the email script). Diaries&#xD;
      should take no longer than 10 min per day to complete. The data will be encrypted and stored&#xD;
      securely through the online survey system Qualtrics.&#xD;
&#xD;
      POST-TREATMENT and 2-MONTH FOLLOW-UP:&#xD;
&#xD;
      All clinical, skill acquisition, and skill utilization measures (including the parent 7 day&#xD;
      diary) will be repeated at post-treatment (approximately 10 weeks) and 2 month follow-up We&#xD;
      will use Qualtrics, a secure internet data collection system, for administering diaries and&#xD;
      questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PARS Treatment response</measure>
    <time_frame>10 weeks</time_frame>
    <description>Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absence of diagnosis on K-SADS</measure>
    <time_frame>10 weeks</time_frame>
    <description>Recovery will be defined as an absence of DSM 5 diagnosis of Separation Anxiety, Social Anxiety, and Generalized Anxiety Disorder on the K-SADS interview.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>child report of anxiety</measure>
    <time_frame>10 weeks</time_frame>
    <description>child report of anxiety severity on the Screen for Childhood Anxiety Related Emotional Disorders (SCARED).</description>
  </other_outcome>
  <other_outcome>
    <measure>parent report of anxiety</measure>
    <time_frame>10 weeks</time_frame>
    <description>parent report of anxiety severity on the Screen for Childhood Anxiety Related Emotional Disorders (SCARED).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>SmartCAT Enhanced Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cognitive Behavioral Therapy enhanced with an ecological momentary treatment enhancement smartphone app called SmartCAT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ecological Momentary Treatment Enhancement</intervention_name>
    <description>Participants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.</description>
    <arm_group_label>SmartCAT Enhanced Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be 40 children of either sex ages 9 years, 0 months to 14 years, 11&#xD;
             months with DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety&#xD;
             Disorder (SAD), and/or Social Phobia (SP) as identified by the Kiddie Schedule of&#xD;
             Affective Disorders.&#xD;
&#xD;
        The primary caregiver is defined as the person who has the most responsibility for taking&#xD;
        care of the child. While this is typically the mother, it can be the father, an adoptive&#xD;
        parent or other legal guardian. The primary caregiver must be a legal guardian of the&#xD;
        child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Requires current ongoing treatment with psychoactive medications other than&#xD;
             stimulants.&#xD;
&#xD;
          2. Acutely suicidal or at risk for harm to self or others.&#xD;
&#xD;
          3. Neuromuscular or neurological disorder.&#xD;
&#xD;
          4. Reading level below 80 on the Wide Range Achievement Test-4 (WRAT-4)&#xD;
&#xD;
          5. Medical illnesses or medications taken for an illness as determined by study&#xD;
             physicians that would affect study adherence, and subject's emotional state.&#xD;
&#xD;
          6. Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who&#xD;
             have primary GAD with co-morbid MDD that is secondary in terms of course and&#xD;
             functional impact are not excluded), obsessive-compulsive disorder (OCD),&#xD;
             post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or&#xD;
             dependence, and ADHD combined type or predominantly hyperactive-impulsive type.&#xD;
&#xD;
          7. Lifetime diagnosis of autism spectrum disorder, bipolar disorder, psychotic&#xD;
             depression, schizophrenia, or schizoaffective disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer S Silk, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh, Dept. of Psychology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Achenbach, T. M. (1991). Manual for the Child Behavior Checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.</citation>
  </reference>
  <reference>
    <citation>Angold, A., Costello, E. J., Messer, S. C., Pickles, A., Winder, F., &amp; Silver, D. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. Interenational Journal of Methods in Psychiatric Research, 5, 237-249.</citation>
  </reference>
  <reference>
    <citation>Birmaher, B., Khetarpal, S., Cully, M., Brent, D. A., &amp; McKenzie, S. (2003). Screen for Child Anxiety Related Disorders (SCARED)--Parent form and child form (8 years and older). In L. VandeCreek (Ed.), Ellis Human Development Institute. (pp. 99-104). Sarasota, FL: Professional Resource Press/Professional Resource Exchange, Inc.</citation>
  </reference>
  <reference>
    <citation>Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.</citation>
    <PMID>10517055</PMID>
  </reference>
  <reference>
    <citation>Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.</citation>
    <PMID>11271757</PMID>
  </reference>
  <reference>
    <citation>Connor-Smith JK, Compas BE, Wadsworth ME, Thomsen AH, Saltzman H. Responses to stress in adolescence: measurement of coping and involuntary stress responses. J Consult Clin Psychol. 2000 Dec;68(6):976-92.</citation>
    <PMID>11142550</PMID>
  </reference>
  <reference>
    <citation>Constantino, J. N. (2002). The Social Responsiveness Scale, Los Angeles: Western Psychological Services.</citation>
  </reference>
  <reference>
    <citation>Guy W (1976): The clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Rockville, MD U.S. Department of Health, Education, and Welfare Public Health Service, Alcohol, Drug Abuse, Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research.</citation>
  </reference>
  <reference>
    <citation>Harter, S. (1988). Manual for the Self-perception Profile for Adolescents Denver, CO: University of Denver.</citation>
  </reference>
  <reference>
    <citation>Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.</citation>
    <PMID>9204677</PMID>
  </reference>
  <reference>
    <citation>Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.</citation>
    <PMID>8034812</PMID>
  </reference>
  <reference>
    <citation>Langley AK, Bergman RL, McCracken J, Piacentini JC. Impairment in childhood anxiety disorders: preliminary examination of the child anxiety impact scale-parent version. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):105-14. doi: 10.1089/104454604773840544.</citation>
    <PMID>15142397</PMID>
  </reference>
  <reference>
    <citation>Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13.</citation>
    <PMID>22459788</PMID>
  </reference>
  <reference>
    <citation>Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.</citation>
    <PMID>9435761</PMID>
  </reference>
  <reference>
    <citation>Ronan, K. R., Kendall, P. C., &amp; Rowe, M. (1994). Negative affectivity in children: Development and validation of a self-statement questionnaire. Cognitive Therapy and Research, 18(6), 509-528.</citation>
  </reference>
  <reference>
    <citation>The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1061-9. doi: 10.1097/00004583-200209000-00006.</citation>
    <PMID>12218427</PMID>
  </reference>
  <reference>
    <citation>Silk JS, Dahl RE, Ryan ND, Forbes EE, Axelson DA, Birmaher B, Siegle GJ. Pupillary reactivity to emotional information in child and adolescent depression: links to clinical and ecological measures. Am J Psychiatry. 2007 Dec;164(12):1873-80. doi: 10.1176/appi.ajp.2007.06111816.</citation>
    <PMID>18056243</PMID>
  </reference>
  <reference>
    <citation>Silk JS, Forbes EE, Whalen DJ, Jakubcak JL, Thompson WK, Ryan ND, Axelson DA, Birmaher B, Dahl RE. Daily emotional dynamics in depressed youth: a cell phone ecological momentary assessment study. J Exp Child Psychol. 2011 Oct;110(2):241-57. doi: 10.1016/j.jecp.2010.10.007. Epub 2010 Nov 26.</citation>
    <PMID>21112595</PMID>
  </reference>
  <reference>
    <citation>Silk JS, Steinberg L, Morris AS. Adolescents' emotion regulation in daily life: links to depressive symptoms and problem behavior. Child Dev. 2003 Nov-Dec;74(6):1869-80. doi: 10.1046/j.1467-8624.2003.00643.x.</citation>
    <PMID>14669901</PMID>
  </reference>
  <reference>
    <citation>Zeman, J., Shipman, K., &amp; Penza Clyve, S. (2001). Development and initial validation of the Children's Sadness Management Scale. Journal of Nonverbal Behavior, 25(3), 187-205.</citation>
  </reference>
  <reference>
    <citation>Ziegert DI, Kistner JA. Response styles theory: downward extension to children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):325-34. doi: 10.1207/S15374424JCCP3103_04.</citation>
    <PMID>12149970</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Jennifer Silk</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>child anxiety</keyword>
  <keyword>worries</keyword>
  <keyword>fears</keyword>
  <keyword>talk therapy</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>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02259036
org study id: MH102666
secondary id: 1R34MH102666-01A1
nct id: NCT02259036
lead sponsor: 
collaborator: 
has dmc: No
The primary goal of this research study is to develop an interactive smartphone app that
      could be used to increase the effectiveness of talk therapy such as cognitive behavioral
      therapy (CBT) for child anxiety.
Boys and girls between the ages of 9-14 who have anxiety and a parent or caregiver are being
      asked to participate in this study. Interested participants who contact the study will be
      asked to undergo a brief phone pre-screen to determine initial eligibility.

      After completing a phone pre-screen, potential participants for the Phase 2 trial will be
      invited to the lab to complete a clinical intake interview. Clinical information will be
      obtained from parent and child by a trained research staff member. The research staff member
      will have specific training to a high degree of reliability in conducting the diagnostic
      interviews relevant to this research study.

      Participants that meet study criteria based on the clinical information obtained at the first
      study visit will be invited to begin a course of Cognitive Behavior Therapy (CBT), an
      empirically validated talk therapy commonly used to treat children with anxiety. Children
      will receive individual treatment using the Brief Coping Cat Manual. The Coping Cat program
      (Kendall 1994) is an empirically supported child-focused CBT treatment for children with
      anxiety disorders. Throughout the program, children are encouraged to practice techniques
      learned during therapy sessions through homework or "Show-That-I-Can" (STIC) tasks. Parents
      attend weekly check-ins and two parent-only sessions. STIC tasks will consist of specific
      SmartCAT modules in the smartphone app as assigned at the end of each session. Participants
      might be asked to interact with other children and adolescents or study staff as well as
      leave the therapy building. This is to allow participants to become more comfortable in
      situations that make them feel anxious by gradually exposing them to the specific situation.
      Parents are not treated as co-clients, but are considered consultants to the child's
      treatment and are asked to provide some collaboration and assistance in exposure planning and
      homework.

      Treatment will be delivered by Masters-level therapists who will have completed training in
      CBT. They will attend a weekly supervision session with Dr. Silk, with consultation from Dr.
      Kendall on difficult cases via videoconference. All sessions will be videotaped.

      SMARTPHONE PROTOCOL:

      Prior to the first therapy session, the child and a parent will be trained how to use the
      SmartCAT app. Youth will be provided with an Android smartphone for the duration of the
      study. If the child already has an Android phone, the app will be installed on the
      participant's phone in order to decrease participant burden of carrying an additional phone.

      Participants will be given a study-provided, pre-programmed smartphone on which they will
      enter their responses to a series of questions about moods and daily experiences using an app
      developed for this study. The child will receive an electronic notification message once per
      day and will be prompted through a series of questions about what he/she is doing, who he/she
      is with, how he/she is feeling, worries or stressful events, and how he/she coped with these
      events. It should take the child approximately 5 minutes each time to complete the questions.
      The child will only be prompted to answer these questions outside of school hours and on
      weekends. Participant data will be securely sent to study therapists via a clinician portal
      connected to the app to be reviewed weekly. The therapists may then integrate this
      information into treatment and provide customized feedback to the patient.

      Parents will be asked to complete an online diary to keep track of what skills their child
      uses during the week. After completion of the initial screening visit, parents are asked to
      complete the Skills Use Diary daily for seven days. After this seven day period, they will be
      asked to complete a diary entry twice per week throughout 8 weeks of treatment, totaling 30
      entries. At the end of treatment, subjects will again be asked to complete the diary daily
      for another seven days. Participants will receive links to the online diary and instructions
      for completion via email (see references and other attachments for the email script). Diaries
      should take no longer than 10 min per day to complete. The data will be encrypted and stored
      securely through the online survey system Qualtrics.

      POST-TREATMENT and 2-MONTH FOLLOW-UP:

      All clinical, skill acquisition, and skill utilization measures (including the parent 7 day
      diary) will be repeated at post-treatment (approximately 10 weeks) and 2 month follow-up We
      will use Qualtrics, a secure internet data collection system, for administering diaries and
      questionnaires.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PARS Treatment response
time frame: 10 weeks
description: Anxiety severity will be rated by an IE on the Pediatric Anxiety Rating Scale (PARS) (RUPP Study Group, 2002). A total score was computed by summing six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week. Treatment response will be defined as a 35% reduction in PARS from pre- to post-treatment.
measure: Absence of diagnosis on K-SADS
time frame: 10 weeks
description: Recovery will be defined as an absence of DSM 5 diagnosis of Separation Anxiety, Social Anxiety, and Generalized Anxiety Disorder on the K-SADS interview.
measure: child report of anxiety
time frame: 10 weeks
description: child report of anxiety severity on the Screen for Childhood Anxiety Related Emotional Disorders (SCARED).
measure: parent report of anxiety
time frame: 10 weeks
description: parent report of anxiety severity on the Screen for Childhood Anxiety Related Emotional Disorders (SCARED).
arm group label: SmartCAT Enhanced Treatment
arm group type: Other
description: Cognitive Behavioral Therapy enhanced with an ecological momentary treatment enhancement smartphone app called SmartCAT.
intervention type: Other
intervention name: Ecological Momentary Treatment Enhancement
description: Participants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.
arm group label: SmartCAT Enhanced Treatment
criteria: 
gender: All
minimum age: 9 Years
maximum age: 14 Years
healthy volunteers: No
last name: Jennifer S Silk, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Achenbach, T. M. (1991). Manual for the Child Behavior Checklist/4-18 and 1991 Profile. Burlington: University of Vermont, Department of Psychiatry.
citation: Angold, A., Costello, E. J., Messer, S. C., Pickles, A., Winder, F., & Silver, D. (1995). Development of a short questionnaire for use in epidemiological studies of depression in children and adolescents. Interenational Journal of Methods in Psychiatric Research, 5, 237-249.
citation: Birmaher, B., Khetarpal, S., Cully, M., Brent, D. A., & McKenzie, S. (2003). Screen for Child Anxiety Related Disorders (SCARED)--Parent form and child form (8 years and older). In L. VandeCreek (Ed.), Ellis Human Development Institute. (pp. 99-104). Sarasota, FL: Professional Resource Press/Professional Resource Exchange, Inc.
citation: Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
PMID: 10517055
citation: Compas BE, Connor-Smith JK, Saltzman H, Thomsen AH, Wadsworth ME. Coping with stress during childhood and adolescence: problems, progress, and potential in theory and research. Psychol Bull. 2001 Jan;127(1):87-127.
PMID: 11271757
citation: Connor-Smith JK, Compas BE, Wadsworth ME, Thomsen AH, Saltzman H. Responses to stress in adolescence: measurement of coping and involuntary stress responses. J Consult Clin Psychol. 2000 Dec;68(6):976-92.
PMID: 11142550
citation: Constantino, J. N. (2002). The Social Responsiveness Scale, Los Angeles: Western Psychological Services.
citation: Guy W (1976): The clinical global impression scale. The ECDEU Assessment Manual for Psychopharmacology-Revised Rockville, MD U.S. Department of Health, Education, and Welfare Public Health Service, Alcohol, Drug Abuse, Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research.
citation: Harter, S. (1988). Manual for the Self-perception Profile for Adolescents Denver, CO: University of Denver.
citation: Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8. doi: 10.1097/00004583-199707000-00021.
PMID: 9204677
citation: Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
PMID: 8034812
citation: Langley AK, Bergman RL, McCracken J, Piacentini JC. Impairment in childhood anxiety disorders: preliminary examination of the child anxiety impact scale-parent version. J Child Adolesc Psychopharmacol. 2004 Spring;14(1):105-14. doi: 10.1089/104454604773840544.
PMID: 15142397
citation: Reynolds S, Wilson C, Austin J, Hooper L. Effects of psychotherapy for anxiety in children and adolescents: a meta-analytic review. Clin Psychol Rev. 2012 Jun;32(4):251-62. doi: 10.1016/j.cpr.2012.01.005. Epub 2012 Feb 13.
PMID: 22459788
citation: Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
PMID: 9435761
citation: Ronan, K. R., Kendall, P. C., & Rowe, M. (1994). Negative affectivity in children: Development and validation of a self-statement questionnaire. Cognitive Therapy and Research, 18(6), 509-528.
citation: The Pediatric Anxiety Rating Scale (PARS): development and psychometric properties. J Am Acad Child Adolesc Psychiatry. 2002 Sep;41(9):1061-9. doi: 10.1097/00004583-200209000-00006.
PMID: 12218427
citation: Silk JS, Dahl RE, Ryan ND, Forbes EE, Axelson DA, Birmaher B, Siegle GJ. Pupillary reactivity to emotional information in child and adolescent depression: links to clinical and ecological measures. Am J Psychiatry. 2007 Dec;164(12):1873-80. doi: 10.1176/appi.ajp.2007.06111816.
PMID: 18056243
citation: Silk JS, Forbes EE, Whalen DJ, Jakubcak JL, Thompson WK, Ryan ND, Axelson DA, Birmaher B, Dahl RE. Daily emotional dynamics in depressed youth: a cell phone ecological momentary assessment study. J Exp Child Psychol. 2011 Oct;110(2):241-57. doi: 10.1016/j.jecp.2010.10.007. Epub 2010 Nov 26.
PMID: 21112595
citation: Silk JS, Steinberg L, Morris AS. Adolescents' emotion regulation in daily life: links to depressive symptoms and problem behavior. Child Dev. 2003 Nov-Dec;74(6):1869-80. doi: 10.1046/j.1467-8624.2003.00643.x.
PMID: 14669901
citation: Zeman, J., Shipman, K., & Penza Clyve, S. (2001). Development and initial validation of the Children's Sadness Management Scale. Journal of Nonverbal Behavior, 25(3), 187-205.
citation: Ziegert DI, Kistner JA. Response styles theory: downward extension to children. J Clin Child Adolesc Psychol. 2002 Sep;31(3):325-34. doi: 10.1207/S15374424JCCP3103_04.
PMID: 12149970
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Jennifer Silk
investigator title: PhD
mesh term: Anxiety Disorders
sharing ipd: No