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/NCT05968560</url>
    </required_header>
    <id_info>
      <org_study_id>GCO 21-0328</org_study_id>
      <secondary_id>R34MH128502</secondary_id>
      <nct_id>NCT05968560</nct_id>
    </id_info>
    <brief_title>Telehealth Cognitive Behavioral Therapy for Youth at Risk for Psychosis</brief_title>
    <official_title>Telehealth Adaptation of Group and Family-Based Cognitive Behavioral Therapy for Youth at Risk for Psychosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</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>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the feasibility and effectiveness of telehealth interventions for&#xD;
        individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during&#xD;
        late adolescence or early adulthood, significantly impacting long-term functioning. While CHR&#xD;
        programs have the potential to reduce illness severity, individuals often face barriers such&#xD;
        as stigma and limited access to services. Telehealth interventions could address these&#xD;
        barriers and improve treatment accessibility and engagement. The study will focus on Group&#xD;
        and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted&#xD;
        for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet&#xD;
        CHR criteria will be randomly assigned to one of these interventions. Feasibility will be&#xD;
        measured by recruitment rate, attendance, and retention. The study will assess the impact of&#xD;
        the interventions on cognitive biases, social connectedness, family emotional climate, and&#xD;
        proficiency in CBT skills. The three intervention groups will be compared in terms of&#xD;
        psychosocial functioning, symptom severity, rates of remission from CHR, and rates of&#xD;
        transition to psychosis. Additionally, factors like patient treatment preference, family&#xD;
        emotional climate, and sociodemographic factors will be explored as potential moderators of&#xD;
        treatment outcomes. Qualitative interviews will be conducted with participants and clinicians&#xD;
        to inform dissemination efforts.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in&#xD;
        social and cognitive development, and can therefore have a profoundly adverse impact on an&#xD;
        individual's long-term functioning. The onset of psychosis is preceded by a clinical high&#xD;
        risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR&#xD;
        programs have enormous potential to reduce the long-term severity of the illness, and the&#xD;
        suffering and cost associated with it. Youth at CHR also typically have environmental and&#xD;
        individual-level barriers to accessing and engaging in services, including stigma, a dearth&#xD;
        of trained providers, clinic location and transportation issues, suspiciousness, and a&#xD;
        tendency to socially isolate. Reducing some of these barriers via telehealth interventions&#xD;
        may improve treatment accessibility and engagement, thereby improving clinical outcomes.&#xD;
        There is a substantial need to evaluate different CHR interventions to determine which are&#xD;
        most effective. There is also a significant need to systematically investigate remote&#xD;
        delivery methods as a way of increasing access to critical services for CHR. The research&#xD;
        team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in&#xD;
        order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition&#xD;
        to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory,&#xD;
        psychosocial resilience models, and research on information processing in delusions. GF-CBT&#xD;
        has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and&#xD;
        Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth&#xD;
        and families learn CBT skills as a family unit, rather than in groups. The research team have&#xD;
        adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and&#xD;
        I-CBT-TH). This study will investigate the feasibility of implementing these telehealth&#xD;
        interventions in the context of routine CHR services, evaluate the impact of the&#xD;
        interventions on engaging target mechanisms hypothesized to underlie their effects, and&#xD;
        conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of&#xD;
        14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly&#xD;
        assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be&#xD;
        collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by&#xD;
        recruitment rate, attendance, and retention. The following intervention targets will be&#xD;
        assessed: cognitive biases, social connectedness, family emotional climate, and family&#xD;
        members' proficiency in CBT skills. The three groups will be compared across the following&#xD;
        domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates&#xD;
        of transition to psychosis. The research team will also explore whether patient treatment&#xD;
        preference, family emotional climate and sociodemographic factors differentially moderate&#xD;
        treatment outcomes. Qualitative interviews will be conducted with patients, families, and&#xD;
        clinicians to inform dissemination and make adaptations to the implementation manuals.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Global Functioning: Role (GFR) Scale</measure>
      <time_frame>Up to week 28</time_frame>
      <description>The Global Functioning: Role (GFR) scale, clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on their primary role. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Ratings on a 10-point scale (1= Extreme Role Dysfunction to 10 = Superior Role Functioning) with higher scores representing better role functioning.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Global Functioning: Social (GFS) Scale</measure>
      <time_frame>Up to week 28</time_frame>
      <description>The Global Functioning: Social (GFS) scales, clinician administered scales, derived from the GAF format. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. The GFS scale scores range from 1 to 10 with higher scores representing better social functioning.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The Structured Interview for Psychosis Risk Syndromes (SIPS)</measure>
      <time_frame>Up to week 28</time_frame>
      <description>Symptom severity will be measured by SIPS, which consists of five positive-symptoms subscales (Unusual thought content/ delusional ideas, Suspiciousness/persecutory ideas, Grandiosity, Perceptual abnormalities/hallucinations, and Disorganized communication), as well as subscales for negative, disorganization, and general symptoms. SIPS will also be used to compare the three arms on rates of remission from CHR and number of transitions to psychosis. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score represents more favorable outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peters' Delusions Inventory (PDI)</measure>
      <time_frame>Up to week 28</time_frame>
      <description>The Peters' Delusions Inventory (PDI), a self-report scale measuring the presence of 21 common delusional thoughts and the distress, preoccupation, and conviction associated with each belief. The Peters Delusional Inventory (PDI) assesses the presence and severity of delusional beliefs. It is used to measure the intensity and conviction of delusions in individuals experiencing psychosis or related conditions. The PDI consists of a series of statements that the respondent rates based on their agreement or disagreement. The PDI includes a total of 21 items, and each item is rated on a 5-point Likert scale ranging from 1 to 5. There are 3 subscales: Distress, preoccupation and conviction. Higher scores on the PDI indicate a greater intensity and conviction of delusional beliefs. The scale ranges from 0 to 336, with 0 indicating no endorsement of delusion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Davos Assessment of Cognitive Biases</measure>
      <time_frame>Up to week 28</time_frame>
      <description>Cognitive biases will be assessed using the Davos Assessment of Cognitive Biases, a self-report scale that measures cognitive biases across the following sub-scales: Jumping to Conclusions Bias, Belief Inflexibility Bias, Attention for Threat Bias, External Attribution Bias, Social Cognition Problems, Subjective Cognitive Problems, and Safety Behaviors. The scale ranges from 42 to 294, with higher scores indicating higher cognitive biases .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Connectedness Scale Revised</measure>
      <time_frame>Up to week 28</time_frame>
      <description>Social connectedness will be assessed using the Social Connectedness Scale Revised, a 20-item self-report scale that measures the degree to which one feels connected to their social environment. The scale ranges from 20 to 120, with higher scores indicating greater social connectedness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family Attitudes Scale (FAS)</measure>
      <time_frame>Up to week 28</time_frame>
      <description>The Family Attitudes Scale (FAS) is a 30-item scale that can be completed by any informant to measure the family emotional climate. Participating family members will complete the Family Attitudes Scale. The scale ranges from 0 to 120, with higher scores indicating more negative attitudes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Angry Behaviors Scale (ABS)</measure>
      <time_frame>Up to week 28</time_frame>
      <description>Youth will complete the Angry Behaviors Scale (ABS), which is comprised of four items from the FAS. The scale ranges from 0 to 16, with higher scores indicating greater expression of anger.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Clinical High Risk for Psychosis (CHR)</condition>
    <arm_group>
      <arm_group_label>Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GF-CBT via telehealth is an intervention consisting of three parts: 15 group sessions for young people, 15 individual sessions for young people, and 15 group sessions for families. The group sessions for young people and families focus on teaching CBT skills. The goal is to enhance reasoning, decision-making, and positive beliefs while reducing cognitive biases, distress, and isolation. The individual sessions personalize the CBT skills learned in the group, focusing on tailoring skills to personal goals. Family members also participate in group sessions to learn the same CBT skills and how to prompt and support their young family members in using these skills. All sessions are conducted via Telehealth</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Family-Based Cognitive Behavioral Therapy (F-CBT-TH)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>F-CBT via telehealth consists of two parts: 15 family sessions and 15 individual sessions for young people. The family sessions focus on teaching CBT skills to a family units. The individual sessions with youth personalize the CBT skills learned in the family sessions, focusing on tailoring skills to personal goals. All sessions are conducted via Telehealth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Individual Cognitive Behavioral Therapy (I-CBT-TH)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>I-CBT-TH via telehealth consists of two components: 15 CBT Skill Learning sessions and 15 follow-up session that personalizes the learned skills. All sessions are conducted via Telehealth.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CBT Skills Group for CHR Youth</intervention_name>
      <description>CBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses &quot;CBT to Prevent Paranoia&quot; manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening.</description>
      <arm_group_label>Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Individual CBT sessions</intervention_name>
      <description>CBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed.</description>
      <arm_group_label>Family-Based Cognitive Behavioral Therapy (F-CBT-TH)</arm_group_label>
      <arm_group_label>Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)</arm_group_label>
      <arm_group_label>Individual Cognitive Behavioral Therapy (I-CBT-TH)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CBT Skills Group for Families</intervention_name>
      <description>Family members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in &quot;CBT Skills for Families&quot; manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week.</description>
      <arm_group_label>Family-Based Cognitive Behavioral Therapy (F-CBT-TH)</arm_group_label>
      <arm_group_label>Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Age 14-25&#xD;
  &#xD;
            -  Ability to participate in assessments and treatment in English&#xD;
  &#xD;
            -  Meets criteria for psychosis-risk on SIPS&#xD;
  &#xD;
            -  Stable on medications; no changes within 1 month prior to enrollment&#xD;
  &#xD;
            -  Identification of one &quot;family member&quot; with &gt;4 hours/week contact who is willing to&#xD;
               participate (&quot;Family member&quot; can be any blood relative, spouse, significant other, or&#xD;
               close friend whom the subject identifies as a consistent and important person in their&#xD;
               life).&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Intellectual disability (IQ&lt;70)&#xD;
  &#xD;
            -  Medical condition known to cause psychosis&#xD;
  &#xD;
            -  Moderate or severe substance use disorder and active use within the past 30 days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yulia Landa</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yulia Landa, PsyD, MS</last_name>
      <phone>212-585-4658</phone>
      <email>yulia.landa@mssm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rachel Jespersen, LMSW</last_name>
      <phone>212-585-4641</phone>
      <email>rachel.jespersen@mssm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yulia Landa, PsyD,MS</last_name>
        <phone>212-585-4658</phone>
        <email>yulia.landa@mssm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Rachel Jespersen, LMSW</last_name>
        <phone>212-585-4641</phone>
        <email>rachel.jespersen@mssm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Yulia Landa</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.</citation>
      <PMID>25585830</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Yulia Landa</investigator_full_name>
      <investigator_title>Assistant Professor of Psychiatry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All of the individual participant data collected during the trial, after deidentification.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Data will be shared via secured file sharing platform</ipd_access_criteria>
    </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/NCT05968560
  org study id: GCO 21-0328
  secondary id: R34MH128502
  nct id: NCT05968560
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study aims to evaluate the feasibility and effectiveness of telehealth interventions for
        individuals at clinical high risk for psychosis (CHR). Psychosis typically emerges during
        late adolescence or early adulthood, significantly impacting long-term functioning. While CHR
        programs have the potential to reduce illness severity, individuals often face barriers such
        as stigma and limited access to services. Telehealth interventions could address these
        barriers and improve treatment accessibility and engagement. The study will focus on Group
        and Family-Based Cognitive Behavioral Therapy, Family-Based CBT, and individual CBT, adapted
        for telehealth delivery (GF-CBT-TH, F-CBT-TH, and I-CBT-TH). Participants aged 14-25 who meet
        CHR criteria will be randomly assigned to one of these interventions. Feasibility will be
        measured by recruitment rate, attendance, and retention. The study will assess the impact of
        the interventions on cognitive biases, social connectedness, family emotional climate, and
        proficiency in CBT skills. The three intervention groups will be compared in terms of
        psychosocial functioning, symptom severity, rates of remission from CHR, and rates of
        transition to psychosis. Additionally, factors like patient treatment preference, family
        emotional climate, and sociodemographic factors will be explored as potential moderators of
        treatment outcomes. Qualitative interviews will be conducted with participants and clinicians
        to inform dissemination efforts.
  Psychosis typically emerges in late adolescence or early adulthood, which is a vital stage in
        social and cognitive development, and can therefore have a profoundly adverse impact on an
        individual's long-term functioning. The onset of psychosis is preceded by a clinical high
        risk (CHR) phase characterized by attenuated psychotic symptoms and functional decline. CHR
        programs have enormous potential to reduce the long-term severity of the illness, and the
        suffering and cost associated with it. Youth at CHR also typically have environmental and
        individual-level barriers to accessing and engaging in services, including stigma, a dearth
        of trained providers, clinic location and transportation issues, suspiciousness, and a
        tendency to socially isolate. Reducing some of these barriers via telehealth interventions
        may improve treatment accessibility and engagement, thereby improving clinical outcomes.
        There is a substantial need to evaluate different CHR interventions to determine which are
        most effective. There is also a significant need to systematically investigate remote
        delivery methods as a way of increasing access to critical services for CHR. The research
        team have established Group and Family-Based Cognitive Behavioral Therapy (GF-CBT) program in
        order to facilitate psychosocial recovery, decrease symptoms, and prevent or delay transition
        to psychosis in youth at CHR. GF-CBT is grounded in sociocultural ecological systems theory,
        psychosocial resilience models, and research on information processing in delusions. GF-CBT
        has been implemented as part of SAMHSA funded CHR services in New York, Missouri, and
        Delaware. The research team have also established Family-Based CBT (F-CBT), in which youth
        and families learn CBT skills as a family unit, rather than in groups. The research team have
        adapted GF-CBT, F-CBT and individual CBT for telehealth delivery (GF-CBT-TH, F-CBT-TH and
        I-CBT-TH). This study will investigate the feasibility of implementing these telehealth
        interventions in the context of routine CHR services, evaluate the impact of the
        interventions on engaging target mechanisms hypothesized to underlie their effects, and
        conduct a preliminary evaluation of their comparative efficacy. Subjects between the ages of
        14 and 25 who meet CHR criteria on the SIPS (n=72) and their families will be randomly
        assigned to receive GF-CBT-TH, F-CBT-TH or I-CBT-TH for a period of 15 weeks. Data will be
        collected at baseline, post-treatment, and 3-month follow-up. Feasibility will be measured by
        recruitment rate, attendance, and retention. The following intervention targets will be
        assessed: cognitive biases, social connectedness, family emotional climate, and family
        members' proficiency in CBT skills. The three groups will be compared across the following
        domains: psychosocial functioning, symptom severity, rates of remission from CHR, and rates
        of transition to psychosis. The research team will also explore whether patient treatment
        preference, family emotional climate and sociodemographic factors differentially moderate
        treatment outcomes. Qualitative interviews will be conducted with patients, families, and
        clinicians to inform dissemination and make adaptations to the implementation manuals.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The Global Functioning: Role (GFR) Scale
  time frame: Up to week 28
  description: The Global Functioning: Role (GFR) scale, clinician administered scales, derived from the GAF format. The GFR scale anchor points refer to performance in school, work, or as a homemaker, depending on their primary role. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. Ratings on a 10-point scale (1= Extreme Role Dysfunction to 10 = Superior Role Functioning) with higher scores representing better role functioning.
  measure: Global Functioning: Social (GFS) Scale
  time frame: Up to week 28
  description: The Global Functioning: Social (GFS) scales, clinician administered scales, derived from the GAF format. The GFS scale assesses quantity and quality of peer relationships, level of peer conflict, age appropriate intimate relationships, and involvement with family members. The GFS scale scores range from 1 to 10 with higher scores representing better social functioning.
  measure: The Structured Interview for Psychosis Risk Syndromes (SIPS)
  time frame: Up to week 28
  description: Symptom severity will be measured by SIPS, which consists of five positive-symptoms subscales (Unusual thought content/ delusional ideas, Suspiciousness/persecutory ideas, Grandiosity, Perceptual abnormalities/hallucinations, and Disorganized communication), as well as subscales for negative, disorganization, and general symptoms. SIPS will also be used to compare the three arms on rates of remission from CHR and number of transitions to psychosis. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score represents more favorable outcomes.
  measure: Peters' Delusions Inventory (PDI)
  time frame: Up to week 28
  description: The Peters' Delusions Inventory (PDI), a self-report scale measuring the presence of 21 common delusional thoughts and the distress, preoccupation, and conviction associated with each belief. The Peters Delusional Inventory (PDI) assesses the presence and severity of delusional beliefs. It is used to measure the intensity and conviction of delusions in individuals experiencing psychosis or related conditions. The PDI consists of a series of statements that the respondent rates based on their agreement or disagreement. The PDI includes a total of 21 items, and each item is rated on a 5-point Likert scale ranging from 1 to 5. There are 3 subscales: Distress, preoccupation and conviction. Higher scores on the PDI indicate a greater intensity and conviction of delusional beliefs. The scale ranges from 0 to 336, with 0 indicating no endorsement of delusion.
  measure: Davos Assessment of Cognitive Biases
  time frame: Up to week 28
  description: Cognitive biases will be assessed using the Davos Assessment of Cognitive Biases, a self-report scale that measures cognitive biases across the following sub-scales: Jumping to Conclusions Bias, Belief Inflexibility Bias, Attention for Threat Bias, External Attribution Bias, Social Cognition Problems, Subjective Cognitive Problems, and Safety Behaviors. The scale ranges from 42 to 294, with higher scores indicating higher cognitive biases .
  measure: Social Connectedness Scale Revised
  time frame: Up to week 28
  description: Social connectedness will be assessed using the Social Connectedness Scale Revised, a 20-item self-report scale that measures the degree to which one feels connected to their social environment. The scale ranges from 20 to 120, with higher scores indicating greater social connectedness.
  measure: Family Attitudes Scale (FAS)
  time frame: Up to week 28
  description: The Family Attitudes Scale (FAS) is a 30-item scale that can be completed by any informant to measure the family emotional climate. Participating family members will complete the Family Attitudes Scale. The scale ranges from 0 to 120, with higher scores indicating more negative attitudes.
  measure: Angry Behaviors Scale (ABS)
  time frame: Up to week 28
  description: Youth will complete the Angry Behaviors Scale (ABS), which is comprised of four items from the FAS. The scale ranges from 0 to 16, with higher scores indicating greater expression of anger.
  arm group label: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)
  arm group type: Experimental
  description: GF-CBT via telehealth is an intervention consisting of three parts: 15 group sessions for young people, 15 individual sessions for young people, and 15 group sessions for families. The group sessions for young people and families focus on teaching CBT skills. The goal is to enhance reasoning, decision-making, and positive beliefs while reducing cognitive biases, distress, and isolation. The individual sessions personalize the CBT skills learned in the group, focusing on tailoring skills to personal goals. Family members also participate in group sessions to learn the same CBT skills and how to prompt and support their young family members in using these skills. All sessions are conducted via Telehealth
  arm group label: Family-Based Cognitive Behavioral Therapy (F-CBT-TH)
  arm group type: Experimental
  description: F-CBT via telehealth consists of two parts: 15 family sessions and 15 individual sessions for young people. The family sessions focus on teaching CBT skills to a family units. The individual sessions with youth personalize the CBT skills learned in the family sessions, focusing on tailoring skills to personal goals. All sessions are conducted via Telehealth.
  arm group label: Individual Cognitive Behavioral Therapy (I-CBT-TH)
  arm group type: Active Comparator
  description: I-CBT-TH via telehealth consists of two components: 15 CBT Skill Learning sessions and 15 follow-up session that personalizes the learned skills. All sessions are conducted via Telehealth.
  intervention type: Behavioral
  intervention name: CBT Skills Group for CHR Youth
  description: CBT skills group is designed to boost peer support, reduce isolation, normalize psychotic-like experiences to lessen distress, reduce cognitive biases, facilitate positive beliefs, and enhance reasoning and decision-making. CBT skills group uses "CBT to Prevent Paranoia" manual to teach individuals to make adaptive appraisals of their experiences (e.g. voices and other cognitive intrusions) to prevent the perception of such events as threatening.
  arm group label: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)
  intervention type: Behavioral
  intervention name: Individual CBT sessions
  description: CBT skills learned in group are personalized in individual sessions focused on: a) facilitating learning of CBT skills; b) tailoring CBT skills to personal goals; c) facilitating successful interaction with peers in the group; and d) providing academic and vocational support. Youth may opt to invite family members to join individual sessions as needed.
  arm group label: Family-Based Cognitive Behavioral Therapy (F-CBT-TH)
  arm group label: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)
  arm group label: Individual Cognitive Behavioral Therapy (I-CBT-TH)
  intervention type: Behavioral
  intervention name: CBT Skills Group for Families
  description: Family members are taught the same CBT skills that are taught to CHR youth to facilitate use of CBT skills at home. Family members also learn how to prompt CHR youth to use CBT skills through effective communication, such as empathic listening and encouraging alternative explanations. CBT skills group for family members uses a combination of didactic learning (skills are described in "CBT Skills for Families" manual and demonstrated via video examples) and practice (skills are role-played). Youth attend one group session and one individual session per week, and family members attend one group session per week.
  arm group label: Family-Based Cognitive Behavioral Therapy (F-CBT-TH)
  arm group label: Group and Family-Based Cognitive Behavioral Therapy (GF-CBT-TH)
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Yulia Landa
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Yulia Landa, PsyD, MS
  phone: 212-585-4658
  email: yulia.landa@mssm.edu
  last name: Rachel Jespersen, LMSW
  phone: 212-585-4641
  email: rachel.jespersen@mssm.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.
  PMID: 25585830
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Yulia Landa
  investigator title: Assistant Professor of Psychiatry
  mesh term: Psychotic Disorders
  mesh term: Mental Disorders
  sharing ipd: Yes
  ipd description: All of the individual participant data collected during the trial, after deidentification.
  ipd info type: Study Protocol
  ipd time frame: Beginning 3 months and ending 5 years following article publication.
  ipd access criteria: Researchers who provide a methodologically sound proposal. Any purpose. Specify Other Mechanism Data will be shared via secured file sharing platform