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/NCT05965648</url>
    </required_header>
    <id_info>
      <org_study_id>6444E</org_study_id>
      <nct_id>NCT05965648</nct_id>
    </id_info>
    <brief_title>Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum</brief_title>
    <official_title>Families FORWARD: Development of a Family-Based Transition Planning Program for Culturally-Diverse Youth on the Autism Spectrum</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston University Charles River Campus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Deborah Munroe Noonan Memorial Research Fund</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boston University Charles River Campus</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>
        The goal of this clinical study is to develop a community-based program to support family&#xD;
        members of transition-aged youth on the autism spectrum to help them plan for the future. The&#xD;
        main aims of the study are:&#xD;
  &#xD;
          1. To develop the Families FORWARD program&#xD;
  &#xD;
          2. To conduct proof-of-concept testing of the Families FORWARD program&#xD;
  &#xD;
        Participants will complete surveys before and after participating in the program and will&#xD;
        participate in exit interviews at the end of the program.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)&#xD;
        program aims to increase family members' active planning for the transition to adulthood in&#xD;
        the context of autism. The program is designed to enable flexible delivery for families of&#xD;
        youth who are diverse across autism features, co-occurring conditions, service needs,&#xD;
        cultural values and preferences, and readiness to engage in planning. The program will be&#xD;
        delivered collaboratively with community organizations that support individuals on the autism&#xD;
        spectrum and/or their families.&#xD;
  &#xD;
        The current project aims to conduct proof-of-concept testing with a culturally-diverse sample&#xD;
        of families of transition-aged youth on the autism spectrum. Parents / primary caregivers&#xD;
        will participate in 6-7 individual, personalized sessions that incorporate aspects of&#xD;
        skill-building (communication, goal-setting, problem-solving, systems navigation), education&#xD;
        about services, and motivational interviewing. Youth will be invited to participate in 3 of&#xD;
        the sessions along with their parent / primary caregiver. Participants will complete surveys&#xD;
        before and after participating in the program and will participate in exit interviews at the&#xD;
        end of the program. The investigators will assess indicators of acceptability, feasibility,&#xD;
        and improvement on proposed mediators and outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Families FORWARD Program Acceptability Form</measure>
      <time_frame>At the conclusion of all sessions in the program (approximately 3 months)</time_frame>
      <description>The parents (and youth, when applicable) will complete the Program Acceptability scale that will assess acceptability, appropriateness, and feasibility. Item scores range from 0 to 4. Higher scores are associated with higher perceptions of intervention acceptability, appropriateness, and feasibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Transition Planning Activities</measure>
      <time_frame>Baseline, 3 months</time_frame>
      <description>The Transition Planning Activity Measure will be used to assess parent's readiness for their youth's transition to adulthood. It is a parent proxy questionnaire. Item scores range from 1 to 4. Higher scores are associated with higher transition readiness.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Family Relations</condition>
    <arm_group>
      <arm_group_label>Families FORWARD</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>This is a single-arm trial of a new transition planning program for families of youth on the autism spectrum. The program includes six or seven bi-weekly parent sessions, three of which are optional for the youth to attend. The program will be facilitated by community-based service providers who work with transition-aged youth on the autism spectrum and/or their families.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)</intervention_name>
      <description>Families FORWARD aims to engage families in planning for adulthood earlier and more actively. Program skills include communication and problem-solving; guided practice in setting realistic goals, breaking down goals into incremental action steps, and problem-solving barriers to goal attainment; repeated engagement in future-oriented communication; and training on how to navigate transition-related and adult services. Parents/caregivers will participate in six or seven telehealth sessions (60-75 minutes each). Youth on the autism spectrum will have the option of participating in up to three program sessions to increase collaborative planning within the family. Families will identify and work toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship).</description>
      <arm_group_label>Families FORWARD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Family Inclusion Criteria&#xD;
  &#xD;
                 1. Parents or primary caregivers of transition-aged youth on the autism spectrum:&#xD;
  &#xD;
                      1. Have one or more child(ren) on the autism spectrum who is/are ages 14-21&#xD;
                         years old&#xD;
  &#xD;
                      2. Identify as the parent, legal guardian, and/or primary caregiver of the&#xD;
                         youth&#xD;
  &#xD;
                      3. Speak English fluently&#xD;
  &#xD;
                      4. Reside in Massachusetts&#xD;
  &#xD;
                 2. Youth on the autism spectrum:&#xD;
  &#xD;
                      1. Have an autism diagnosis OR identify as autistic&#xD;
  &#xD;
                      2. Age 14-21&#xD;
  &#xD;
                      3. Have ability to communicate verbally or in written format in English&#xD;
  &#xD;
                      4. Reside in Massachusetts&#xD;
  &#xD;
          Exclusion Criteria: none&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kristin A. Long, PhD</last_name>
      <phone>617-358-4296</phone>
      <email>kalong@bu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Suma Suswaram, PhD</last_name>
      <phone>617-358-8914</phone>
      <email>forward@bu.edu</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Boston University Charles River Campus</investigator_affiliation>
      <investigator_full_name>Kristin Long</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It is not yet known if there will be a plan to make IPD available.</ipd_description>
    </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/NCT05965648
  org study id: 6444E
  nct id: NCT05965648
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical study is to develop a community-based program to support family
        members of transition-aged youth on the autism spectrum to help them plan for the future. The
        main aims of the study are:
  
          1. To develop the Families FORWARD program
  
          2. To conduct proof-of-concept testing of the Families FORWARD program
  
        Participants will complete surveys before and after participating in the program and will
        participate in exit interviews at the end of the program.
  The Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)
        program aims to increase family members' active planning for the transition to adulthood in
        the context of autism. The program is designed to enable flexible delivery for families of
        youth who are diverse across autism features, co-occurring conditions, service needs,
        cultural values and preferences, and readiness to engage in planning. The program will be
        delivered collaboratively with community organizations that support individuals on the autism
        spectrum and/or their families.
  
        The current project aims to conduct proof-of-concept testing with a culturally-diverse sample
        of families of transition-aged youth on the autism spectrum. Parents / primary caregivers
        will participate in 6-7 individual, personalized sessions that incorporate aspects of
        skill-building (communication, goal-setting, problem-solving, systems navigation), education
        about services, and motivational interviewing. Youth will be invited to participate in 3 of
        the sessions along with their parent / primary caregiver. Participants will complete surveys
        before and after participating in the program and will participate in exit interviews at the
        end of the program. The investigators will assess indicators of acceptability, feasibility,
        and improvement on proposed mediators and outcomes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Families FORWARD Program Acceptability Form
  time frame: At the conclusion of all sessions in the program (approximately 3 months)
  description: The parents (and youth, when applicable) will complete the Program Acceptability scale that will assess acceptability, appropriateness, and feasibility. Item scores range from 0 to 4. Higher scores are associated with higher perceptions of intervention acceptability, appropriateness, and feasibility.
  measure: Transition Planning Activities
  time frame: Baseline, 3 months
  description: The Transition Planning Activity Measure will be used to assess parent's readiness for their youth's transition to adulthood. It is a parent proxy questionnaire. Item scores range from 1 to 4. Higher scores are associated with higher transition readiness.
  arm group label: Families FORWARD
  arm group type: Other
  description: This is a single-arm trial of a new transition planning program for families of youth on the autism spectrum. The program includes six or seven bi-weekly parent sessions, three of which are optional for the youth to attend. The program will be facilitated by community-based service providers who work with transition-aged youth on the autism spectrum and/or their families.
  intervention type: Behavioral
  intervention name: Families FORWARD (Focusing on Relationships, Well-being, and Responsibility aheaD)
  description: Families FORWARD aims to engage families in planning for adulthood earlier and more actively. Program skills include communication and problem-solving; guided practice in setting realistic goals, breaking down goals into incremental action steps, and problem-solving barriers to goal attainment; repeated engagement in future-oriented communication; and training on how to navigate transition-related and adult services. Parents/caregivers will participate in six or seven telehealth sessions (60-75 minutes each). Youth on the autism spectrum will have the option of participating in up to three program sessions to increase collaborative planning within the family. Families will identify and work toward individualized transition planning goals that may fall within any area of planning or functioning (e.g., housing, education, guardianship).
  arm group label: Families FORWARD
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kristin A. Long, PhD
  phone: 617-358-4296
  email: kalong@bu.edu
  last name: Suma Suswaram, PhD
  phone: 617-358-8914
  email: forward@bu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Boston University Charles River Campus
  investigator full name: Kristin Long
  investigator title: Associate Professor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  sharing ipd: No
  ipd description: It is not yet known if there will be a plan to make IPD available.