<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/NCT04505488</url>
  </required_header>
  <id_info>
    <org_study_id>90IFST0004</org_study_id>
    <nct_id>NCT04505488</nct_id>
  </id_info>
  <brief_title>Efficacy of the ASPEN Intervention Program in Low-Resource Communities</brief_title>
  <acronym>ASPEN</acronym>
  <official_title>Efficacy of the ASD Screening and Parent ENgagement (ASPEN) Intervention Program in Low-Resource Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas State University, San Marcos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas State University, San Marcos</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 ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted,&#xD;
      parent-mediated intervention program. The ASPEN program is tailored to address social&#xD;
      communication and behavioral difficulties that young children with developmental delays may&#xD;
      experience in early childhood. The ASPEN Program includes 12 sessions where parents are&#xD;
      provided with psychoeducation about self-care, child development, and evidence-based&#xD;
      strategies. Coaching is also provided to train parents on using evidence-based strategies&#xD;
      within the home setting. The ASPEN program is delivered by a student clinician and a peer&#xD;
      leader. We hypothesize that coaching strategies delivered by the clinician will lead to&#xD;
      primary family caregivers learning evidence-based strategies and this will result in improved&#xD;
      child outcomes. We hypothesize that education and family support delivered by peer leaders&#xD;
      will help primary family caregivers learn social support strategies and this will lead to&#xD;
      improved parent outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Adaptive Behavior</measure>
    <time_frame>Baseline to Post-Intervention (12-14 weeks post baseline) Change</time_frame>
    <description>Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adaptive Behavior</measure>
    <time_frame>Baseline to Follow-Up (24-28 weeks post baseline) Change</time_frame>
    <description>Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Stress</measure>
    <time_frame>Baseline to Post-Intervention (12-14 weeks post baseline) Change</time_frame>
    <description>Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Stress</measure>
    <time_frame>Baseline to Follow-Up (24-28 weeks post baseline) Change</time_frame>
    <description>Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Empowerment</measure>
    <time_frame>Baseline to Post-Intervention (12-14 weeks post baseline) Change</time_frame>
    <description>Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parent Empowerment</measure>
    <time_frame>Baseline to Follow-Up (24-28 weeks post baseline) Change</time_frame>
    <description>Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Child Challenging Behavior</measure>
    <time_frame>Baseline to Post-Intervention (12-14 weeks post baseline) Change</time_frame>
    <description>Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Challenging Behavior</measure>
    <time_frame>Baseline to Follow-Up (24-28 weeks post baseline) Change</time_frame>
    <description>Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Quality of Life</measure>
    <time_frame>Baseline to Post-Intervention (12-14 weeks post baseline) Change</time_frame>
    <description>PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Quality of Life</measure>
    <time_frame>Baseline to Follow-Up (24-28 weeks post baseline) Change</time_frame>
    <description>PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ASD Screening Parent ENgagement Intervention Program (ASPEN)</intervention_name>
    <description>The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>ASPEN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child is between 18 months through 6 years of age&#xD;
&#xD;
          -  Child has a medical diagnosis or educational classification of Autism or Autism&#xD;
             Spectrum Disorder (ASD) or child is at-risk for Autism/ASD as determined by the&#xD;
             Modified-Checklist for Autism in Toddlers - Revised/Follow-up Interview (M-CHAT-R/F)&#xD;
             and/or Social Communication Questionnaire (SCQ)&#xD;
&#xD;
          -  Child resides in a low-resource household as determined by at least one of the&#xD;
             following criteria:&#xD;
&#xD;
          -  -Child or family has Medicaid as an insurance provider&#xD;
&#xD;
          -  -Child's primary caregiver has achieved a high school or lower education&#xD;
&#xD;
          -  -Child resides in a household with an annual income of 200% of the Federal Poverty&#xD;
             Level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary caregiver does not speak/understand English or Spanish&#xD;
&#xD;
          -  Child is younger 18 months or older than 6 years of age&#xD;
&#xD;
          -  Child does not have a medical diagnosis or educational classification of Autism/ASD or&#xD;
             does not meet at-risk criteria on the M-CHAT-R/F and/or SCQ&#xD;
&#xD;
          -  Child does not reside in low-resource household&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra B Vanegas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra B Vanegas, PhD</last_name>
    <phone>5122454579</phone>
    <email>svanegas@txstate.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sandy Magaña, PhD, MSW</last_name>
    <phone>5122329216</phone>
    <email>smagana@austin.utexas.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas State University</name>
      <address>
        <city>San Marcos</city>
        <state>Texas</state>
        <zip>78666</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra B Vanegas, PhD</last_name>
      <phone>512-245-4579</phone>
      <email>svanegas@txstate.edu</email>
    </contact>
    <investigator>
      <last_name>Sandra B Vanegas, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas State University, San Marcos</investigator_affiliation>
    <investigator_full_name>Sandra Vanegas</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Autism</keyword>
  <keyword>Parent-mediated intervention</keyword>
  <keyword>Naturalistic developmental behavioral intervention</keyword>
  <keyword>Low resource households</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available 1 year after study completion.</ipd_time_frame>
    <ipd_access_criteria>Electronic data from assessments will be submitted to Inter-university Consortium for Political and Social Research within 1 year after study completion for archival and storage purposes.</ipd_access_criteria>
  </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/NCT04505488
org study id: 90IFST0004
nct id: NCT04505488
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The ASD Screening and Parent ENgagement (ASPEN) program is a culturally adapted,
      parent-mediated intervention program. The ASPEN program is tailored to address social
      communication and behavioral difficulties that young children with developmental delays may
      experience in early childhood. The ASPEN Program includes 12 sessions where parents are
      provided with psychoeducation about self-care, child development, and evidence-based
      strategies. Coaching is also provided to train parents on using evidence-based strategies
      within the home setting. The ASPEN program is delivered by a student clinician and a peer
      leader. We hypothesize that coaching strategies delivered by the clinician will lead to
      primary family caregivers learning evidence-based strategies and this will result in improved
      child outcomes. We hypothesize that education and family support delivered by peer leaders
      will help primary family caregivers learn social support strategies and this will lead to
      improved parent outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Adaptive Behavior
time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
description: Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
measure: Adaptive Behavior
time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
description: Vineland Adaptive Behavior Scales - 3: Adaptive Behavior Composite Standard Score Minimum value = 20; Maximum value = 140; Higher scores indicate a better outcome
measure: Parenting Stress
time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
description: Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
measure: Parenting Stress
time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
description: Parenting Stress Index - Short Form Total Stress T Score Minimum value = 32; Maximum value = 92; Higher scores indicate a worse outcome
measure: Parent Empowerment
time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
description: Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
measure: Parent Empowerment
time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
description: Family Outcomes Scales - Revised Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome
measure: Child Challenging Behavior
time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
description: Scales of Independent Behavior-Revised: Problem Behavior Subscale Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
measure: Child Challenging Behavior
time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
description: Minimum value = +10; Maximum value = -74; Higher scores indicate a better outcome
measure: Family Quality of Life
time frame: Baseline to Post-Intervention (12-14 weeks post baseline) Change
description: PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
measure: Family Quality of Life
time frame: Baseline to Follow-Up (24-28 weeks post baseline) Change
description: PedsQL Family Impact Module: Family Functioning Minimum value = 0; Maximum value = 100; Higher scores indicate a better outcome
arm group label: Intervention Group
arm group type: Experimental
description: The intervention group will receive a parent manual, a resource packet, and 12 weekly sessions delivered by the clinician and peer leader.
arm group label: Control Group
arm group type: No Intervention
description: The control group will receive a parent manual and a resource packet. Four phone check-ins will be conducted across 12-14 weeks to address questions by the research team.
intervention type: Behavioral
intervention name: ASD Screening Parent ENgagement Intervention Program (ASPEN)
description: The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.
arm group label: Intervention Group
other name: ASPEN
criteria: 
gender: All
minimum age: 18 Months
maximum age: 6 Years
healthy volunteers: No
last name: Sandra B Vanegas, PhD
role: Principal Investigator
affiliation: Texas State University
last name: Sandra B Vanegas, PhD
phone: 5122454579
email: svanegas@txstate.edu
last name: Sandy Magaña, PhD, MSW
phone: 5122329216
email: smagana@austin.utexas.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas State University, San Marcos
investigator full name: Sandra Vanegas
investigator title: Assistant Professor
mesh term: Autism Spectrum Disorder
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: Data will be available 1 year after study completion.
ipd access criteria: Electronic data from assessments will be submitted to Inter-university Consortium for Political and Social Research within 1 year after study completion for archival and storage purposes.