<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/NCT02255786</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001563</org_study_id>
    <nct_id>NCT02255786</nct_id>
  </id_info>
  <brief_title>&quot;ACT&quot; for Parents of Children With Autism Spectrum Disorder</brief_title>
  <official_title>Taking ACTion: Acceptance and Commitment Therapy for Parents of Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Organization for Autism Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will develop and pilot test an intervention called &quot;ACT for Parents&quot; which&#xD;
      aims to decrease stress and improve quality of life in parents of children &lt; 15 years who&#xD;
      have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be&#xD;
      conducted to gather initial data on the treatment feasibility and acceptability, detect&#xD;
      treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine&#xD;
      the treatment design for a future clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of&#xD;
      uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued&#xD;
      behavior in the presence of these emotions. ACT has been successfully applied to parents with&#xD;
      similar mental health presentations. Using a randomized controlled study design,&#xD;
      investigators seek to gather initial data on the treatment feasibility and acceptability,&#xD;
      detect treatment effects in a cohort of parents who have a child (under the age of 15) with&#xD;
      autism spectrum disorder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Acceptance and Action Questionnaire-II Score</measure>
    <time_frame>From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)</time_frame>
    <description>The Acceptance and Action Questionnaire (AAQ-II, Bond et al., 2011) is a 10-item Likert scale that measures experiential acceptance (i.e., tendency to accept, rather than avoid, uncomfortable internal experiences) in adult samples.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>ACT Parent Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete a total of five Acceptance and Commitment Therapy - Parent Group Sessions First four are held weekly, last session held one month from 4th session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment as usual-Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy</intervention_name>
    <description>Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents of children with a variety of mental health presentations.</description>
    <arm_group_label>ACT Parent Group</arm_group_label>
    <other_name>ACT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A parent with a child (under the age of 15) with a diagnosis of Pervasive&#xD;
             Developmental Disorder-NOS, Asperger's Disorder or Autistic Disorder&#xD;
&#xD;
          -  Child with ASD diagnosed by a mental health or medical professional&#xD;
&#xD;
          -  Must be comfortable speaking and reading and understanding English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to attend sessions in person on the specified date/time/location of the&#xD;
             intervention sessions&#xD;
&#xD;
          -  unwillingness to be audio-taped should randomization into the experimental (ACT) group&#xD;
             occur.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa A. Nowinski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital - Lurie Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirstin Brown Birtwell, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Massachusetts General Hospital - Lurie Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lurie Center | Massachusetts General Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Lisa A. Nowinski, PhD</investigator_full_name>
    <investigator_title>Director, Neuropsychology Training</investigator_title>
  </responsible_party>
  <keyword>Group Therapy</keyword>
  <keyword>Parents</keyword>
  <keyword>Autism</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT02255786
org study id: 2014P001563
nct id: NCT02255786
lead sponsor: 
collaborator: 
has dmc: No
The investigators will develop and pilot test an intervention called "ACT for Parents" which
      aims to decrease stress and improve quality of life in parents of children < 15 years who
      have a diagnosis of autism spectrum disorder. A small randomized trial testing phase will be
      conducted to gather initial data on the treatment feasibility and acceptability, detect
      treatment effects between groups (ACT for Parents versus Treatment as Usual), and to refine
      the treatment design for a future clinical trial.
Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of
      uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued
      behavior in the presence of these emotions. ACT has been successfully applied to parents with
      similar mental health presentations. Using a randomized controlled study design,
      investigators seek to gather initial data on the treatment feasibility and acceptability,
      detect treatment effects in a cohort of parents who have a child (under the age of 15) with
      autism spectrum disorder.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Acceptance and Action Questionnaire-II Score
time frame: From Basline to Month 2 (post-intervention) and from Month 2 to Month 3 (maintenance)
description: The Acceptance and Action Questionnaire (AAQ-II, Bond et al., 2011) is a 10-item Likert scale that measures experiential acceptance (i.e., tendency to accept, rather than avoid, uncomfortable internal experiences) in adult samples.
arm group label: ACT Parent Group
arm group type: Experimental
description: Participants will complete a total of five Acceptance and Commitment Therapy - Parent Group Sessions First four are held weekly, last session held one month from 4th session.
arm group label: Treatment as Usual
arm group type: No Intervention
description: Treatment as usual-Control
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy
description: Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents of children with a variety of mental health presentations.
arm group label: ACT Parent Group
other name: ACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lisa A. Nowinski, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital - Lurie Center
last name: Kirstin Brown Birtwell, PhD
role: Study Director
affiliation: Massachusetts General Hospital - Lurie Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Lisa A. Nowinski, PhD
investigator title: Director, Neuropsychology Training
mesh term: Autism Spectrum Disorder