<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/NCT02995408</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002037</org_study_id>
    <nct_id>NCT02995408</nct_id>
  </id_info>
  <brief_title>Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder</brief_title>
  <acronym>ASD</acronym>
  <official_title>Development of a Resiliency Training Program 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>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study has three aims:&#xD;
&#xD;
      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and&#xD;
      parents with children with ASD, this study aims to identify the psychosocial needs of parents&#xD;
      of children with ASD, specifically a) the types of concerns that parents find most difficult&#xD;
      and stressful b) areas of concern that lack support and resources, and c) areas of need for&#xD;
      education and skill training. This study also aims to gather feedback on the Benson-Henry&#xD;
      Institute's Relaxation Response Resiliency Program (3RP).&#xD;
&#xD;
      Phase II: Informed by Phase I findings, this study aims to develop and determine the&#xD;
      feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)&#xD;
      program for parents of children with ASD.&#xD;
&#xD;
      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,&#xD;
      establishing efficacy of a virtual resiliency program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the Center for Disease Control in 2012, 14.6 per 1,000 children aged 8 years old&#xD;
      have a diagnosis of Autism Spectrum Disorder (ASD). Having a child with ASD is associated&#xD;
      with medical expenditures of 4.1-4.6 times more than having a child without autism, and&#xD;
      associated with 8.4-9.5 times greater general expenditures. Furthermore, children with ASD&#xD;
      are more likely to use out-of-school behavioral health services than children without&#xD;
      developmental or psychiatric diagnoses. Parents of children with ASD consistently show high&#xD;
      levels of perceived distress and anxiety related to child-parent relationships, intellectual&#xD;
      functioning, adaptive behaviors, in addition to poorer health than parents of children of&#xD;
      typical development. These parents also exhibit significant stress related to the emotional&#xD;
      and financial challenges of putting together treatment and future-related plans for their&#xD;
      children. Recent studies have found a positive relationship between caregivers' stress levels&#xD;
      while raising a child with ASD and child behavioral and conduct problems.&#xD;
&#xD;
      There is growing literature on the increased levels of parental stress associated with caring&#xD;
      for children with ASD. One study found that caregivers of children with ASD with behavioral,&#xD;
      hyperactivity, and emotional problems displayed atypical cortisol patterns, a biological&#xD;
      marker of increased stress. A review article provides a comprehensive overview of the links&#xD;
      between high levels of parental stress among parents of children with intellectual and&#xD;
      developmental disabilities and child health and well-being. In addition to social phobias&#xD;
      associated with children with ASD, one study even found that caring for a child with ASD&#xD;
      showed higher stress levels for the parents correlated with the child's social impairment&#xD;
      severity. Finally, recent studies have also found that many parents of children with ASD&#xD;
      exhibit psychological and physical depressive symptoms. Therefore, having a children with ASD&#xD;
      is associated with an increased risk of problems with emotional and physical health and&#xD;
      social well-being. Resiliency is a multidimensional construct that refers to the ability to&#xD;
      maintain adaptation and effective functioning when faced with stressors.&#xD;
&#xD;
      Resiliency provides a framework for understanding the adjustment to stress as a dynamic&#xD;
      process. Allostasis refers to the capacity to maintain stability of physiological systems in&#xD;
      the face of adversity. When exposed to chronic stressors, such as care for a child with ASD,&#xD;
      individuals expend a great deal of energy attempting to maintain allostasis; this can lead to&#xD;
      the metabolic wear and tear described as allostatic load. Evidence is accumulating that this&#xD;
      wear and tear is mediated by changes in basal stress system activity and by effects of these&#xD;
      changes on dependent systems. Allostatic load and resilience can therefore be assessed by&#xD;
      measuring basal stress system activity (HPA axis and salivary alpha-amylase).&#xD;
&#xD;
      Thus, research to reduce these parents' exposure to stress and, moreover, improve parental&#xD;
      responses to stress, may improve the wellbeing of both parents and their children. Yet, a&#xD;
      treatment focused on the psychosocial needs in relation to stress and allostatic load of&#xD;
      parents of children with ASD has not been developed. Research is warranted to examine and&#xD;
      intervene upon parental stress. This study aims to design and develop a resiliency&#xD;
      intervention to provide support to parents of children with ASD.&#xD;
&#xD;
      This intervention will be a modified version of Dr. Park's evidence-based 8-week multimodal&#xD;
      treatment which is designed to promote adaptation to stress and promotion of resiliency. The&#xD;
      program is an 8 session, 1-1.5 hours a week multi modal intervention that incorporates&#xD;
      relaxation techniques, stress awareness discussion, and adaptive strategies for coping with&#xD;
      stress. This study will refine an 8-session group virtual-delivered resiliency treatment&#xD;
      program consisting of 8 virtual group 1-1.5 hour sessions. The goal of this study would be to&#xD;
      advance our ultimate objective to implement a national parental resiliency program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distress Tolerance</measure>
    <time_frame>change between baseline (week 0) to post intervention (week 12)]</time_frame>
    <description>Distress Tolerance Scale, Visual Analogue Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress Reactivity</measure>
    <time_frame>change between baseline (week 0) to post intervention (week 12)</time_frame>
    <description>Measure of current status validated self report questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Experimental: 3RP treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relaxation Response Resiliency Program for Parents of Children with ASD</intervention_name>
    <arm_group_label>Experimental: 3RP treatment</arm_group_label>
    <arm_group_label>Waitlist control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Being the parent of at least one child with a diagnosed autism spectrum disorder&#xD;
&#xD;
          2. Age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Unable or unwilling to sign the informed consent documents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Karen Kuhlthau, PhD</last_name>
    <phone>617-724-2842</phone>
    <email>kkuhlthau1@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Kuhlthau, PhD</last_name>
      <phone>617-724-2842</phone>
      <email>kkuhlthau1@PARTNERS.ORG</email>
    </contact>
    <investigator>
      <last_name>Karen Kuhlthau, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Karen Kuhlthau</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>resiliency training</keyword>
  <keyword>parenting</keyword>
  <keyword>Autism Spectrum Disorders</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>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 14, 2021</submitted>
    <returned>February 3, 2021</returned>
    <submitted>April 4, 2022</submitted>
    <returned>October 24, 2022</returned>
  </pending_results>
  <!-- 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/NCT02995408
org study id: 2016P002037
nct id: NCT02995408
lead sponsor: 
has dmc: Yes
This study has three aims:

      Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and
      parents with children with ASD, this study aims to identify the psychosocial needs of parents
      of children with ASD, specifically a) the types of concerns that parents find most difficult
      and stressful b) areas of concern that lack support and resources, and c) areas of need for
      education and skill training. This study also aims to gather feedback on the Benson-Henry
      Institute's Relaxation Response Resiliency Program (3RP).

      Phase II: Informed by Phase I findings, this study aims to develop and determine the
      feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP)
      program for parents of children with ASD.

      Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial,
      establishing efficacy of a virtual resiliency program.
According to the Center for Disease Control in 2012, 14.6 per 1,000 children aged 8 years old
      have a diagnosis of Autism Spectrum Disorder (ASD). Having a child with ASD is associated
      with medical expenditures of 4.1-4.6 times more than having a child without autism, and
      associated with 8.4-9.5 times greater general expenditures. Furthermore, children with ASD
      are more likely to use out-of-school behavioral health services than children without
      developmental or psychiatric diagnoses. Parents of children with ASD consistently show high
      levels of perceived distress and anxiety related to child-parent relationships, intellectual
      functioning, adaptive behaviors, in addition to poorer health than parents of children of
      typical development. These parents also exhibit significant stress related to the emotional
      and financial challenges of putting together treatment and future-related plans for their
      children. Recent studies have found a positive relationship between caregivers' stress levels
      while raising a child with ASD and child behavioral and conduct problems.

      There is growing literature on the increased levels of parental stress associated with caring
      for children with ASD. One study found that caregivers of children with ASD with behavioral,
      hyperactivity, and emotional problems displayed atypical cortisol patterns, a biological
      marker of increased stress. A review article provides a comprehensive overview of the links
      between high levels of parental stress among parents of children with intellectual and
      developmental disabilities and child health and well-being. In addition to social phobias
      associated with children with ASD, one study even found that caring for a child with ASD
      showed higher stress levels for the parents correlated with the child's social impairment
      severity. Finally, recent studies have also found that many parents of children with ASD
      exhibit psychological and physical depressive symptoms. Therefore, having a children with ASD
      is associated with an increased risk of problems with emotional and physical health and
      social well-being. Resiliency is a multidimensional construct that refers to the ability to
      maintain adaptation and effective functioning when faced with stressors.

      Resiliency provides a framework for understanding the adjustment to stress as a dynamic
      process. Allostasis refers to the capacity to maintain stability of physiological systems in
      the face of adversity. When exposed to chronic stressors, such as care for a child with ASD,
      individuals expend a great deal of energy attempting to maintain allostasis; this can lead to
      the metabolic wear and tear described as allostatic load. Evidence is accumulating that this
      wear and tear is mediated by changes in basal stress system activity and by effects of these
      changes on dependent systems. Allostatic load and resilience can therefore be assessed by
      measuring basal stress system activity (HPA axis and salivary alpha-amylase).

      Thus, research to reduce these parents' exposure to stress and, moreover, improve parental
      responses to stress, may improve the wellbeing of both parents and their children. Yet, a
      treatment focused on the psychosocial needs in relation to stress and allostatic load of
      parents of children with ASD has not been developed. Research is warranted to examine and
      intervene upon parental stress. This study aims to design and develop a resiliency
      intervention to provide support to parents of children with ASD.

      This intervention will be a modified version of Dr. Park's evidence-based 8-week multimodal
      treatment which is designed to promote adaptation to stress and promotion of resiliency. The
      program is an 8 session, 1-1.5 hours a week multi modal intervention that incorporates
      relaxation techniques, stress awareness discussion, and adaptive strategies for coping with
      stress. This study will refine an 8-session group virtual-delivered resiliency treatment
      program consisting of 8 virtual group 1-1.5 hour sessions. The goal of this study would be to
      advance our ultimate objective to implement a national parental resiliency program.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Distress Tolerance
time frame: change between baseline (week 0) to post intervention (week 12)]
description: Distress Tolerance Scale, Visual Analogue Scale
measure: Stress Reactivity
time frame: change between baseline (week 0) to post intervention (week 12)
description: Measure of current status validated self report questionnaire
arm group label: Experimental: 3RP treatment
arm group type: Experimental
description: An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
arm group label: Waitlist control
arm group type: Active Comparator
description: An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
intervention type: Behavioral
intervention name: Relaxation Response Resiliency Program for Parents of Children with ASD
arm group label: Experimental: 3RP treatment
arm group label: Waitlist control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Kuhlthau, PhD
phone: 617-724-2842
email: kkuhlthau1@partners.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Karen Kuhlthau
investigator title: Associate Professor of Pediatrics
mesh term: Autism Spectrum Disorder
sharing ipd: No
submitted: January 14, 2021
returned: February 3, 2021
submitted: April 4, 2022
returned: October 24, 2022