<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/NCT02210455</url>
  </required_header>
  <id_info>
    <org_study_id>1017014</org_study_id>
    <nct_id>NCT02210455</nct_id>
  </id_info>
  <brief_title>Parenting Training for Children With FASD</brief_title>
  <acronym>SF-FASD</acronym>
  <official_title>Strongest Families FASD: Parent Training for Challenging Behaviour in Children With Fetal Alcohol Spectrum Disorder (FASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IWK Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NeuroDevNet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Agency of Canada (PHAC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IWK Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children,&#xD;
      and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum&#xD;
      disorders (FASD) was established to encompass the full spectrum of teratogenic effects&#xD;
      induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in&#xD;
      North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births,&#xD;
      making this a public health problem of epidemic proportion. Even though considerable efforts&#xD;
      have been aimed at identifying children with FASD, the need for access to services and&#xD;
      supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is&#xD;
      little empirical data available to influence policy change in how these services and supports&#xD;
      are delivered.&#xD;
&#xD;
      A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol&#xD;
      Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types&#xD;
      of supports children with FASD and their families require and to develop appropriate&#xD;
      mechanisms to provide these services at the community, provincial/territorial and federal&#xD;
      levels. This identified need forms the basis of the current proposal.&#xD;
&#xD;
      Although a variety of psychosocial interventions have been developed to treat&#xD;
      neurobehavioural disorders, relatively little research has been conducted that is&#xD;
      specifically aimed at improving the behavioral challenges identified in children with FASD.&#xD;
      Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be&#xD;
      developed using input from major stakeholders to meet the current limitations in access for&#xD;
      families seeking services and supports; and (ii) this intervention and its evaluation will&#xD;
      provide evidence for feasibility and efficacy to support changes in policy by key&#xD;
      decision-makers and provide the basis for developing promising practices in the area of&#xD;
      interventions for families affected by FASD. This grant will link academic teams with&#xD;
      parents/guardians and decision makers to develop and evaluate a training program for the&#xD;
      parents/guardians of children with FASD.&#xD;
&#xD;
      Participants will be recruited from across Canada. The specific objectives of the proposed&#xD;
      research program, which will be addressed in three inter-related studies, are to:&#xD;
&#xD;
        1. Develop an Internet-based intervention program for parents/guardians of children with&#xD;
           FASD between the ages of 4-12 years, that is based on information collected from&#xD;
           interviews completed by major stakeholders (e.g., parents/guardians, clinicians,&#xD;
           decision-makers, community-based organizations);&#xD;
&#xD;
        2. Evaluate the feasibility (usability) of the intervention; and&#xD;
&#xD;
        3. Obtain data on outcomes from the randomized controlled trial This research will adopt an&#xD;
           integrated knowledge translation and exchange approach where knowledge production,&#xD;
           dissemination, uptake and usage will occur seamlessly throughout the project and&#xD;
           researchers and knowledge users are engaged in the project right from its inception.&#xD;
&#xD;
      The intervention will be based on the Strongest Families program that is designed to help&#xD;
      families learn to deal with common childhood problems in the comfort and privacy of their&#xD;
      home, and provide treatment and care via telephone contact with trained coaches, written&#xD;
      manuals, videotapes, and audiotapes. This program has been successful in children&#xD;
      neurodevelopmental disorders; and will be adapted for use in the FASD population, as children&#xD;
      with FASD, share many of the same behavioral characteristics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">July 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A change on the Child Behavior Checklist from baseline to 11 months</measure>
    <time_frame>At baseline, and 5 months and 11 months after randomization</time_frame>
    <description>It is a standardized questionnaire that assesses adaptive functioning and problems. We will use two versions of the CBCL (CBCL/1 ½ -5 and CBCL/6-18) to accommodate the age range of the sample</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A change on the Depression Anxiety &amp; Stress Scale Short Form (DASS-21) from baseline to 11 months</measure>
    <time_frame>At baseline, and 5 months and 11 months after randomization</time_frame>
    <description>It will be used to evaluate parental distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>Participants will be asked to complete this measure at the end of the intervention, which will probably last on average 5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">119</enrollment>
  <condition>Fetal Alcohol Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>The Strongest Families FASD intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is a web-based parent training program with a coach. The program is comprised of 11 sessions, each focusing on a different parenting strategy, delivered using easy to read text, instructional videos and audio clips. One Booster Session is conducted 1 month after completion of Session 11.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is a static webpage on IRIS providing FASD information and resources, including recommended book titles, websites and organizations that may be helpful.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strongest Families FASD intervention</intervention_name>
    <arm_group_label>The Strongest Families FASD intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_label>The Strongest Families FASD intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a child between 4-12 years of age with a diagnosis which falls under the umbrella&#xD;
             term &quot;Fetal Alcohol Spectrum Disorder&quot; as reported by parents/caregivers.&#xD;
&#xD;
          -  The child has been experiencing behavioural problems (as defined by the caregiver) for&#xD;
             at least 6 months prior to study screening.&#xD;
&#xD;
          -  Have been the primary caregiver for a minimum of 6 months prior to entry into the&#xD;
             study.&#xD;
&#xD;
          -  Have a reasonable expectation of being be the primary caregiver for at least 6 months&#xD;
             after study enrolment.&#xD;
&#xD;
          -  Read, write, and understand English.&#xD;
&#xD;
          -  Have access to a telephone.&#xD;
&#xD;
          -  Have access to a computer connected to the Internet.&#xD;
&#xD;
          -  Live in Canada.&#xD;
&#xD;
          -  CBCL Externalizing t-Score must be ≥64 (clinical range)&#xD;
&#xD;
          -  The child meets criteria for behaviour suggestive of FASD&#xD;
&#xD;
          -  No suicide attempts within the previous 6 months&#xD;
&#xD;
          -  No current risk of suicide attempts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child is NOT able to speak in full sentences or understand everyday language and&#xD;
             instructions.&#xD;
&#xD;
          -  Parent/caregiver has previously taken part in a Strongest Families Parenting Program.&#xD;
&#xD;
          -  Parent/caregiver OR child has been diagnosed with Psychosis.&#xD;
&#xD;
          -  Child does not have a diagnosis of schizophrenia, bipolar disorder or major&#xD;
             depression.&#xD;
&#xD;
          -  Child does not put others as risk of serious harm (i.e., requiring medical attention).&#xD;
&#xD;
          -  Parent/caregiver has not completed any of the following parenting programs in the last&#xD;
             6 months: Triple P, COPE, Incredible Years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick McGrath, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IWK Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://mystudies.ca/studies/fasd</url>
    <description>Recruitment site</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IWK Health Centre</investigator_affiliation>
    <investigator_full_name>Patrick J. McGrath</investigator_full_name>
    <investigator_title>Integrated Vice President Research and Innovation</investigator_title>
  </responsible_party>
  <keyword>FASD</keyword>
  <keyword>pFAS</keyword>
  <keyword>ARND</keyword>
  <keyword>Fetal Alcohol Syndrome</keyword>
  <keyword>Partial Fetal Alcohol Syndrome</keyword>
  <keyword>Alcohol Related Neurodevelopmental Disorder</keyword>
  <keyword>Static Encephalopathy (Alcohol Exposed)</keyword>
  <keyword>Neurobehavioural Disorder (Alcohol Exposed)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fetal Alcohol Spectrum Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only aggregate data will be shared.</ipd_description>
  </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/NCT02210455
org study id: 1017014
nct id: NCT02210455
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Prenatal alcohol exposure can lead to a myriad of adverse developmental outcomes in children,
      and is the leading cause of mental disability in Canada. The term fetal alcohol spectrum
      disorders (FASD) was established to encompass the full spectrum of teratogenic effects
      induced by alcohol. FAS is believed to occur in approximately 1 to 3 per 1000 live births in
      North America, and it is estimated that FASD may occur as frequently as 1 in 100 live births,
      making this a public health problem of epidemic proportion. Even though considerable efforts
      have been aimed at identifying children with FASD, the need for access to services and
      supports for Canadian families affected by FASD remains unfulfilled. Additionally, there is
      little empirical data available to influence policy change in how these services and supports
      are delivered.

      A key recommendation contained in the Public Health Agency of Canada's (PHAC) Fetal Alcohol
      Spectrum Disorder (FASD): A Framework for Action document was the need to determine the types
      of supports children with FASD and their families require and to develop appropriate
      mechanisms to provide these services at the community, provincial/territorial and federal
      levels. This identified need forms the basis of the current proposal.

      Although a variety of psychosocial interventions have been developed to treat
      neurobehavioural disorders, relatively little research has been conducted that is
      specifically aimed at improving the behavioral challenges identified in children with FASD.
      Thus, we hypothesize that (i) a FASD-specific parent/guardian training intervention can be
      developed using input from major stakeholders to meet the current limitations in access for
      families seeking services and supports; and (ii) this intervention and its evaluation will
      provide evidence for feasibility and efficacy to support changes in policy by key
      decision-makers and provide the basis for developing promising practices in the area of
      interventions for families affected by FASD. This grant will link academic teams with
      parents/guardians and decision makers to develop and evaluate a training program for the
      parents/guardians of children with FASD.

      Participants will be recruited from across Canada. The specific objectives of the proposed
      research program, which will be addressed in three inter-related studies, are to:

        1. Develop an Internet-based intervention program for parents/guardians of children with
           FASD between the ages of 4-12 years, that is based on information collected from
           interviews completed by major stakeholders (e.g., parents/guardians, clinicians,
           decision-makers, community-based organizations);

        2. Evaluate the feasibility (usability) of the intervention; and

        3. Obtain data on outcomes from the randomized controlled trial This research will adopt an
           integrated knowledge translation and exchange approach where knowledge production,
           dissemination, uptake and usage will occur seamlessly throughout the project and
           researchers and knowledge users are engaged in the project right from its inception.

      The intervention will be based on the Strongest Families program that is designed to help
      families learn to deal with common childhood problems in the comfort and privacy of their
      home, and provide treatment and care via telephone contact with trained coaches, written
      manuals, videotapes, and audiotapes. This program has been successful in children
      neurodevelopmental disorders; and will be adapted for use in the FASD population, as children
      with FASD, share many of the same behavioral characteristics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: A change on the Child Behavior Checklist from baseline to 11 months
time frame: At baseline, and 5 months and 11 months after randomization
description: It is a standardized questionnaire that assesses adaptive functioning and problems. We will use two versions of the CBCL (CBCL/1 ½ -5 and CBCL/6-18) to accommodate the age range of the sample
measure: A change on the Depression Anxiety & Stress Scale Short Form (DASS-21) from baseline to 11 months
time frame: At baseline, and 5 months and 11 months after randomization
description: It will be used to evaluate parental distress
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: Participants will be asked to complete this measure at the end of the intervention, which will probably last on average 5 months
arm group label: The Strongest Families FASD intervention
arm group type: Experimental
description: It is a web-based parent training program with a coach. The program is comprised of 11 sessions, each focusing on a different parenting strategy, delivered using easy to read text, instructional videos and audio clips. One Booster Session is conducted 1 month after completion of Session 11.
arm group label: Psychoeducation
arm group type: Active Comparator
description: It is a static webpage on IRIS providing FASD information and resources, including recommended book titles, websites and organizations that may be helpful.
intervention type: Behavioral
intervention name: Strongest Families FASD intervention
arm group label: The Strongest Families FASD intervention
intervention type: Other
intervention name: Psychoeducation
arm group label: Psychoeducation
arm group label: The Strongest Families FASD intervention
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: No
last name: Patrick McGrath, PhD
role: Principal Investigator
affiliation: IWK Health Centre
facility: 
country: Canada
url: https://mystudies.ca/studies/fasd
description: Recruitment site
responsible party type: Principal Investigator
investigator affiliation: IWK Health Centre
investigator full name: Patrick J. McGrath
investigator title: Integrated Vice President Research and Innovation
mesh term: Fetal Alcohol Spectrum Disorders
sharing ipd: No
ipd description: Only aggregate data will be shared.