<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/NCT03005431</url>
  </required_header>
  <id_info>
    <org_study_id>HS20295 (H2016:427)</org_study_id>
    <nct_id>NCT03005431</nct_id>
  </id_info>
  <brief_title>Parents of Newly Diagnosed Preschool Children With Autism Spectrum Disorder:</brief_title>
  <official_title>Parents of Newly Diagnosed Preschool Children With Autism Spectrum Disorder: The Effectiveness of a Self-Directed On-line Parent Training and Support Program on Parent and Child Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to&#xD;
      receive government funded services for their child. During this delay parents need support&#xD;
      and training to promote their child's development. The purpose of this research is to develop&#xD;
      and evaluate an on-line, parent training and support program that will assist parents during&#xD;
      this time. It is predicted that if parents receive on-line training and support they will&#xD;
      increase their parenting knowledge and skills, reduce their stress, and create better&#xD;
      outcomes for their child, in comparison to parents who do not receive the training. The&#xD;
      experimental study (n=60) will use a randomized, masked, waitlist control design that&#xD;
      compares a treatment group to a control group. Descriptive statistics will be used to&#xD;
      describe differences between groups, ANCOVA's to test for differences between groups, and&#xD;
      Pearson correlations to describe the relationship between parent stress and outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statement of the Research Problem/Purpose/Objectives Autism Spectrum Disorder (ASD) is a&#xD;
      neurological disorder that causes complex developmental difficulties within the first three&#xD;
      years of life. Preschool children diagnosed with ASD typically have pervasive deficits in&#xD;
      social interaction and communication, and the occurrence of repetitive and restrictive&#xD;
      behaviours. Parenting a preschool child with these characteristics, coupled with the&#xD;
      devastating impact of their child receiving a diagnosis of ASD, creates high levels of&#xD;
      parental anxiety, stress, depression, and general mental health difficulties. Given the&#xD;
      seriousness of the child's diagnosis and the compromise in parenting and family functioning,&#xD;
      families are referred to formalized treatment programs that provide support for both the&#xD;
      child and parents. However, with the recent rise in Autism prevalence rates Manitoba parents&#xD;
      now wait up to a year to receive formalized government funded treatment services for their&#xD;
      child and family. This delay in formalized service has critically important consequences for&#xD;
      the child, the family, and society.&#xD;
&#xD;
      To bridge this gap in service, parents could be afforded the opportunity to participate in a&#xD;
      cost efficient self-directed online training and support program specific to parents in&#xD;
      Manitoba. Given that there is consistent evidence to support the effectiveness of parent&#xD;
      training and involvement once a child has entered a formalized treatment program, the&#xD;
      potential effectiveness of parent training and support while waiting for a formalized&#xD;
      treatment program should also be considered.&#xD;
&#xD;
      Research on the efficacy and effectiveness of on-line self-directed Autism parent training&#xD;
      programs is extremely limited. Additionally, there is a lack of knowledge regarding the&#xD;
      appropriate content, timing, and duration of a training program for parents of newly&#xD;
      diagnosed children with ASD and conflicting evidence on the interactional effects between&#xD;
      parent training and levels of parenting stress during this time period.&#xD;
&#xD;
      The primary purpose of this study is to address the training and support requirements of&#xD;
      parents of preschool children newly diagnosed with ASD, by developing and evaluating the&#xD;
      effectiveness of a self-directed on-line ASD parent training and support program. The&#xD;
      secondary purpose is to assess the interactional effects, of a self-directed on-line ASD&#xD;
      parent training and support program, and parent stress, on parent and child outcomes. It is&#xD;
      predicted that if parents receive on-line training and support they will increase their&#xD;
      parenting knowledge and skills, reduce their levels of stress, and create better engagement&#xD;
      and communication outcomes for their child, in comparison to parents who do not receive the&#xD;
      training and support.&#xD;
&#xD;
      Methods: The experimental study will use a randomized, masked, waitlist control design that&#xD;
      compares an intervention treatment group to a waitlist control group. After meeting criteria&#xD;
      and consent requirements for participation in the study, all families will participate in&#xD;
      pre-measures. Families will then be randomized to either a treatment group or a waitlist&#xD;
      control group. After pre measures the treatment group parents will receive access to the&#xD;
      on-line self-directed training and support program for a 4-month period. After this time&#xD;
      period both groups will then be re-assessed on the Parent and Child outcome measures and then&#xD;
      the Waitlist Group will be given access to the on-line self-directed training and support&#xD;
      program.&#xD;
&#xD;
      Procedure. After a family has been assessed as eligible for the study, and have signed&#xD;
      consent forms to participate in the study, they will be given an appointment time to attend&#xD;
      the nursery setting for pre-measures. One parent will be asked to engage in free play with&#xD;
      their child similar to how they would at home (using a standardized set of toys). The parent&#xD;
      will be video recorded playing with their child for a ten-minute period, and then asked to&#xD;
      answer the three questionnaires. This procedure will occur at baseline (Time 1, within 2&#xD;
      months of diagnosis), and after the treatment period (Time 2, at least four months after the&#xD;
      baseline measure). After base-line measures, families will be randomly assigned to the&#xD;
      treatment group, and the waitlist group, using a random numbers table and a pre-arranged&#xD;
      opaque envelope system. Treatment group parents will then be given access to participate in&#xD;
      the on-line self-directed parent training and support intervention between Time 1 and Time 2,&#xD;
      and the waitlist group parents will be given access to the intervention after Time 2. Parents&#xD;
      will be given codes to access the on-line resources to ensure their anonymity to other&#xD;
      participants. The codes will also allow the principle investigator to track when parents&#xD;
      access the on-line training and support and when they have completed the on-line training.&#xD;
      When treatment group parents have completed the on-line training (and after at least a&#xD;
      four-month period has elapsed since the baseline measure) the parent and child will be&#xD;
      invited back to the nursery setting for Time 2 measurements.&#xD;
&#xD;
      Additionally, after a four-month period the matched waitlist group parent and child will be&#xD;
      invited back to the original setting for Time 2 measurements, after which they will be given&#xD;
      access to the on-line training and support. Families that signed consent forms and then&#xD;
      dropped out, will also be given access to the on-line training and support, at this time. The&#xD;
      personnel used to administer, score and input the data for the questionnaires, and&#xD;
      observational measures, will be masked as to the participant's group assignment and time of&#xD;
      measure. All data will contain only the code with no specific participant identifiers. All&#xD;
      digital video recordings, questionnaires, observations sheets, and participant code sheets&#xD;
      will be kept in a locked cabinet in the office of the main investigator and on a password&#xD;
      protected secured government server. Inter-observer agreement will be used in the observation&#xD;
      measures of the parent's intervention techniques and the child's measures of engagement and&#xD;
      communication. For these observational measures, personnel will be trained by the primary&#xD;
      investigator. Inter-observer agreement will be used in a training procedure until personnel&#xD;
      meet or exceed 80% agreement on each measure for two consecutive observation trials.&#xD;
      Additionally, after all observation data has been collected, a random sample of 20% of the&#xD;
      data for each measure will be scored by two personnel, and inter-observer agreement will be&#xD;
      reported.&#xD;
&#xD;
      The independent variable is the on-line self-directed parent training and support program.&#xD;
      Each on-line module contains multi-media presentations (written material, graphics, and&#xD;
      video's), links to additional materials found on the internet, summaries of key information,&#xD;
      small quizzes that help parents focus on important material and an accompanying parent&#xD;
      workbook. In addition, parents are directed in Module 2 to an on-line parenting support and&#xD;
      information sharing forum exclusive to the parents in the training program. Through the&#xD;
      on-line forum parents can access a professional autism specialist and other parents involved&#xD;
      in the study, and are able to ask questions, answer questions, provide comments, discuss&#xD;
      issues, and in general receive support and give support to others.&#xD;
&#xD;
      Four specific hypotheses will be tested for statistical significance. The first hypothesis&#xD;
      is: Parents in the treatment group will have significantly higher Family Support, Knowledge&#xD;
      and Intervention Techniques scores, and significantly lower Stress scores at Time 2, compared&#xD;
      to the control group. This hypothesis will be tested individually for each measure using an&#xD;
      Analysis of Covariance design (ANCOVA) to test for differences between groups while adjusting&#xD;
      for any initial difference.&#xD;
&#xD;
      The second hypothesis is: Children of parents in the treatment group will have significantly&#xD;
      higher scores in Engagement and Communication at Time 2 compared to children of parents in&#xD;
      the control group. This hypothesis will be tested individually for each measure using an&#xD;
      Analysis of Covariance design (ANCOVA) to test for differences between groups while adjusting&#xD;
      for any initial difference.&#xD;
&#xD;
      The third hypothesis is: Parent's perceived level of stress will moderate the treatment&#xD;
      effects on Parent outcomes measures of Knowledge and Intervention Techniques at Time 2.&#xD;
      Specifically, it is hypothesized that there will be a negative (inverse) correlation between&#xD;
      Parent stress scores at Time 1 and Parent Knowledge and Intervention Technique scores at time&#xD;
      2 (the higher the parent's stress score at Time 1, the lower the parent's Knowledge and&#xD;
      Intervention Technique scores at Time 2). Additionally, it is hypothesized that there will be&#xD;
      a negative (inverse) correlation between the parent's change in stress scores from Time 1 to&#xD;
      Time 2 to parent's Knowledge and Intervention Technique scores at Time 2 (as parents&#xD;
      perceived level of stress decreases from Time 1 to Time 2 parent's Knowledge and Intervention&#xD;
      Technique scores will increase at Time 2). Correlations will be conducted using Pearson's&#xD;
      product-moment (r) calculations.&#xD;
&#xD;
      The fourth hypothesis is: Parent's perceived level of stress will moderate the treatment&#xD;
      effects on Child outcomes measures of Engagement and Communication at Time 2. Specifically,&#xD;
      it is hypothesized that there will be a negative (inverse) correlation between Parent stress&#xD;
      scores at Time 1 and Child Engagement and Communication scores at time 2 (the higher the&#xD;
      parent's stress score at Time 1, the lower the Child Engagement and Communication scores at&#xD;
      Time 2). Additionally, it is hypothesized that there will be a negative (inverse) correlation&#xD;
      between the parent's change in stress scores from Time 1 to Time 2 to the Child's Engagement&#xD;
      and Communication scores at Time 2 (as parents perceived level of stress decreases from Time&#xD;
      1 to Time 2 the Child's Engagement and Communication scores will increase at Time 2).&#xD;
      Correlations will be conducted using Pearson's product-moment (r) calculations.&#xD;
&#xD;
      Process for Seeking Consent Initial screening for patients that meet the criteria will be&#xD;
      done by the Developmental Pediatricians at the Child Development Clinic. When patients are in&#xD;
      the SSCY Centre for a counsel with their Pediatrician, the Pediatrician will provide the&#xD;
      families of all those who meet the inclusion criteria with a study advertisement containing&#xD;
      the PIs contact information. Parents who phone the Principal Investigator to find out more&#xD;
      about their participation in the study will be given the option of meeting the Principal&#xD;
      Investigator at an office in the SSCY Centre or at their home, or at a place of their&#xD;
      choosing. The Principal Investigator will explain the study and the consent form at that&#xD;
      time. Parents will be told that they do not need to decide immediately and that they have the&#xD;
      option of reviewing the study documentation and consent forms with others, and at their&#xD;
      convenience. They will also be given a phone number to call if they have any further&#xD;
      questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">April 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Parent's Knowledge of ASD and Early Home Intervention Questionnaire.</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>This questionnaire was developed specifically for this study to assess the parent's perceptions of their knowledge of ASD and early home intervention techniques. This questionnaire was developed because no pre-existing measure could be found that addressed caregiver perceptions of their knowledge of ASD and early intervention techniques. Parents in the study will respond to 30 questions related to the diagnosis of ASD (e.g. I understand how ASD is diagnosed.); characteristics of children with ASD (e.g. I understand why my child may have unusual sensory interests); parental support (e.g. I know the services available in the community to support my child and family); and parent early intervention techniques (e.g. I know ways to promote communication in my child) using a 5 point scale from 1 (no understanding) to 5 (an excellent understanding) to produce an overall score (range 30 to 150).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Early Intervention Techniques Parent Rating Scale.</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>This rating scale assesses the parent's use of early intervention techniques during the pre and post 10 minute video recorded parent/child play session. The rating scale was developed specifically for this study to assess the parent's use of the early intervention techniques specific to the training involved in this study. The examiner will watch the ten minute video and then rate the parents on their frequency of usage of seven early intervention techniques; 1) Follows the Child's Lead/Engages Child, 2) Imitation, 3) Expanding/Modelling, 4) Reciprocity/Turn Taking, 5) Promotes Communication, 6) Promotes Regulation, and 7) Promotes Appropriate Behaviour. Each individual item is rated using 1-5 Likert scale for frequency, 1) Never, 2) Rarely, 3) Sometimes, 4) Often, 5) Always, to produce an overall score (Range 7-35).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parent/Child Joint Engagement</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>An observational measure will be used to evaluate the child's level of joint engagement with the parent during the pre and post 10 minute video recorded parent/child play session. An evaluation of joint engagement was chosen as it is an important metric of parent child interactions, an important developmental precursor to communication, and a measurement that has been shown to be sensitive to treatment related changes for toddlers and early preschool children (Kasari et al., 2010; Schertz, Odem, Baggett, &amp; Sideris, 2013). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for three levels of child engagement: Unengaged, Object Engagement, and Joint Engagement. A data collection sheet for the time sampling procedure will be used to record a 120 - 5 second intervals, which will total 10 minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Expressive Communication Measure</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>An observational measure will be used to evaluate the child's expressive communication during the pre and post 10 minute video recorded parent/child play session. An expressive communication measure was chosen because it is a core deficit of ASD and a common outcome measure used to evaluate parent training interventions for toddlers and preschoolers with ASD (Beaudoin, Sebire, &amp; Couture, 2014). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for five levels of child expressive communications: Gestures, Vocalizations, Word approximations, Words, and Multi-word utterances. Operational definitions from Harjuson-Webb and Robbins, (2012), are used. A data collection sheet will be used to record a frequency count in each category over the 10 minute video recorded caregiver/child play session.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Parenting Stress Index-Short Form</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>The PSI-SF was chosen because it is a widely-used instrument for measuring parent stress with a variety of parent groups including parents of children with autism (Zaidman-Zait, et al., 2011). Parent's respond to 36 items (e.g. &quot;I feel trapped by my responsibilities as a parent.&quot; &quot;I feel alone and without friends.&quot;) using a five point scale from 1 (strongly agree) to 5 (strongly disagree). All 36 items are then reverse scored with a final higher score indicating a higher level of stress. The overall score (range 36-180) of parent stress is produced, as well as three subscale scores; Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). The short form is correlated to the full length PSI at .94 and has an internal consistency coefficient alpha of .91 for the total scale, .87 for (PD), .80 for (P-CDI), and .85 for (DC); and a test-retest reliability coefficient of .84 for the total scale, .85 for (PD), .68 for (P-CDI), and .78 for (DC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Family Support Scale</measure>
    <time_frame>Baseline and then in four months</time_frame>
    <description>The FSS was chosen to identify and quantify the sources of the parent's social support network pre and post intervention. Parents respond to 18 items (e.g. My Friends, Co-workers, Day Care, Other parents, etc.) in regards to a single question, &quot;How helpful has each of the following been to you in terms of raising your child?&quot; Parent's respond by using a five point scale from 0 (Not available) to 5 (Extremely helpful) to produce a total overall score (Range 0 - 90). The Scale has an internal coefficient alpha of .79, and a test-retest reliability coefficient of .91 (Dunst, Jenkins, &amp; Trivette, 1984).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Parent training and support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These parents will receive regular or typical services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent training and support</intervention_name>
    <description>Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.</description>
    <arm_group_label>Parent training and support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children will be eligible for the study if they are less than 60 months of age and have a&#xD;
        formal documented diagnosis of ASD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have another formally diagnosed co-morbidity (e.g. Cerebral Palsy, FASD,&#xD;
             ADHD), or who have parents not able to read English will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew T Robson, M.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>ARobson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Parenting</keyword>
  <keyword>Training</keyword>
  <keyword>Support</keyword>
  <keyword>On-line</keyword>
  <keyword>Stress</keyword>
  <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>
  </patient_data>
  <pending_results>
    <submitted>October 10, 2018</submitted>
    <returned>February 20, 2019</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/NCT03005431
org study id: HS20295 (H2016:427)
nct id: NCT03005431
lead sponsor: 
has dmc: Yes
Manitoba parents of preschool children newly diagnosed with Autism must wait up to a year to
      receive government funded services for their child. During this delay parents need support
      and training to promote their child's development. The purpose of this research is to develop
      and evaluate an on-line, parent training and support program that will assist parents during
      this time. It is predicted that if parents receive on-line training and support they will
      increase their parenting knowledge and skills, reduce their stress, and create better
      outcomes for their child, in comparison to parents who do not receive the training. The
      experimental study (n=60) will use a randomized, masked, waitlist control design that
      compares a treatment group to a control group. Descriptive statistics will be used to
      describe differences between groups, ANCOVA's to test for differences between groups, and
      Pearson correlations to describe the relationship between parent stress and outcomes.
Statement of the Research Problem/Purpose/Objectives Autism Spectrum Disorder (ASD) is a
      neurological disorder that causes complex developmental difficulties within the first three
      years of life. Preschool children diagnosed with ASD typically have pervasive deficits in
      social interaction and communication, and the occurrence of repetitive and restrictive
      behaviours. Parenting a preschool child with these characteristics, coupled with the
      devastating impact of their child receiving a diagnosis of ASD, creates high levels of
      parental anxiety, stress, depression, and general mental health difficulties. Given the
      seriousness of the child's diagnosis and the compromise in parenting and family functioning,
      families are referred to formalized treatment programs that provide support for both the
      child and parents. However, with the recent rise in Autism prevalence rates Manitoba parents
      now wait up to a year to receive formalized government funded treatment services for their
      child and family. This delay in formalized service has critically important consequences for
      the child, the family, and society.

      To bridge this gap in service, parents could be afforded the opportunity to participate in a
      cost efficient self-directed online training and support program specific to parents in
      Manitoba. Given that there is consistent evidence to support the effectiveness of parent
      training and involvement once a child has entered a formalized treatment program, the
      potential effectiveness of parent training and support while waiting for a formalized
      treatment program should also be considered.

      Research on the efficacy and effectiveness of on-line self-directed Autism parent training
      programs is extremely limited. Additionally, there is a lack of knowledge regarding the
      appropriate content, timing, and duration of a training program for parents of newly
      diagnosed children with ASD and conflicting evidence on the interactional effects between
      parent training and levels of parenting stress during this time period.

      The primary purpose of this study is to address the training and support requirements of
      parents of preschool children newly diagnosed with ASD, by developing and evaluating the
      effectiveness of a self-directed on-line ASD parent training and support program. The
      secondary purpose is to assess the interactional effects, of a self-directed on-line ASD
      parent training and support program, and parent stress, on parent and child outcomes. It is
      predicted that if parents receive on-line training and support they will increase their
      parenting knowledge and skills, reduce their levels of stress, and create better engagement
      and communication outcomes for their child, in comparison to parents who do not receive the
      training and support.

      Methods: The experimental study will use a randomized, masked, waitlist control design that
      compares an intervention treatment group to a waitlist control group. After meeting criteria
      and consent requirements for participation in the study, all families will participate in
      pre-measures. Families will then be randomized to either a treatment group or a waitlist
      control group. After pre measures the treatment group parents will receive access to the
      on-line self-directed training and support program for a 4-month period. After this time
      period both groups will then be re-assessed on the Parent and Child outcome measures and then
      the Waitlist Group will be given access to the on-line self-directed training and support
      program.

      Procedure. After a family has been assessed as eligible for the study, and have signed
      consent forms to participate in the study, they will be given an appointment time to attend
      the nursery setting for pre-measures. One parent will be asked to engage in free play with
      their child similar to how they would at home (using a standardized set of toys). The parent
      will be video recorded playing with their child for a ten-minute period, and then asked to
      answer the three questionnaires. This procedure will occur at baseline (Time 1, within 2
      months of diagnosis), and after the treatment period (Time 2, at least four months after the
      baseline measure). After base-line measures, families will be randomly assigned to the
      treatment group, and the waitlist group, using a random numbers table and a pre-arranged
      opaque envelope system. Treatment group parents will then be given access to participate in
      the on-line self-directed parent training and support intervention between Time 1 and Time 2,
      and the waitlist group parents will be given access to the intervention after Time 2. Parents
      will be given codes to access the on-line resources to ensure their anonymity to other
      participants. The codes will also allow the principle investigator to track when parents
      access the on-line training and support and when they have completed the on-line training.
      When treatment group parents have completed the on-line training (and after at least a
      four-month period has elapsed since the baseline measure) the parent and child will be
      invited back to the nursery setting for Time 2 measurements.

      Additionally, after a four-month period the matched waitlist group parent and child will be
      invited back to the original setting for Time 2 measurements, after which they will be given
      access to the on-line training and support. Families that signed consent forms and then
      dropped out, will also be given access to the on-line training and support, at this time. The
      personnel used to administer, score and input the data for the questionnaires, and
      observational measures, will be masked as to the participant's group assignment and time of
      measure. All data will contain only the code with no specific participant identifiers. All
      digital video recordings, questionnaires, observations sheets, and participant code sheets
      will be kept in a locked cabinet in the office of the main investigator and on a password
      protected secured government server. Inter-observer agreement will be used in the observation
      measures of the parent's intervention techniques and the child's measures of engagement and
      communication. For these observational measures, personnel will be trained by the primary
      investigator. Inter-observer agreement will be used in a training procedure until personnel
      meet or exceed 80% agreement on each measure for two consecutive observation trials.
      Additionally, after all observation data has been collected, a random sample of 20% of the
      data for each measure will be scored by two personnel, and inter-observer agreement will be
      reported.

      The independent variable is the on-line self-directed parent training and support program.
      Each on-line module contains multi-media presentations (written material, graphics, and
      video's), links to additional materials found on the internet, summaries of key information,
      small quizzes that help parents focus on important material and an accompanying parent
      workbook. In addition, parents are directed in Module 2 to an on-line parenting support and
      information sharing forum exclusive to the parents in the training program. Through the
      on-line forum parents can access a professional autism specialist and other parents involved
      in the study, and are able to ask questions, answer questions, provide comments, discuss
      issues, and in general receive support and give support to others.

      Four specific hypotheses will be tested for statistical significance. The first hypothesis
      is: Parents in the treatment group will have significantly higher Family Support, Knowledge
      and Intervention Techniques scores, and significantly lower Stress scores at Time 2, compared
      to the control group. This hypothesis will be tested individually for each measure using an
      Analysis of Covariance design (ANCOVA) to test for differences between groups while adjusting
      for any initial difference.

      The second hypothesis is: Children of parents in the treatment group will have significantly
      higher scores in Engagement and Communication at Time 2 compared to children of parents in
      the control group. This hypothesis will be tested individually for each measure using an
      Analysis of Covariance design (ANCOVA) to test for differences between groups while adjusting
      for any initial difference.

      The third hypothesis is: Parent's perceived level of stress will moderate the treatment
      effects on Parent outcomes measures of Knowledge and Intervention Techniques at Time 2.
      Specifically, it is hypothesized that there will be a negative (inverse) correlation between
      Parent stress scores at Time 1 and Parent Knowledge and Intervention Technique scores at time
      2 (the higher the parent's stress score at Time 1, the lower the parent's Knowledge and
      Intervention Technique scores at Time 2). Additionally, it is hypothesized that there will be
      a negative (inverse) correlation between the parent's change in stress scores from Time 1 to
      Time 2 to parent's Knowledge and Intervention Technique scores at Time 2 (as parents
      perceived level of stress decreases from Time 1 to Time 2 parent's Knowledge and Intervention
      Technique scores will increase at Time 2). Correlations will be conducted using Pearson's
      product-moment (r) calculations.

      The fourth hypothesis is: Parent's perceived level of stress will moderate the treatment
      effects on Child outcomes measures of Engagement and Communication at Time 2. Specifically,
      it is hypothesized that there will be a negative (inverse) correlation between Parent stress
      scores at Time 1 and Child Engagement and Communication scores at time 2 (the higher the
      parent's stress score at Time 1, the lower the Child Engagement and Communication scores at
      Time 2). Additionally, it is hypothesized that there will be a negative (inverse) correlation
      between the parent's change in stress scores from Time 1 to Time 2 to the Child's Engagement
      and Communication scores at Time 2 (as parents perceived level of stress decreases from Time
      1 to Time 2 the Child's Engagement and Communication scores will increase at Time 2).
      Correlations will be conducted using Pearson's product-moment (r) calculations.

      Process for Seeking Consent Initial screening for patients that meet the criteria will be
      done by the Developmental Pediatricians at the Child Development Clinic. When patients are in
      the SSCY Centre for a counsel with their Pediatrician, the Pediatrician will provide the
      families of all those who meet the inclusion criteria with a study advertisement containing
      the PIs contact information. Parents who phone the Principal Investigator to find out more
      about their participation in the study will be given the option of meeting the Principal
      Investigator at an office in the SSCY Centre or at their home, or at a place of their
      choosing. The Principal Investigator will explain the study and the consent form at that
      time. Parents will be told that they do not need to decide immediately and that they have the
      option of reviewing the study documentation and consent forms with others, and at their
      convenience. They will also be given a phone number to call if they have any further
      questions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Parent's Knowledge of ASD and Early Home Intervention Questionnaire.
time frame: Baseline and then in four months
description: This questionnaire was developed specifically for this study to assess the parent's perceptions of their knowledge of ASD and early home intervention techniques. This questionnaire was developed because no pre-existing measure could be found that addressed caregiver perceptions of their knowledge of ASD and early intervention techniques. Parents in the study will respond to 30 questions related to the diagnosis of ASD (e.g. I understand how ASD is diagnosed.); characteristics of children with ASD (e.g. I understand why my child may have unusual sensory interests); parental support (e.g. I know the services available in the community to support my child and family); and parent early intervention techniques (e.g. I know ways to promote communication in my child) using a 5 point scale from 1 (no understanding) to 5 (an excellent understanding) to produce an overall score (range 30 to 150).
measure: Change in the Early Intervention Techniques Parent Rating Scale.
time frame: Baseline and then in four months
description: This rating scale assesses the parent's use of early intervention techniques during the pre and post 10 minute video recorded parent/child play session. The rating scale was developed specifically for this study to assess the parent's use of the early intervention techniques specific to the training involved in this study. The examiner will watch the ten minute video and then rate the parents on their frequency of usage of seven early intervention techniques; 1) Follows the Child's Lead/Engages Child, 2) Imitation, 3) Expanding/Modelling, 4) Reciprocity/Turn Taking, 5) Promotes Communication, 6) Promotes Regulation, and 7) Promotes Appropriate Behaviour. Each individual item is rated using 1-5 Likert scale for frequency, 1) Never, 2) Rarely, 3) Sometimes, 4) Often, 5) Always, to produce an overall score (Range 7-35).
measure: Change in Parent/Child Joint Engagement
time frame: Baseline and then in four months
description: An observational measure will be used to evaluate the child's level of joint engagement with the parent during the pre and post 10 minute video recorded parent/child play session. An evaluation of joint engagement was chosen as it is an important metric of parent child interactions, an important developmental precursor to communication, and a measurement that has been shown to be sensitive to treatment related changes for toddlers and early preschool children (Kasari et al., 2010; Schertz, Odem, Baggett, & Sideris, 2013). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for three levels of child engagement: Unengaged, Object Engagement, and Joint Engagement. A data collection sheet for the time sampling procedure will be used to record a 120 - 5 second intervals, which will total 10 minutes.
measure: Change in Expressive Communication Measure
time frame: Baseline and then in four months
description: An observational measure will be used to evaluate the child's expressive communication during the pre and post 10 minute video recorded parent/child play session. An expressive communication measure was chosen because it is a core deficit of ASD and a common outcome measure used to evaluate parent training interventions for toddlers and preschoolers with ASD (Beaudoin, Sebire, & Couture, 2014). The 10 minute parent/child video recorded play session from both pre and post intervention will be observed continuously and coded in 5 second intervals for five levels of child expressive communications: Gestures, Vocalizations, Word approximations, Words, and Multi-word utterances. Operational definitions from Harjuson-Webb and Robbins, (2012), are used. A data collection sheet will be used to record a frequency count in each category over the 10 minute video recorded caregiver/child play session.
measure: Change in the Parenting Stress Index-Short Form
time frame: Baseline and then in four months
description: The PSI-SF was chosen because it is a widely-used instrument for measuring parent stress with a variety of parent groups including parents of children with autism (Zaidman-Zait, et al., 2011). Parent's respond to 36 items (e.g. "I feel trapped by my responsibilities as a parent." "I feel alone and without friends.") using a five point scale from 1 (strongly agree) to 5 (strongly disagree). All 36 items are then reverse scored with a final higher score indicating a higher level of stress. The overall score (range 36-180) of parent stress is produced, as well as three subscale scores; Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). The short form is correlated to the full length PSI at .94 and has an internal consistency coefficient alpha of .91 for the total scale, .87 for (PD), .80 for (P-CDI), and .85 for (DC); and a test-retest reliability coefficient of .84 for the total scale, .85 for (PD), .68 for (P-CDI), and .78 for (DC).
measure: Change in the Family Support Scale
time frame: Baseline and then in four months
description: The FSS was chosen to identify and quantify the sources of the parent's social support network pre and post intervention. Parents respond to 18 items (e.g. My Friends, Co-workers, Day Care, Other parents, etc.) in regards to a single question, "How helpful has each of the following been to you in terms of raising your child?" Parent's respond by using a five point scale from 0 (Not available) to 5 (Extremely helpful) to produce a total overall score (Range 0 - 90). The Scale has an internal coefficient alpha of .79, and a test-retest reliability coefficient of .91 (Dunst, Jenkins, & Trivette, 1984).
arm group label: Parent training and support
arm group type: Experimental
description: Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.
arm group label: Waitlist control group
arm group type: No Intervention
description: These parents will receive regular or typical services
intervention type: Behavioral
intervention name: Parent training and support
description: Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.
arm group label: Parent training and support
criteria: 
gender: All
minimum age: N/A
maximum age: 59 Months
healthy volunteers: No
last name: Andrew T Robson, M.Sc.
role: Principal Investigator
affiliation: University of Manitoba
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: ARobson
investigator title: Principal Investigator
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No
submitted: October 10, 2018
returned: February 20, 2019