<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/NCT02187952</url>
  </required_header>
  <id_info>
    <org_study_id>13-PAF07294</org_study_id>
    <nct_id>NCT02187952</nct_id>
  </id_info>
  <brief_title>Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children</brief_title>
  <official_title>Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Gerber Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <brief_summary>
    <textblock>
      The primary objective of the proposed study is to determine whether behavioral feeding&#xD;
      intervention impacts mother-child attachment in infants and toddlers with feeding problems.&#xD;
      The investigators propose the following hypotheses:&#xD;
&#xD;
        -  Behavioral feeding intervention will not significantly impact parent-child attachment.&#xD;
&#xD;
        -  Behavioral feeding intervention will not significantly impact parent-child unstructured&#xD;
           play interactions.&#xD;
&#xD;
        -  Severity of feeding problems will decrease after behavioral feeding intervention is&#xD;
           implemented.&#xD;
&#xD;
        -  Behavioral feeding intervention will have either no significant effect or a significant&#xD;
           positive effect on general child behavior.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 4</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 attachment status</measure>
    <time_frame>Enrollment, 6 months, 1 year</time_frame>
    <description>The Strange Situation (SS) will be used to assess any changes in mother-child attachment status. The SS consists of a series of separations and reunions between a mother and her child.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in infant social and emotional behavior</measure>
    <time_frame>Enrollment, 6 months, 1 year</time_frame>
    <description>Brief Infant Toddler Social Emotional Assessment (BITSEA) will be used to assess any changes in the social and emotional behavior of children who are 12-36 months of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child externalizing and internalizing behavior.</measure>
    <time_frame>Enrollment, 6 months, 1 year</time_frame>
    <description>The Child Behavior Checklist will be used to assess any changes in the internalizing and externalizing behavior of children who are 1.5 to 5 years of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in maternal behavior when interacting with her child</measure>
    <time_frame>Enrollment, 6 months, 1 year</time_frame>
    <description>Mother-child dyads will be given toys and asked to play as they normally would for 10 minutes. The purpose of this measure is to detect any changes in parent-child interaction patterns that may be more sensitive to short-term intervention than attachment status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in child feeding behavior.</measure>
    <time_frame>Enrollment, 6 months, 1 year</time_frame>
    <description>The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) will be used to measure any changes in the feeding behavior of children.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pediatric Feeding Disorders</condition>
  <arm_group>
    <arm_group_label>Behavioral feeding intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral feeding intervention</intervention_name>
    <description>Behavioral feeding intervention will include escape extinction.</description>
    <arm_group_label>Behavioral feeding intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Caregiver Based&#xD;
&#xD;
          -  Mothers&#xD;
&#xD;
          -  Conducts feeding intervention ≥75% of the time at home&#xD;
&#xD;
          -  Understands and speaks English&#xD;
&#xD;
        Child Based&#xD;
&#xD;
          -  12-14 or 30-48 months old at initial assessment&#xD;
&#xD;
          -  Clinically significant feeding problem&#xD;
&#xD;
          -  Self-initiates movement&#xD;
&#xD;
          -  Can be left alone in a room for 3 minutes&#xD;
&#xD;
          -  Capable of initiating eye contact&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy K Drayton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>April 12, 2016</last_update_submitted>
  <last_update_submitted_qc>April 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Amy K. Drayton</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Feeding and Eating Disorders</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/NCT02187952
org study id: 13-PAF07294
nct id: NCT02187952
lead sponsor: 
collaborator: 
The primary objective of the proposed study is to determine whether behavioral feeding
      intervention impacts mother-child attachment in infants and toddlers with feeding problems.
      The investigators propose the following hypotheses:

        -  Behavioral feeding intervention will not significantly impact parent-child attachment.

        -  Behavioral feeding intervention will not significantly impact parent-child unstructured
           play interactions.

        -  Severity of feeding problems will decrease after behavioral feeding intervention is
           implemented.

        -  Behavioral feeding intervention will have either no significant effect or a significant
           positive effect on general child behavior.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in attachment status
time frame: Enrollment, 6 months, 1 year
description: The Strange Situation (SS) will be used to assess any changes in mother-child attachment status. The SS consists of a series of separations and reunions between a mother and her child.
measure: Change in infant social and emotional behavior
time frame: Enrollment, 6 months, 1 year
description: Brief Infant Toddler Social Emotional Assessment (BITSEA) will be used to assess any changes in the social and emotional behavior of children who are 12-36 months of age.
measure: Change in child externalizing and internalizing behavior.
time frame: Enrollment, 6 months, 1 year
description: The Child Behavior Checklist will be used to assess any changes in the internalizing and externalizing behavior of children who are 1.5 to 5 years of age.
measure: Change in maternal behavior when interacting with her child
time frame: Enrollment, 6 months, 1 year
description: Mother-child dyads will be given toys and asked to play as they normally would for 10 minutes. The purpose of this measure is to detect any changes in parent-child interaction patterns that may be more sensitive to short-term intervention than attachment status.
measure: Change in child feeding behavior.
time frame: Enrollment, 6 months, 1 year
description: The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) will be used to measure any changes in the feeding behavior of children.
arm group label: Behavioral feeding intervention
arm group type: Experimental
description: Behavioral feeding intervention will be conducted as usual. The intervention will not be altered for purposes of the study.
arm group label: Waitlist control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Behavioral feeding intervention
description: Behavioral feeding intervention will include escape extinction.
arm group label: Behavioral feeding intervention
criteria: 
gender: All
minimum age: 12 Months
maximum age: 48 Months
healthy volunteers: No
last name: Amy K Drayton, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Amy K. Drayton
investigator title: Assistant Professor
mesh term: Feeding and Eating Disorders