<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/NCT02970565</url>
  </required_header>
  <id_info>
    <org_study_id>AAAQ9547</org_study_id>
    <nct_id>NCT02970565</nct_id>
  </id_info>
  <brief_title>Family Nurture Intervention, A Group Model in Connecticut</brief_title>
  <official_title>Family Nurture Intervention, A Group Model: Short and Long Term Effects on Behavior and Development of Preschool Aged Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this current study is to investigate the efficacy of a group model of Family&#xD;
      Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The&#xD;
      behavioral, neurobiological and clinical insights gained from this project may eventually&#xD;
      lead to better treatment of emotional, behavioral and developmental disorders. The&#xD;
      investigator hypothesizes that the children who are treated with Family Nurture Intervention&#xD;
      (FNI), which incorporates interactive touch with vocal soothing, and family practice in&#xD;
      comforting, will show increased emotional connection and mother child co-regulation with&#xD;
      better results in the outcome measures in the short term and long term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are several early intervention programs that are available for children with emotional,&#xD;
      behavioral and developmental disorders, ranging from behavioral treatment and sensory&#xD;
      exposure therapy to pharmaceutical treatments. Although improvements in behavior have&#xD;
      resulted from these interventions, they are limited in numerous ways. They are usually&#xD;
      time-consuming, both for the child and the teacher or clinician providing the intervention.&#xD;
      In order to see an effect of the intervention, most children must engage in the intervention&#xD;
      procedure for several years. Moreover, the effects of most current intervention procedures&#xD;
      are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable&#xD;
      side effects that may modulate behavior, emotion, and physiological functions. The&#xD;
      behavioral, neurobiological and clinical insights gained from this project may eventually&#xD;
      lead to better treatment of emotional, behavioral and developmental disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Childhood Behavior Checklist (CBCL) Score</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Co-regulation of Vagal Tone</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Maternal Anxiety and Depressive Symptoms</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Mothers will complete various questionnaires measuring their mood and state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Welch Emotional Connection Scale</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Behavior Problem</condition>
  <condition>Development Delay</condition>
  <condition>Emotional Disturbance</condition>
  <condition>Family Conflict</condition>
  <arm_group>
    <arm_group_label>Nutrition and Play Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family Nurture Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Nurture Intervention</intervention_name>
    <description>The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact.</description>
    <arm_group_label>Family Nurture Intervention</arm_group_label>
    <other_name>FNI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition and Play Intervention</intervention_name>
    <description>Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.</description>
    <arm_group_label>Nutrition and Play Intervention</arm_group_label>
    <other_name>NPI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child is a singleton&#xD;
&#xD;
          -  Mother can speak in English or Spanish&#xD;
&#xD;
          -  Child is between the ages of 2 to 4 ½ years at date of enrollment&#xD;
&#xD;
          -  Mother is 18 years of age or older at the time of consent&#xD;
&#xD;
          -  Child demonstrates developmental deficit as measured by the SDQ (cutoff of 13 or more&#xD;
             on the total score excluding the pro-social questions; OR 4 or less on the pro-social&#xD;
             questions, which are reverse scored i.e. higher is better)&#xD;
&#xD;
          -  Child must reside with mother&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The child has severe congenital anomalies or chromosomal anomalies including Downs&#xD;
             syndrome and Cerebral Palsy&#xD;
&#xD;
          -  The child has a diagnosis of Autism&#xD;
&#xD;
          -  The child has severe motor or physical disability&#xD;
&#xD;
          -  Mother currently presents with psychosis or is currently taking antipsychotic&#xD;
             medication&#xD;
&#xD;
          -  Current maternal drug and/or alcohol abuse&#xD;
&#xD;
          -  Mother has any current involvement with Child Protective Services (Department of&#xD;
             Children and Families)&#xD;
&#xD;
          -  Mother is pregnant&#xD;
&#xD;
          -  Mother and/or infant has a medical condition or contagion that precludes intervention&#xD;
             components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>54 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martha G Welch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwalk Housing Authority</name>
      <address>
        <city>Cos Cob</city>
        <state>Connecticut</state>
        <zip>06807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Martha G Welch</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)</investigator_title>
  </responsible_party>
  <keyword>Family Nurture Intervention</keyword>
  <keyword>Martha G. Welch MD</keyword>
  <keyword>Randomized Control Trial</keyword>
  <keyword>Pre-school Intervention</keyword>
  <keyword>Preschool Intervention</keyword>
  <keyword>Multiple Family Group Intervention</keyword>
  <keyword>Emotional Connection</keyword>
  <keyword>Co-regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Problem Behavior</mesh_term>
    <mesh_term>Affective Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02970565
org study id: AAAQ9547
nct id: NCT02970565
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this current study is to investigate the efficacy of a group model of Family
      Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The
      behavioral, neurobiological and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral and developmental disorders. The
      investigator hypothesizes that the children who are treated with Family Nurture Intervention
      (FNI), which incorporates interactive touch with vocal soothing, and family practice in
      comforting, will show increased emotional connection and mother child co-regulation with
      better results in the outcome measures in the short term and long term.
There are several early intervention programs that are available for children with emotional,
      behavioral and developmental disorders, ranging from behavioral treatment and sensory
      exposure therapy to pharmaceutical treatments. Although improvements in behavior have
      resulted from these interventions, they are limited in numerous ways. They are usually
      time-consuming, both for the child and the teacher or clinician providing the intervention.
      In order to see an effect of the intervention, most children must engage in the intervention
      procedure for several years. Moreover, the effects of most current intervention procedures
      are minimal to moderate. Pharmaceutical prescriptions are often accompanied by undesirable
      side effects that may modulate behavior, emotion, and physiological functions. The
      behavioral, neurobiological and clinical insights gained from this project may eventually
      lead to better treatment of emotional, behavioral and developmental disorders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Change in Childhood Behavior Checklist (CBCL) Score
time frame: Baseline, 6 months
description: The Childhood Behavior Checklist (CBCL) is a device by which parents or other individuals who know the child well rate a child's problem behaviors and competencies. This instrument can either be self-administered or administered through an interview. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The first section of this questionnaire consists of 20 competence items and the second section consists of 120 items on behavior or emotional problems.
measure: Co-regulation of Vagal Tone
time frame: Up to 12 months
description: Using ECG data obtained during each follow-up visit, the investigators will characterize various parameters of cardiac function and regulation including assessments of parasympathetic modulation of heart rate. Long term individual differences in attention and emotional regulation are correlated with these parameters. Heart rate and respiration obtained from analogue outputs from standard clinical monitors or from specially designed hardware utilized routinely in the studies of human infants. The digitized recordings of ECG and respiration will be processed using software designed specifically for displaying, marking, and analyzing data from these records.
measure: Change in Maternal Anxiety and Depressive Symptoms
time frame: Up to 12 months
description: Mothers will complete various questionnaires measuring their mood and state.
measure: Changes in Welch Emotional Connection Scale
time frame: Up to 12 months
description: This is a clinical tool to assess the emotional connectedness of a mother-child dyad. The aim of the WECS is to assess behaviors observed during mother-child interaction, and score these behavioral observations across four domains to better inform health professionals of a dyad's interventional need. This scale will be completed by study staff.
arm group label: Nutrition and Play Intervention
arm group type: Experimental
description: Mother-child dyads who are enrolled into the study will be randomly assigned to the Nutrition and Play Intervention group.
arm group label: Family Nurture Intervention
arm group type: Experimental
description: Mother-child dyads who are enrolled into the study will be randomly assigned to the Family Nurture Intervention group.
intervention type: Behavioral
intervention name: Family Nurture Intervention
description: The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact.
arm group label: Family Nurture Intervention
other name: FNI
intervention type: Behavioral
intervention name: Nutrition and Play Intervention
description: Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
arm group label: Nutrition and Play Intervention
other name: NPI
criteria: 
gender: All
minimum age: 24 Months
maximum age: 54 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Martha G Welch, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Martha G Welch
investigator title: Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)
mesh term: Problem Behavior
mesh term: Affective Symptoms
sharing ipd: No