<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/NCT03268408</url>
  </required_header>
  <id_info>
    <org_study_id>BabyNewsletter</org_study_id>
    <nct_id>NCT03268408</nct_id>
  </id_info>
  <brief_title>Impact Evaluation of the &quot;Baby Newsletter&quot;</brief_title>
  <acronym>BabyNewsletter</acronym>
  <official_title>Impact Evaluation of the &quot;Baby Newsletter&quot; Project: an Intervention to Improve Parenting Self-efficacy in the First Year of Newborn's Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Unità Sanitaria Locale Reggio Emilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Unità Sanitaria Locale Reggio Emilia</source>
  <oversight_info>
    <has_dmc>No</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>
      Not-randomized controlled study to evaluate a community intervention to promote self-efficacy&#xD;
      parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza&#xD;
      (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health&#xD;
      District of Montecchio and born in Montecchio Hospital in the same period are the control&#xD;
      group (278 in 2013). Preterm or hospitalized children are excluded.&#xD;
&#xD;
      Self-efficacy parenting is evaluated through a questionnaire administered at baseline, after&#xD;
      5 and 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      The importance of promoting parenting skills is worldwide recognized and, in Italy, different&#xD;
      projects are implemented in order to develop these competences. The impact of these&#xD;
      experiences is rarely evaluated.&#xD;
&#xD;
      The aim of this study is to evaluate the improvement in self-efficacy parenting produced by&#xD;
      an intervention which consists in sending to every new parents, during the first year of life&#xD;
      of their son, eight newsletters with advices and recommendations on child care and&#xD;
      development (project &quot;Baby Newsletter&quot;).&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Not-randomized controlled study to evaluate a community intervention to promote self-efficacy&#xD;
      parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza&#xD;
      (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health&#xD;
      District of Montecchio and born in Montecchio Hospital in the same period are the control&#xD;
      group (278 in 2013). Preterm or hospitalized children are excluded.&#xD;
&#xD;
      Self-efficacy parenting is evaluated through the TOPSE (Tool to measure Parenting&#xD;
      Self-Efficacy) questionnaire administered at baseline, in Montecchio Birth Unit or at the&#xD;
      paediatric clinics, and at the vaccination appointments after 5 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parenting score on the scale &quot;emotion and affection&quot;</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score on the scale &quot;play and enjoyment&quot;</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score on the scale &quot;empathy and understanding&quot;</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score control</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score on the scale &quot;discipline and setting boundaries&quot;</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score pressures</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score self-acceptance</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting score on the scale &quot;learning and knowledge&quot;</measure>
    <time_frame>12 months</time_frame>
    <description>score based on 6 items of TOPSE questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">136</enrollment>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>Intervention aimed at improving self-efficacy parenting which consists in sending to new parents, during the first year of life of their son, eight newsletters with advices and recommendations on child care and development (project &quot;Baby Newsletter&quot;).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Baby Newsletter</intervention_name>
    <description>eight newsletters sent home to newborns' parents with advices and recommendations on child care and development</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Newsletter Group&#xD;
&#xD;
               -  all the parents of newborns delivered during the study period (01/09/2014 -&#xD;
                  31/12/2015) resiident in the Sant'Ilario municipality.&#xD;
&#xD;
          -  Control Group&#xD;
&#xD;
               -  all the parents f newborns delivered during the study period (01/09/2014 -&#xD;
                  31/12/2015) resident in other municipalities of the Montecchio health district&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being parent of a child born during the study enrollment period and resident in the&#xD;
             Montecchio Health District&#xD;
&#xD;
          -  good comprehension of Italian language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  delivering in other facilities than the Montecchio hospitals (only for controls)&#xD;
&#xD;
          -  parents of newborns with pathological conditions at born&#xD;
&#xD;
          -  parents of newborns that were transferred to another hospital immediately after born&#xD;
             due to clinical reasons&#xD;
&#xD;
          -  parents of pre-term newborns&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Costantino Panza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUSL Reggio Emilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montecchio Hospital</name>
      <address>
        <city>Montecchio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005 Jul;51(2):174-81. doi: 10.1111/j.1365-2648.2005.03479.x.</citation>
    <PMID>15963189</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>community intervention</keyword>
  <keyword>newsletter</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03268408
org study id: BabyNewsletter
nct id: NCT03268408
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Not-randomized controlled study to evaluate a community intervention to promote self-efficacy
      parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza
      (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health
      District of Montecchio and born in Montecchio Hospital in the same period are the control
      group (278 in 2013). Preterm or hospitalized children are excluded.

      Self-efficacy parenting is evaluated through a questionnaire administered at baseline, after
      5 and 12 months.
Background

      The importance of promoting parenting skills is worldwide recognized and, in Italy, different
      projects are implemented in order to develop these competences. The impact of these
      experiences is rarely evaluated.

      The aim of this study is to evaluate the improvement in self-efficacy parenting produced by
      an intervention which consists in sending to every new parents, during the first year of life
      of their son, eight newsletters with advices and recommendations on child care and
      development (project "Baby Newsletter").

      Methods

      Not-randomized controlled study to evaluate a community intervention to promote self-efficacy
      parenting. The treated group will be composed by all newborns resident in S.Ilario d'Enza
      (105 in 2013) where the Baby Newsletter is implemented. Newborns resident in the Health
      District of Montecchio and born in Montecchio Hospital in the same period are the control
      group (278 in 2013). Preterm or hospitalized children are excluded.

      Self-efficacy parenting is evaluated through the TOPSE (Tool to measure Parenting
      Self-Efficacy) questionnaire administered at baseline, in Montecchio Birth Unit or at the
      paediatric clinics, and at the vaccination appointments after 5 and 12 months.
observational model: Ecologic or Community
time perspective: Prospective
measure: Parenting score on the scale "emotion and affection"
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score on the scale "play and enjoyment"
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score on the scale "empathy and understanding"
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score control
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score on the scale "discipline and setting boundaries"
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score pressures
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score self-acceptance
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
measure: Parenting score on the scale "learning and knowledge"
time frame: 12 months
description: score based on 6 items of TOPSE questionnaire
arm group label: Intervention
description: Intervention aimed at improving self-efficacy parenting which consists in sending to new parents, during the first year of life of their son, eight newsletters with advices and recommendations on child care and development (project "Baby Newsletter").
arm group label: Control
description: Usual care
intervention type: Behavioral
intervention name: Baby Newsletter
description: eight newsletters sent home to newborns' parents with advices and recommendations on child care and development
arm group label: Intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Costantino Panza, MD
role: Principal Investigator
affiliation: AUSL Reggio Emilia
facility: 
country: Italy
citation: Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005 Jul;51(2):174-81. doi: 10.1111/j.1365-2648.2005.03479.x.
PMID: 15963189
responsible party type: Sponsor
sharing ipd: Undecided