Impact Evaluation of the "Baby Newsletter" (BabyNewsletter)

August 30, 2017 updated by: Azienda Unità Sanitaria Locale Reggio Emilia

Impact Evaluation of the "Baby Newsletter" Project: an Intervention to Improve Parenting Self-efficacy in the First Year of Newborn's Life

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Montecchio Emilia, Italy
        • Montecchio Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • Newsletter Group

    • all the parents of newborns delivered during the study period (01/09/2014 - 31/12/2015) resiident in the Sant'Ilario municipality.

  • Control Group

    • all the parents f newborns delivered during the study period (01/09/2014 - 31/12/2015) resident in other municipalities of the Montecchio health district

Description

Inclusion Criteria:

  • being parent of a child born during the study enrollment period and resident in the Montecchio Health District
  • good comprehension of Italian language

Exclusion Criteria:

  • delivering in other facilities than the Montecchio hospitals (only for controls)
  • parents of newborns with pathological conditions at born
  • parents of newborns that were transferred to another hospital immediately after born due to clinical reasons
  • parents of pre-term newborns

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
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").
Behavioral: Baby Newsletter
eight newsletters sent home to newborns' parents with advices and recommendations on child care and development
Control
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting score on the scale "emotion and affection"
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score on the scale "play and enjoyment"
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score on the scale "empathy and understanding"
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score control
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score on the scale "discipline and setting boundaries"
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score pressures
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score self-acceptance
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months
Parenting score on the scale "learning and knowledge"
Time Frame: 12 months
score based on 6 items of TOPSE questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Unità Sanitaria Locale Reggio Emilia

Investigators

  • Principal Investigator: Costantino Panza, MD, AUSL Reggio Emilia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BabyNewsletter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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