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Completed

NCT Number: NCT03268408

Impact Evaluation of the "Baby Newsletter"

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.

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Key information

Conditions

Parenting

Sex eligibility

All sexes

Study type

Observational

Primary location

Montecchio Hospital

Montecchio Emilia, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baby Newsletter

Behavioral

eight newsletters sent home to newborns' parents with advices and recommendations on child care and development

Primary outcomes

  1. Parenting score on the scale "emotion and affection"

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  2. Parenting score on the scale "play and enjoyment"

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  3. Parenting score on the scale "empathy and understanding"

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  4. Parenting score control

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  5. Parenting score on the scale "discipline and setting boundaries"

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  6. Parenting score pressures

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  7. Parenting score self-acceptance

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

  8. Parenting score on the scale "learning and knowledge"

    Time frame: 12 months

    score based on 6 items of TOPSE questionnaire

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: BabyNewsletter

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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