Clinical trial NCT03268408: Impact Evaluation of the "Baby Newsletter"
Official title: Impact Evaluation of the "Baby Newsletter" Project: an Intervention to Improve Parenting Self-efficacy in the First Year of Newborn's Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parenting
Keywords: community intervention
newsletter
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2017-08-31
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parenting score on the scale "emotion and affection"
timeFrame: 12 months
measure: Parenting score on the scale "play and enjoyment"
timeFrame: 12 months
measure: Parenting score on the scale "empathy and understanding"
timeFrame: 12 months
measure: Parenting score control
timeFrame: 12 months
measure: Parenting score on the scale "discipline and setting boundaries"
timeFrame: 12 months
measure: Parenting score pressures
timeFrame: 12 months
measure: Parenting score self-acceptance
timeFrame: 12 months
measure: Parenting score on the scale "learning and knowledge"
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montecchio Emilia
country: Italy
facility: Montecchio Hospital
Study officials:
affiliation: AUSL Reggio Emilia
name: Costantino Panza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: Panza C, Volta A, Broccoli S, Bonvicini L, Kendall S, Marchesi M, Giorgi Rossi P. Evaluation of an intervention aimed at supporting new parents: the Baby Newsletter project. Ital J Pediatr. 2020 Sep 4;46(1):123. doi: 10.1186/s13052-020-00886-5.