Impact Evaluation of the "Baby Newsletter"

Parenting Clinical Trial

— BabyNewsletter  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03268408
• Other study ID #: BabyNewsletter
• Status: Active, not recruiting
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 30, 2017
• Start date: September 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2017
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2015
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parenting

Intervention

Behavioral:
• Baby Newsletter
eight newsletters sent home to newborns' parents with advices and recommendations on child care and development

Locations

Country	Name	City	State
Italy	Montecchio Hospital	Montecchio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Unità Sanitaria Locale Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Kendall S, Bloomfield L. Developing and validating a tool to measure parenting self-efficacy. J Adv Nurs. 2005 Jul;51(2):174-81. — View Citation

Outcome

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