ParentingBabyNewsletterNCT03268408
Impact Evaluation of the "Baby Newsletter"
An observational study of Parenting, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parenting
- What is being tested?
- Baby Newsletter
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 136 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- being parent of a child born during the study enrollment period and resident in the Montecchio Health District
- good comprehension of Italian language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parenting
- Being tested
- Baby Newsletter
- Keywords
- community intervention, newsletter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby NewsletterBehavioural
eight newsletters sent home to newborns' parents with advices and recommendations on child care and development
| Study group | Role | What they receive |
|---|---|---|
| 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"). Receives: Behavioral: Baby Newsletter | |
| Control | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parenting score on the scale "emotion and affection"
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score on the scale "play and enjoyment"
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score on the scale "empathy and understanding"
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score control
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score on the scale "discipline and setting boundaries"
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score pressures
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score self-acceptance
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Parenting score on the scale "learning and knowledge"
score based on 6 items of TOPSE questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2014
- Primary completion31 Dec 2015
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Costantino Panza, MD, Principal investigator, AUSL Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268408
- Sponsor's protocol ID
- BabyNewsletter
- Acronym
- BabyNewsletter
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15963189Panza 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.
PubMed 32887637
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the "Baby Newsletter" Project: an Intervention to Improve Parenting Self-efficacy in the First Year of Newborn's Life
- ClinicalTrials.gov ID
- NCT03268408
- Acronym / sponsor ID
- BabyNewsletter / BabyNewsletter
- Conditions
- Parenting
- Keywords
- community intervention, newsletter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: Baby NewsletterIntervention 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"). |
| Control | – | –Usual care |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- being parent of a child born during the study enrollment period and resident in the Montecchio Health District
- good comprehension of Italian language
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baby Newslettereight newsletters sent home to newborns' parents with advices and recommendations on child care and development | Behavioural | Intervention |
Primary outcome
Parenting score on the scale "emotion and affection"
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score on the scale "play and enjoyment"
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score on the scale "empathy and understanding"
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score control
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score on the scale "discipline and setting boundaries"
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score pressures
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score self-acceptance
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Parenting score on the scale "learning and knowledge"
Time frame: 12 months
score based on 6 items of TOPSE questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 15963189Kendall 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.
- Derived from this study: PubMed 32887637Panza 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Costantino Panza, MD principal investigator
AUSL Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenting, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting score on the scale "emotion and affection" (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.