Evidence map›Paper›PMID 32699128›Full record

ArticleBMJ open2020

Early Parenting Intervention - Biobehavioral Outcomes in infants with Neurodevelopmental Disabilities (EPI-BOND): study protocol for an Italian multicentre randomised controlled trial.

Rosario Montirosso, Elisa Rosa, Roberto Giorda, Elisa Fazzi, Simona Orcesi, Anna Cavallini, Livio Provenzi, Early Intervention Study Group

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03853564 (Clinical Trial of an Early Parenting Empowerment Intervention to Promote Socioemotional Development in Infants With Developmental Disabilities), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03853564 nacompletednot on this map

Clinical Trial of an Early Parenting Empowerment Intervention to Promote Socioemotional Development in Infants With Developmental Disabilities: Parent and Infant Behavioral, Neuroendocrine and Epigenetics Outcomes

TypeinterventionalSponsorIRCCS Eugenio MedeaRan2019 to 2023Enrolled45ConditionsEpigenomics, Developmental Disability, Early Intervention, Parent-Child RelationsArmsVideo-Feedback Intervention, Phone-Call Intervention
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Rosario Montirosso0-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy rosario.montirosso@lanostrafamiglia.it.
Elisa Rosa0-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.
Roberto GiordaBiology Lab, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.
Elisa FazziDepartment of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Simona OrcesiChild Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.
Anna CavalliniNeuropsychiatry and Neurorehabilitation Unit, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy.
Livio ProvenziChild Neurology and Psychiatry Unit, IRCCS Mondino Foundation, Pavia, Italy.ORCID 0000-0001-7424-8744
Early Intervention Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionNeurodevelopmental disability (ND) represents an adverse condition for infants' socio-emotional and behavioural development as well as for caregiving (eg, parental sensitivity) and mother-infant interaction. Adverse exposures are associated with altered neuroendocrine hormones concentrations (eg, oxytocin and cortisol) and epigenetic regulation (eg, methylation of stress-related genes), which in turn may contribute to less-than-optimal mother-infant interaction. Parental sensitivity is a protective factor for childrens' development and early parental interventions (eg, video-feedback intervention) can promote parental caregiving and better developmental outcomes in children. The present multi-centric and longitudinal randomised controlled trial aims to assess if and to which extent early VFI could benefit both infants and mothers in terms of behavioural outcomes as well as neuroendocrine and epigenetic regulation. METHODS AND ANALYSIS: Dyads will be randomly assigned to the video-feedback Intervention Group or Control Group ('dummy' intervention: telephone calls). Infants with ND aged 3 to 18 months will be recruited from three major child neuropsychiatric units in northern Italy. A multi-layer approach to intervention effects will include videotapes of mother-infant interaction, maternal reports as well as saliva samples for hormones concentrations and target-gene methylation analysis (eg, ETHICS AND DISSEMINATION: Ethics approval has been obtained in all three participating units. Results of the main trial and each of the secondary endpoints will be submitted for publication in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: NCT03853564; Pre-results.

Indexed as

Developmental DisabilitiesDNA MethylationMother-Child RelationsNervous System DiseasesAdultEarly Intervention, EducationalEpigenesis, GeneticFemaleFormative FeedbackHumansHydrocortisoneInfantItalyMaleMulticenter Studies as TopicOxytocinHydrocortisoneOxytocindevelopmental neurology & neurodisabilitygeneticspaediatrics

Identifiers

PMID32699128
PMCPMC7375429

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.