An observational study in Factors Associated With a Child's Development of Interaction and Communication Skills and Measures Taken and Reported Stress Level of the Parents of a Newborn and Measures Taken, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
Though primary care pediatricians (PCPs) and general practitioners solve 90% of children's health problems without referral to specialized care (about 10% of total health expenditures) there is little data on the common health problems PCPs treat, mainly because pediatric primary care practices have little time to collect data and rarely have academic or administrative support to implement studies. We intend to create a digital pediatric cohort called Pediatric Research in the Outpatient Setting CoHort - PROS-CH (Switzerland), based on routine data collected with tablets using the digital data collection tool of REDCap. PCPs collect pediatric data from parents in practices' waiting rooms, and add their observations, treatment plans, and recommendations. To test the PROS-CH infrastructure's feasibility in pediatric practices under real-life conditions (pilot study), we will start with the following two pilot projects: 1) factors associated with a child's development of interaction and communication skills and measures taken; and 2) self-reported stress level of the parents of a newborn and measures taken.
203 studies on the registry are indexed under Communication; 89 are open to participants now.
This study's planned enrollment of 200 is above the median of 105 across 28 observational studies indexed under Communication.
Browse Communication studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 738 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All children attending well-child visits with their participating Primary Care Pediatrician (PCP) and accepting to use a tablet-based questionnaire.
Inclusion Criteria (all via Primary Care Pediatrician) :
Exclusion Criteria:
Characteristics associated with anomalies in interaction and communication skills (AICS) at 24 months
AICS assessed by diagnosis or suspicion of ASD or similar condition, or SACS-R of ≥3. Characteristics and predictors include: * family demographics * languages spoken at home * daycare attendance * sleeping and eating habits, * exposure to second-hand smoke and screentime * validated screening tools (Standardized Infant Neuro-Developmental Assessment (SINDA) at 9 and 12 months, Social Attention and Communication Study - Revised (SACS-R) at 12, 18 and 24 months, and the speech-language test SBE-2 KT at 24 months)
Time frame: At age 2
Stress level and causes of stress in parents of a newborn
Stress level of parents on a visual analog scale from 0 to 10, and causes of stress such as: * postpartum depression - Edinburgh Postnatal Depression Scale (EPDS) * problems within the family * financial issues * health problems
Time frame: In the first year of life of the newborn
Engagement in support activities in children with or without anomalies in interaction and communication skills (AICS )
Previously used support services and specified recommendations given at every visit up to age 2
Time frame: Up to age 2
Engagement in support activities of parents with a newborn
Self-reported engagement and primary care pediatrician (PCP)-reported recommendation of * watchful waiting with the PCP * establishing contact with the midwife * referring the parent to their primary care practitioner * referring the parent to a psychologist * referring the parent to community support offers
Time frame: In the first year of life of the newborn
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Plan to share: No — Further use of biological material and health-related personal data for research pursuant to Articles 32 and 33 HRA (Switzerland).
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Insel Gruppe AG, University Hospital Bern →