Parental StressPROS-CHNCT07911228
Pediatric Research in the Outpatient Setting CoHort
An observational study of Parental Stress and Communication Disorder, Childhood, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parental Stress, Communication Disorder, Childhood, Development and Health
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Oct 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All children attending well-child visits with their participating Primary Care Pediatrician (PCP) and accepting to use a tablet-based questionnaire.
Who may be able to join
- All children aged <2 at their first well-child visit
Who cannot join
- Declining the General Consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Bern, Institute of Primary Health Care (BIHAM)
Bern, 3012
Julian Jakob, MD, PhD, +41 31 684 57 93, julian.jakob@unibe.ch
About this study
Official title: Pediatric Research in the Outpatient Setting - CoHort (PROS-CH)
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.
- Keywords
- primary care, pros-ch, pros, interaction, communication, stress, tablet, cohort, switzerland, CH, routine data, further use
- Medical subject headings
- Communication Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children included to study factors associated with development of interaction / communication skills | Not described | |
| Parrents included to study self-reported stress level in parents of a newborn | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: In the first year of life of the newborn
Secondary outcomes (2)
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
Measured: 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
Measured: In the first year of life of the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start26 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental StressStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Primary Health Care BIHAM, University of Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911228
- Sponsor's protocol ID
- B2026-00468
- Acronym
- PROS-CH
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Further use of biological material and health-related personal data for research pursuant to Articles 32 and 33 HRA (Switzerland).
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Research in the Outpatient Setting - CoHort (PROS-CH)
- ClinicalTrials.gov ID
- NCT07911228
- Acronym / sponsor ID
- PROS-CH / B2026-00468
- Keywords
- primary care, pros-ch, pros, interaction, communication, stress, tablet, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Institute for Primary Health Care BIHAM, University of Bern
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children included to study factors associated with development of interaction / communication skills | – | – |
| Parrents included to study self-reported stress level in parents of a newborn | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All children attending well-child visits with their participating Primary Care Pediatrician (PCP) and accepting to use a tablet-based questionnaire.
Key inclusion criteria (1 listed)
- All children aged <2 at their first well-child visit
Key exclusion criteria (1 listed)
- Declining the General Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics associated with anomalies in interaction and communication skills (AICS) at 24 months
Time frame: At age 2
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)
Stress level and causes of stress in parents of a newborn
Time frame: In the first year of life of the 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
2 secondary outcomes
Engagement in support activities in children with or without anomalies in interaction and communication skills (AICS )
Time frame: Up to age 2
Engagement in support activities of parents with a newborn
Time frame: In the first year of life of the newborn
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Further use of biological material and health-related personal data for research pursuant to Articles 32 and 33 HRA (Switzerland).
Related trials for Parental Stress
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Recruiting
Preliminary Efficacy of the AdoptMindful2Care@Web: A Web-Based Mindful Parenting Post-Adoption Intervention for Adoptive Parents
Parenting Stress, Positive Mental Health
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruitingObservational study
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
Anxiety
Active, not recruiting
Pai.ACT: AI-Driven ACT Chatbot for Mental Health Triage and Service Evaluation
Autism Spectrum Disorder, Attention Deficit Disorder With Hyperactivity (ADHD)
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.
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 Parental Stress and Communication Disorder, Childhood, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julian Jakob, MD PhD (+41 31 684 57 93, julian.jakob@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics associated with anomalies in interaction and communication skills (AICS) at 24 months (time frame: At age 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.