Mental Health Screening for Babies. What Can We Learn from Infant and Caregiver Behaviors During Immunization Appointments?
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-010417
Sponsor Protocol Number: 17-010417
About this study
Aim 1. To examine the feasibility of a simple 5 minutes screening procedure that assesses relationship between an infant and their caregiver and the caregiver's capacity to repair and re-regulate the infants' state at 4 and 12 months WBVs (Well-Baby Visits).
Aim 2. To develop a brief and easy to implement intervention that could be applied in dyads that show signs of distress at 4 and/or 12 months vaccination appointment and examine the difference in retention rate between patients who were identified at risk at either of the appointments (at 4 or at 12 months) or at both of the appointments (at 4 and at 12 months).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Only healthy infants born greater than 36 weeks of gestation
- Who had no suspected developmental delays or neurological impairments
- Are without prolonged medical or foster care
- In addition, caregivers will have to be fluent in English
Exclusion Criteria:
- Infants born prematurely
- Infants with known impairments
- Caregivers not fluent in English
- Children who were adopted
- Parents who did not give authorization to participate in the study
- Parents who did not consent to vaccination
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available