Clinical trial NCT04825210: Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants
Official title: Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: Behavioral Health
Integrated Behavioral Health
Infant Self-Regulation
Parenting Skills
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the acceptability and preliminary efficacy of a universal prevention program delivered by psychologists in conjunction with pediatric primary care well-child visits.

Detailed description: Integrated behavioral health has emerged as an effective approach to addressing emotional and behavioral health needs of children in the pediatric setting, yet there is little evidence for a standardized model of care for providing universal preventive services in pediatric primary care. Current models are typically loosely constructed, inconsistently applied, and unspecified. Our aim is to evaluate a model of care developed to address these gaps. Integrated Behavioral Health-Prevention (IBH-P) is a collection of clinical strategies and structured approaches designed to promote emotional and behavioral health. IBH-P is delivered by psychologists in the pediatric setting as part of scheduled well-child visits. The overall objective of this study is to evaluate the efficacy of the intervention in promoting infant self-regulation. Maternal experience and satisfaction, adherence to well-child visits and immunizations will also be examined.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Biological mother of a newborn infant presenting at the newborn well-child visit
* Intends to continue to receive infant's pediatric care at one of the three participating clinics over the next year.

Exclusion Criteria:

* Infant diagnosed as failure to thrive
* Infant exposure to illicit drugs in utero with the exception of THC
* Extensive care in the Neonatal Intensive Care Unit (\>7 days)
* Child has other serious medical condition or acute psychosocial circumstances that results in child not receiving medical clearance from the pediatrician or psychologist for randomization
* mother or father of infant has received Building Futures intervention training

Primary outcomes:
measure: Infant self-regulation
timeFrame: 7-month follow-up
measure: Parental knowledge of child development
timeFrame: 7-month follow-up
measure: Maternal parenting behaviors
timeFrame: 7-month follow-up
Secondary outcomes:
measure: Parenting beliefs and practices
timeFrame: 7-month follow-up
measure: Maternal feelings of efficacy in infant care
timeFrame: 7-month follow-up
measure: Maternal appraisement of life stress
timeFrame: 7-month follow-up
Other outcomes:
measure: Maternal experiences of violence and adversity in childhood
timeFrame: Baseline
measure: Adherence to well-child visits in first 7 months of life
timeFrame: Infants' birth through 7-months of age
measure: Health Service Utilization - Immunizations
timeFrame: Infants' birth through 5-months of age
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's Hospital Medical Center Cincinnati, OH USA
name: Robert T Ammerman, PhD
role: PRINCIPAL_INVESTIGATOR
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