Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Prevention

Treatments: Behavioral: Integrated Behavioral Health - Prevention; Behavioral: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

Study type: Interventional

Funder types: Other

Identifiers

NCT04825210

2020-1007 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Integrated Behavioral Health - Prevention (IBH-P)

Experimental group

Description:

The IBH-P intervention addresses four areas: 1) assessment of emotional and behavioral adjustment, 2) parental education on important supports for emotional and behavioral health, 3) modeling and guidance on nurturing and responsive parenting, and 4) addressing parental concerns about and promoting child self-regulation. The primary focus of IBH-P is promoting infant self-regulation by teaching mothers how to soothe and calm their baby. Trauma-informed and relationship building methods are emphasized to acknowledge maternal experiences with violence and adversity and the desire to establish a strong working alliance. IBH-P is distinguished from Bright Futures through its emphasis on experiential learning, modeling of effective parenting skills, in-session practice and feedback, and proactive problem-solving. Families in IBH-P will receive all standard care elements of the well-child visit including pediatrician implementation of Bright Futures curriculum.

Treatment:

Behavioral: Integrated Behavioral Health - Prevention

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

Active Comparator group

Description:

The Bright Futures control condition consists of standard of care in addressing emotional and behavioral health as provided by pediatricians. Pediatricians will follow the 4th edition of the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents \[pocket guide\]. Guidelines are provided for topics to discuss and anticipatory guidance at each well-child visit. In contrast to IBH-P, there is an emphasis on didactic presentation, teaching mothers about developmental milestones, and responding to questions and concerns. These include discussions of crying, soothing, and feeding, although self-regulation is not a unifying theme.

Treatment:

Behavioral: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition