Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants

Conditions
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Prevention

Intervention / Treatment
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* Behavioral: Integrated Behavioral Health - Prevention
* Behavioral: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated Behavioral Health - Prevention (IBH-P)<br>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. | Behavioral: Integrated Behavioral Health - Prevention<br>* IBH-P consists of 15-30 minute visits with mothers as part of the 1, 2, 4, and 6 month well-child visits. The intervention is delivered by doctoral level pediatric psychologists that are an integrated member of the primary care team.<br>|
| Active Comparator: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition<br>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. | Behavioral: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition<br>* Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant self-regulation | The Infant Behavior Questionnaire-Revised Very Short Form is a 36-item measure of three factors, positive affect, negative emotionality, and orienting/regulatory capacity. Scores range from 0 to 7, with higher scores representing greater positive affect, negative emotionality and orienting and regulatory capacity. | 7-month follow-up | 
| Parental knowledge of child development | The Knowledge of Infant Development Inventory is 58-item measure of caregiver knowledge of infant development. The total score will be calculated as the percentage of correct answers out of 58 items. | 7-month follow-up | 
| Maternal parenting behaviors | The Keys to Interactive Parenting Scale (KIPS) will be used to assess maternal parenting behaviors. KIPS is a structured observational measure and assesses 12 domains of parenting. The domains are scored on a 1 to 5-point scale with higher scores indicating higher quality parenting behaviors. | 7-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parenting beliefs and practices | The Baby Care Questionnaire is a 30-item measure of parenting belief and practices with 2 subscales, structure and attunement. Total scores range from 1 to 4 with higher scores indicating greater structure and attunement. | 7-month follow-up | 
| Maternal feelings of efficacy in infant care | The Maternal Self-Efficacy Scale is a 10-item self-report of feelings of efficacy in infant care. The total score will be used and ranges from 10 to 40 with higher scores representing greater maternal self-efficacy. | 7-month follow-up | 
| Maternal appraisement of life stress | The Perceived Stress Scale is a 14-item self-report of the degree to which situations in one's life within the past month are appraised as stressful. Scores range from 0 to 56 with higher scores indicating greater perceived stress. | 7-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral Health, Integrated Behavioral Health, Infant Self-Regulation, Parenting Skills