An interventional study of Integrated Behavioral Health - Prevention and Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition in Prevention, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Prevention
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.
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.
Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
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Exclusion Criteria:
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
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
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.
Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.
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.
Time frame: 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.
Time frame: 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.
Time frame: 7-month follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: 7-month follow-up
Maternal experiences of violence and adversity in childhood
The Philadelphia Urban Adverse Childhood Experiences is a 22-item self-report that will be used to measure maternal experience of childhood violence and adversity. The total score is a tally of the 22 items endorsed with higher scores indicating more experiences of violence and adversity.
Time frame: Baseline
Adherence to well-child visits in first 7 months of life
The American Academy of Pediatrics recommends preventive pediatric care is provided across 5 visits in an infant's first 7 months of life. Percentage of adherence to the 5 well-child visits will be calculated.
Time frame: Infants' birth through 7-months of age
Health Service Utilization - Immunizations
Completion of immunizations at 5 months
Time frame: Infants' birth through 5-months of age
Plan to share: Yes — Consistent with the open science movement and with the directive of clinicaltrials.gov to include a data sharing plan in submissions, we will have the following data sharing policy: we will share with other investigators (1) all individual participant data after deidentification, and (2) study management documents (protocol, statistical analysis plan, consent form, analytic code, data dictionary).
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati