Integrated Behavioral Health Prevention in Pediatric Primary Care for Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Infant self-regulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Integrated Behavioral Health - Prevention (IBH-P)
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.
干预措施: Integrated Behavioral Health - Prevention (Behavioral)
Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition
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.
干预措施: Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition (Behavioral)
结局指标
主要结局
Infant self-regulation
时间窗: 7-month follow-up
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.
Parental knowledge of child development
时间窗: 7-month follow-up
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.
Maternal parenting behaviors
时间窗: 7-month follow-up
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.
次要结局
- Maternal feelings of efficacy in infant care(7-month follow-up)
- Maternal appraisement of life stress(7-month follow-up)
- Parenting beliefs and practices(7-month follow-up)