Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 2
- 主要终点
- Caregiver depression
研究概览
简要总结
This study tests a comprehensive approach to the promotion of school readiness in low-income families, beginning shortly after the birth of the child, through enhancement of positive parenting practices (and when present, reduction of psychosocial stressors) within the pediatric primary care platform. The investigators do so by integrating two evidence-based interventions: 1) a universal primary prevention strategy (Video Interaction Project [VIP]); and 2) a targeted secondary/tertiary prevention strategy (Family Check-up [FCU]) for families with infants/toddlers identified as having additional risks. VIP provides parents with a developmental specialist who videotapes the parent and child and coaches the parent on effective parenting practices at each pediatric primary care visit. FCU is a home-based, family-centered intervention that utilizes an initial ecologically-focused assessment to promote motivation for parents to change child-rearing behaviors, with follow-up sessions on parenting and factors that compromise parenting quality.
Two primary care settings serving low-income communities in New York City, NY and Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based clinics, providing information about translation across venues where one of the two interventions has been previously used alone.
The investigators plan to test the VIP/FCU model in a randomized trial of 400 families utilizing parent surveys, observational data on parent-child interactions, and direct assessments of children's development, at key points during intervention follow-up. Analyses will address questions of program impact for the integrated program across all families and by key subgroups.
The largest single contribution made by this study is to test whether an integrated primary and secondary/tertiary prevention strategy implemented in pediatric primary care can produce impacts on early school readiness outcomes, including social-emotional, pre-academic, and self-regulation. As such, this study has the potential to provide the scientific and practice communities with information about an innovative approach to promoting school readiness skills among low-income children.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital
- •Caregiver primary language is English or Spanish
- •Family can be contacted (has a working phone)
- •Family attended second (follow-up) meeting with study team between when the child was aged 10days and 6weeks old
排除标准
- •Birth weight <2500gm
- •Gestational age < 37 weeks
- •Not singleton birth (twin, triplet, etc.)
- •Known or suspected significant genetic abnormality
- •Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference)
- •Known sensory defect
- •Known significant malformation likely to affect development or likely to require significant therapy
- •Meets criteria for Early Intervention at birth
- •Not in level I nursery at time of enrollment
- •Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures
- •Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia)
- •Baby not being discharged to mother or father
- •Mother and baby will be staying in shelter
- •Not planning to stay in NYC/ Pittsburgh for at least 3 years
- •Has previously participated in VIP or FCU projects
- •Baby experiencing significant medical issues
- •Doctor has concerns about baby's hearing or vision
研究组 & 干预措施
VIP/FCU
VIP (Video Interaction Project) will be offered to all families assigned to the treatment group. FCU (Family Check Up) will be offered to families identified as high risk within the treatment group. Both treatments are parenting interventions.
干预措施: Video Interaction Project (Behavioral)
VIP/FCU
VIP (Video Interaction Project) will be offered to all families assigned to the treatment group. FCU (Family Check Up) will be offered to families identified as high risk within the treatment group. Both treatments are parenting interventions.
干预措施: Family Check Up (Behavioral)
Control
结局指标
主要结局
Caregiver depression
时间窗: When the child is 6 months - 6 years old
Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden \& Sagovsky, 1987; Cox, Chapman, Declan \& Jones, 1995)
Caregiver's cognitive stimulation
时间窗: When the child is 6 months - 6 years old
Caregiver's reports of cognitive stimulation. For example engagement in reading, teaching, and play (e.g., StimQ, Dreyer, Mendelsohn, \& Tamis-LeMonda, 1995; Mendelsohn, Dreyer, \& Tamis-LeMonda, 1999)
Child prosocial and problem behavior
时间窗: When the child is 6 months - 6 years old
Caregiver's reports of their child's behavioral problems, including externalizing and internalizing problems and prosocial behavior and social skills (e.g., Child Behavior Checklist; Achenbach \& Rescorla, 2000; BASC-3, Altmann et al., 2017; Infant-Toddler Social Emotional Assessment, ITSEA, Carter \& Briggs-Gowan, 1993; Brief Infant Toddler Social Emotional Assessment, BITSEA, Briggs-Gowan \& Carter, 2006; Positive Behavior Scale, Epps et al., 2003)
Caregiver's harsh parenting and discipline
时间窗: When the child is 18 months - 6 years old
Caregiver's reports of discipline strategies (e.g., Socolar et al., 2004; Incredible Years, Webster-Stratton, 2001; Steele et al., 2005)
Caregiver stress/ support
时间窗: When the child is 6 months - 6 years old
Caregiver's reports of stress, support, and perceptions of daily hassles (e.g., Abidin Parenting Stress Index, Abidin, 1990; General Life Satisfaction Questionnaire, Crnic, 1983; Parenting Daily Hassle scale, Crnic \& Greenberg, 1990; Concern for Children scale, Vines \& Baird, 2009)
Children's early language skills
时间窗: When the child is 6 months - 2 years old
Caregiver report of non-verbal communication and early expressive language (e.g., MacArthur Communicative Development Inventory; CDI, Fenson et al., 2008; Communication and Symbolic Behavior Scale, CSBS, Wetherby et al., 2001)
Child executive functioning skills
时间窗: When the child is 4 years old - 6 years old
Direct assessment of children's executive functioning, including cognitive skills, inhibitory control, and effortful control (e.g., Dimensional Change Card Sort, DCCS, Zelazo, 2006; Walk a Line, Cookie Waiting, Kochanska et al., 2000)
Caregiver-child interaction quality
时间窗: When the child is 6 months - 6 years old
Caregiver's reports and coded videotaped interactions between caregivers and children (e.g., Parenting Young Children, PARYC; McEachern et al., 2011)
Quality of the home environment
时间窗: When the child is 18 months old
Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley \& Caldwell, 1984)
Child achievement
时间窗: When the child is 4 years old - 6 years old
Direct assessment of children's achievement, including receptive language skills, early academic skills including, reading, math, and writing as well as oral language abilities and academic knowledge (e.g., Receptive One-Word Picture Vocabulary Tests; ROWPVT, Martin and Brownell, 2010; Woodcock Johnson-IV Letter-Word Identification, Applied Problems and Oral Language Comprehension (WJ-IV)/ Bateria III Woodcock-Munoz, Muñoz-Sandoval et al., 2007; McGrew et al., 2014; Test of Word Reading Eficiency (TOWRE), Tarar et al., 2015)
Caregiver-child relationship quality
时间窗: When the child is 4 years old - 6 years old
Caregiver's reports of relationship quality, including the caregiver's perception of conflict and warmth/openness in relationship with the child (e.g., Adult Child Relationship Scale, Pianta \& Steinberg, 1991)
Children's self-regulation
时间窗: When the child is 4 years old - 6 years old
Observer reports of children's attention/emotional regulation during the direct assessment (e.g., Preschool Self-Regulation Interviewer Assessment, PSRA, Smith-Donald et al., 2007; Moffit Scale, Caspi et al., 1995)
次要结局
- Caregiver relationship satisfaction(When the child is 6 months - 6 years old)
- Basic child health(When the child is 6 months - 6 years old)
- Parenting Quality(Time Frame: When the child is 2 - 4 years old)
- Child temperament(When the child is 6 months, 4 years old, 6 years old)
- Special services(When the child is 6 months - 6 years old)
- Caregiver-child relationship quality(When the child is 18 months - 2 years old)
- Caregiver routines and activities(When the child is 6 months - 6 years old)
- Caregiver regulation of negative emotion(When the child is 24 months old and 6 years old)
- Child narrative comprehension(When the child is 4 years old - 6 years old)
- Caregiver Mindfulness(When the child is 18 months old)
- Caregiver confidence(When the child is 6 months - 4 years old)
- Child Theory of Mind(When the child is 4 years old)