An interventional study of Video Interaction Project and Family Check Up in Infant Behavior, Child Behavior and Parenting, sponsored by New York University. Completed at 2 sites in United States. Open to participants aged 0 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by New York University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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.
Behavioral: Video Interaction Project · Behavioral: Family Check Up
VIP utilizes pediatric well-child visits to build a relationship with an interventionist who facilitates self-reflection regarding interactions with the child through review of videotapes of the parent and child made that day and further facilitates interactions through provision of learning materials (toys and books).
Also known as: VIP
FCU utilizes home visitation to build a relationship with an interventionist who assesses family strengths and challenges and uses motivational interviewing and evidence-based family management strategies to support parent and child behavioral change.
Also known as: FCU
Caregiver's cognitive stimulation
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)
Time frame: When the child is 6 months - 6 years old
Caregiver's harsh parenting and discipline
Caregiver's reports of discipline strategies (e.g., Socolar et al., 2004; Incredible Years, Webster-Stratton, 2001; Steele et al., 2005)
Time frame: When the child is 18 months - 6 years old
Caregiver-child interaction quality
Caregiver's reports and coded videotaped interactions between caregivers and children (e.g., Parenting Young Children, PARYC; McEachern et al., 2011)
Time frame: When the child is 6 months - 6 years old
Quality of the home environment
Observer reports of the home environment (e.g., HOME inventory: Infant-Toddler (IT), Bradley \& Caldwell, 1984)
Time frame: When the child is 18 months old
Caregiver depression
Caregiver's reports of depression (Edinburgh Postnatal Depression Scale (EPDS), Cox, Holden \& Sagovsky, 1987; Cox, Chapman, Declan \& Jones, 1995)
Time frame: When the child is 6 months - 6 years old
Caregiver stress/ support
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)
Time frame: When the child is 6 months - 6 years old
Child prosocial and problem behavior
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)
Time frame: When the child is 6 months - 6 years old
Children's early language skills
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)
Time frame: When the child is 6 months - 2 years old
Child achievement
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)
Time frame: When the child is 4 years old - 6 years old
Child executive functioning skills
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)
Time frame: When the child is 4 years old - 6 years old
Caregiver-child relationship quality
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)
Time frame: When the child is 4 years old - 6 years old
Children's self-regulation
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)
Time frame: When the child is 4 years old - 6 years old
Parenting Quality
Examiner impressions of parenting quality, including measures of responsivity, acceptance, involvement, social skills, and affect. (e.g., items adapted from HOME inventory: Infant-Toddler (IT), Bradley \& Caldwell, 1984)
Time frame: Time Frame: When the child is 2 - 4 years old
Child temperament
Caregiver's reports of their child's temperament (e.g., Infant Characteristics Questionnaire, Bates, Freeland, \& Lounsbury, 1979; Children's Behavior Questionnaire, CBQ, Rothbart, 2007)
Time frame: When the child is 6 months, 4 years old, 6 years old
Special services
Caregiver's reports of their child's Early Intervention referrals and services received
Time frame: When the child is 6 months - 6 years old
Basic child health
Attendance in well-child care, growth/ nutrition
Time frame: When the child is 6 months - 6 years old
Caregiver-child relationship quality
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)
Time frame: When the child is 18 months - 2 years old
Caregiver routines and activities
Caregiver's reports of routines and activities, including, play, planning, feeding, sleep and media (e.g., McEachern, Dishion, Weaver, Shaw, Wilson, Gardner, 2012; Mendelsohn et al., 2008; Infant Feeding Style Questionnaire, Thompson, A. L., et al. 2009; Parent Teacher Involvement, Kohl et al., 2000)
Time frame: When the child is 6 months - 6 years old
Caregiver relationship satisfaction
Caregiver's reports of relationship satisfaction and conflict (e.g., Dyadic Adjustment Scale, Spanier, 1976)
Time frame: When the child is 6 months - 6 years old
Caregiver regulation of negative emotion
Caregiver's reports of their ability to maintain emotional equilibrium when faced with child rearing challenges (e.g., Raver, 2003) and difficulties with emotion regulation (Kaufman et al., 2015)
Time frame: When the child is 24 months old and 6 years old
Caregiver confidence
Caregiver's reports of their self-efficacy and beliefs related to children's behavior and school readiness. readiness (e.g., adapted Pachter, Sheehan \& Cloutier, 2000; Parenting Self-Agency Measure, PSAM, Dumka et al., 1996)
Time frame: When the child is 6 months - 4 years old
Child narrative comprehension
Direct assessment of children's ability to understand and retell narratives, and use higher-order language (e.g., Reese et al., 2012)
Time frame: When the child is 4 years old - 6 years old
Child Theory of Mind
Direct assessment of children's ability to mentally represent others' internal states, including measures of false belief and memory control (e.g., Mahy et al., 2017)
Time frame: When the child is 4 years old
Caregiver Mindfulness
Caregiver's reports of mindfulness in parenting behavior (e.g., Interpersonal Mindfulness in Parenting, IM-P, Duncan, 2007)
Time frame: When the child is 18 months old
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Infant Behavior
New York University