Infant BehaviorNCT02459327
Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
A study testing Video Interaction Project and Family Check Up in people with Infant Behavior and Child Behavior, run by New York University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior, Child Behavior, Parenting
- What is being tested?
- Video Interaction Project and Family Check Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2015to 9 May 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bellevue Hospital Center
New York, New York, 11211
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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.
Read more
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.
- Conditions
- Infant Behavior, Child Behavior, Parenting, Child Rearing, Depression, Personal Satisfaction
- Being tested
- Video Interaction Project, Family Check Up
- Keywords
- Infant behavior, Child behavior, Parenting, Child rearing, Depression, Personal satisfaction, Randomized controlled trials, Intervention studies, Behavioral symptoms, Social behavior
- Medical subject headings
- Infant Behavior, Child Behavior, Depression, Personal Satisfaction, Behavioral Symptoms, Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Interaction ProjectBehavioural
Also called VIP
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).
Family Check UpBehavioural
Also called FCU
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.
| Study group | Role | What they receive |
|---|---|---|
| VIP/FCU | Experimental | 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. Receives: Behavioral: Video Interaction Project; Behavioral: Family Check Up |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: When the child is 4 years old - 6 years old
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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
Measured: When the child is 6 months - 6 years old
Basic child health
Attendance in well-child care, growth/ nutrition
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: When the child is 18 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start3 Jun 2015
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Infant BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Pamela Morris, Ph.D, Principal investigator, New York UniversityAlan Mendelsohn, MD, Principal investigator, NYU Langone HealthDaniel Shaw, Ph.D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459327
- Sponsor's protocol ID
- 1R01HD07639001A1
- Status last verified
- Sep 2025
- First submitted
- 26 May 2015
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendelsohn AL, Dreyer BP, Flynn V, Tomopoulos S, Rovira I, Tineo W, Pebenito C, Torres C, Torres H, Nixon AF. Use of videotaped interactions during pediatric well-child care to promote child development: a randomized, controlled trial. J Dev Behav Pediatr. 2005 Feb;26(1):34-41.
PubMed 15718881Shaw DS, Dishion TJ, Supplee L, Gardner F, Arnds K. Randomized trial of a family-centered approach to the prevention of early conduct problems: 2-year effects of the family check-up in early childhood. J Consult Clin Psychol. 2006 Feb;74(1):1-9. doi: 10.1037/0022-006X.74.1.1.
PubMed 16551138Dishion TJ, Shaw D, Connell A, Gardner F, Weaver C, Wilson M. The family check-up with high-risk indigent families: preventing problem behavior by increasing parents' positive behavior support in early childhood. Child Dev. 2008 Sep-Oct;79(5):1395-414. doi: 10.1111/j.1467-8624.2008.01195.x.
PubMed 18826532Mendelsohn AL, Huberman HS, Berkule SB, Brockmeyer CA, Morrow LM, Dreyer BP. Primary care strategies for promoting parent-child interactions and school readiness in at-risk families: the Bellevue Project for Early Language, Literacy, and Education Success. Arch Pediatr Adolesc Med. 2011 Jan;165(1):33-41. doi: 10.1001/archpediatrics.2010.254.
PubMed 21199978Roby E. Erin Roby: ECI biocommentary. Pediatr Res. 2026 May 13. doi: 10.1038/s41390-026-05093-2. Online ahead of print.
PubMed 42129365Roby E, O'Connell LK, Griffin MG, Guevara VA, Aviles AI, Larkins BC, Guyon-Harris KL, Hunter LJ, McLoughlin M, Ndee C, Vaca-Condado L, Canfield CF, Miller EB, Mendelsohn AL, Morris-Perez PA, Shaw DS, Gross RS. Promoting early relational health and resilience in pediatric primary care: a qualitative study. Pediatr Res. 2026 Mar 15:10.1038/s41390-026-04842-7. doi: 10.1038/s41390-026-04842-7. Online ahead of print.
PubMed 41833975Roby E, Miller EB, Canfield CF, Shaw DS, Morris-Perez PA, Mendelsohn AL. Supporting Early Social-Emotional Competencies Through Reading and Play: Findings From an RCT of the Tiered Smart Beginnings Program. Soc Dev. 2025 Nov;34(4):e70024. doi: 10.1111/sode.70024. Epub 2025 Sep 14.
PubMed 41394760Miller EB, Roby E, Zhang Y, Coskun L, Rosas JM, Scott MA, Gutierrez J, Shaw DS, Mendelsohn AL, Morris-Perez PA. Promoting Cognitive Stimulation in Parents Across Infancy and Toddlerhood: A Randomized Clinical Trial. J Pediatr. 2023 Apr;255:159-165.e4. doi: 10.1016/j.jpeds.2022.11.013. Epub 2022 Dec 5.
PubMed 36481243Reno R, Whipps M, Wallenborn JT, Demirci J, Bogen DL, Gross RS, Mendelsohn AL, Morris PA, Shaw DS. Housing Insecurity, Housing Conditions, and Breastfeeding Behaviors for Medicaid-Eligible Families in Urban Settings. J Hum Lact. 2022 Nov;38(4):760-770. doi: 10.1177/08903344221108073. Epub 2022 Jul 1.
PubMed 35775199Roby E, Miller EB, Shaw DS, Morris P, Gill A, Bogen DL, Rosas J, Canfield CF, Hails KA, Wippick H, Honoroff J, Cates CB, Weisleder A, Chadwick KA, Raak CD, Mendelsohn AL. Improving Parent-Child Interactions in Pediatric Health Care: A Two-Site Randomized Controlled Trial. Pediatrics. 2021 Mar;147(3):e20201799. doi: 10.1542/peds.2020-1799.
PubMed 33608413Canfield CF, Miller EB, Shaw DS, Morris P, Alonso A, Mendelsohn AL. Beyond language: Impacts of shared reading on parenting stress and early parent-child relational health. Dev Psychol. 2020 Jul;56(7):1305-1315. doi: 10.1037/dev0000940. Epub 2020 Apr 30.
PubMed 32352828