Clinical trial NCT02459327: Integrated Model for Promoting Parenting and Early School Readiness in Pediatrics
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infant Behavior
Child Behavior
Parenting
Child Rearing
Depression
Personal Satisfaction
Behavioral Symptoms
Social Control, Informal
Keywords: Infant behavior
Child behavior
Parenting
Child rearing
Depression
Personal satisfaction
Randomized controlled trials
Intervention studies
Behavioral symptoms
Social behavior
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: NYU Langone Health
name: University of Pittsburgh
First posted: 2015-06-02
Enrollment: 403
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Caregiver's cognitive stimulation
timeFrame: When the child is 6 months - 6 years old
measure: Caregiver's harsh parenting and discipline
timeFrame: When the child is 18 months - 6 years old
measure: Caregiver-child interaction quality
timeFrame: When the child is 6 months - 6 years old
measure: Quality of the home environment
timeFrame: When the child is 18 months old
measure: Caregiver depression
timeFrame: When the child is 6 months - 6 years old
measure: Caregiver stress/ support
timeFrame: When the child is 6 months - 6 years old
measure: Child prosocial and problem behavior
timeFrame: When the child is 6 months - 6 years old
measure: Children's early language skills
timeFrame: When the child is 6 months - 2 years old
measure: Child achievement
timeFrame: When the child is 4 years old - 6 years old
measure: Child executive functioning skills
timeFrame: When the child is 4 years old - 6 years old
measure: Caregiver-child relationship quality
timeFrame: When the child is 4 years old - 6 years old
measure: Children's self-regulation
timeFrame: When the child is 4 years old - 6 years old
Secondary outcomes:
measure: Parenting Quality
timeFrame: Time Frame: When the child is 2 - 4 years old
measure: Child temperament
timeFrame: When the child is 6 months, 4 years old, 6 years old
measure: Special services
timeFrame: When the child is 6 months - 6 years old
measure: Basic child health
timeFrame: When the child is 6 months - 6 years old
measure: Caregiver-child relationship quality
timeFrame: When the child is 18 months - 2 years old
measure: Caregiver routines and activities
timeFrame: When the child is 6 months - 6 years old
measure: Caregiver relationship satisfaction
timeFrame: When the child is 6 months - 6 years old
measure: Caregiver regulation of negative emotion
timeFrame: When the child is 24 months old and 6 years old
measure: Caregiver confidence
timeFrame: When the child is 6 months - 4 years old
measure: Child narrative comprehension
timeFrame: When the child is 4 years old - 6 years old
measure: Child Theory of Mind
timeFrame: When the child is 4 years old
measure: Caregiver Mindfulness
timeFrame: When the child is 18 months old
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: New York University
name: Pamela Morris, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Alan Mendelsohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Daniel Shaw, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Shaw 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.
citation: Dishion 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.
citation: Mendelsohn 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.
citation: Reno 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.
citation: Roby 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.
citation: Canfield 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.