Clinical trial NCT05444205: The Pittsburgh Study Early Childhood
Official title: The Pittsburgh Study Early Childhood Collaborative
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Child Language
Child Behavior Problem
Parenting
Parent Child Abuse
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: The Grable Foundation
name: The Shear Family Foundation
name: Heinz Endowments
First posted: 2022-07-05
Enrollment: 24000
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The Early Childhood Collaborative is an implementation study and therefore, all participants are offered intervention. An innovative aspect of the study is supporting parent choice of intervention. Participants are given a choice of interventions based on a tiered model, and they can also decline to engage in programs and continue in follow-up.
Primary purpose: PREVENTION

Brief summary: The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.

Detailed description: The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families. Specifically, The Early Childhood Collaborative seeks to increase engagement (uptake and retention) in evidence-based interventions by (1) initially assessing families' resources and challenges, (2) offering families a menu of intervention options tailored to their resources/needs, and (3) providing these services at multiple locations to optimize accessibility. The Early Childhood Collaborative involves population-level utilization of multiple platforms that families, particularly families at greater risk for health disparities, typically use, including health care (birthing hospitals, pediatric care, federally qualified health centers), Women, Infants, and Children nutritional clinics, and family centers. The Early Childhood Collaborative will locate services in these platforms and at family's homes. The Early Childhood Collaborative focuses on child thriving and flourishing as key outcomes of interest, and community strengths as key drivers of change. To promote sustainability, investigators include representatives from the Departments of Human Services and Health who are responsible for funding and implementing home visiting programs in the greater Pittsburgh community, with the goal of generating infrastructures and capacity in existing community agencies for providing evidence-based behavioral health care.

Eligibility criteria: Inclusion Criteria:

* Allegheny County Residency, legal custodian of child

Exclusion Criteria:

* Non-English speaking

Primary outcomes:
measure: Child inhibitory control
timeFrame: 4 years
measure: Parent Reading Behaviors - Infancy
timeFrame: 4 years
measure: Socioemotional adjustment - ITSEA
timeFrame: 4 years
measure: Socioemotional adjustment - BITSEA
timeFrame: 4 years
measure: Socioemotional adjustment - CBCL
timeFrame: 4 years
Secondary outcomes:
measure: Positive parenting skills - PYB
timeFrame: 4 years
measure: Positive parenting skills - PYT
timeFrame: 4 years
measure: Positive parenting skills - PARYC
timeFrame: 4 years
measure: Harsh parenting
timeFrame: 4 years
measure: Parent depressive symptoms
timeFrame: 4 years
measure: Parent anxiety symptoms
timeFrame: 4 years
measure: Parent social support
timeFrame: 4 years
measure: Well-child care
timeFrame: 4 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Primary Care Health Services
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh Primary Care Centers
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny County Family Centers
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Women, Infants, and Children Program
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Miller, MD, PhD
role: STUDY_DIRECTOR
References: