The Pittsburgh Study Early Childhood (TPS-ECC)

University of Pittsburgh

Status: Active, not recruiting

Conditions: Child Language; Child Development; Parenting; Parent Child Abuse; Child Behavior Problem

Treatments: Behavioral: Healthy Families America Warm Referral; Behavioral: Video Interaction Project; Behavioral: Family Center Warm Referral; Behavioral: Text4Baby or Bright by Text Referral; Behavioral: Smart Beginnings; Behavioral: Family Check-UP; Behavioral: Nurture Program Warm Referral

Study type: Interventional

Funder types: Other

Identifiers

NCT05444205

STUDY19060235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24,000 estimated patients

Sex: All

Ages: Under 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Allegheny County Residency, legal custodian of child

Exclusion criteria

• Non-English speaking

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24,000 participants in 4 patient groups

Higher resources/lower challenges

Experimental group

Description:

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they did not posses any measured risk factors. Participants are provided with a choice of the following preventive interventions: Text4Baby/Bright by Text (depending on child age), Nurture Program, and/or Family Centers.

Treatment:

Behavioral: Nurture Program Warm Referral

Behavioral: Text4Baby or Bright by Text Referral

Behavioral: Family Center Warm Referral

Lower Resources/Lower Challenges

Experimental group

Description:

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they were low-income, a teen parent, their newborn had health challenges (more than five weeks premature or a neonatal intensive care unit stay of longer than 4 weeks, or they reported mild parenting challenges. They did not endorse any more serious measured risk factors. Participants are provided with a choice of the following preventive interventions: Nurture Program and/or Video Interaction Project.

Treatment:

Behavioral: Nurture Program Warm Referral

Behavioral: Video Interaction Project

Moderate Challenges

Experimental group

Description:

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they had a history of mental health problems, low social support, or moderate parenting challenges. They did not endorse any more serious measured risk factors. Participants are provided with a choice of the following preventive interventions: Nurture Program and/or Video Interaction Project.

Treatment:

Behavioral: Family Check-UP

Behavioral: Video Interaction Project

Serious Challenges

Experimental group

Description:

Participants are assigned to this arm based on results of a brief screen; self-reports indicated that they had a histories of involvement with child welfare, incarceration, opioid use disorder, recent homelessness, or that their child is displaying serious behavior problems. Participants are provided with a choice of the following preventive interventions: Smart Beginnings, Family Check-Up or if the child was less than two weeks old, Healthy Families America.

Treatment:

Behavioral: Smart Beginnings

Behavioral: Family Check-UP

Behavioral: Healthy Families America Warm Referral