The Pittsburgh Study Early Childhood
TPS-ECC
1 other identifier
interventional
24,000
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2020
CompletedFirst Submitted
Initial submission to the registry
February 25, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
December 3, 2025
November 1, 2025
10.5 years
February 25, 2022
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Child inhibitory control
Change in inhibitory control as measured using the 13-item Inhibitory Control scale of the Children's Behavior Questionnaire. Mean scores will be calculated with a possible range of 0-7 (higher scores indicate greater inhibitory control). Citation: Rothbart, M. K., Ahadi, S. A., Hershey, K. L. \& Fisher, P. (2001). Investigations of temperament at 3-7 years: The Children's Behavior Questionnaire. Child Development, 72(5), 1394-1408.
4 years
Parent Reading Behaviors - Infancy
Change in parent reading behaviors as measured using the StimQ self-report. We will use the 15-item reading factor. Scores used for outcome will be determined by our collaborator (and scale developer) Dr. Alan Mendelsohn and his research team at NYU. Citations: StimQ2-Infant©2016. NYU School of Medicine Alan L. Mendelsohn MD, Carolyn B. Cates PhD, Matthew Johnson, PhD, Adriana Weisleder PhD, Benard Dreyer MD
4 years
Socioemotional adjustment - ITSEA
Change in infant and toddler problem behaviors and socioemotional adjustment: Measured by the The infant-toddler social and emotional assessment (ITSEA). We will use the 14-item negative emotionality factor. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-28 (higher scores indicate greater problems). Citations: Carter, A. S., Briggs-Gowan, M. J., Jones, S. M., \& Little, T. D. (2003). The infant-toddler social and emotional assessment (ITSEA): Factor structure, reliability, and validity. Journal of abnormal child psychology, 31(5), 495-514.
4 years
Socioemotional adjustment - BITSEA
Change in infant and toddler problem behaviors: Measured by a subset of 28 items derived from the Brief infant-toddler social and emotional assessment (BITSEA) Total Problems scale. Items are measured on a 3-point likert-type scale. A sum score will be calculated, with a possible range of 0-56 (higher scores indicate greater problems). Citation: Briggs-Gowan, M. J. \& Carter, A.S. (2006). BITSEA : Brief infant-toddler social and emotional assessment. San Antonio, TX: Pearson 2006.
4 years
Socioemotional adjustment - CBCL
Change in child problem behaviors and socioemotional adjustment: Measured by the Child Behavior Checklist (CBCL). We will use 60 items that comprise the Externalizing and Internalizing broadband factors. Items are measured on a 3-point Likert-type scale. A raw sum score will be calculated for each factor, with a possible range of 0-48 for Externalizing problems and 0-72 for Internalizing problems (higher scores indicate greater problems). We will also calculate t-scores for both scales. Citation: Achenbach, T. M. (2009). The Achenbach System of Empirically Based Assessment (ASEBA): Development, Findings, Theory, and Applications. Burlington, VT: University of Vermont Research Center for Children, Youth, \& Families.
4 years
Secondary Outcomes (8)
Positive parenting skills - PYB
4 years
Positive parenting skills - PYT
4 years
Positive parenting skills - PARYC
4 years
Harsh parenting
4 years
Parent depressive symptoms
4 years
- +3 more secondary outcomes
Study Arms (4)
Higher resources/lower challenges
EXPERIMENTALParticipants 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.
Lower Resources/Lower Challenges
EXPERIMENTALParticipants 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.
Moderate Challenges
EXPERIMENTALParticipants 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.
Serious Challenges
EXPERIMENTALParticipants 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.
Interventions
Passive texting programs where participants receive free text messages on topics such as child development and parenting tips three times per week. Text4Baby serves parents of children under one year. Bright by Text serves parents of children under eight years of age.
Nurture Program is a nonprofit organization that promotes healthy development in young children by pairing moms with experienced and knowledgeable mentors who use text messaging to answer questions and provide helpful information, while offering support and encouragement throughout the child's first few years of life.
The Video Interaction Project is a program to support parents and their young children. Video Interaction Project is typically offered at a convenient location, such as a pediatric clinic. Parents are observed and videotaped for 3 to 5 minutes while interaction with their child. The Video Interaction Project coach then watches the video with the parent and talks about their interaction, highlighting how best to support the child's growth and language development.
The Family Check-Up is brief, taking place over the course of three sessions, each about an hour long. A Family Check-Up family coach will spend time getting to know the family during an "Initial Interview." Second, parents complete questionnaires that assess child and family adjustment, relationships, and other areas that influence children and families. The assessment includes videotaped family interaction tasks, where parents take part in activities with their child like playing together with toys and puzzles. Third, the Feedback session consists of sharing feedback - including strengths and challenges - about child and family well-being based on survey responses and video clips. Parents are invited to set goals for their family to support and maintain strengths and address areas of concern. Parents are paid 25 dollars after the Feedback Session. Parents have the option to continue meeting with the family coach to support the child's development and improve parental well-being.
Smart Beginnings consists of delivering both Video Interaction Project and the Family Check-up packed together as a single intensive intervention.
As part of Healthy Families America, professionally trained Nurse Home Visitors provide information during weekly home visits so that parents can provide the best for your new baby. Topics addressed are ways to keep the baby safe, how to take care of the baby, and activities parents can enjoy with their babies.
There are 27 Family Centers across Allegheny County provide services to families of young children 5 and under. These centers focus on three primary activities: 1. enhancing child development; 2. facilitating parent education, and 3. ensuring parents are supported and connected.
Eligibility Criteria
You may qualify if:
- Allegheny County Residency, legal custodian of child
You may not qualify if:
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- The Grable Foundationcollaborator
- The Shear Family Foundationcollaborator
- Heinz Endowmentscollaborator
Study Sites (5)
Primary Care Health Services
Pittsburgh, Pennsylvania, 15208, United States
Children's Hospital of Pittsburgh Primary Care Centers
Pittsburgh, Pennsylvania, 15213, United States
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Allegheny County Family Centers
Pittsburgh, Pennsylvania, 15221, United States
Women, Infants, and Children Program
Pittsburgh, Pennsylvania, 15222, United States
Related Publications (1)
Krug CW, Mendelsohn AL, Wuerth J, Roby E, Shaw DS. The Pittsburgh Study: A Tiered Model to Support Parents during Early Childhood. J Pediatr. 2025 Feb;277:114396. doi: 10.1016/j.jpeds.2024.114396. Epub 2024 Nov 12.
PMID: 39536860DERIVED
Related Links
Study Officials
- STUDY DIRECTOR
Elizabeth Miller, MD, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- The Early Childhood Collaborative is an implementation study and therefore, all participants are offered intervention and there in so masking.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 25, 2022
First Posted
July 5, 2022
Study Start
June 2, 2020
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2031
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- De-identified data will be made public at the conclusion of the study. The data will be available indefinitely.
- Access Criteria
- Data will be available to anyone who wishes to access the data for any type of analysis.
De-identified IPD will be made public after the trial.